(Note: OLPM sections on this page may be cited following the format of, for example, "UNH.VIII.A.1.1". These policies may be amended at any time, do not constitute an employment contract, and are provided here only for ease of reference and without any warranty of accuracy. See OLPM Main Menu for details.)

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1.   Introduction

1.1   A core value of the University of New Hampshire (University) is the open exchange of research and scholarly information both within the University and between the University and the public. This policy addresses the circumstances under which University research and scholarship are conducted in an open environment, regardless of whether or not a sponsored program is involved.

2.   Authority and Responsibility

2.1   The Senior Vice Provost for Research holds the responsibility to uphold the University's policy on openness, access, and participation in research and scholarly activities.

3.   Applicability and Scope

3.1   This Policy applies to all members of the University community including, but not limited to, faculty, staff, and students; visiting scholars, scientists, and postdoctoral fellows; and any other persons engaged in research at or under the auspices of the University.

3.2   This policy does not apply to consulting or other activities conducted in an individual capacity and without the use of University facilities or resources.

4.   Policy

4.1   Research and scholarship will be accomplished openly for the exchange of ideas and information and without prohibitions on the dissemination of the results of these activities. The University will not accept restrictions that limit the access of any interested parties, including foreign nationals, to the University's research and scholarly activities. This is essential to the progress of research and scholarship in all disciplines across the University.

4.2   There can be no fundamental limitation on the freedom to disseminate the results of research and scholarship conducted on the part of the University. Therefore:

4.2.1   The University will enter into no agreement that bars any University researcher or scholar from publishing or otherwise disclosing his/her findings publicly. However, the University may agree to delay a publication or other form of disclosure for no more than 30 days to allow a sponsor to determine whether a) sponsor proprietary information may be revealed or b) the sponsor will exercise rights under patent clauses in agreements with the University. With the researcher’s written consent, the University may extend such delay for a maximum of an additional 60 days to allow for the filing of appropriate patent protection. All publication or other disclosure delays agreed to by the University must be detailed in the written sponsored project agreement.

4.2.2   The University may accept a sponsor's proprietary materials or information when the materials or information convey(s) important background information for a specific research project. Requirements regarding access, use, and protection of such materials or information must be agreed to in a written Non-Disclosure Agreement (NDA) or other confidentiality agreement and must not restrict the dissemination of research results. Sponsor requirements should not proscribe citation of the sponsor name in publications.

4.2.3   Proprietary materials or information must be labeled as such by the sponsor before release to the University researcher. The researcher’s use of such materials or information must comply with the terms of the NDA as negotiated between the sponsor and the University.

4.3   Projects conducted at a government or sponsor site may require sponsor approval of a foreign national's access to their facilities. The University will agree to such conditions provided there is no expectation that the dissemination of research or scholarly results would also be subject to restrictions or require approval.

4.4   Under circumstances where it is clear and demonstrable that the objectives of the University will be served (using the University's Academic Plan or, where applicable, a Unit’s Academic or Strategic Plans as guides), rare exceptions to this Policy may be granted by the Senior Vice Provost for Research. Researchers wanting an exception should forward a written request (endorsed by the relevant Dean or Unit Director) that describes:

4.4.1   How the request is consistent with the University's objectives (Academic Plan, Strategic Plan, or other); and

4.4.2   How the researcher and others in their lab/research group will comply with the specific requirements and limit the impact of the requirements to the particular sponsored project under consideration.

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Related University Policies and Guidelines:

Policy on Classified Work
Policy on Ownership and Management of Research Data
Policy on Conflict of Interest: Professional Consulting Activities
Guidelines on Export Controls and Embargoes Management Systems

 (Note: OLPM sections on this page may be cited following the format of, for example, "UNH.VIII.B.1.1". These policies may be amended at any time, do not constitute an employment contract, and are provided here only for ease of reference and without any warranty of accuracy. See OLPM Main Menu for details.)

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1.   Introduction

    1.1   A core value of the University of New Hampshire (University) is the open discovery and exchange of knowledge through publication, education, and public outreach. Because of this core value, the University does not endorse or support the conduct of classified work on campus.

2.   Definitions

    2.1   Classified information or material. Information or material determined by the U.S. government to require protection against unauthorized disclosure for reasons of national security or any restricted data as defined in paragraph r or section 11 of the Atomic Energy Act of 1954. Classified information or material is categorized at one of three levels: top secret, secret, or confidential.

    2.2   Classified work. Any activity that uses classified information or material.

3.   Authority and Responsibility

    3.1   The President of the University holds the authority and responsibility to uphold the University's core value of free and open exchange of scholarly information.

4.   Applicability and Scope

    4.1   This Policy applies to all members of the University community including, but not limited to, faculty, staff, and students; visiting scholars, scientists, and postdoctoral fellows; and any other persons engaged in scholarly activity at or under the auspices of the University.

    4.2   This policy does not apply to consulting or other activities conducted in an individual capacity and without the use of University facilities or resources. Consulting activities must conform to the separate University System of New Hampshire policy on conflict of interest (https://www.usnh.edu/policy/usy/v-personnel-policies/d-employee-relatio…) and, if applicable, the AAUP-UNH/University System of New Hampshire Collective Bargaining Agreement.

5.   Policy Statement

    5.1   It is the policy of the University that instruction, scholarship, and service will be accomplished openly and without prohibitions on the publication and dissemination of the results of scholarly and research activities. Specifically:

        5.1.1   The University neither conducts classified work on campus nor permits use of University facilities for such work.

        5.1.2   Classified information will not be stored or maintained on campus, and the University will not provide the campus-based facilities required to assure the security of such information.

        5.1.3   If a change in security requirements places a research project in conflict with this policy, the University shall endeavor to (1) have the change in security requirements withdrawn; (2) negotiate the University's continued performance of work not affected by changes to the security requirements; or (3) terminate the project in whole or in part, as may be appropriate.

        5.1.4   No restrictions are placed by this policy on the pursuit of funding for, or participation in, collaborative research that uses classified information, as long as that information is used and secured off-campus. Obtaining the clearances required for such off-campus work is the responsibility of the researcher. If the basis for the researcher's work is classified information, related on-campus activity must remain open.

    5.2   This policy does not require disclosure of the identity of human research subjects whose participation in research projects is secured through pledges of anonymity. Further, this policy does not require disclosure of confidential student, patient, or employee records protected by Federal, state or University policies or of information protected by professional ethics.

 

Related University Policy:

Openness, Access, and Participation in Research and Scholarly Activity (https://www.usnh.edu/policy/unh/viii-research-policies/openness-access-…)

Related Federal Requirements:

PL 96-456, Classified Information Procedures Act
EO 12356, National Security Information
42 USC 2014(y), Atomic Energy Act of 1954 or section 11

(Note: OLPM sections on this page may be cited following the format of, for example, "UNH.VIII.C.1". These policies may be amended at any time, do not constitute an employment contract, and are provided here only for ease of reference and without any warranty of accuracy. See OLPM Main Menu for details.)

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1.   Introduction

1.1  Collection and generation of research data are integral aspects of research activity at the University of New Hampshire (UNH), whether the data are primary in nature or compiled, assembled, or otherwise derived. These data have several purposes: to serve as a record of the investigation, to form the basis on which conclusions are made, and to enable the reconstruction of procedures and protocols. In keeping with its commitment to promote integrity in the scholarly process, UNH's research data management practices should ensure open and timely access to and sharing of research data. Access, sharing, and retention are especially vital with respect to questions about compliance with legal or regulatory requirements governing the conduct of research, accuracy or authenticity of data, primacy of findings, and reproducibility of results.

1.2  UNH has developed this policy to protect UNH investigators and the integrity of research data generated under the auspices of UNH. Investigators have the right to choose the nature and the direction of their investigations, to use research data generated to pursue future research, to publish their results, and to share their findings with scientific and academic communities. The exercise of these rights, however, is subject to compliance with aws and regulations, as well as contractual obligations, governing the conduct of research. In conducting research as part of the UNH community, investigators are obligated to assist UNH in fulfilling its responsibilities of complying with applicable federal, state, and local laws, and sponsor requirements governing the conduct of research, including the management and sharing of research data.

1.3  UNH’s responsibility for stewardship of research data, including access to data, derives from the Office of Management and Budget (OMB) Circular A-110, Subpart C.53 for awards with a start date prior to December 26, 2014 or Uniform Guidance, Section 200.333 for awards with a start date on or after December 26, 2014. While this regulatory authority applies specifically to federally funded activities, the principle that it espouses informs good management practices with respect to all research activities undertaken at UNH. Further an increasing number of sponsors (e.g., National Science Foundation [NSF], National Institutes of Health [NIH]) have requirements for sharing research data and disseminating research results.

2.   Definitions

2.1   Investigator.

2.1.1   Faculty or Staff Principal Investigator (PI): A faculty or staff employee of UNH who holds primary responsibility for the research project/activity for which data will be collected.

2.1.2   Student Investigator: A graduate or undergraduate student involved in the design, conduct, data collection, or reporting of a research project/activity at or under the auspices of UNH.

2.1.3   Other Investigator: A visiting scholar, scientist, postdoctoral fellow¹, or other visiting person who holds primary responsibility for a research project/activity for which data will be collected at or under the auspices of UNH.

2.1.4   Sponsoring Principal Investigator (Sponsoring PI). The UNH faculty or staff advisor, instructor, or mentor on a student-initiated research project/activity serves as the Sponsoring PI for purposes of this policy. (See also footnote 1.)

2.2   Research. Investigation undertaken to gain knowledge and understanding, including that conducted in the classroom setting. An investigation may be conducted without any particular application or generalization in mind, for possible future application or generalization, or to address an immediate need.

2.3   Research Data. The recorded factual material commonly accepted in the scientific community as necessary to validate research findings, but not any of the following: preliminary analyses, drafts of scientific papers, plans for future research, peer views, or communications with colleagues. Research data may be in hard-copy form (including research notes, laboratory notebooks, or photographs) or in electronic form, such as computer software, computer storage/backup, or digital images.

2.3.1   Research data are not limited to raw experimental results and instrument outputs; they encompass associated protocols, numbers, graphs, tables, and charts used to collect and reconstruct the data. Research data include numbers, field notes or observations, procedures for data analysis and/or reduction, data obtained from interviews, or surveys, computer files and databases, research notebooks or laboratory journals, slides, audio/video recordings, and/or photographs.

2.3.2   Research materials are tangible physical objects from which data are obtained such as, environmental samples, biological specimens, cell lines, derived reagents, drilling core samples, or genetically-altered microorganisms. While these are not considered to be research data, they should be retained consistent with disciplinary standards.

2.3.3   Research data do not include: unreported preliminary analyses of data, drafts of scientific papers, future research plans, peer reviews, or communications with colleagues; trade secrets, commercial information, or materials necessary to be held confidential by a researcher until they are published, or similar information protected under law; personnel, medical, and similar information, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. (See OMB Circular A-110 Subpart C.36(d)(2)(i) for awards with a start date prior to December 26, 2014 or Uniform Guidance, Section 200.315 for awards with a start date on or after December 26, 2014.)

2.4   Ownership. Ownership is that condition under which an organization, individual(s), or any combination of the foregoing has (have) all rights and title to specific property owned.

2.5   Custodianship. For purposes of this policy, Custodianship is the physical possession of and direct responsibility for protecting research data, including accurate recording and proper retention, maintenance, access, sharing, and disposition of the data.

2.6   Stewardship. For purposes of this policy, Stewardship is the UNH's overarching responsibility to develop, maintain, and ensure adherence to appropriate policies for data ownership and management.

3.   Authority and Responsibilities

3.1   The Senior Vice Provost for Research (SVPR). The SVPR has the authority and responsibility for administering and enforcing this policy for UNH, including, but not limited to, the following:

3.1.1   Communicating this policy to all members of the UNH community;

3.1.2   Ensuring UNH complies with terms of sponsored agreements, including requirements to share research data;

3.1.3   Protecting rights of faculty, staff, students, and other investigators to access data from projects/activities in which they participated as researchers at or under the auspices of UNH²;

3.1.4   Securing UNH’s intellectual property rights³; and

3.1.5   Facilitating investigation of charges, such as scientific misconduct or financial conflict of interest in research⁴.

3.2   Faculty or Staff Principal Investigator (PI), Other Investigator, or Sponsoring Principal Investigator (Sponsoring PI).

3.2.1   Each PI, Other Investigator, or Sponsoring PI and each member of the research group is responsible for following this policy and the PI's, Other Investigator's, or Sponsoring PI's established practices for the research project/activity.

3.2.2   The PI, Other Investigator, or Sponsoring PI for a research project/activity is responsible for all aspects of:  (1) procuring and maintaining research data, including collection and/or recording, and providing adequate accompanying documentation; (2) security during collection, maintenance, and retention phases; (3) timely access to data, materials, and essential records; (4) sharing research data and results as required; and (5) retention. The PI, Other Investigator, or Sponsoring PI for a research project/activity is responsible for carrying out these responsibilities in a manner consistent with the standard practices for her/his discipline and/or the terms of a governing sponsored agreement. They are also responsible for educating those supervised about these practices and associated rationale.

3.3   Student Investigator. Each Student Investigator is responsible for following this policy and the direction of her/his Sponsoring PI. (See also footnote 1.)

4.   Applicability and Scope

4.1   This policy applies to all members of the UNH community including, but not limited to, faculty, staff, students; visiting scholars, scientists, and postdoctoral fellows; and any other persons at the UNH involved in the design, conduct, or reporting of research at or under the auspices of UNH.

4.2   This policy applies regardless of the source of support for the research project/activity and therefore does not distinguish between funded and unfunded efforts, except where specific sponsor requirements prevail.

4.3   This policy should not be construed to limit the right of any member of the UNH community who is an Investigator on a project/activity to have access to and to work with the research data generated in that project/activity, nor should this policy be construed to constrain the practices that are particular to the field of inquiry of which the data are a part.

5.   Ownership⁵ and Custody (See also section 10.)

5.1   Faculty or Staff Principal Investigator (PI) or Other Investigator. UNH shall own all research data generated for research projects/activities initiated by a PI or Other Investigator in each of the following instances:

5.1.1   The Investigator performed the research project/activity while supported by UNH-administered funds in the form of salary, wages, or stipend, including externally-sponsored funds; or

5.1.2   The Investigator used UNH-owned facilities or equipment for the research project/activity (other than UNH libraries and similar facilities available to the general public, or occasional use of equipment and office space); or

5.1.3   There is a legal obligation that otherwise restricts ownership of the research data by virtue of a prevailing sponsored research, material transfer, confidential disclosure, or other legally binding written agreement accepted in the UNH’s name on behalf of the Investigator.

5.2   Student Investigator. UNH shall own all research data generated by a Student Investigator for research projects/activities in each of the following instances:

5.2.1   The Student Investigator performed the research project/activity while supported by University-administered funds in the form of salary, wages, or stipend, including externally-sponsored funds.

5.2.2   The Student Investigator used UNH-owned facilities or equipment for the research project/ activity (other than UNH libraries and similar facilities available to the general public).

5.2.3   The Student Investigator received course credit or conducted the research project/activity for her/his thesis or dissertation.

5.2.4   UNH is the legal owner of the research data by virtue of a prevailing sponsored research, material transfer, confidential disclosure, or other legally binding written agreement accepted in the UNH's name on behalf of the Student or Sponsoring PI.

5.3   Custody. Through this policy, UNH automatically assigns custody of all UNH-owned research data to the PI, Other Investigator, or Sponsoring PI (for students), as applicable, who carries out her/his custodial responsibilities in accordance with this policy.

5.3.1   For research studies initiated by UNH where data about the institution are collected for purposes of institutional decision making, UNH assigns custody of the research data to an UNH Academic Administrator who carries out her/his custodial responsibilities in accordance with this policy.

6.   Recording Research Data

6.1   Investigators shall record research data consistent with the standard practices of their discipline. In the absence of such standards, UNH's minimum standard is that research records are written/recorded, dated, and identified by the project title and name(s) of the individual(s) conducting the activity, experiment(s), or other investigation(s). Whatever the organizational system used, the Investigator should ensure that all personnel involved with the research project/activity, including any key administrative personnel, understand and adhere to the system.

7.   Maintaining/Retaining Research Data

7.1   General principles:

7.1.1   Research data and associated materials/correspondence must be retained in sufficient detail and duration to allow appropriate response to questions about research accuracy, authenticity, primacy, and compliance with laws and regulations governing the conduct of research.

7.1.2   The recordkeeping systems/practices used by Investigators should allow unmediated access by UNH over their entire retention period. Of particular importance are instances in which an Investigator leaves UNH.

7.1.3   Investigators are responsible for the physical storage and security of research data during collection and retention periods, consistent with the standard practices of their discipline and/or the terms of a sponsored agreement. Of particular importance are issues involving confidentiality and general management of data obtained from human subjects, security of research data against theft or loss, and maintenance of backup or archival copies of research data that may be needed in the event of a disaster, as well as any software.

7.2   Data Retention Period. Except as noted below, UNH requires a data retention period of at least: (a) three years from the date of data collection, (b) three years from the termination of a sponsored agreement under which the data were collected (or longer if the agreement mandates), or (c) three years from the publication of a paper based on the data. The longest term of the three options cited shall be the controlling period.

7.2.1   Exceptions:

7.2.1.1   For Student Investigators, research data must be retained in an authorized manner until the pertinent three year controlling period (above) has elapsed, the student's degree is awarded, or the research project/activity is closed or completed, whichever is longer. In addition, if the student’s department requires a longer retention period, the latter would prevail.

