1. Statement of Need and Purpose
1.1 Externally sponsored research is a vital part of the University of New Hampshire (University) 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 The University 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 became effective on October 1, 1995. It applies to any University employee responsible for the design, conduct, or reporting of research activities funded or proposed for funding at the University by external sources. 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 University Executive Director of Sponsored Research that their institutions are in compliance with pertinent federal policies and that they in turn are in compliance with their own institutional policies. Subcontractors from commercial firms need make a certification only when the prime award is from the Public Health Service (PHS).
3. Significant Financial Interests
3.1 Any employee responsible for the design, conduct, or reporting of research activities funded or proposed for funding at the University by external sources must reveal all current significant financial interests that would reasonably appear to be affected by the research.
3.2 Significant financial interest is defined as
3.2.1 Any current financial interest of the investigator and his/her immediate family that could reasonably appear to be affected by the activities proposed for funding; or
3.2.2 Any interest held by the investigator and his/her immediate family in a business entity (company, corporation, or other enterprise) whose financial interests might reasonably appear to be affected by such activities.
3.3 Specifically, significant financial interests might include, but are not limited to, any of the following:
3.3.1 Anything of significant monetary value, including salary or other payments for services such as consulting fees or honoraria;
3.3.2 Direct equity interests such as stock, stock options, or ownership interests;
3.3.3 Intellectual property rights owned by the investigator such as patents, copyrights, and royalties from such rights.
3.4 Significant financial interests do not include:
3.4.1 Financial interests in business enterprises or entities that, when aggregated for the investigator and his/her immediate family, meet both of the following tests:
3.4.1.1 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
3.4.1.2 The financial interest does not represent more than a five percent ownership interest in any single entity;
3.4.2 Salary, royalties, or other remuneration from UNH;
3.4.3 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 next 12 month period;
3.4.4 Income from seminars, lectures, or teaching engagements sponsored by public or nonprofit entities;
3.4.5 Income from service on advisory committees or review panels for public or non-profit entities.
3.5 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. Disclosure Process
4.1 All Disclosure Statements and related documents are considered sensitive information and only those persons involved in the implementation of this policy will have access to such records.
4.2 Each investigator who has significant financial interests possibly affected by the research must complete a University of New Hampshire Financial Disclosure Statement and attach all required supporting documentation. In addition, the investigator must submit a proposed conflict of interest management plan that details steps that could be taken to manage, reduce, or eliminate any conflict of interest. The form, documentation, and plan should be submitted in a sealed envelope marked “Confidential” to the Vice President for Research (VPR). If the disclosure statement indicates involvement of human subjects in the research, the VPR 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 all financial disclosures during the period of the award as new reportable significant financial interests are obtained.
5. Review of Disclosures
5.1 A Disclosure Review Committee (DRC) will review all disclosure statements. The committee will be co-chaired by the VPR and the Provost and Executive Vice President for Academic Affairs. The President will appoint three additional 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. The DRC may request additional clarifying information from the individual which will be treated as non-public information to the extent allowed by law.
6. Management Plans for Conflict
6.1 The DRC will 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:
6.1.1 Public disclosure of significant financial interests;
6.1.2 Monitoring of the research by independent reviewers;
6.1.3 Modification of the planned activities (possibly subject to sponsor approval);
6.1.4 Disqualification from participation in all or part of the project;
6.1.5 Divestiture of significant financial interests;
6.1.6 Severance of relationships creating conflict.
6.2 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 the University.
7. Appeals
7.1 Appeal of the DRC’s decision may be made to the University President who will consult with the investigator and the DRC, and make a final determination.
8. Compliance
8.1 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.
9. Enforcement
9.1 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 the University.
9.2 Alleged violations of this policy will be investigated by the DRC, which will make recommendations for action to the 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.
10. Records
10.1 The Office of the VPR will maintain records of all disclosures and associated activities securely and confidentially.
10.2 All records will be maintained for three years following termination or completion of the project or resolution of any government action involving the records.
10.3 Records will not be routinely provided to sponsors unless such is an agency requirement, the agency submits a written request, or the University is unable to satisfactorily manage an actual or potential conflict of interest. The University Executive Director of Sponsored Research will be responsible for communications with sponsors. Disclosure statements and associated information will not be released without notification to the investigator.
Footnotes
1Department of Health and Human Services. Responsibility of Applicants for Promoting Objectivity in Research for Which
PHS Funding is Sought. July 11, 1995. 60 FR 35810, Part III.
National Science Foundation. Investigator Financial Disclosure Policy. July 11, 1995. 60 FR 35810, Part III.