Financial Conflict of Interest Policy
Applicable to Research Proposals Submitted to Government Agencies
Investigator Financial Disclosure Policy
When an investigator involved in scientific research has significant financial interests in a company, organization, or institution external to the College, or receives compensation, funding, or other assistance from entities external to the College that can be affected by the investigator’s research, there is the potential for the creation of a conflict of interest or the appearance of a conflict. As a result, federal regulations require that institutions applying for research grants from federal agencies maintain a policy on conflicts of interest and require that investigators disclose any potential conflicts of interest to the College when applying for support for their research. The objective of this Policy and the federal regulations on which it is based is to promote “objectivity in research by establishing standards to ensure there is no reasonable expectation that the design, conduct, or reporting of research funded under [federal grants] will be biased by any conflicting financial interest of an Investigator” (defined below). 45 CFR § 50.601.
Definitions:
The following definitions apply to this policy:
Research – means a systematic investigation designed to develop or contribute to generalizable knowledge. The term encompasses basic and applied research and product development. The term includes any such activity for which research funding is available from a federal agency.
Investigator – means the principal investigator, co-principal investigator(s) and any other person at the College who is responsible for the design, conduct, or reporting of research or educational activities. For the purposes of this policy, the definition of “Investigator” includes the Investigator’s spouse and dependent children.
Significant Financial Interest - means anything of monetary value, including but not limited to, salary or other payments for services (e.g., consulting fees or honoraria); equity interests (e.g., stocks, stock options or other ownership interests); and intellectual property rights (e.g., patents, copyrights and royalties from such rights). Stock in companies that have not yet undergone a public offering should be valued at the last sale price recognized by the company, not the share price originally paid by the Investigator. The sale price should be obtained from the company and should be updated annually at the time of reporting. The term does not include:
- Salary or other remuneration from Haverford College;
- Income from seminars, lectures, or teaching engagements sponsored by public or nonprofit entities
- Income from service on advisory committees or review panels for public or nonprofit entities
- An equity interest that when aggregated for the Investigator and the Investigator’s spouse and dependent children, meets both of the following tests: (a) does not exceed $10,000 in value as determined through reference to public prices or other reasonable measures of fair market value, and (b) does not represent more than a five percent (5%) ownership interest in any single entity; or
- Salary, royalties or other payments that when aggregated for the Investigator and the Investigator’s spouse and dependent children over the next twelve months, are not expected to exceed $10,000.
Investigator Obligations:
To comply with federal law, federal regulations, and the College’s Conflict of Interest Policy, Investigators must take the following steps when submitting research proposals:
- Complete and submit a Financial Interest Disclosure Form to the College that lists the Investigator’s known Significant Financial Interests (1) that would reasonably appear to be affected by the research; and (2) that are in entities whose financial interests would reasonably appear to be affected by the research. Investigators with no Significant Financial Interests to disclose should also complete the Form and indicate the lack of Significant Financial Interests therein. Forms must be submitted to the College in advance of submission of applications for research grants to federal agencies.
- Update their Disclosure Forms annually or as new reportable Significant Financial Interests are obtained.
This Financial Interest Disclosure Form should be submitted to the Associate Provost. If, upon review of the form, there appears to be a potential conflict, the Associate Provost will, along with the department chair/laboratory director, review the potential conflict of interest and initiate steps to manage or eliminate the conflict(s) if appropriate.
Except to the extent required by law and federal regulations, the information disclosed will be kept confidential. You should know, however, that the College is required to report the existence of real or potential conflicts of interest to certain federal agencies. Specifically, the NIH (PHS) requires institutions to report to the PHS the existence of any conflicting interests and to assure that the interest has been managed, reduced or eliminated. NSF requires that only conflicts that have not been managed, reduced or eliminated prior to the expenditure of funds under an award be reported to NSF.
Institution’s Obligations
Policy Creation
Federal agencies require Haverford to take a number of steps to insure the discovery and elimination of any conflicts of interest in research programs. First, the College is required to develop, maintain, and enforce a policy on conflicts of interest. To this end, the College has developed the foregoing policy, appointed individuals to review Financial Disclosure Forms, and created mechanisms for enforcement.
In order to manage, reduce or eliminate potential conflicts, the College may take any of the following steps:
- public disclosure of Significant Financial Interests
- monitoring of research by independent reviewers
- modification of the research plan to avoid conflicts of interest
- disqualification of Investigators from the portion of the funded research that could create conflicts of interest
- require divestiture of Significant Financial Interests
- require severance of relationships that create conflicts of interest.
Subgrantees
Subgrantees who are not employed by or otherwise affiliated with the College must be in compliance with this Policy. They can comply in two ways:
- A subgrantee may have his or her conflicts resolved through the Haverford College process for identifying and resolving financial conflicts of interest; or,
- If the subgrantee is employed by an institution that has enacted a financial conflict of interest policy that is in compliance with applicable federal regulations, including 42 CFR § 50.604, the subgrantee's employer may provide assurances that any conflicts related to the project under consideration have been managed, reduced or eliminated pursuant to the employer’s policy.
The appropriate assurances can be provided by having the subgrantee’s employer complete the subguarentee form
If the subgrantee chooses to comply through providing assurances, the assurance form must be submitted with the Investigator's conflict-of-interest form. If the subgrantee is not employed by an institution that has enacted a policy in compliance with applicable federal rules and regulations, he or she must submit to Haverford College Financial Conflict of Interest Policy and follow Haverford College’s instructions for managing, reducing or otherwise eliminating any conflicts.
Reporting Obligations
Haverford College is required to certify in each application for research funding from federal agencies the existence of this Policy and to identify any existing conflicts of interest and assure that they have been managed, reduced or eliminated. The College also must report any conflicting interests to the appropriate federal agency before expending any grant funds. In addition, if any conflicts of interest become apparent after the initial report to the relevant federal agency, the College is required to report the existence of such a conflict within 60 days of its identification. The College will comply with federal agency requests to make information available about any conflicts of interest and how they have been managed, reduced, or eliminated.
Record Retention
Federal regulations require the College to maintain records of all financial disclosures and all actions taken by the College with respect to each conflict of interest for a minimum of three (3) years from the date of submission of the final expenditure report at the completion of the grant, or if any litigation, claim, financial management review, or audit is started before the expiration of the 3-year period, until all such actions have been resolved and final action taken.
Sanctions
Federal regulations require the College to impose sanctions where appropriate. Haverford maintains the right to impose sanctions on Investigators for failure to disclose Significant Financial Interests and for failure to abide by this Policy. Sanctions may include restrictions on future submission of research proposals and other disciplinary actions up to and including dismissal as described in Section III. J. of the Haverford College Faculty Handbook.
Applicable Federal Regulations and Policies:
Investigators or Supervisors who wish to learn more about the federal regulations governing conflicts of interest can take advantage of the applicable sections of the NIH Regulations, the NSF Proposal and Award Policies and Procedures Guide, and the Tutorial from NIH on Compliance with Federal Regulations on Conflicts of Interest.
If you have any questions about the College’s conflict of interest policy, please contact the Associate Provost at 610-896-1014.
Effective Date of this Policy: April 1, 2009