7.2.1.2   When existing research data are relevant to an allegation of misconduct in scholarly activity or of financial conflict of interest, or to an open case of litigation, claim, or audit, the retention period must extend at least to the resolution of the case and final action taken, comply with the retention requirements of the policy/regulation/law governing the case (e.g., seven years for cases adjudicated under the UNH policy on Misconduct in Scholarly Activity), or the three year controlling period (above) has elapsed, whichever is longer.

7.2.1.3   Data relevant to intellectual property interests must be retained for as long as may be necessary to protect those interests, at minimum for the (above) three year controlling period. (For example, data relevant to patent applications must be retained in accordance with US Patent and Trademark Office guidelines). (http://www.uspto.gov)

7.2.1.4   Data subject to specific federal, state, or local regulation must be retained for the period indicated by the regulation, or the three year controlling period (above), whichever is longer. (For example, most records of radioactive material use must be retained for as long as UNH is granted a license by the New Hampshire Bureau of Radiological Health. Consult the UNH Office of Environmental Health and Safety (OEHS) for guidance.

7.2.1.5   When records are transferred to or maintained by the federal awarding agency, the three year retention requirement is not applicable to the award recipient (UNH).

7.3   Destruction of Data. At the discretion of the PI, Other Investigator, or Sponsoring PI, research data may be destroyed or otherwise disposed of after retention period requirements have been met. (See section 7.2) In some cases it may be advisable to document the manner of destruction if, for example, animals, human subjects, or hazardous materials were involved.

8.   Accessing Research Data

8.1   Members of Research Groups. Reasonable access to research data should normally be available to any member of the research group in which the data were collected, when such access is not limited otherwise by written agreement, policy, or regulation. Prior to the initiation of a research project/activity, the PI, Other Investigator, or Sponsoring PI should come to a written understanding with each Student Investigator and/or member of the research group, specifying who has access to what research data and when. For unique materials prepared in the course of the research, such as intermediates in chemical synthesis, cell lines, or reagents, items that can be proportioned should be divided among members of a research group at different locations under negotiated terms of a written Material Transfer Agreement. If there is any possibility that a copyright or patent application might emerge from a group project or other collaborative effort, the PI, Other Investigator, or Sponsoring PI should promptly contact UNHInnovation for guidance.

8.2   UNH. There may be instances in which it is necessary for UNH to access research data in situations including, but not limited to, sponsor requests, patent disputes, allegations of data misuse, subpoena, or Freedom of Information Act/Right to Know Law requests. To facilitate necessary, timely, and appropriate access to research data, UNH reserves the right to take physical possession of such data. This responsibility lies with the SVPR.

8.2.1   With Prior Notification. Where there exists a legitimate official need to take physical possession of research data in situations not covered by existing UNH policies such as those on Intellectual Property, Misconduct in Scholarly Activity, Financial Conflict of Interest in Research, or Privacy and Security of Technological Resources, the SVPR will notify the Investigator in writing of such need. The SVPR's request will describe the data sought and set forth the legitimate official need(s) sufficient to justify the request. The Investigator may appeal the request to the UNH President. Any such appeal must be in writing and submitted to the President within 5 days of the SVPR's request. The President shall review the appeal, make any further inquiry deemed appropriate, determine whether there is sufficient legitimate official need, and inform the Investigator of the decision in writing within 5 working days of receipt of the appeal. The President's decision shall be final.

8.2.2   Without Prior Notification. If the SVPR determines it would be impractical (e.g., deceased Investigator) or would be contrary to UNH's interests (e.g., Investigator has violated a UNH contractual obligation) to notify the Investigator that the SVPR intends to take physical possession of the research data, the SVPR will present the written request and justification to the UNH President. The President will determine whether to grant the request, and her/his decision shall be final. If the request is granted, the President will communicate this decision to the Investigator after the research data have been secured by the SVPR.

9.   Sharing Research Data

9.1   UNH recognizes the importance of data sharing in the advancement of knowledge and education.

9.2   Research data created by Investigators may be shared for research or scholarly purposes consistent with standard practices of their discipline with other individuals when such sharing is not limited by written agreement, policy, or regulation. Investigators shall make every effort to protect intellectual property rights as defined and governed by the UNH Intellectual Property policy.

9.3   Certain external sponsors (e.g., the National Science Foundation and the U.S. Public Health Service) require that data gathered in the course of research supported with their funds be shared broadly in a timely manner after the associated research results have been published or provided to the sponsor. When data sharing is not governed otherwise by another written agreement or an applicable policy or regulation, research data created by Investigators may be shared in a manner consistent with standard practices of their discipline. Tangible research materials (e.g., cell lines, technical data, manufactures of matter, or any unique material) shall be shared only by specific agreement with persons or entities outside UNH (or vice-versa). Such specific agreements may include but are not limited to Material Transfer Agreements, Uniform Biological Material Transfer Agreements, License Agreements, Grants, and Contracts.

10.   UNH Use of Research Data

10.1   UNH retains a non-exclusive, irrevocable, royalty-free license to use all research data for purposes of internal research, education, and/or protection of intellectual property when the data are generated at or under the auspices of UNH.

11.   Disposition of UNH-owned Research Data when Investigator Permanently Leaves UNH and/or Ceases Involvement in Project or Activity

11.1   Faculty or Staff Principal Investigator (PI), Other Investigator, or Sponsoring PI.

11.1.1   The PI, Other Investigator, or Sponsoring PI should come to a written understanding with each Student Investigator and/or member of the research group, specifying which parts of the research data may be copied and taken by the individual when s/he leaves the group or ceases involvement in the research project/activity. The written understanding should address research data generated both before and after the individual's departure from the research group or cessation of her/his involvement in the research project/activity. The original data must remain in the custody of the PI, Other Investigator, or Sponsoring PI.

11.1.2   If/when the PI, Other Investigator, or Sponsoring PI permanently leaves UNH, s/he may normally take original research data for which s/he is custodian. In doing so, s/he must notify her/his Dean/Director of the location of such data. However, original research data must remain at UNH when (a) the data have been used for a patent application filed or pending filing by UNH , (b) the research data are relevant to an ongoing inquiry/investigation under UNH's policy on Misconduct in Scholarly Activity or (c) the funding sponsor of the project/activity specifically requires UNH retain original data. Departing PIs, Other Investigators, and Sponsoring PIs are obligated to hold the data in trust for UNH and return the data when requested to do so. The data must not be disposed of within the controlling retention period (see section 7.2) without written permission of UNH’s SVPR.

11.2   Student Investigators. Upon departure from UNH, a Student Investigator may take a copy of UNH-owned data related to her/his research project/activity (including thesis or dissertation). (See section 5.2) However, s/he must leave the original research data, including laboratory notebooks, with the Sponsoring PI.

12.   Appeal of Determination of Ownership

12.1   Faculty or Staff Principal Investigator or Other Investigator. In cases where assertions of UNH ownership of research data are in dispute, the individual with the dispute should initiate a written appeal to the SVPR. Within 30 days of receipt of the appeal, the SVPR shall appoint an ad hoc review committee consisting of three persons. One person shall be selected by the individual(s) to be represented, one by the SVPR, and one by the Provost. The review committee shall make the ownership determination which shall take effect unless a further appeal is made by the individual(s) involved, or by the SVPR. Within 30 days of appointment of the review committee, the committee's decision will be communicated in writing by the SVPR to the individual who initiated the appeal. If a further appeal is indicated, the review committee will present the case to the UNH President, whose written decision shall be issued within 15 days of her/his receipt of appeal, and shall be final and binding upon all parties.

12.2   Student Investigators. A student wishing to appeal UNH ownership of research data generated in the student’s research project/activity conducted at or under the auspices of UNH should initiate a written appeal to the Dean of the Graduate School, if a graduate student, or to the undergraduate college/school Dean if an undergraduate student. Within 30 days of receipt of the appeal, the Dean, in consultation with the Sponsoring PI and the SVPR (or her/his representative), shall make a determination as to whether an exception to this policy shall be granted and ownership of the research data assigned to the student. The Dean's decision will be communicated promptly in writing to the student. If a further appeal is indicated, the Dean will present the case to the Provost and Executive Vice President for Academic Affairs whose written decision shall be issued within 15 days of her/his receipt of appeal and shall be final and binding upon all parties.

13.   Enforcement

13.1   Failure to comply with the requirements of this policy will be considered a deviation from accepted standards of conducting research at UNH.

13.2   The SVPR will investigate alleged violations of this policy and will make recommendations for action to the UNH President. Breaches of policy include, but are not limited to: Failure to maintain/retain research data as stipulated; and failure to provide to UNH research data as outlined in Section 8. If the President determines that the policy has been violated, he/she may impose sanctions including, but not limited to: Formal admonition; a letter to the individual’s personnel file; notification to the study sponsor; or withholding of degree.

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Footnotes
¹For purposes of this Policy, individuals appointed to positions at UNH as Postdoctoral Research or Teaching Associates and NIH Postdoctoral Trainees - as distinct from Postdoctoral Fellows - are considered to have the same rights and responsibilities as Student Investigators.
²See the Faculty Handbook and Students' Rights, Rules and Responsibilities.
³See the UNH Intellectual Property policy.
⁴See University policies on Financial Conflict of Interest in Research and Misconduct in Scholarly Activity.
⁵Issues involving potential financial gain or commercial value of intellectual property based on or derived from research data are covered by the UNH Intellectual Property policy.

 

 (Note: OLPM sections on this page may be cited following the format of, for example, "UNH.VIII.D.1". These policies may be amended at any time, do not constitute an employment contract, and are provided here only for ease of reference and without any warranty of accuracy. See OLPM Main Menu for details.)

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1.   References

     UNH Policy on Ownership and Management of Research Data – UNH VIII.C

     UNH Policy on Misconduct in Scholarly Activity - UNH II.C

     UNH Policy on Financial Conflict of Interest in Research – UNH VIII.E

     UNH Policy on Management of Equity Interests in Start-up Companies - UNH IV.D

     UNH Guidelines on Material Transfer Agreements

     UNH Primer on Copyright Law and Recommended Procedures

     Acknowledgement of Intellectual Property Policy and Assignment

2.   Preamble

2.1   The University of New Hampshire (University) recognizes its responsibility to produce and disseminate knowledge. Inherent in this responsibility is the need to encourage the production of creative and scholarly works and the development of new and useful materials, devices, processes, and other Intellectual Property. The creation of this Intellectual Property may have potential for commercialization, which thereby contributes to the professional development of the individuals involved, enhances the reputation of the University, provides expanded educational opportunities for students, and promotes public welfare.

2.2   Intellectual Property that has commercial potential may be protected under a variety of legal mechanisms. Most commonly these are legal protections covering Copyrights, Patents, Plant Variety Protection, Trademarks, and Trade Secrets. The incentive to the creators of Intellectual Property must be preserved so that their creative abilities and the creative abilities of others are encouraged and stimulated. The benefits derived from Intellectual Property should be used to further the teaching and/or research programs of the University.

2.3   The University has a responsibility to use all available resources to ensure utilization of Intellectual Property and materials for the public good and to expedite their development and transfer. Concurrently, the rights and privileges of Innovators must be preserved so that their initiatives and entrepreneurship may be encouraged, stimulated, and rewarded.

2.4   To foster such activities, the University shall maintain an Intellectual Property policy that is balanced with the University’s mission and is fair to all parties.

3.   Intellectual Property Administration

3.1   On behalf of the Office of the Senior Vice Provost for Research (OSVPR), UNHInnovation (UNHI) is responsible for managing the University's Intellectual Property. Administration of the principles and policy set forth herein shall be the responsibility of UNHI. This responsibility includes, but is not limited to, the following:

3.1.1   To act in accordance with the policy herein set forth;

3.1.2   To make recommendations to the Senior Vice Provost for Research (SVPR) and the President with respect to any changes in the Intellectual Property policy of the University as, from time to time, may be deemed appropriate;

3.1.3   To maintain files and records of Intellectual Property activities including the institutional expenses related to protection of the Intellectual Property and commercialization;

3.1.4   To submit an annual report to the President concerning the University's Intellectual Property activities;

3.1.5   To publicize and promote the University’s Intellectual Property policy and to vigorously pursue opportunities arising therefrom;

3.1.6   To comply with Federal regulations regarding the reporting, licensing, and maintenance of Inventions;

3.1.7   To allocate appropriate resources to manage the University’s Intellectual Property; and

3.1.8   To offer information and assistance to the University community concerning the procedures that should be followed in order to gain adequate protection between the time of conception of an Invention, discovery, Trademark or Copyrightable Work and the processing of a formal application for a patent or registration.

4.   Applicability

4.1   This policy applies to all members of the University community (hereinafter referred to as Covered Individuals) including, but not limited to, all faculty, administrators, staff, students; visiting scholars, scientists, and postdoctoral fellows; and any other persons at the University involved in carrying out the University's mission at or under the auspices of the University.

4.2   This policy applies regardless of the source of support for the research/scholarly activity and therefore does not distinguish between funded and unfunded efforts, except where specific sponsor requirements prevail.

4.3   This policy should not be construed to limit the right of any member of the University community to conduct his/her research/scholarly work.

5.   Definitions. Throughout this policy statement, terms related to development, transfer, and commercialization of Intellectual Property are used. These terms are briefly described below.

5.1   Assignment. The process of transferring ownership of the Intellectual Property from the Innovator to another individual or entity, such as another educational institution or corporation. For purposes of this policy, assignment is to the University of New Hampshire.

5.2   Copyright and Copyrightable Work(s). As defined in 17 US Code, copyright is granted by the United States government to the author of "original works of authorship fixed in a tangible form of medium." As often found in academia, these works include the following:

5.2.1   Scholarly works (e.g., textbooks, class notes, research monographs and articles, journal publications, classroom and research instructional materials);

5.2.2   Creative/artistic works (e.g., music, art, dance, poetry, fiction, photography, audio-visual works, and film);

5.2.3   Copyrightable software (academic, research, and commercial);

5.2.4   Mask Work(s) (semiconductor chip designs protected under a Federal law administered by the U.S. Copyright Office);

5.2.5   Other developing areas, including but not limited to multimedia works and electronic communications (including media used for distance learning).

5.3   Covered Individual. Any faculty member, staff member, student, visiting scholar, or any other person at the University involved in carrying out the University’s mission at or under the auspices of the University.

5.4   Disclosure. The act of reporting a creation of Intellectual Property as required under this policy.

5.5   Exempted Scholarly Work. This applies to Copyrightable Works where the University waives its ownership interest in favor of the author. See Section 8 of this policy.

5.6   Innovator(s). The person(s) who devises, creates, and produces Intellectual Property.

5.7   Intellectual Property. As used in this policy, includes not only Inventions, authored works, Trademarks, or other knowledge products which may be protected legally (such as with Patents and Copyrights), but also physical or tangible embodiments, such as biological organisms, unpatented plant varieties, or other Tangible Research Properties. See Section 5.21 of this policy. Intellectual Property is also known as Innovation(s) in this policy.

5.8   Invention. Any invention or discovery which is or may be patentable or otherwise protectable in regards to ownership. Examples: new fluorescence optics instrument, new algorithm for data compression, new chemical process, new plant variety, or new monoclonal antibody.

5.9   Inventor(s). The person(s) who devises, creates, and produces something not previously known or existing and who is determined to be an inventor under applicable patent law. Inventor(s) is a specific category of Innovator.

5.10   Intellectual Property Disclosure. The process of disclosing Intellectual Property to UNHI.

5.11   Know-How. Often associated with Tangible Research Property, Know-How may include detailed and specific information regarding how to manipulate specific biological materials or create and maintain specific devices. Know-How may add value to Intellectual Property Licenses.

5.12   License. A legal contract that grants to others certain legally protected rights of use in Intellectual Property. The License establishes the rights and obligations of each party and sets Royalties. It also identifies whether the License is exclusive or non-exclusive, the field of use, and the territory.

5.13   Material Transfer Agreement (MTA). A legal document that governs the transfer of Tangible Research Property between the University and a potential partner for purposes including testing and evaluation.

5.14   Net Income. As used in this policy, Net Income is the amount of money received by UNH from licensing after deduction of certain expenses connected with developing, securing, maintaining, and commercializing the Intellectual Property. For example: UNH receives a royalty payment of $100,000 and incurs Patent-related expenses of $15,000 and licensing expenses of $3,000. The Net Income is $100,000 minus $18,000, leaving $82,000. Net Income does not include research funding provided by a licensee, equipment, gifts, or other non-Royalty-based items of value.

5.15   Owner(s). The individual(s) or entity holding the rights and title to the property. Property can be either tangible or intangible.

5.16   Patent. As defined in 35 US Code, a Patent is a grant of a property right by the U.S. Patent and Trademark Office to the Inventor for an Invention. The USPTO grants three types of Patents: utility Patents for novel, useful, and non-obvious Inventions; plant Patents for any distinct and new variety of plant that is asexually reproduced; and design Patents for a new, original, and ornamental design for an article of manufacture.

5.17   Plant Variety Protection Certificates. These certificates are issued by the U. S. Department of Agriculture for sexually produced plants.

5.18   Research Data. Data generated through research, including lab notebooks, research notes, research data reports, notebooks, survey data, etc. See UNH Policy on Ownership and Management of Research Data.

