(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.)
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