E. Financial Conflict of Interest in Research
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.
2.1 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.
3.1 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:
184.108.40.206 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
220.127.116.11 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:
18.104.22.168 Anything of significant monetary value, including salary or other payments for services such as consulting fees or honoraria;
22.214.171.124 Direct equity interests such as stock, stock options, or ownership interests;
126.96.36.199 Intellectual property rights and interests owned by the investigator such as patents, copyrights, and royalties from such rights and interests. As further described in 188.8.131.52 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:
184.108.40.206 Financial interests in business enterprises or entities that, when aggregated for the investigator and his/her immediate family, meet both of the following tests:
220.127.116.11.1 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
18.104.22.168.2 The financial interest does not represent more than a five percent ownership interest in any single entity.
22.214.171.124 Salary, royalties, or other remuneration from UNH;
126.96.36.199 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;
188.8.131.52 Income from seminars, lectures, or teaching engagements sponsored by public or nonprofit entities;
184.108.40.206 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.
6.1 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.
7.1 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.
8.1 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.
9.1 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.
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://usnh.edu/olpm/UNH/VIII.Res/T.htm