5.19   Royalty. The value paid by a commercial partner, other university, or other entity for the right to use Intellectual Property. Royalties are often expressed as a percentage of the licensee's sales revenue earned through use of the Intellectual Property.

5.20   Start-Up. For purposes of this policy, any company started as a result of licensing the University’s Intellectual Property.

5.21   Tangible Research Property. Perceptible items produced in the course of research including such items as biological materials, engineering drawings, integrated circuit chips, computer databases, prototype devices, circuit diagrams, and equipment. Individual items of Tangible Research Property may be associated with one or more intangible properties, such as Inventions, Copyrightable Works, Trademarks, and Know-How. An item of Tangible Research Property may be the product of a single individual or a group of individuals who have collaborated on a project.

5.22   Trademark. As recognized by Federal and state laws, a Trademark is any word, name, symbol, or device adopted and used by an individual or a corporation to distinguish its goods or services from the goods or services of others.

5.23   Trade Secret. Technical or business information, including formulae, processes, and devices used or usable to achieve a competitive advantage in a trade or business and not publicly available. Trade Secret protection may be available under state law. Trade Secrets may be retained by the University for a brief period of time for specific purposes, such as to allow for the preservation of rights to file a Patent application. (See Uniform Trade Secrets Act for further information.) As an academic institution, the University does not accept Trade Secrets.

5.24   Use of University Resources. The use of University facilities and services not available to the general public. Examples include special resources, use of special instrumentation, or special financial assistance.

6.   Intellectual Property Ownership

6.1   UNHI shall determine the appropriate ownership classification for each Intellectual Property case reviewed.

6.2   A Covered Individual shall own Intellectual Property discovered, created, or developed by the individual, unless one or more of the following prevails, in which case the Intellectual Property is hereby assigned to the University:

6.2.1   The Covered Individual discovered, created, or developed the Intellectual Property while conducting the University duties, responsibilities, and/or assignments for which the individual was or is employed (received/s salary, wages, stipend, or grant funds) by the University.

6.2.2   Intellectual Property resulted from a Covered Individual making significant Use of University Resources or equipment beyond what is considered normal usage.

6.2.3   The Covered Individual discovered, created, or developed the Intellectual Property for which there is a legal obligation that designates ownership by virtue of a Sponsored Research, Material Transfer, Confidential Disclosure, or other legally binding agreement. Intellectual Property in these instances shall be governed by the contract or other agreement between the University and the other legal entity. Federally-sponsored projects shall also follow 37 CFR 401.

6.2.4   The Intellectual Property is a “work made for hire” under the U.S. Copyright Act of 1976 (17 USC 101), in which case the University is the author and owner.

7.   Student Intellectual Property

7.1   Undergraduate students: Undergraduate students shall own any Intellectual Property they make, discover, or create unless one or more of the following applies, in which case the Intellectual Property is hereby assigned to the University:

7.1.1   The student developed the Intellectual Property while receiving financial support from the University in the form of wages, salary, stipend, or grant funds;

7.1.2   The student made significant Use of University Resources (including University-administered funds, facilities, or equipment);

7.1.3   The student developed the Intellectual Property in the course of research funded by a sponsor pursuant to a grant or Sponsored Research Agreement or is subject to a Material Transfer Agreement, Confidential Disclosure Agreement, or other legal obligation that designates ownership of Intellectual Property;

7.1.4   In all instances of Assignment to the University by undergraduate students, the student will share in the distribution of Royalties. See Section 12 of this policy.

7.2   Graduate Students: Graduate students shall own any Intellectual Property they make, discover, or create unless one or more of the following applies, in which case the Intellectual Property is hereby assigned to the University:

7.2.1   Intellectual Property was developed by graduate students in the course of employment at the University or research carried out in University laboratories as part of a post-baccalaureate or postdoctoral degree or non-degree program;

7.2.2   Intellectual Property was developed from work directly related to the graduate student’s employment or research responsibilities at the University;

7.2.3   Intellectual Property was developed from work performed under a grant or other sponsorship, or undertaken with other Covered Individuals who have a duty to make Assignment to the University.

7.3   Intellectual Property arising from a dissertation submitted as a part of the requirements for a degree shall be subject to this Intellectual Property policy. In instances where graduate students are required to make Assignment to the University, such students will share in the distribution of Royalties. See Section 12 of this policy.

7.4   Theses and Dissertations. All student theses and dissertations and derivatives of these works are considered Exempted Scholarly Works (see Section 8 of this policy) and the student will own the Copyright unless the work was commissioned by the University or is under legal obligation. The University, however, retains a non-exclusive, irrevocable, Royalty-free License to reproduce and publish the works with appropriate attribution.

8.   Copyrightable Works

8.1   Copyrightable Works developed in the course of completing an individual's University duties are assigned per Section 6 and/or Section 7 of this policy. However, where not contrary to the terms of legal agreements, the University waives its ownership in the interest to the author for Exempted Scholarly Works, subject to the retained license prescribed by Section 8.2 of this policy. Examples of Copyrightable Work considered Exempted Scholarly Works include the following:

8.1.1   Traditional publications in academia regardless of their medium of expression, such as textbooks, course material, case studies, peer-reviewed manuscripts, syllabi, tests, study-guides, glossaries;

8.1.2   Academic software (not for commercial use);

8.1.3   Electronic publications such as websites, course descriptions/notes published electronically;

8.1.4   Photographs, films, charts, transparencies, video and audio recordings;

8.1.5   Graphic and sculptural works, works of art, architectural plans and structures;

8.1.6   Dress and fabric designs;

8.1.7   Theses and dissertations;

8.1.8   Music;

8.1.9   Furniture design.

8.2   If a Covered Individual is granted, pursuant to this section, Copyrights that would otherwise be owned by the University in instructional materials, such as class notes, curriculum guides, theses, or dissertations, the University retains a non-exclusive, irrevocable, Royalty-free License to use, display, duplicate, create derivative works from and/or distribute the materials with appropriate attribution for University educational and/or research purposes.

9.   Intellectual Property Records and Reporting

9.1   Covered Individuals engaged in any projects from which any Intellectual Property is likely to arise shall keep records consistent with the UNH Policy on Ownership and Management of Research Data and witnessed where necessary, and shall report promptly to UNHI any Intellectual Property, whether or not the Covered Individual believes the University has a direct interest, by completing an Intellectual Property Disclosure.

9.2   If an Invention was funded wholly or in part by the Federal government, the Intellectual Property Disclosure form must be filed promptly as required by Federal law 37 CFR 401.

9.3   Property rights shall depend upon the classification of the Intellectual Property. (Refer to Section 6 and/or Section 7 of this policy.)

9.4   Disclosure to UNHI is highly recommended before any other disclosure, presentation, display, performance, or publication of the work to any sizable audience. Failure to do so may result in loss of rights and subsequent commercial potential.

10.   Protection of Intellectual Property Rights

10.1   Patents and Trademarks. The opportunity to patent an Invention and/or file for a Trademark registration is brought to the attention of UNHI when the Innovator documents the Invention or Trademark using the Intellectual Property Disclosure. UNHI will then consider whether the Invention or Trademark should be protected through filing an application or registration with the USPTO. In making this decision, UNHI may call upon other persons, associated or not associated with the University, for technical or other advice. To reach a decision, UNHI will consider not only the importance of the Invention or Trademark, but also whether or not the interests of the Innovator, the University, and the public would be served best by a Patent or Trademark registration. When the Invention/Trademark is assigned to the University under Section 6 and/or Section 7 of this policy, UNHI will respond to the Innovator(s) within a reasonable time from its receipt of the Intellectual Property Disclosure with a decision on patentability or trademarking, taking into consideration the nature of the disclosure, stage of development of the Intellectual Property, any legal obligations, and commercial potential.

10.1.1   When the Invention/Trademark is assigned to the University under Section 6 and/or Section 7 of this policy, UNHI shall make a determination about patenting or trademarking based upon the commercial potential or other legal obligations.

10.1.1.1   If UNHI decides to file a Patent or Trademark application, the Innovator will be expected to provide all reasonable assistance in preparing the application. For Inventions developed under Federal sponsorship, the Patent process must also conform to grant and contract terms and conditions, with particular attention to 37 CFR 401.

10.1.1.2   If UNHI decides not to file a Patent or Trademark application, UNHI may, upon request and to the extent possible under the terms of any agreements that supported the work, reassign ownership to the Innovator(s). In such cases, the Invention/Trademark will be released to the Innovator(s) and the University will waive its rights to Assignment in a formal Release Agreement that clarifies title in the Intellectual Property. The Innovator(s) shall be free to make a Patent or Trademark application on his/her own responsibility but understands that any future work or improvement which utilizes any released Innovation will require a new Intellectual Property Disclosure and UNHI will evaluate and may elect title to the new use/improvement (this will not affect title of the original Innovation). When an Invention results from Federal funding, the right to patent is held by the Federal sponsor. In such cases, the Inventor(s) may request that the sponsor grant rights in the Invention directly to the Inventor(s). Once the University waives its interest in an Intellectual Property, the Innovator must assume all liabilities connected with the exploitation and defense of the Intellectual Property or discovery and must acknowledge any rights held by research sponsors. The Innovator(s) must not use the name of the University in advertising or otherwise promoting the development, manufacture, or use of the Intellectual Property. In the event the Intellectual Property was the subject of a Patent or Patent application or Trademark or Trademark application paid for by the University, the Innovator(s) agree to reimburse the University for all out-of-pocket Intellectual Property-related expenses out of future revenues generated through exploitation of said Patent or Patent application or Trademark or Trademark application.

10.2   Copyrights and Mask Works Protection.

10.2.1   Notices.

10.2.1.1   If materials are published (i.e., distributed to any sizable audience) without a proper notice as described below, full protection against infringement is jeopardized. Prior to any publication, the Covered Individual should place the following notice on all materials in which the University owns the Copyright:

Copyright © [year] University of New Hampshire. All rights reserved.

10.2.1.2   To protect Mask Work rights, the Covered Individual should apply the following notice on all University-owned semi-conductor chip products, which incorporate Mask Works:

Mask Work *M* [year] University of New Hampshire

10.2.1.3   No other institutional or departmental name is to be used in the notice, although the name and address of the department to which readers can direct inquiries may be listed below it. The date in the Copyright or Mask Work notice should be the year in which the work was first published.

10.2.2   Registration. Additional rights and protection for Copyrightable Works and Mask Works require registration with the U.S. Copyright Office, which will be coordinated through UNHI after Disclosure.

11.   Commercialization of University-Owned Intellectual Property

The commercialization of the University’s Intellectual Property can be a lengthy process and requires relationships with businesses that have the ability and desire to utilize the Intellectual Property. The benefits of transferring the Intellectual Property include increased recognition of the University’s quality of research and scholarship as well as the potential for financial rewards. The University will seek to license all Intellectual Property assigned to the University. The typical means to transfer the Intellectual Property to a commercial partner is through legal agreements. These agreements can take a variety of forms: Cooperative Research Agreements, License Agreements, Option Agreements, and/or Contract Research Agreements. Successful commercialization also requires the Innovator(s)' participation and cooperation.

12.   Income Received from Intellectual Property

12.1   The University will distribute Royalties and other Net Income received from the licensing of Intellectual Property according to the following schedule:

30% of Net Income to the Innovator(s)/author(s)/developer(s), hereinafter called Innovator;

30% of Net Income to the Innovator's college or school (or program, if the Innovator is not associated with a college or school);

30% of Net Income to a University-wide Research and Development Fund administered by the SVPR; and

10% of Net Income to UNHI.

12.2   Where Intellectual Property is conceived jointly by two or more Innovators, each of the co-Innovators shall share in the Innovator's distribution equally unless another distribution is desired and included in the original Intellectual Property Diclosure Form.

12.3   For administrative efficiencies, UNHI shall make annual Net Income payments per the above schedule in the instances when any individual Net Income payment is less than $25.

13.   Equity

The University strives to achieve a creative and entrepreneurial environment for commercializing its Innovations. As such, the University recognizes that the Innovations may result in a new company, as earlier defined as a Start-Up. See Section 5.20 of this policy. The University in these instances may accept equity in the Start-Up company as a portion of its consideration for the License.

14.   Participation Agreement

All University faculty (including but not limited to tenured, tenure-track, research, clinical, adjunct, and emeriti faculty); visiting faculty or other visitors using research facilities; postdoctoral employees or fellows; graduate students and undergraduate students participating in sponsored research as employees or otherwise; and all salaried employees shall execute an Acknowledgement of Intellectual Property Policy and Assignment as a condition of employment, participation in sponsored research, or Use of University Resources. Notwithstanding the above, an individual acknowledges that he or she is bound by the University Intellectual Property policy by accepting or continuing University employment or by using University resources or facilities. All students shall be advised of the University Intellectual Property policy and procedures through its publication and dissemination in the UNH Student Rights, Rules and Responsibilities.

15.   Appeal

In cases where rights and/or equities are in dispute, UNHI shall report in writing such dispute to the SVPR. Within 30 days of receipt of the notice, the SVPR shall appoint an ad hoc review committee consisting of four persons: one person selected by the Innovator(s), the Executive Director of UNHI, one person selected by the SVPR, and one by the Provost. This committee shall recommend an agreement which shall take effect unless a further appeal is made by the individual or individuals involved, or by the SVPR. In this event, the review committee will present the case to the University President, whose decision shall be final and binding upon all parties, except for faculty who are members of the UNH American Association of University Professors collective bargaining unit, who retain the right to grieve the decision via the grievance procedure outlined in Article 9 of the AAUP-UNH/ University System of New Hampshire Collective Bargaining Agreement.

(Note: OLPM sections on this page may be cited following the format of, for example, "UNH.VIII.E.1.1". These policies may be amended at any time, do not constitute an employment contract, and are provided here only for ease of reference and without any warranty of accuracy. See OLPM Main Menu for details.)

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1.   Statement of Need and Purpose

1.1   Externally sponsored research is a vital part of the University of New Hampshire (UNH) mission. As this activity grows in sophistication and complexity, it intersects increasingly with industrial explorations and entrepreneurial ventures creating for investigators the potential for conflicting interests.

1.2   A conflict of interest exists when it can be reasonably determined that an investigator's personal financial concerns could directly and significantly influence the design, conduct, or reporting of sponsored research activities. Faculty and staff of the University have an obligation to scrupulously maintain the objectivity of their research so as to avoid any conflict of interest.

1.3   UNH has developed this policy to protect the integrity of sponsored research and to comply with federal regulations1. It is the intent and policy of the University, as an institution of higher education in receipt of federal research support, to comply with present and future regulations. To that end, this policy is subject to further refinements as other rules are published.

1.4   Specifically, the intent of this policy is to identify and eliminate or manage any possible threat to research objectivity at the University. The main components are disclosure of investigators' financial interests that might be affected by the research, and application of methods to minimize or eliminate the risks associated with such connections. It is not meant to discourage, but rather to safeguard the pursuit and dissemination of knowledge.

1.5   Some conflicts of interest could affect the rights and welfare of human subjects in research. This policy intends to identify and eliminate or manage financial conflicts of interest in research that could lead to the unethical treatment of research subjects.

2.   Applicability

2.1   This policy applies to any UNH employee responsible for the design, conduct, or reporting of research activities funded or proposed for funding at the University by external sources other than the Public Health Service (PHS)². The policy also applies to the investigator's immediate family, which is defined as his/her spouse or domestic partner and dependent children.

2.2   Project directors are responsible for ensuring that all participants in a project who are responsible for the design, conduct, or reporting of the research disclose any significant financial interests that would reasonably appear to be affected by the research. Individuals who begin work on an established project through reallocation of effort, hiring, transfer, promotion, etc., and thereby take on a responsible position in a project, must also disclose any such significant financial interests.

2.3   Collaborators, sub-contractors, sub-recipients, and visiting scientists must either comply with this policy or provide a certification to the UNH Director of Sponsored Programs Administration (SPA) that their institutions are in compliance with pertinent federal policies and that they in turn are in compliance with their own institutional policies.

3.   Definitions

3.1   Disclosure of Significant Financial Interests: An investigator's disclosure of significant financial interests to UNH.

3.2   Disclosure Review Committee (DRC): The UNH committee charged with protecting the integrity of UNH's externally-funded research enterprise, and UNH employees who engage in externally-funded research, by identifying and resolving financial conflicts of interest in research. The DRC conducts its duties in a manner intended to promote, not hinder, research relationships. (See sections 5 and 8 of this policy for DRC membership and responsibilities.)

3.3   Financial Conflict of Interest (FCOI): A significant financial interest that could directly and significantly affect the design, conduct, or reporting of research.

3.4   FCOI Report: UNH's report of a financial conflict of interest to a sponsor.

3.5   Financial Interest: Anything of monetary value, whether or not the value is readily ascertainable.

3.6   Investigator: The project director or principal investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by external sources, or proposed for such funding, which may include, for example, collaborators or consultants.

3.7   Manage: Taking action to address a financial conflict of interest, which can include reducing or eliminating the financial conflict of interest, to ensure, to the extent possible, that the design, conduct, and reporting of research will be free from bias.

3.8   Research: A systematic investigation, study or experiment designed to develop or contribute to generalizable knowledge relating broadly to public health, including behavioral and social-sciences research. The term encompasses basic and applied research (e.g., a published article, book or book chapter) and product development (e.g., a diagnostic test or drug).

3.9   Significant Financial Interest:

3.9.1   A financial interest consisting of one or more of the following interests of the investigator (and those of the investigator's spouse or domestic partner, and dependent children) that could reasonably appear to be affected by the activities proposed for funding:

3.9.1.1   Any current financial interest of the investigator (and his/her spouse or domestic partner, and dependent children) that could reasonably appear to be affected by the activities proposed for funding; or

3.9.1.2   Any financial interest held by the investigator (and his/her spouse or domestic partner, and dependent children) in a business entity (company, corporation, or other enterprise) whose financial interests might reasonably appear to be affected by such activities.

3.9.2   Specifically, significant financial interests might include, but are not limited to, any of the following:

3.9.2.1   Anything of significant monetary value, including salary or other payments for services such as consulting fees or honoraria;

3.9.2.2   Direct equity interests such as stock, stock options, or ownership interests;

3.9.2.3   Intellectual property rights and interests owned by the investigator such as patents, copyrights, and royalties from such rights and interests. As further described in 3.9.3.2 this does not include intellectual property rights and interests assigned to UNH nor royalty income received from UNH per the UNH Intellectual Property policy (UNH VIII.D).

3.9.3   Significant financial interests do not include:

3.9.3.1   Financial interests in business enterprises or entities that, when aggregated for the investigator and his/her immediate family, meet both of the following tests:

3.9.3.1.1   The financial interest does not exceed $10,000 in value as determined through reference to public prices or other reasonable measures of fair market value, and

3.9.3.1.2   The financial interest does not represent more than a five percent ownership interest in any single entity.

3.9.3.2   Salary, royalties, or other remuneration from UNH;

3.9.3.3   Salary, royalties, or other payments that, when aggregated for the investigator and his/her immediate family, are not expected to exceed $10,000 during the preceding 12 month period;

3.9.3.4   Income from seminars, lectures, or teaching engagements sponsored by public or nonprofit entities;

 3.9.3.5   Income from service on advisory committees or review panels for public or non-profit entities.

4.   Disclosure Process

4.1   Any employee responsible for the design, conduct, or reporting of research activities (investigator) funded or proposed for funding at UNH by external sources must disclose all current significant financial interests that would reasonably appear to be affected by the research.

4.2   Each investigator who has significant financial interests possibly affected by the research must complete a UNH Financial Disclosure Statement and attach any requested supporting documentation. The form and supporting documentation should be submitted in a sealed envelope marked "Confidential" to the Senior Vice Provost for Research (SVPR). If the disclosure statement indicates involvement of human subjects in the research, the SVPR will notify the chairperson of the Institutional Review Board for the Protection of Human Subjects in Research (IRB) so the situation may be considered, and, if appropriate, addressed by the IRB.

4.3   All significant financial interests must be disclosed prior to the time a proposal is submitted to an external sponsor. Investigators must update within thirty (30) days all financial disclosures during the period of the award as new reportable significant financial interests are obtained.

4.4   An investigator may choose to disclose any other financial or related interest that might present an actual, potential, or perceived conflict of interest. Disclosure can be a key factor in protecting an individual's reputation and career from potentially harmful allegations of misconduct.

4.5   All Disclosure Statements and related documents are considered sensitive information. As such, they will be treated as confidential and will not be disclosed outside the DRC and its staff without the investigator's consent except: In response to a request from a sponsor; or pursuant to a judicial order or lawfully issued subpoena. UNH will make reasonable efforts to notify the investigator of any judicial order or lawfully issued subpoena in advance of disclosure of this information, unless the order is from a federal grand jury or is for law enforcement purposes and its terms prohibit UNH from disclosing its existence or contents.

5.   Review of Disclosures

5.1   A Disclosure Review Committee (DRC) will review all disclosure statements. The DRC will consist of a minimum of five (5) members, appointed by the SVPR, at least three of whom will be faculty members representing the diverse colleges, schools, and programs of UNH. Members will serve three-year staggered terms.

5.2   The DRC will be responsible for determining whether the significant financial interests of the investigator could reasonably be expected to affect the design, schedule, conduct, or reporting of the activities funded or proposed for funding, and, if so related, whether the significant financial interest represents a financial conflict of interest. An investigator's significant financial interest is related to the research when the DRC reasonably determines that the significant financial interest could be affected by the research; or is in an entity whose financial interest could be affected by the research. The DRC may involve the investigator in its determination of whether a significant financial interest is related to the research. A financial conflict of interest exists when the DRC reasonably determines that the significant financial interest could directly and significantly affect the design, conduct, or reporting of the research. The DRC may request additional clarifying information from the individual which will be treated as non-public information to the extent allowed by law.

5.3   If a financial conflict of interest exists, the DRC shall request the investigator submit a proposed conflict management plan that details steps that could be taken to manage, reduce, or eliminate the financial conflict of interest. The DRC shall review the proposed conflict management plan and approve it or add conditions or restrictions to ensure that any conflict is managed, reduced, or eliminated. Such conditions or restrictions may include, but are not limited to, the following:

5.3.1   Public disclosure of financial conflicts of interest (e.g., when presenting or publishing the research);

5.3.2   Monitoring of the research by independent reviewers;

5.3.3   Modification of the planned activities (possibly subject to sponsor approval);

5.3.4   Disqualification from participation in all or part of the project;

5.3.5   Divestiture of significant financial interests;

5.3.6   Severance of relationships creating conflict;

5.3.7   For research involving human subjects, disclosure of financial conflicts of interest directly to research subjects.

5.4   In all cases, resolution of the conflict or establishment of an acceptable conflict management plan must be achieved before expenditure of any funds under an award to UNH.

6.   Appeals

6.1   Appeal of the DRC's decision may be made to the UNH President who will consult with the investigator the DRC, and the SVPR. The UNH President will make a final determination, which shall be final and binding upon all parties, except for faculty who are members of the UNH American Association of University Professors collective bargaining unit, who retain the right to grieve the decision via the grievance procedure outlined in Article 9 of the AAUP-UNH/University System of New Hampshire Collective Bargaining Agreement.

7.   Compliance

7.1   As part of the Financial Disclosure Statement, each investigator must certify that if the DRC determines a conflict exists, the investigator will adhere to all conditions or restrictions imposed upon the project and will cooperate fully with the individual(s) assigned to monitor compliance.

8.   Enforcement

8.1   Failure to properly disclose relevant financial interests or to adhere to conditions or restrictions imposed by the DRC will be considered a deviation from accepted standards of conducting research at UNH.

8.2   The DRC will investigate alleged violations of this policy, and will make recommendations for action to the UNH President. Breaches of policy include failure to file the necessary disclosure statements; knowingly filing incomplete, erroneous or misleading disclosure forms; or failure to comply with procedures prescribed by the DRC. If the President determines that the policy has been violated, he/she may impose sanctions including, but not limited to, notification of sponsor and termination of award; formal admonition; a letter to the investigator's personnel file; and suspension of the privilege to apply for external funding.

9.   Records

9.1   The Office of the SVPR will maintain records of all disclosures and associated activities securely and confidentially (see section 4.5 of this policy for exceptions).

9.2   All records will be maintained for three years following termination or completion of the project or resolution of any government action involving the records.

9.3   Records will not be routinely provided to sponsors unless such is an agency requirement, the agency submits a written request, or UNH is unable to satisfactorily manage an actual or potential conflict of interest. The Director of SPA will be responsible for communications with sponsors.

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Footnotes

¹National Science Foundation. Investigator Financial Disclosure Policy. July 11, 1995. 60 FR 35810, Part III

²See UNH Policy on Financial Conflicts of Interest in Research for PHS-Funded Projects http://www.usnh.edu/policy/unh/viii-research-policies/t-financial-confl…

 (Note: OLPM sections on this page may be cited following the format of, for example, "UNH.VIII.F.1.1". These policies may be amended at any time, do not constitute an employment contract, and are provided here only for ease of reference and without any warranty of accuracy. See OLPM Main Menu for details.)

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1.   Preamble

1.1   The University of New Hampshire (UNH) recognizes its responsibility to produce and disseminate knowledge in accordance with its mission of research, teaching, and public service. When non-human models are insufficient, use of human subjects in research is an integral aspect of scholarly activity at UNH. UNH recognizes its ethical and legal responsibilities to provide a mechanism to protect individuals involved as subjects in research conducted under the auspices of UNH. Accordingly, to protect the rights and welfare of every human subject involved in research activities, UNH maintains a policy on the use of human subjects in research. UNH strives to ensure that all members of its community understand and adhere to this policy.

2.   Definitions

2.1   Assurance: Federalwide Assurance of Protection for Human Subjects.

2.2   Human Subject: A living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.

2.3   Institutional Official: The individual designated by the UNH President to ensure that research involving human subjects conducted under the auspices of UNH is in compliance with all applicable laws and regulations. This individual is the Senior Vice Provost for Research.

2.4   Institutional Review Board for the Protection of Human Subjects in Research (IRB): The committee established by the UNH President to oversee the use of human subjects in research conducted under the auspices of UNH.

2.5   Research: A systematic investigation (including research development, testing, or evaluation), designed to develop or contribute to generalizable knowledge.

2.6   The Belmont Report: The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research report titled Ethical Principles and Guidelines for the Protection of Human Subjects of Research.

3.   Statement of the Policy

3.1   All UNH research activities proposing to involve human subjects must be reviewed and receive written, unconditional approval from the IRB before commencing. This applies to all research activities conducted under the auspices of UNH involving human subjects regardless of discipline or whether or not the activities are funded. In addition, all research activities involving human subjects must be conducted in accordance with:

3.1.1   Federal, state, and local laws and regulations applicable to use of human subjects in research. These include, but are not limited to, Federal Policy for the Protection of Human Subjects, Title 45 Code of Federal Regulations Part 46; Food and Drug Administration (FDA) Regulations for Human Subjects Protections, Title 21 Code of Federal Regulations Parts 50 and 56; and, the principles set forth in "The Belmont Report"; and

3.1.2   UNH policy as set forth in the Assurance.

4.   Applicability. This policy is applicable to any research activity:

4.1   Sponsored by UNH, or

4.2   Conducted by or under the direction of any employee, student, or agent of UNH in connection with his or her UNH responsibilities, or

4.3   Conducted by or under the direction of any employee, student, or agent of UNH involving the use of any UNH property or facility, or

4.4   Conducted by or involving any individual or institution working with UNH as part of a collaboration, subgrant, or subcontract.

5.   Examples. Examples of activities involving the use of human subjects covered by this policy include, but are not limited to:

5.1   Research involving surveys or questionnaires, administered in person, by mail, or via the telephone or electronically, designed to elicit information about individuals, including behaviors, experiences, attitudes, or beliefs.

5.2   Research involving interviews or focus groups designed to elicit information about individuals, including behaviors, experiences, attitudes, or beliefs.

5.3   Educational practices or tests conducted for research purposes.

5.4   Research involving program evaluation.

5.5   Research involving observation of public behavior.

5.6   Research involving the collection and/or study of data, documents, records, or biological, pathological, or diagnostic specimens, including voice or image recordings, medical, academic, or court records, and, invasive and noninvasive clinical procedures.

5.7   Clinical studies of drugs and medical devices.

6.   Effective Date

6.1   The requirements of this policy have been in effect since the execution of UNH's first Assurance on April 21, 1980.

7.   Administration of Policy

7.1   The Institutional Official is responsible for the administration of this policy and its procedures as set forth in the Assurance. Approval by the UNH President is required to amend this policy.

8.   Enforcement

8.1   The Institutional Official is responsible for enforcing this policy. Violations of this policy fall under the purview of the Assurance.

 

Reference:

UNH Federalwide Assurance of Compliance for the Protection of Human Research Subjects at https://www.usnh.edu/sites/www.usnh.edu/files/media/olpm/docs/unh/fwa-update-190118.pdf

 

 (Note: OLPM sections on this page may be cited following the format of, for example, "UNH.VIII.G.1". These policies may be amended at any time, do not constitute an employment contract, and are provided here only for ease of reference and without any warranty of accuracy. See OLPM Main Menu for details.)

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1.   Preamble

1.1   The University of New Hampshire (UNH) recognizes its responsibility to produce and disseminate knowledge in accordance with its mission of research, teaching, and public service. Some activities conducted at UNH necessitate the use of live vertebrate animals. Recognizing the importance of using live animals for these purposes, UNH, for both ethical and scientific reasons, insists upon the highest standards for the care and use of such animals. Accordingly, UNH maintains a policy for the care and use of live vertebrate animals at the institution that is balanced with UNH's mission. UNH strives to ensure that all members of its community understand and adhere to this policy.

2.   Definitions

2.1   Activities: Include, but are not limited to, research, research training, biological testing, instruction of students, and maintenance of animal collections, exhibits, flocks, or herds.

2.2   Animal Welfare Act: Public Law 89-544, 1966, as amended, (P.L. 91-579, P.L. 94-279 and P.L. 99-198) 7 U.S.C. 2131 et. Seq. Implementing regulations are published in the Code of Federal Regulations (CFR, Title 9, Chapter 1, Subchapter A, parts 1, 2, and 3), and are administered by the U.S. Department of Agriculture.

2.3   Assurance: UNH Assurance of Compliance with U.S. Public Health Service Policy on Humane Care and Use of Laboratory Animals.

2.4   Care and Use: Petting, feeding, watering, cleaning, manipulating, loading, crating, shifting, transferring, immobilizing, restraining, treating, training, working and moving, or any similar activity with respect to any animal.

2.5   Guide: The Guide for the Care and Use of Laboratory Animals, National Academy Press, 1996, Washington, D.C., or succeeding revised editions.

2.6   Institutional Animal Care and Use Committee (IACUC): The committee established by the UNH President to oversee UNH's animal program, facilities, and procedures.

2.7   Institutional Official: The individual designated by the UNH President to ensure that activities involving the care and use of animals at UNH are humane and in compliance with all applicable regulations and internal policies. This individual is the Senior Vice Provost for Research.

3.   Statement of the Policy

3.1   At UNH, all activities proposed to involve the care and use of live vertebrate animals must be reviewed and receive written, unconditional approval from the IACUC before commencing. In addition, all activities involving vertebrate animals must be in accordance with:

3.1.1   Federal, state, and local laws and regulations applicable to the care and/or use of animals. These include, but are not limited to, the Animal Welfare Act; federal regulations implementing the Animal Welfare Act; the Health Research Extension Act of 1985; the Public Health Service Policy on the Humane Care and Use of Laboratory Animals; the provisions and principles set forth in the most recent editions of the Guide; the Guide for the Care and Use of Agricultural Animals in Agricultural Research and Teaching; and,

3.1.2   UNH policy as set forth in the Assurance.

4.   Applicability. This policy is applicable to any activity involving the care and use of vertebrate animals:

4.1   Sponsored by UNH, or

4.2   Conducted by or under the direction of any employee, student, or agent of UNH in connection with his or her individual UNH responsibilities, or

4.3   Conducted by or under the direction of any employee, student, or agent of UNH involving the use of any UNH property or facility, or

4.4   Involving any collaborating, sub granting, or subcontracting individual or institution working with UNH.

5.   Effective Date

5.1   The requirements of this policy have been in effect since the execution of UNH's first Assurance on November 4, 1987.

6.   Administration of Policy

6.1   The Institutional Official is responsible for the administration of this policy and its procedures as set forth in the Assurance. Approval by the UNH President is required to amend this policy.

7.   Enforcement

7.1   The Institutional Official is responsible for establishing and enforcing this policy. Violations of this policy fall under the purview of the Assurance.

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Reference:

UNH Assurance of Compliance with PHS Policy on Humane Care and Use of Laboratory Animals

 (Note: OLPM sections on this page may be cited following the format of, for example, "UNH.VIII.I.1.1". These policies may be amended at any time, do not constitute an employment contract, and are provided here only for ease of reference and without any warranty of accuracy. See OLPM Main Menu for details.)

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1.   Preamble

1.1   The University of New Hampshire (UNH) recognizes its ethical and legal responsibilities to comply with pertinent regulations regarding the use, storage, and disposal of controlled substances in scholarly and teaching activities conducted under the auspices of UNH. Accordingly, UNH maintains a policy on the use of controlled substances in scholarly and teaching activities. UNH strives to ensure that all members of its community understand and adhere to this policy.

1.2   UNH developed this policy to comply with federal and state laws regarding controlled substances, including U.S. Drug Enforcement Administration (DEA) requirements at 21 CFR 1300-1308 and with New Hampshire Department of Health and Human Services (DHHS), Title XXX, Occupations and Professions, Chapter 318-B, Controlled Drug Act.

2.   Definitions

2.1   Controlled substance: A substance listed on the five (5) DEA Controlled Substance Schedules (Schedules I-V).

2.2   Use: Includes, but is not limited to: manufacture, distribution, importation, exportation, conduct of research, or performance of chemical analysis.

3.   Statement of the Policy

3.1   Use of controlled substances at UNH in scholarly and teaching activities is restricted to authorized persons working under the direct supervision of a DEA registrant in accordance with the DEA registration, and in compliance with all applicable federal and state requirements, and the UNH Controlled Substances Management Plan. This applies to all scholarly and teaching activities conducted under the auspices of UNH involving controlled substances, regardless of discipline or whether the activities are funded.

4.   Applicability. This policy is applicable to any scholarly and teaching activities:

4.1   Sponsored by UNH, or

4.2   Conducted by or under the direction of any employee, student, or agent of UNH in connection with his or her UNH responsibilities, or

4.3   Conducted by or under the direction of any employee, student, or agent of UNH involving the use of any UNH property or facility, or

4.4   Conducted by or involving any individual or institution working with UNH as part of a collaboration, subgrant, or subcontract.

5.   Effective Date

5.1   The requirements of this policy are effective May 8, 2012.

6.   Administration of Policy

6.1   The Senior Vice Provost for Research (SVPR) is responsible for the administration of this policy and its procedures as set forth in the UNH Controlled Substances Management Plan. Approval by the UNH President is required to amend this policy.

7.   Enforcement

7.1   The SVPR is responsible for enforcing this policy. Failure to comply with this policy may be grounds for employee disciplinary action or termination of the scholarly or teaching activity.

 (Note: OLPM sections on this page may be cited following the format of, for example, "UNH.VIII.M.1.1". These policies may be amended at any time, do not constitute an employment contract, and are provided here only for ease of reference and without any warranty of accuracy. See OLPM Main Menu for details.)

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1.   Preamble

This University of New Hampshire (UNH) policy was created in order to provide guidance to faculty and staff concerning cost sharing commitments in externally funded programs, including:

1.1   Requirements for including cost sharing in proposals;

1.2   The management of cost sharing according to Federal requirements; and

1.3   The procedures to record cost-shared expenditures in UNH's financial system.

UNH is committed to supporting the sponsored activities of its faculty and staff but, in order to ensure that its cost sharing commitments do not overburden its resources, cost sharing should be limited to those situations where it is an eligibility requirement for a proposal submission or when the program description identifies it as a review criterion.

This policy addresses federal requirements for cost sharing. However, all cost sharing is subject to this policy, regardless of the project sponsor.

2.   Definitions

2.1   Cost sharing or matching means the portion of project costs not paid by a sponsor

2.1.1   Mandated cost sharing means cost sharing which is explicitly required, as reflected in the sponsor's notice of funding opportunity.

2.1.2   Voluntary cost sharing means cost sharing pledged on a voluntary basis in the proposal's budget that becomes a binding requirement of award.

2.1.3 Voluntary uncommitted cost sharing means faculty/senior researcher effort that is over and above that which is committed and budgeted for in a sponsored agreement.

2.2   Companion cost sharing funds are UNH account funds established for the purpose of budgeting, accumulating, and tracking the cost shared expenses associated with a particular sponsored program.

3.   Policy

3.1   Cost sharing must be proposed, managed, and accounted for in a correct and consistent manner. This includes understanding when cost sharing is appropriate, and accurately charging and reporting cost shared expenses.

3.2   Prior to submitting a proposal to a prospective sponsor, UNH formally reviews each potential offer of cost sharing and determines whether or not to approve the offer for inclusion in the proposal to the sponsor. To be proposed as cost sharing, costs generally must be

(1) be verifiable within UNH's accounting system and dated;

(2) be necessary and reasonable for proper and efficient accomplishment of program objectives;

(3) be allowable under a sponsor's terms and conditions, and cost principles, if applicable;

(4) be provided for in the sponsor approved budget;

(5) not be included as a contribution under another federal award; and

(6) not be paid using federal funds (except where the federal statue authorizing a program specificially provides that federal funds made available for such program can be applied to matching or cost sharing requirements of other federal programs).

3.3   Non-cash donations and contributions (i.e., services, materials, and equipments) must be valued according to federal requirements.

3.4   Companion UNH account funds for budgeting, accumulating, and tracking expenses cost shared on UNH awards, must be established contemporaneously with the award and funded promptly and regularly through the award project period.

4.   Cost Sharing Sources. Cost sharing sources may include:

4.1   Expenses funded from UNH accounts (e.g., educational and general funds);

4.2   Expenses funded from non-federal sponsored program accounts;

4.3   Program income related to the particular sponsored program when approved in advance by the sponsor;

4.4   Unrecovered F&A costs for the particular sponsored program, with UNH and sponsor prior approval;

4.5   Federally sponsored awards where authorized by Federal statute (very rare)

4.6   Cash and in-kind contributions from sources external to UNH, including volunteer services by professional and technical personnel, consultants, and other skilled and unskilled labor; and donated supplies and equipment.

5. Cost Sharing vs Institutional Support

The terms "cost sharing" and institutional support" are commonly used interchangeably even though their meanings are very different. Cost sharing as applied in a grant application is generally a documented, auditable commitment of funds to a specific project. Institutional support, on the other hand, is a description of the multiple ways in which the institution provides resources and infrastructure which make the proposed work feasible. Institutional support can be a very powerful tool in providing the desired “commitment” of the University to an investigator’s research plans without a formal cost sharing obligation. Institutional support may include the description of items such as

a) specialized core facilities (e.g., microscopy, imaging, research, computing,

b)  laboratory speace,

c) clinical resources, and

d) library resources

 

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Administrative Responsibility:    UNH Senior Vice Provost for Research
Effective Date: 7/1/95; revised 5/30/07 and 12/26/14

 

(Note: OLPM sections on this page may be cited following the format of, for example, "UNH.VIII.N.1.1". These policies may be amended at any time, do not constitute an employment contract, and are provided here only for ease of reference and without any warranty of accuracy. See OLPM Main Menu for details.)

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1.    Preamble

1.1   This University of New Hampshire (UNH) policy was created in order to provide guidance to faculty and staff concerning program income generated under sponsored programs, including:

• Requirements for including program income in proposals for sponsored programs;
• The management of program income according to federal requirements; and
• The procedures to record program income expenditures in UNH's financial system

1.2   This policy applies to all externally sponsored grants at UNH regardless of the source of sponsorship. That said, income generated through non-federal awards will be administered on a case-by-case basis according to the terms and conditions in the award document. If the sponsor does not address the issue of program income, the income is not reportable and therefore not considered program income. In these instances, income is handled according to the USNH Administrative Procedures for Revenue and Cash Receipts. This policy does not apply to externally sponsored contracts unless required by the terms and conditions of a specific contract.

2.   Definitions

2.1   Program income is the gross income directly generated by a sponsored activity or earned as a result of an externally funded award during the period of performance. Examples of program income include, but are not limited to:

• Fees earned from services performed under the project, such as laboratory tests;
• Funds generated from sales of commodities and research materials, such as tissue cultures, cell lines and research animals;
• Conference fees charged when a grant funds a conference;
• Income from registration fees, consulting, and sales of educational materials; and
• Sale, rental, or usage fees, such as fees charged for the use of computing or laboratory equipment purchased with grant funds

2.2   "Project performance" means the time during which UNH may incur new obligations to carry out the work authorized under an externally sponsored program.

3.   Policy

3.1   Anticipated program income must be declared in the proposal or application to the prospective sponsor. Unanticipated program income realized during the project period must be reported promptly to the sponsor with a request for disposition instructions as noted below.

3.2   Program income earned during the sponsored program project period is administered according to one of the following methods as specified by sponsor policies and/or the terms of the award:

• Additive Method: Program income will be added to funds committed to the project by the sponsor and UNH, and used to further eligible program or project objectives.
• Cost-sharing Method: Program income will be used to finance in part or in total any required non-sponsor share of the program or project.
• Deductive Method: Program income will be deducted from the total project allowable costs in determining the net allowable costs on which the sponsor's share is based.

3.3   Salaries and wages paid from a program income account are assessed fringe benefits charges at UNH's federally-approved rate for externally sponsored programs. Similarly, all direct costs are subject to Facilities & Administrative (F&A) cost charges at the same rate charged to the sponsored award itself.

3.4   To ensure proper reporting and record keeping for audit purposes, program income must be accounted for separately but in conjunction with the sponsored program award it supports. Expenses to program income accounts must not exceed budgets. Any deficit of program income expenses against program income revenues at the end of the project period must be resolved with UNH non-restricted funds by mutual agreement of the principal investigator and the relevant Responsibility Center (RC) unit head or designee.

3.5   The RC unit is responsible for maintaining all documentation on how program income is generated and how it is spent. Deposit slips, copies of checks, and registration forms are acceptable forms of documentation. This information will be required as supporting material in the event of an audit.

3.6   Unless otherwise provided by a sponsor's regulations or the terms and conditions of a specific award, the University has no obligation to the sponsor regarding program income earned after the period of performance. Accounting for such program income is the responsibility of the relevant Responsibility Center (RC) unit.

3.7   Unless required by federal statute or the terms and conditions of a specific non-federal award, the University has no obligation to the sponsor for program income earned from license fees and royalties for copyrighted material, patents, etc.

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References:    
For awards made prior to 12/26/14

  
For awards made after 12/26/14

2 CFR §200.307

Administrative Responsibility: UNH Senior Vice Provost for Research

 (Note: OLPM sections on this page may be cited following the format of, for example, "UNH.VIII.O.1.1". These policies may be amended at any time, do not constitute an employment contract, and are provided here only for ease of reference and without any warranty of accuracy. See OLPM Main Menu for details.)

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1.   Background

NFE accounts, also known as "at risk" accounts, provide principal investigators the opportunity to initiate work under an externally sponsored program and begin incurring associated expenses prior to the conclusion of negotiations and the institutional acceptance of an award by an Authorized official. NFE accounts allow investigators an opportunity to:

• Begin a seasonally-dependent project;
• Place an advanced order for long lead time items (i.e., equipment);
• Provide continuity of funding for students and research staff;
• Record and track expenditures and eliminate the need to charge other unrelated accounts as well as the need to transfer expenses once an award is executed

2.   Definitions

2.1   A not-fully-executed (NFE) account: is a budgeted account established in the University System of New Hampshire (USNH) financial accounting system for the purpose of permitting expenses in anticipation of receiving externally-sponsored funds for a University of New Hampshire (UNH) program.

2.2   Pre-award costs are those costs incurred prior to the start date of the period of performance and in anticipation of an award where such costs are necessary for efficient and timely performance of the scope of work.

3.   Policy

3.1   Sponsored Program Administration (SPA) may establish a unique NFE spending account on the authority of a principle investigator's UNH Responsibility Center (RC) unit head (normally a dean, institute director, vice president, or officially-named designee).

3.2   SPA will ordinarily establish an NFE upon request because UNH has an established history and previous dealings with a sponsor, and the issues to be resolved prior to executing an agreement are routine. There are cases, however, where terms and conditions that are of significant concern to the PI, the RC, and the University may have to be negotiated. In these instances, prior to establishing the NFE, SPA will identify known areas of concern and the associated financial and/or non-financial risks to ensure the investigator and his/her RC are aware of the risks they are accepting. Examples of negotiation issues include, but are not limited to: publication restrictions and confidentiality requirements; intellectual property; and indemnification.

3.3   In making the decision to approve an NFE spending account for a specific program, the RC unit head must have received reasonable assurance that the externally-funded award will be made to UNH and must evaluate the level of financial risk to his/her unit budget. Any expenses charged to the NFE spending account that are not reimbursed ultimately by the externally-funded award must be reimbursed from the RC unit operating budget or some other non-restricted UNH funding source under the RC unit head's purview.

3.4   The RC unit head will make the final determination about whether to approve or deny the request to establish an NFE. When an RC unit head approves an NFE for $500,000 or more, s/he must notify the Senior Vice Provost for Research, the Vice President for Finance and Administration, the Provost and the Executive Vice President for Academic Affairs.

3.5   All parties, including principal investigator, the RC unit head, and SPA, will endeavor to minimize the expenses against NFE spending accounts and minimize the time between establishing an NFE spending account and fully executed award. All expenses to NFE spending accounts must be allowable under the applicable regulations and terms and conditions of the award and must be incurred within the period of performance.

3.6   UNH will normally not assume the risk of guaranteeing a subrecipient’s costs under an NFE account, and requests for sub-recipient costs under an NFE must provide compelling justification.

3.7   Establishing an NFE account does not create the ability to incur pre-award costs. Before incurring pre-award expenses, the investigator should consult with SPA to confirm that pre-award spending is permissible under the applicable regulations and terms and conditions of the award.

4.    Procedures

4.1   Requesting an NFE account: A principal investigator initiates an NFE request (form) and submits it to his/her department chair and RC unit head for approval, which in turn requests an account from SPA on the investigator's behalf. This same procedure will be repeated to either increase the budget and/or extend the term of an NFE.

4.2   SPA will inform the RC if it has any concerns about the terms in the award and will establish the NFE account if the RC remains willing to bear the risk.

4.3   Period. The recommended period of a NFE is 90 days. Longer periods may be anticipated for awards being transferred into UNH (i.e., awards new faculty bring with them from another institution). SPA will request that RC’s review NFE accounts that have not been converted to active status within 2090 days of the start date of the budget period.

4.4   Upon acceptance of an award by UNH, the account will be converted from NFE to Active status by SPA. The RC is responsible for removing expenditures from the NFE account if the award is not made, not accepted, or if the terms of the award deem expenditures to be unallowable.

 (Note: OLPM sections on this page may be cited following the format of, for example, "UNH.VIII.Q.1". These policies may be amended at any time, do not constitute an employment contract, and are provided here only for ease of reference and without any warranty of accuracy. See OLPM Main Menu for details.)

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1.   Definitions

"Supplies" means all tangible personal property that fall below the cost or useful life thresholds for equipment. A computing device is a supply if the acquisition cost is less than the UNH capitalization threshold of $5,000, regardless of the length of its useful life. Other examples of supplies include calculators, books, computer software and peripherals (when not purchased as part of a system whose total purchase price is $5,000 or more), paper, pencils, notebooks, markers, and laboratory chemicals.

"Federally sponsored" refers to all federal funds, including those received through the State of New Hampshire, other educational institutions, private industry, or other entities.

2.   Policy

2.1   Any supply charged to a federally sponsored program must meet all four of the following criteria in order to be allowable as a direct charge:

2.1.1   Reasonable. The supply must be necessary for the performance of the sponsored agreement. The cost must conform to all applicable government requirements and be consistent with institutional policies.

2.1.2   Allocable. The supply must be used solely to advance the work of the particular sponsored agreement during its performance period. If the supply benefits more than one project or activity, the cost must be allocated proportionately to each project or activity according to the degree of benefit.

2.1.3   Consistent. The supply cost must be treated consistently as either a direct or indirect cost in like circumstances throughout the institution.

2.1.4   Limitations. The supply item must conform to limitations imposed by the sponsor's policies and the agreement itself.

2.2   The cost of supplies from stock or services rendered by specialized institutional facilities or other operations (such as departmental copiers) may be charged directly to sponsored agreements provided the above criteria are met and the costs conform to USNH policy on "Establishing a Recharge Center Rate."

2.3   Items typically considered to be office, administrative, departmental, or general lab supplies (such as paper, pencils, notebooks, file cabinets, paper towels, gloves) are normally charged indirectly to sponsored agreements through the institution's federally negotiated Facilities and Administrative (F&A) cost rate. However, under appropriate circumstances, such special needs items may be charged directly to the sponsored agreement if they are:

• Essential to the project's programmatic or technical purpose,
• Explicitly identified with the project,
• Explicitly approved or not specifically disapproved by the sponsor as reflected in the award budget.

2.4   Examples.

• It is allowable to directly charge a sponsored agreement for the cost of paper and envelopes for a project requiring data collection through a mail survey.
• Paper, pencils, and similar supplies may be allowable direct charges to a workshop or conference grant.
• Supplies for an administrative office specifically funded as such by the sponsor may be allowable direct charges.

2.5   If there is a residual inventory of unused supplies exceeding $5,000 in total aggregate value upon termination or completion of a federally-funded project and the supplies are not needed for any other Federal award, UNH must retain the supplies for use on other activities or sell them, but must, in either case, compensate the Federal government an amount calculated by multiplying the current market value or proceeds from sale by the Federal awarding agency's percentage of participation in the cost of the original purchase. If the supplies are sold, the sponsoring agency may allow UNH to retain $500 or ten percent of the proceeds, whichever is less, for its selling and handling expenses.

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References:

For awards made prior to December 26, 2014:

 

A-21 Appendix A, CAS 9905.502        Consistency in allocating costs incurred for the same purpose by educational institutions.

OMB Circular A-110:     Subpart C, _.27        Allowable costs.

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For awards made after December 26, 2014

2 CFR § 200    Subpart E – Cost Principles

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For all awards

USNH Policy on Unallowable Costs, Financial and Administrative Procedure 2-060

USNH Policy on Establishing a Recharge Center Rate, Financial and Administrative Procedure 2-073

Administrative Responsibility: UNH Senior Vice Provost for Research
Effective date: 7/1/95; revised 12/14/98, 5/23/07

 

 (Note: OLPM sections on this page may be cited following the format of, for example, "UNH.VIII.R.1". These policies may be amended at any time, do not constitute an employment contract, and are provided here only for ease of reference and without any warranty of accuracy. See OLPM Main Menu for details.)

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1.   Introduction In accordance with the Office of Management and Budget (OMB),  it is necessary to explain and justify transfers of charges onto federally funded sponsored awards, when the original charge was previously recorded elsewhere on USNH’s General Ledger (GL). Timeliness and completeness of the explanation of the transfer are important factors in supporting allowability and allocability in accordance with federal requirements.

2.   Definition

Cost Transfer
A cost transfer is a journal entry that transfers an expense onto a federally-funded sponsored award that was previously recorded elsewhere on the University’s General Ledger (GL) and identified by USNH as requiring institutional approval before it can be posted to the GL.

Late Cost Transfer
A cost transfer that is requested more than 90 days after the monthly accounting period of the original transaction posting date is considered late. For example, if an original cost posted on 6/15/XX, then the 90 days would begin on 7/1/XX and end on 9/28/XX. Therefore, any cost transfer made on or after 9/29/XX would be considered late.

3.   Policy USNH has established the following policy for the processing of cost transfers to comply with the requirements of OMB Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards (“Uniform Guidance”) and federal agency policies and procedures. Cost transfers are for correcting errors and are not to be used as a means of managing available balances. Project funds are not interchangeable, and the integrity of each grant account must be maintained.

4.   Cost Transfer Requirements Cost transfers are for correcting errors and are not to be used as a means of managing available balances. Project funds are not interchangeable, and the integrity of each grant account must be maintained.

The following are unallowable cost transfers:

• Cost transfers solely for the purpose of utilizing unexpended funds of a sponsored award
• Cost transfers used as a cost management strategy
• Cost transfers between unrelated sponsored projects to avoid or eliminate cost overruns
• Cost transfers that circumvent pre- and/or post-award restrictions
• Cost transfers for any other reasons of convenience

With the exception of the below criteria, all cost transfers onto federally-funded sponsored projects require the completion of a Cost Transfer Justification Form approved by the Support Team for the Administration of Research (STAR), the Principal Investigator (PI) and Accounting and Financial Compliance (AFC) before entering the cost transfer into the USNH financial accounting system.

The following items do not require a cost transfer and should be processed as a journal (JEGR):

1. A single direct cost of $1,000 or less

2. A debit made within the same accounting period (same month) regardless of the original transaction amount

3. A debit made to a non-federal funding source

The following transaction types do not require the completion of a Cost Transfer Justification Form:

A. Transfers of true overdrafts (off sponsored awards to unrestricted accounts). These transfers may be made in lump sum entries rather than identifying individual transactions.

B. Transfers of expenditures between funds or GL accounts under the same award, in cases where there are no sponsor restrictions on the funds set aside in a particular fund.

C. Reallocation of salaries and fringe to reflect actual effort when the following apply:

i. When processed within 90 days of the month the charge originally posted; and

ii. Before the annual effort has been certified in the effort reporting system; and

iii. The effort certification due date has not passed.

D. Reallocation of Procurement Card (PCard) expense from a non-sponsored default fund when processed within 90 days of the month the charge originally posted.

E. Transfers of allowable and allocable expenditures incurred within the period of performance of an award but charged to a departmental, unrestricted, or other non-sponsored account while awaiting the fully executed sponsored agreement (transferred within 90 days of the end of the monthly accounting period of the original transaction posting date).

F. Reallocation of recurring expenses, or expenses that must otherwise default to non-sponsored FOAPAL for administrative reasons. All such expenses should have documentation of the allocation methodology.

G. Correction of administrative errors such as transposition/typos.

5. Roles and Responsibilities

Principal Investigator

• Ensures that expenditures are allocable, allowable, and reasonable to a specific sponsored project.
• Ensures that expenditures are allocated in accordance with award budget, sponsor guidelines, and Institutional policy.
• Ensures that individuals have appropriate authority to incur and allocate expenditures.
• Ensures monitoring of expenditures, timely correction of errors, and reallocation of expenses, including personnel effort, occurs.
• Ensures compliance with USNH Cost Transfer Policy.
• Initiates and/or authorizes requests for cost transfers.
• Provides complete, clear and reasonable justification for transfers as required by this policy.
• Manages project to minimize the need for cost transfers.

Sponsored Programs Administration: STAR

• Ensures that personnel responsible for financial administration of sponsored projects are familiar with USNH Cost Transfer Policy.
• Provides oversight and advice on sponsored post-award administration including cost transfers and effort reports.
• Provides support to answer questions and concerns from PI’s, research staff and administrative staff regarding cost transfer issues.
• Prepares cost transfer forms under direction of PI or designee and obtains approvals.
• Ensures compliance with USNH Cost Transfer Policy.
• Processes JV/JCST in Banner and uploads documentation to Xtender once all approvals are obtained.

Sponsored Programs Administration: AFC

• Exercises stewardship over sponsored projects in accordance with specific award terms and conditions and sponsor policy.
• Advises the research community, in particular the PI, designee and STAR on processing cost transfer adjustments and procedures.
• Reviews and approves cost transfers and supporting documentation in accordance with Institutional policy and sponsor guidelines.
• Provides training on Cost Transfer Policy and principles of sponsored project administration.

6. Notes

1. Agencies that fall under the Department of Health and Human Services e.g., Agency for Healthcare Research and Quality (AHRQ), Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), Health Resources and Services Administration (HRSA), Substance Abuse and Mental Health Services Administration (SAMHSA), Administration on Aging (AoA) as well as other HHS agencies (excluding the National Institutes of Health)] have the following condition in the HHS Grants Policy Statement, “Permissible cost transfers should be made promptly after the error occurs but no later than 90 days following occurrence unless a longer period is approved in advance by the GMO.” Cost transfers requiring sponsor prior approval must be routed to Sponsored Programs Administration for institutional approval and submission to the sponsor.

2. *To avoid unnecessary cost transfers, a Not Fully Executed (NFE) account STAR.

3. An account for an existing sponsored agreement must never be used as a holding account for another award’s pre-award expenses, including labor.

4. Expenditures must be transferred to an unrestricted account if the cost transfer is not approved by SPA.

5. Email is an acceptable form of approval.

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1.   Definitions

1.1   Administration. Services that benefit common or joint university or department activities in organized research units, academic departments or programs, and in the offices of the deans, vice presidents, provost, and president. For purposes of this policy, "Administration" also includes proposal preparation for competing renewal and new applications.

1.2   Departmental/University Research. Research, development, scholarly, and creative activities conducted under University of New Hampshire (UNH) auspices but not funded by an externally-sponsored project.

1.3   Effort. Time spent by a UNH employee on any USNH activity, including Sponsored Programs.

1.3.1   Committed Effort. Total projected amount of time the UNH employee has agreed to work on a sponsored project or other USNH activity.

1.3.2   Cost Shared (Contributed) Effort. Percentage of committed Effort not funded by the sponsor, i.e., to be paid for and contributed as cost sharing by UNH.

1.3.2.1   Mandatory Cost Sharing of Effort. Funding that, either due to award terms/ conditions or by federal statute, requires UNH to contribute personnel costs and corresponding Effort to the project as a condition of receiving the award.

1.3.2.2   Voluntary Committed Cost Sharing of Effort. Personnel costs and corresponding Effort associated with a sponsored project, which were identified in the proposal, but not required or funded by the sponsor.

1.3.2.3   Voluntary Uncommitted Cost Sharing of Effort. Personnel costs and corresponding Effort associated with a sponsored project and not funded by the sponsor, which were not committed in the proposal or in any other communication to the sponsor.

1.3.3   De minimis Effort. Infrequent, irregular activity that normally would be considered "so small" that it cannot (and should not) be accounted for. Activities can be considered de minimis in amount when, in the aggregate, they represent one percent or less of the individual's Total University Effort. (See UNH VIII.S.1.3.4.)

1.3.4   Total University Effort (TUE)

All activities for which the employee is compensated with USNH-administered funds for performing Regular Duties and for work for which the employee receives Additional Pay. (See UNH V.F.1.1.13 for definition of Regular Duties and UNH V.F.7 for the Additional Pay policy.) Types of Additional Pay unrelated to Effort (e.g., Employee Transition Allowance or monetary awards for recognition) are excluded from consideration for TUE. TUE is 100% regardless of FTE %.

TUE includes all USNH Effort-based activities regardless of when during the daytime, evening, weekend, or year, or where (e.g., on campus, at home, while traveling) the activities take place. TUE is not based on a 40-hour work week, but rather on the total USNH hours the employee spends on the combination of Regular Duties and Effort expended for Additional Pay. For example, if a person averages 60 hours per week on USNH activities and spends an average of 15 of the 60 hours per week on a Sponsored Program, that person is spending 25% Effort on the Sponsored Program and 75% on other duties.

See UNH VIII.S.3.8 – "Table on Total University Effort" – for examples of activities allowable as direct charges on Sponsored Programs.

1.4   Effort Certification. Process by which the UNH Principal Investigator (PI),  or persons having first-hand knowledge of employee effort on sponsored programs affirm that the percentages of received pay reflected on the Effort Report are a reasonable reflection of the percentages of Effort that the paid individual expended on each Sponsored Program and other work activities.

1.5   Effort Report. Listing of USNH accounts from which the UNH employee has been paid for Effort expended during a specified period; used for Effort Certification.

1.6   Instruction. Preparation, evaluation, and delivery of the university’s teaching and training activities, regardless of whether offered on a credit or non-credit basis. Also includes Instruction-related activities, such as thesis advice, student mentoring, and similar activities. Student mentoring directly related to a faculty member’s sponsored research is considered a research activity that may be allocated to the Sponsored Program.

1.7   Service. Membership in a standing committee (e.g., admissions committee, governance body, Human Subjects Review Board) or an ad hoc committee such as a search committee or task force. Service may qualify as de minimis Effort, depending on the extent of the individual’s involvement. (See UNH VIII.S.1.3.3 above.)

1.8   Sponsored Program. Project funded by an award from a grant, contract, or cooperative agreement under which UNH agrees to perform a certain scope of work, according to specific terms and conditions, and which requires detailed financial accountability and compliance with sponsor terms and conditions.

1.9   Sponsor Salary Cap

In some cases, sponsors impose limitations on the amount of Institutional Base Salary (IBS) or Rate (IBR) that may be used as the basis for charging salary to their projects. (See UNH Regular Pay policy at V.F.1.1.9 and V.F.1.1.10 for IBR and IBS definitions.) This is known as the "Sponsor Salary Cap." This does not affect the employee’s actual pay, just the source.

2.   Scope, Applicability, and Purpose

2.1   This policy sets forth requirements for proposing, managing, and certifying Effort on externally-Sponsored Program awards administered by UNH. The policy applies to all employees whose pay is charged to UNH-administered sponsored projects, in whole or in part, and to all UNH employees who have committed Effort to a sponsor but are not receiving salary support from the sponsor, also known as cost sharing. The policy applies regardless of whether or not the sponsor is Federal.

2.2   In requesting external funding for projects and programs, UNH must ensure that the proposed commitments of Effort are reasonable and conform to UNH’s and the sponsor’s expectations of the employees involved. If external funding is awarded, UNH must assure the sponsor that the proposed Effort will be effectively managed within the parameters of the sponsor’s requirements and UNH policy.

2.3   In addition to complying with the sponsor's expectations and requirements for allowable and appropriate charges to Sponsored Programs for Effort expended, UNH must comply with federal regulations regarding Compensation for Personal Services.

3.   Policy

3.1   Proposals: Proposing Effort Commitments and Requesting Related Salary/Wage Support on Sponsored Programs

3.1.1   General

3.1.1.1   In preparing proposals, Principal Investigators (PIs) must propose some level of activity (1% or the minimum required by the program) unless specifically exempted by the sponsor. PIs are expected by UNH to provide reasonable estimates of the percentage of Effort for themselves and all other key personnel necessary to carry out the proposed project. Proposed levels of Effort should be consistent with the actual Effort each employee is expected to expend on the project during the relevant project period(s). The amount of salary support requested normally should be determined by multiplying the proposed level of Effort percent by the employee's IBS or IBR. Salary support that is not requested normally should be stated as cost shared (contributed) Effort. (See UNH VIII.S.3.1.2 below.) In no event, should the requested salary support exceed the amount determined by multiplying the proposed level of effort by IBS or IBR.

3.1.1.2   Regardless of the amount of Effort provided and ultimately certified, the total amount of effort may not exceed 100%. Reductions of Committed Effort on a sponsored program should be appropriately justified and documented and reductions on federally sponsored program of 25% or more, from the proposed and awarded level, require prior approval from the sponsor.

3.1.2   Cost Shared (Contributed) Effort (See also UNH VIII.S.1.3.2.)

3.1.2.1   If the sponsor requires Mandatory Cost Sharing for the program, this requirement can be met through cost sharing of PI or key personnel Effort, with approval prior to proposal submission by the Responsibility Center unit head (normally the dean or institute director) and the UNH sponsored programs administration (SPA).

3.1.2.2   UNH typically does not cost share/ contribute Effort on a voluntary basis (see UNH VIII.M, Cost Sharing on Externally Sponsored Programs). Approval for Voluntary Committed Cost Sharing of Effort must be obtained prior to proposal submission from the Responsibility Center unit head and SPA. This type of cost sharing is agreed to as part of the award and is required to be documented, tracked, and reported. Voluntary Uncommitted Cost Sharing of Effort is not required to be documented, tracked, or reported.

3.1.3   Sponsor Salary Caps (See also UNH VIII.S.1.9.)

3.1.3.1   Where Sponsor Salary Cap limitations apply, the requested salary support is determined by multiplying the proposed level of Effort percent by the maximum IBS allowed by the sponsor.

Such limitations result in an automatic situation of cost shared (contributed) Effort, where the total Effort is split between Effort allowed to be charged to the sponsor and Effort funded by UNH. There may be other circumstances in which UNH may elect to request salary support at a lesser amount than the salary that could be requested based on proposed level of Effort.

3.1.4   Maximum Proposed Salary

3.1.4.1   Normally, a PI may not request in a single proposal to receive externally-sponsored salary support for more than 95% of his/her IBS. Faculty with 9-month appointments normally may not request in a single proposal to receive externally-sponsored summer salary support for a full 3 months. (See also UNH V.F.7.1.35, V.F.7.3.5, and UNH VIII.S.3.3 for additional information on Summer Pay and Effort.)

3.1.4.2   It is understood that the sum of active + proposed percentage commitments for a given period may exceed 100%, because proposals may not result in awards. However, to the extent that a proposal results in an award, reductions must be made to existing commitments (and the sponsors notified when required and/or appropriate) to ensure that the total Effort percentage committed to Sponsored Programs does not exceed 95% during the regular appointment period (or 100% during the Summer Period for academic-year faculty) for each UNH employee who will receive pay from the award. ("Summer Period" is defined as the approximately 13 weeks between academic years.)

3.1.4.3   In rare situations, Additional Pay for Effort beyond the employee’s Regular Duties (see UNH V.F.1.1.13 for definition of Regular Duties) may be proposed to the sponsor. (See UNH V.F.7 for Additional Pay types and policy for requesting and obtaining UNH approval.)

3.2   Awards: Establishing Salaries on Sponsored Project Award Accounts

3.2.1   Sponsors generally consider estimates of Effort (and corresponding salary requests) in proposals to be commitments if such proposals are awarded. If an award is accepted by UNH, the PI and key personnel are committed to provide this level of Effort over the award budget period unless sponsor policies permit otherwise. As a recipient of sponsored funds, UNH must assure sponsors that the Effort expended on the projects is at least commensurate with the salaries charged to those projects. In addition, sponsors require assurance that any Effort committed to a project, even Effort not compensated by the sponsor, is provided. PIs are responsible for ensuring that all Effort commitments are met for the program and ultimately certified.

3.2.2   UNH uses two methods for effort reporting, Plan Confirmation and After-The-Fact Effort Certification. (See UNH VIII.S.3.5.5 and UNH VIII.S.3.5.6.) Under Plan Confirmation, the distribution of salaries and wages of professorial staff applicable to sponsored agreements is based on budgeted, planned, or assigned work activity, periodically updated to reflect any significant changes in work distribution when those occur. Non-Instructional sponsored staff and other operating staff utilize After-The-Fact Effort Certification. In either method, salary/labor distribution consistent with committed Effort should begin on sponsored program award accounts (and cost sharing accounts, if applicable) concurrently with actual project Effort. It is the PI's responsibility to be aware of committed Effort for himself/herself and all project staff, and to promptly communicate via a written work plan with his/her UNH Business Service Center (BSC) to assign salary charges to the award and adjust charges to other USNH accounts as appropriate.

3.2.3   Maximum Allowed Regular Pay from Externally-Sponsored Programs

An employee's pay may not be charged directly to an externally-Sponsored Program for activities that are not identified in that specific program. Pay for Administration, Instruction, Service, clinical activity, institutional governance, and new or competitive proposal preparation must not be charged directly to externally-Sponsored Programs unless the activities are specifically approved activities of those Sponsored Programs. 

(See UNH VIIII.S.3.8, Table on Total University Effort, for examples of activities allowable for directly charging Sponsored Programs.)

Some sponsors may impose a cap on the amount they will reimburse for individual salaries in awards. For example, the National Institutes of Health will not reimburse at an annual rate that exceeds the cap it publishes each year. Also, the National Science Foundation normally limits compensation it will provide to two months in a one year period. For the purposes of this policy the year is defined as the beginning of the academic year plus the following summer session, e.g., August 25th through August 24th. Any request for salary greater than two months that was not specifically approved by NSF in the award notice budget, that would not cause the objective or scope of the project to change, should be submitted to the appropriate Grants and Contracts Administrator (GCA) in SPA with supporting documentation.

3.2.3.1   Academic Year Faculty during the Regular Appointment Period

Normally, faculty members have responsibilities during the academic year that preclude them from devoting 100% of their time to externally-sponsored activities. Deans and department chairs or their designees, and faculty should review proposed sponsored activity to assure that, if other activities required of the faculty member reduce the available Effort to devote to sponsored activities, payroll distribution adjustments are made consistent with sponsor terms and conditions.

3.2.3.2   Fiscal Year Faculty and Staff during the Regular Appointment Period

Fiscal year faculty and full-time staff members with teaching, research, service, and/or administrative responsibilities normally are precluded from devoting 100% of their time to and receiving 100% of their UNH pay from USNH-administered externally-Sponsored Programs. With written approval from the UNH Senior Vice Provost for Research (SVPR) or designee exceptions can be made up to 100% if the employee is working exclusively on the Sponsored Program(s) (See UNH VIIII.S.3.8, Table on Total University Effort, for examples of activities allowable for directly charging Sponsored Programs.)

Some fiscal year full-time staff members in certain classifications (e.g., research scientists and research technicians) are expected to devote 100% time to Sponsored Programs; these positions are given categorical approval by the SVPR to charge 100% of their pay to Sponsored Programs.

3.2.3.3   Adjunct Appointees

The employee's related pay may be charged directly to USNH-administered externally-Sponsored Programs in accordance with UNH VIII.S.3.2.3 above.

3.3   Summer Effort/Salary for Faculty with 9-Month Academic Appointments

For purposes of this policy, the definition of a Summer Period (see UNH V.F.1.1.16) workweek is consistent with the definition of an Academic Year workweek (see prevailing Collective Bargaining Agreement). It is expected that faculty engaging in externally-sponsored projects during the Summer Period will not allow other activities (e.g., teaching, proposal writing) performed during the Summer Period to interfere with or reduce the faculty member's ability to expend summer Effort on externally-sponsored projects, as that Effort is committed to sponsors and for which he/she is earning summer salary. If the Effort associated with any such other activities could not be conducted reasonably along with externally-sponsored commitments, the faculty member has the obligation to adjust, and likely decrease, summer commitments and salary on externally-sponsored projects.

A request for summer salary indicates a commitment to put forth the comparable Effort on the particular project during the Summer Period. Effort expended during the Academic Year does not satisfy a commitment related to receipt of summer salary. Faculty members receiving 3/9th of their salary are expected to forego vacation during the period coinciding with the work effort.

3.4   Post-Award: Revising and Monitoring Effort and/or Salary Commitments on Sponsored Project Awards

3.4.1   With each new award received, changes in other USNH commitments, and/or other changes in activity that could impact the level of effort proposed/awarded for sponsored projects, the PI is responsible for reviewing the Effort commitments for each activity to ensure there is sufficient time available to meet all obligations. PIs must ensure that with each new award or additional assignment (such as for Service on a UNH committee), he/she adjusts the percentage of Effort and associated compensation plan for each activity accordingly. It is the PI's responsibility to communicate promptly with his/her Business Service Center (BSC) to assign labor distributions to the new awards/activities and adjust for future charges to other UNH accounts as appropriate.

3.4.1.1   Retroactive salary/labor adjustments to Sponsored Programs are discouraged. If an error has occurred, the PI must provide written documentation to the BSC to explain the reason for the error. Except for UNH-mandated adjustments such as retroactive salary increases, no retroactive salary/labor adjustments greater than 90 days from end of month original transaction was posted may be made to Sponsored Programs without approval from the BSC and SPA. All adjustments are subject to after-the-fact review and possible disallowance by SPA.

3.4.2   When sponsor approval is required for reductions in Effort on awarded projects, PIs must obtain UNH and sponsor approval prior to reducing their Effort. If an Effort reduction is indicated for a sponsored project award, the salary charged to the sponsor must be reduced commensurate with the Effort reduction.

3.4.3   The PI must communicate significant changes in level of Sponsored Programs effort to his/her BSC such that salary distribution adjustments are made on a timely basis.

3.4.4   It is recommended that PIs monitor salary/labor charges to their Sponsored Programs on a monthly basis, but no less frequently than quarterly. Salary distribution adjustments should be communicated to his/her BSC in a timely manner.

3.5   Certifying Effort

3.5.1   Each UNH employee (or other responsible person with specific knowledge of the employee's Effort) must certify his/her TUE if all or part of the related compensation was funded by UNH Sponsored Programs during the period covered by the Effort Certification. Graduate student effort is certified by PI(s) or designee(s).

3.5.2   If the individual certifying the Effort is other than the employee, the certifier must use "suitable means of verification" that the work was performed and that the associated pay was reasonable in relation to the Effort. It is the PI's responsibility to ensure that appropriate records (e.g., calendars, teaching schedules, lab log books) are up-to-date and available for review or audit to substantiate that the work was performed. Such records may be considered suitable means of verification. Other means of verification might include e-mail messages attesting to Effort devoted, based on firsthand knowledge. Oral verification alone will not suffice.

3.5.3   If the percentages of actual TUE differ from the percentages of actual pay on Sponsored Programs by more than 5% for the certification period, the PI must promptly communicate to the BSC the details such that corrections can be made to the payroll system. Differences of 5% or less do not require payroll system adjustments unless the associated costs are unallowable. An example of an unallowable cost is time spent on competitive proposal writing.

3.5.4   De minimis activity (1% or less of TUE) devoted to non-sponsored university activities is not required to be identified on the Effort Report, but may be allocated to Sponsored Programs and non-sponsored activities consistently and equitably. Examples of de minimis activities may include attending departmental meetings, completing performance reviews for supervisees, and enrolling in employee benefit programs. Proposal writing for new and competitive renewal projects, and well-defined, regular Administration (see UNH VIII.S.1.1) and Service (see UNH VIII.S.1.7) activities cannot be considered "small", therefore must not be treated as de minimis.

3.5.5   Utilizing either Plan Confirmation or the After-the-Fact Confirmation Method, Effort Certification must be completed annually by or for each salaried employee who received pay from one or more UNH Sponsored Programs during the Effort Certification period. Effort Certifications are to be provided to UNH SPA no later than October 15 each year for the preceding UNH fiscal year reporting period.

3.5.6   Hourly-based employees use Web Time Entry (WTE) as part of the UNH bi-weekly payroll process. When certified by the employee and approved by his/her supervisor, or an individual with first-hand knowledge of the employees’ activity, WTEs reflecting TUE meet the requirements of After-the-Fact Effort Certification for hourly-based employees receiving wages from UNH Sponsored Programs.

3.5.7  Because it is expected that the PI will promptly initiate future labor distributions and correct errors to prior salary/labor charges to his/her Sponsored Programs, instances of re-certification of Effort after the original certification is filed should be rare. Approval by the UNH Senior Director for Research and Sponsored Programs or designee is required in order for UNH to accept a correction of a previously-filed Effort Certification.

3.6   Training

3.6.1   UNH effort certification training is available at https://www.unh.edu/research/effort-reporting-and-certification-training. Principal Investigators of UNH externally-Sponsored Programs should complete the Effort Certification training made available by UNH, or receive training at a kickoff meeting prior to allocating salaries to a sponsored project. It is the responsibility of the PI to explain effort certification to research staff paid on their grants and/or to direct them to UNH effort certification training.

3.6.2   Each PI should complete the UNH Effort Certification training module even if s/he does not receive pay but supervises employees who are paid by the PI's-Sponsored Program.

3.6.3   The PI's BSC and local business/administrative staff supporting UNH Sponsored Programs are encouraged to complete this training.

3.7   Consequences of Non-Compliance

3.7.1   If a PI does not complete the specified training, the PI's next award may not be accepted by UNH until such time as s/he successfully completes the training.

3.7.2   If an employee fails to return his/her Effort Certification within the required period, no further proposals may be submitted nor awards accepted by UNH for the employee/PI until such time as the certification is completed and submitted to SPA.

3.7.3   Sponsored Programs funds expended for employees who violate this policy may be disallowed by the sponsor and/or UNH. In such cases, the PI and his/her college/school/department must provide unrestricted UNH funds to reimburse the sponsor.

3.7.4   Other violations of this policy will be addressed under the USNH Employee Code of Ethics and other policies as appropriate.

3.8   Total University Effort Table

 (Note: OLPM sections on this page may be cited following the format of, for example, "UNH.VIII.T.1.1". These policies may be amended at any time, do not constitute an employment contract, and are provided here only for ease of reference and without any warranty of accuracy. See OLPM Main Menu for details.)

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Spanish version

1.   Statement of Need and Purpose

1.1   Externally sponsored research is a vital part of the University of New Hampshire's (UNH) mission. As this activity grows in sophistication and complexity, it intersects increasingly with industrial explorations and entrepreneurial ventures creating for investigators the potential for conflicting interests.

1.2   A conflict of interest exists when it can be reasonably determined that an investigator's personal financial concerns could directly and significantly influence the design, conduct, or reporting of sponsored research activities. Further, some financial conflicts of interest could affect the rights and welfare of human subjects participating in research. UNH faculty and staff have an obligation to scrupulously maintain the objectivity of their research avoiding any conflict of interest.

1.3   UNH has developed this policy to protect the integrity of sponsored research and to comply with Public Health Service (PHS) federal regulations1. It is the intent and policy of UNH, as an institution of higher education in receipt of federal research support, to comply with present and future regulations. To that end, this policy is subject to further refinements as other rules are published.

1.4   Specifically, the intent of this policy is to identify and eliminate or manage any possible threat to research objectivity in PHS-funded research at UNH, including those that could lead to the unethical treatment of research subjects. It is not meant to discourage, but rather to safeguard the pursuit and dissemination of knowledge.

2.   Applicability

2.1   This policy became effective August 24, 2012, and applies to any investigator who is responsible for the design, conduct, or reporting of research activities in projects: (1) funded by PHS (see footnote #2) with Notice of Award issue date on, or subsequent to, the effective date; or (2) proposed for funding by PHS in applications submitted to PHS (see footnote #2) on or after the effective date. The policy also applies to the investigator's immediate family, which is defined as his/her spouse or domestic partner and dependent children.

2.2   Principal investigators are responsible for ensuring that all participants in a PHS –funded research project who are responsible for the design, conduct, or reporting of the research disclose any significant financial interests related to their institutional responsibilities. Individuals who come to work on an established project through reallocation of effort, hiring, transfer, promotion, etc., and thereby take on a responsible position in a project, must also disclose any such significant financial interests.

2.3   Collaborators, subcontractors, sub-recipients, and visiting scientists must either comply with this policy or provide a certification to the UNH Director of Sponsored Programs Administration (SPA) that their institutions are in compliance with pertinent federal policies and that they in turn are in compliance with their own institutional policies.

2.4   This policy applies to PHS research funding by means of a grant or cooperative agreement. It does not apply to Small Business Innovation Research (SBIR) Program Phase I applications.

3.   Definitions

3.1   Disclosure of Significant Financial Interests: An investigator's disclosure of significant financial interests to UNH.

3.2   Disclosure Review Committee (DRC): The UNH committee charged with protecting the integrity of UNH's externally-funded research enterprise, and UNH employees who engage in externally-funded research, by identifying and resolving financial conflicts of interest in research. The DRC conducts its duties in a manner intended to promote, not hinder, research relationships (see sections 5 and 8 of the UNH Policy on Financial Conflict of Interest in Research³ for DRC membership and responsibilities).

3.3   Financial Conflict of Interest (FCOI): A significant financial interest that could directly and significantly affect the design, conduct, or reporting of PHS-funded research.

3.4   FCOI Report: UNH's report of a financial conflict of interest to a PHS Awarding Component.

3.5   Financial Interest: Anything of monetary value, whether or not the value is readily ascertainable.

3.6   HHS: United States Department of Health and Human Services, and any components of the Department to which the authority involved may be delegated.

3.7   Institutional Responsibilities: An investigator's professional responsibilities on behalf of UNH as defined by UNH as follows:

3.7.1   Faculty: An individual's appointment letter and/or the Collective Bargaining Agreement, whichever is more specific with regard to the definition of institutional responsibilities.

3.7.2   Staff: Position description.

3.8   Institutional Official (IO): The Senior Vice Provost for Research (SVPR).

3.9   Investigator: The project director or principal investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by PHS, or proposed for such funding, which may include, for example, collaborators or consultants.

3.10   Manage: Taking action to address a financial conflict of interest, which can include reducing or eliminating the financial conflict of interest, to ensure, to the extent possible, that the design, conduct, and reporting of research will be free from bias.

3.11   PD/PI: A project director or principal Investigator of a PHS-funded research project; the PD/PI is included in the definitions of senior/key personnel and investigator in this policy.

3.12   PHS: The Public Health Service of the U.S. Department of Health and Human Services, and any components of the PHS to which the authority involved may be delegated, including the National Institutes of Health (NIH).

3.13   PHS Awarding Component: The organizational unit of the PHS that funds the research that is subject to 42 CFR 50 subpart F.

3.14   Public Health Service Act or PHS Act: The statute codified at 42 U.S.C. 201 et seq.

3.15   Research: A systematic investigation, study or experiment designed to develop or contribute to generalizable knowledge relating broadly to public health, including behavioral and social-sciences research. The term encompasses basic and applied research (e.g., a published article, book or book chapter) and product development (e.g., a diagnostic test or drug). The term includes any such activity for which research funding is available from a PHS Awarding Component through a grant or cooperative agreement, whether authorized under the PHS Act or other statutory authority, such as a research grant, career development award, center grant, individual fellowship award, infrastructure award, institutional training grant, program project, or research resources award.

3.16   Senior/Key Personnel: The PD/PI and any other person identified as senior/key personnel by UNH in the grant application, progress report, or any other report submitted to the PHS by UNH.

3.17   Significant Financial Interest:

3.17.1   A financial interest consisting of one or more of the following interests of the investigator (and those of the investigator's spouse or domestic partner, and dependent children) that reasonably appears to be related to the investigator's institutional responsibilities:

3.17.1.1   With regard to any publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000. Remuneration includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship); equity interest includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value;

3.17.1.2   With regard to any non-publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the investigator (or the investigator's spouse or domestic partner or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest); or

3.17.1.3   Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests. As further described in 3.17.3, this does not include intellectual property rights and interests assigned to UNH nor royalty income received from UNH per the UNH Intellectual Property policy (UNH VIII.D).

3.17.2   Investigators also must disclose the occurrence of any reimbursed or sponsored travel (i.e., that which is paid on behalf of the investigator and the investigator's spouse or domestic partner, and dependent children, and not reimbursed to the investigator so that the exact monetary value may not be readily available), related to their institutional responsibilities that occurred in the twelve months preceding the disclosure.

3.17.2.1   This disclosure requirement does not apply to travel that is reimbursed or sponsored by a Federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education.

3.17.2.2   This disclosure will include, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration.

3.17.2.3   The institutional official(s) will determine if further information is needed, including a determination or disclosure of monetary value, in order to determine whether the travel constitutes an FCOI with the PHS-funded research.

3.17.3   The term significant financial interest does not include the following types of financial interests:

3.17.3.1   Salary, royalties, or other remuneration paid by UNH to the investigator if the investigator is currently employed or otherwise appointed by UNH, including intellectual property rights assigned to UNH and agreements to share in royalties related to such rights;

3.17.3.2   Income from investment vehicles, such as mutual funds and retirement accounts, as long as the investigator does not directly control the investment decisions made in these vehicles;

3.17.3.3   Income from seminars, lectures, or teaching engagements sponsored by a Federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education; or

3.17.3.4   Income from service on advisory committees or review panels for a Federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education.

3.18   Small Business Innovation Research (SBIR) Program: The extramural research program for small businesses that is established by the Awarding Components of PHS and certain other Federal agencies under Public Law 97–219, the Small Business Innovation Development Act, as amended. SBIR Program also includes the Small Business Technology Transfer (STTR) Program, which was established by Public Law 102–564.

4.   Disclosure and Review Processes

4.1   Disclosure Process

4.1.1   Each investigator responsible for the design, conduct, or reporting of research activities funded or proposed for funding by PHS must disclose to UNH all his/her significant financial interests and those of his/her spouse or domestic partner and dependent children related to his/her institutional responsibilities no later than the time of application by UNH for PHS-funded research.

4.1.2   Each investigator who has significant financial interests related to his/her institutional responsibilities must complete a UNH Financial Conflict of Interest in Research Disclosure Statement and attach all required supporting documentation. The form and supporting documentation should be submitted in a sealed envelope marked confidential to the Office of the Senior Vice Provost for Research (OSVPR). If the disclosure statement indicates involvement of human subjects in the research, the OSVPR will notify the chairperson of the UNH Institutional Review Board for the Protection of Human Subjects in Research (IRB) so the situation may be considered, and if appropriate, addressed, by the IRB. If UNH determines that a financial conflict of interest exists (see 4.2.1) UNH shall request the investigator submit a proposed conflict management plan that details steps that could be taken to manage, reduce, or eliminate the financial conflict of interest. Resolution of the conflict or establishment of an acceptable conflict management plan must be achieved before expenditure of any funds under a PHS award.

4.1.3   Each investigator who is participating in PHS-funded research must submit to UNH an updated disclosure of significant financial interests at least annually (fiscal year [July 1 – June 30]) during the period of the award. Such disclosure shall include any information that was not disclosed initially to UNH or in a subsequent disclosure of significant financial interests (e.g., any financial conflict of interest identified on a PHS-funded project that was transferred from another institution), and shall include updated information regarding any previously disclosed significant financial interest (e.g., the updated value of a previously disclosed equity interest).

4.1.4   Each investigator who is participating in PHS-funded research must submit an updated disclosure of significant financial interests within thirty (30) business days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new significant financial interest.

4.1.5   All disclosure statements and related documents are considered sensitive information. As such, they will be treated as confidential and will not be disclosed outside the DRC and its staff without the investigator’s consent except: In response to a request from HHS; or pursuant to a judicial order or lawfully issued subpoena. UNH will make reasonable efforts to notify the investigator of any judicial order or lawfully issued subpoena in advance of disclosure of this information, unless the order is from a federal grand jury or is for law enforcement purposes and its terms prohibit UNH from disclosing its existence or contents.

4.2   Review of Disclosures

4.2.1   Prior to UNH's expenditure of any funds under a PHS-funded research project, UNH shall review all disclosure statements and accompanying documentation, and shall determine whether an investigator's significant financial interest is related to the PHS-funded research and, if so related, whether the significant financial interest represents a financial conflict of interest. An investigator's significant financial interest is related to the PHS-funded research when UNH reasonably determines that the significant financial interest could be affected by the PHS-funded research; or is in an entity whose financial interest could be affected by the research. UNH may involve the investigator in its determination of whether a significant financial interest is related to PHS-funded research. UNH may request additional clarifying information from the investigator which will be treated as non-public information to the extent allowed by law. A financial conflict of interest exists when UNH reasonably determines that the significant financial interest could directly and significantly affect the design, conduct, or reporting of the PHS-funded research.

4.2.2   If a financial conflict of interest exists, UNH shall request the investigator submit a proposed conflict management plan that details steps that could be taken to manage, reduce, or eliminate the financial conflict of interest. UNH shall review the proposed conflict management plan and approve it or add conditions or restrictions to ensure that any conflict is managed, reduced, or eliminated. Such conditions or restrictions may include, but are not limited to, the following:

4.2.2.1   Public disclosure of financial conflicts of interest (e.g., when presenting or publishing the research);

4.2.2.2   Monitoring of the research by independent reviewers;

4.2.2.3   Modification of the planned activities (possibly subject to sponsor approval);

4.2.2.4   Disqualification from participation in all or part of the project;

4.2.2.5   Divestiture of significant financial interests;

4.2.2.6   Severance of relationships creating conflict;

4.2.2.7   For research involving human subjects, disclosure of financial conflicts of interest directly to research subjects.

4.2.3   In all cases, resolution of the conflict or establishment of an acceptable conflict management plan must be achieved before expenditure of any funds under a PHS award.

4.2.4   When an investigator who is new to participating in a PHS-funded research project discloses a significant financial interest or an existing investigator discloses a new significant financial interest to UNH, UNH shall: review the disclosure of the significant financial interest within sixty (60) business days; determine whether it is related to PHS-funded research; determine whether a financial conflict of interest exists; and, if so, implement, on at least an interim basis, a management plan that shall specify the actions that have been and will be taken to manage such financial conflict of interest. Depending on the nature of the significant financial interest, UNH may determine that additional interim measures are necessary with regard to the investigator's participation in the PHS-funded research project between the date of disclosure and the completion of its review.

4.2.5   Whenever UNH identifies a significant financial interest that was not disclosed in a timely manner by an investigator or, for whatever reason, was not previously reviewed by UNH during an ongoing PHS-funded research project (e.g., was not reviewed or reported timely by a sub-recipient), UNH shall: review the significant financial interest within sixty (60) business days; determine whether it is related to PHS-funded research; determine whether a financial conflict of interest exists; and, if so implement, on at least an interim basis, a management plan that shall specify the actions that have been, and will be, taken to manage such financial conflict of interest going forward.

4.2.5.1   In addition, whenever a financial conflict of interest is not identified or managed in a timely manner, including failure by the investigator to disclose a significant financial interest that is determined by UNH to constitute a financial conflict of interest; failure by UNH to review or manage such a financial conflict of interest; or failure by the investigator to comply with a financial conflict of interest management plan, within 120 business days of the its determination of noncompliance UNH shall complete a retrospective review of the investigator's activities and the PHS-funded research project to determine whether any PHS-funded research conducted during the period of the noncompliance was biased in the design, conduct, or reporting of such research.

4.2.5.2   UNH shall document the retrospective review. Such documentation shall include, but not necessarily be limited to, the following key elements: (1) Project number; (2) Project title; (3) PD/PI or contact PD/PI if a multiple PD/PI model is used; (4) Name of the investigator with the FCOI; (5) Name of the entity with which the investigator has a financial conflict of interest; (6) Reason(s) for the retrospective review; (7) Detailed methodology used for the retrospective review (e.g., methodology of the review process, composition of the review panel, documents reviewed); (8) Findings of the review; and (9) Conclusions of the review.

4.2.5.3   Based on the results of the retrospective review UNH shall update the previously submitted FCOI report if appropriate (see section 5 of this policy), specifying the actions that will be taken to manage the financial conflict of interest going forward. If bias is found, UNH is required to notify the PHS Awarding Component promptly and submit a mitigation report. The mitigation report must include, at a minimum, the key elements documented in the retrospective review above and a description of the impact of the bias on the research project and UNH's plan of action taken to eliminate or mitigate the effect of the bias (e.g., impact on the research project; extent of harm done, including any qualitative and quantitative data to support any claim of actual or future harm; analysis of whether the research project is salvageable). Thereafter, UNH must submit FCOI reports annually. Depending on the nature of the financial conflict of interest, UNH may determine that additional interim measures are necessary with regard to the investigator's participation in the PHS-funded research project between the date that the financial conflict of interest or the investigator’s noncompliance is determined and the completion of UNH's retrospective review.

4.3   Appeals

4.3.1   Appeal of UNH's decision may be made to the UNH President who will consult with the investigator, the SVPR, and the DRC, and make a final determination.

4.4   Compliance

4.4.1   As part of the Financial Conflict of Interest in Research Disclosure Statement, each investigator must certify that if UNH determines a financial conflict of interest exists, the investigator will adhere to all conditions or restrictions imposed upon the project and will cooperate fully with the individual(s) assigned to monitor compliance.

4.5   Enforcement

4.5.1   Failure to properly disclose relevant financial interests or to adhere to conditions or restrictions imposed by UNH will be considered a deviation from accepted standards of conducting research at UNH.

4.5.2   The DRC will investigate alleged violations of this policy, and will make recommendations for action to the UNH President. Breaches of policy include, but are not limited to: failure to file the necessary disclosure statements; knowingly filing incomplete, erroneous or misleading disclosure forms; or failure to comply with procedures prescribed by UNH. If the UNH President determines that the policy has been violated, he/she may impose sanctions including, but not limited to, notification to PHS and termination of the award; formal admonition; a letter to the investigator's personnel file; and suspension of the privilege to apply for external funding.

4.6   Records

4.6.1   The OSVPR will maintain records of all disclosures and associated activities securely and confidentially (see section 4.1.5 of this policy for exceptions).

4.6.2   All records will be maintained for three years following termination or completion of the project, submission of the final expenditures report to the PHS, or resolution of any government action involving the records, whichever is later.

4.6.3   Records will be provided to PHS as required in section 5 of this policy. The Director of SPA will be responsible for communications with PHS.

5.   Reporting to PHS and PHS Oversight

5.1   Prior to UNH's expenditure of any funds under a PHS-funded research project, UNH, via the Director of SPA, shall provide to the PHS Awarding Component an FCOI report regarding any investigator's significant financial interest found to be conflicting. In cases in which UNH identifies a financial conflict of interest and eliminates it prior to the expenditure of PHS-awarded funds, UNH shall not submit an FCOI report to the PHS Awarding Component.

5.2   For any significant financial interest that UNH identifies as conflicting subsequent to the UNH's initial FCOI report during an ongoing PHS-funded research project (e.g., upon the participation of an investigator who is new to the research project) UNH shall provide to the PHS Awarding Component an FCOI report regarding the financial conflict of interest within sixty (60) business days, and ensure that UNH has implemented a management plan in accordance with 42 CFR 50 subpart F.

5.3   Where a FCOI report involves a significant financial interest that was not disclosed in a timely manner by an investigator or, for whatever reason, was not previously reviewed or managed by UNH (e.g., was not reviewed or reported in a timely manner by a sub-recipient), UNH also is required to complete a retrospective review to determine whether any PHS-funded research conducted prior to the identification and management of the financial conflict of interest was biased in the design, conduct, or reporting of such research. Additionally, if bias is found, UNH is required to notify the PHS Awarding Component promptly and submit a mitigation report to the PHS Awarding Component.

5.4   In FCOI reports required in 5.1 and 5.2 of this policy, UNH shall include sufficient information to enable the PHS Awarding Component to understand the nature and extent of the financial conflict and to assess the appropriateness of UNH's management plan. Elements of the FCOI report shall include, but are not necessarily limited to, the following:

(i) Project number; (ii) PD/PI or Contact PD/PI if a multiple PD/PI model is used; (iii) Name of the investigator with the financial conflict of interest; (iv) Name of the entity with which the Investigator has a financial conflict of interest; (v) Nature of the financial interest (e.g., equity, consulting fee, travel reimbursement, honorarium); (vi) Value of the financial interest (using dollar ranges) or a statement that the interest is one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value; (vii) A description of how the financial interest relates to the PHS-funded research and the basis for UNH's determination that the financial interest conflicts with such research; and (viii) A description of the key elements of UNH's management plan, including: (A) Role and principal duties of the conflicted investigator in the research project; (B) Conditions of the management plan; (C) How the management plan is designed to safeguard objectivity in the research project; (D) Confirmation of the investigator's agreement to the management plan; (E) How the management plan will be monitored to ensure investigator compliance; and (F) Other information as needed.

5.5   For any financial conflict of interest previously reported by UNH with regard to an ongoing PHS-funded research project, UNH shall provide to the PHS Awarding Component an annual FCOI report that addresses the status of the financial conflict of interest and any changes to the management plan for the duration of the PHS-funded research project. The annual FCOI report shall specify whether the financial conflict is still being managed or explain why the financial conflict of interest no longer exists. UNH shall provide annual FCOI reports to the PHS Awarding Component for the duration of the project period (including extensions with or without funds) in the time and manner specified by the PHS Awarding Component.

5.6   If the failure of an investigator to comply with this policy or a financial conflict of interest management plan appears to have biased the design, conduct, or reporting of the PHS-funded research, UNH shall promptly notify the PHS Awarding Component of the corrective action taken or to be taken. The PHS Awarding Component may consider the situation and take appropriate action or refer the matter to UNH for further action, which may include directions to UNH on how to maintain appropriate objectivity in the PHS-funded research project.

5.7   The PHS Awarding Component and/or HHS may inquire at any time before, during, or after award into any investigator disclosure of financial interests and UNH's review (including any retrospective review) of, and response to, such disclosure, regardless of whether the disclosure resulted in UNH's determination of a financial conflict of interest. UNH is required to submit, or permit on site review of, all records pertinent to compliance with 42 CFR 50 subpart F. To the extent permitted by law, HHS will maintain the confidentiality of all records of financial interests. On the basis of its review of records or other information that may be available, the PHS Awarding Component may decide that a particular financial conflict of interest will bias the objectivity of the PHS-funded research to such an extent that further corrective action is needed or that UNH has not managed the financial conflict of interest in accordance with 42 CFR 50 subpart F. The PHS Awarding Component may determine that imposition of special award conditions under 45 CFR 74.14 and 92.12, or suspension of funding or other enforcement action under 45 CFR 74.62 and 92.43, is necessary until the matter is resolved.

5.8   In any case in which the HHS determines that a PHS-funded project of clinical research whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment has been designed, conducted, or reported by an investigator with a financial conflict of interest that was not managed or reported by UNH as required by 42 CFR 50 subpart F, UNH shall require the investigator involved to disclose the financial conflict of interest in each public presentation of the results of the research and to request an addendum to previously published presentations.

5.9   UNH may require the reporting of other financial conflicts of interest to PHS as UNH deems appropriate.

6.   Public Accessibility

6.1   UNH shall ensure public accessibility via a written response to any requestor within five (5) business days of receipt of a request by the OSVPR for information concerning any significant financial interest disclosed to UNH that meets the following three (3) criteria:

6.1.1   The significant financial interest was disclosed and is still held by the senior/key personnel as defined by this policy;

6.1.2   UNH determines that the significant financial interest is related to PHS-funded research; and

6.1.3   UNH determines that the significant financial interest is a financial conflict of interest.

6.2   The information that UNH will make available via a written response to any requestor within five (5) business days of receipt of a request by the OSVPR, shall include, at a minimum, the following: (i) The investigator's name; (ii) The investigator's title and role with respect to the research project; (iii) The name of the entity in which the significant financial interest is held; (iv) The nature of the significant financial interest; and (v) The approximate dollar value of the significant financial interest using dollar ranges, or a statement that the interest is one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value.

6.3   Information concerning the significant financial interests of an individual subject to section 6.1 of this policy shall remain available for responses to written requests for at least three (3) years from the date that the information was most recently updated.

7.   Training

7.1   Investigators must complete training regarding financial conflicts of interest, investigators' responsibilities regarding disclosure of significant financial interests, and the PHS regulations prior to engaging in research related to any PHS-funded grant and at least every four (4) years.

7.2   In addition, investigators must complete training within thirty (30) days in the following circumstances:

7.2.1   UNH revises its policy on Financial Conflict of Interest in Research for PHS-Funded Projects or procedures related to this policy in any manner that affects the requirements of investigators;

7.2.2   An investigator is new to UNH; or

7.2.3   UNH finds that an investigator is not in compliance with this policy or management plan.

 

Footnotes

¹Department of Health and Human Services. Responsibility of Applicants for Promoting Objectivity in Research for Which PHS Funding is Sought. 42 CFR 50 Subpart F (revised August 25, 2011).

²While this policy specifies throughout research funded, or proposed for funding, by the Public Health Services, it also applies to other organizations that require compliance with the PHS financial conflict of interest in research regulations).While this policy specifies throughout research funded, or proposed for funding, by the Public Health Services, it also applies to other organizations that require compliance with the PHS financial conflict of interest in research regulations).

³See UNH VIII.E.5.1

1.   Preamble

1.1   The University of New Hampshire (UNH) recognizes its legal responsibilities to comply with pertinent regulations regarding the use, release, and exporting of export-controlled technical data, information, materials, and equipment in all activities conducted under the auspices of UNH, including outreach, scholarly, research, and teaching activities. Accordingly, UNH maintains this policy and underlying procedures. UNH strives to ensure that all members of its community – whether staff, faculty, students, consultants, subcontractors or visitors – understand and adhere to this policy.

1.2   UNH developed this policy to comply with federal export regulations, including but not limited to the International Traffic in Arms Regulations (ITAR), the Export Administration Regulations (EAR), and the Office of Foreign Assets Control (OFAC) regulations. The EAR and the ITAR govern the shipment or transfer (directly or indirectly) of export ­controlled technical data, information, materials and equipment to destinations outside the United States, as well as the provision of services and access to certain export controlled technical data, information, materials or equipment to debarred persons or entities and to non-U.S. persons within or outside the United States. In addition, the OFAC regulations impose sanctions and embargoes on transactions or exchanges with designated countries, entities and individuals, which in turn restricts UNH’s ability to conduct certain activities with those subject to the sanctions.

1.3   UNH recognizes that these regulations support critical national-security, economic, and foreign policy interests of the United States.

2.   Definitions

2.1   Definitions related to export controls are codified in the Export Administration Regulations (EAR) at 15 CFR § 772, the International Traffic in Arms Regulations (ITAR) at 22 CFR § 120, and the Office of Foreign Assets Control (OFAC) regulations at 31 CFR Part 501.

2.2   “Activities” include, but are not limited to: research; research training; provision of services; payment for services; instruction of students; hosting visiting scholars and other official guests; foreign travel; attendance at conferences and meetings, and presentations made at such; procurement; approval or payment of invoices; shipping and mailing; and, international collaborations, whether formally sponsored or not.

2.3   “U.S. Person” means any U.S. citizen, lawful permanent resident (a/k/a “green card” holder) of the U.S., or an individual who has been granted asylum or refugee status in the U.S. This definition also includes any corporation, society, or other entity or group that is incorporated or organized to do business in the U.S., and any federal, state, or local government entity in the U.S.

3.   Statement of the Policy

All individuals affiliated with UNH who work with, or have access to, export­ controlled technical data, information, materials and equipment or who engage in Activities are required to be familiar with and fulfill the requirements of the U.S. export controls laws and regulations by following applicable UNH guidelines, procedures and related policies, and consulting with UNH’s Empowered Official (see Section 5.2) as needed.

4.   Applicability. This policy is applicable to any Activity involving the use of export-controlled technical data, information, materials and equipment, or involving a non-U.S. Person, that is:

4.1   Conducted by or under the direction of any employee, student, or agent of UNH in connection with his or her individual UNH responsibilities;

4.2   Conducted by or under the direction of any employee, student, or agent of UNH involving the use of any UNH equipment, property or facility;

4.3   Involving any collaborating, sub-granting, or subcontracting individual or institution working with UNH;

whether such Activity is unsponsored, or is sponsored by UNH or extramural funding from any source.

5.   Administration of Policy

5.1   The Senior Vice-Provost for Research is responsible for the administration of this policy and applicable UNH guidelines and procedures.  Approval by the UNH President is required to amend this policy.

5.2   The Senior Vice Provost for Research will designate Empowered Officials to facilitate compliance and assist the UNH community with training, guidance, and administration of applicable regulations.

6.   Enforcement

6.1   UNH’s workforce members are expected to follow federal and state laws and regulations, as well as UNH’s policies and procedures regarding information security and export controls and regulations.

6.2   Besides the possibility of incurring significant reputational damage, civil and criminal penalties for violations of export control regulations are substantial, including significant fines, debarment from participation in federal contracting, loss of export privileges, and in some cases imprisonment.  Such penalties can be imposed upon the individual(s) involved, as well as the institution.