Financial Conflict of Interest Policy for NIH grants
The U.S. Department of Health and Human Services (HHS) has issued a final rule in the Federal Register that amends the Public Health Service (PHS) regulations on Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought (42 C.F.R. Part 50, Subpart F) and Responsible Prospective Contractors (45 C.F.R. Part 94). An Institution applying for or receiving NIH funding from a grant or cooperative agreement must be in compliance with all of the revised regulatory requirements no later than 365 days after publication of the regulation in the Federal Register, i.e., August 24, 2012, and immediately upon making the Institution’s Financial Conflict of Interest policy publicly accessible as described in 42 CFR part 50.604(a).
Reed College is committed to ensuring that NIH-funded research is free from the bias created by a financial conflict of interest held by an investigator or subawardee, and from the appearance of a bias resulting from a financial conflict of interest held by an investigator or subawardee. To that end, the College will undertake efforts to identify significant financial interests held by investigators that may relate to NIH-funded research, and to determine whether or not those significant financial interests constitute a financial conflict of interest. The College recognizes that investigators and members of their family may hold significant financial interests related in some measure to NIH-funded research. This is not inappropriate, but such interests must be disclosed to the College to ensure that NIH-funded research is not in any form biased by the presence of these interests.
Consequently, Reed College adopts the following Financial Conflict of Interest Policy related to NIH-funded research, and requires that all investigators who apply for or receive grants from the Federal agencies identified above are required to follow the procedures set forth below.
A. Requirements--pre-application, and first year of grant
1. Faculty members who intend to submit a proposal to the National Institutes of Health are required to have completed the Financial Conflict of Interest form for NIH grants prior to submitting the proposal.
2. The completed form is to be submitted to the grants & special gifts officer, or to the person responsible for working with faculty on grants to the National Institutes of Health.
3. If the PI does not report any significant financial interests, the form will be placed into the project folder, and maintained with the application by the corporate and foundation support office.
a. If the proposal is funded, the conflict of interest form will be provided to the business office, and will be stored with the official folder for the proposal in the business office.
4. If the PI reports a significant financial interest, the Grants & Special Gifts officer will provide the form to the Dean of Faculty, who will determine, in consultation with the Vice-President/Treasurer, whether the significant financial interest represents a conflict of interest.
5. If no conflict of interest is found, the form will be returned to the Grants & Special Gifts Officer.
6. If a conflict of interest is found, the Vice-President/Treasurer shall, in consultation with the Dean of Faculty and the investigator, be responsible for formulating a plan of action to mitigate the impact this conflict may have, or may appear to have, upon the proposal in question.
7. The plan of action will be affixed to the conflict of interest form, and will be returned to the Grants & Special Gifts Officer. If the proposal is funded, the form and plan of action will be transferred to the project folder in the business office.
B. Requirements--second (and successive) years of grant
1. Faculty with NIH grants are required to complete the conflict of interest form upon submission of the proposal, and for a second time upon the start date of the grant, and on or before the start of each subsequent funding period.
(Example: a PI applies for a three year NIH AREA grant, due on October 25, and requests a start date of 6/1. The PI must complete the FCOI form on or before 10/25, a second time on 6/1, and then on 6/1 for grant years 2 and 3, for a total of four times.)
2. Faculty with NIH grants are responsible for notifying the Grants & Special Gifts Officer should they, their spouse, or a dependent child gain a significant financial interest during the time period covered by a grant from NIH.
(Example: a PI working on a grant completes a FCOI form on 6/1, and indicates no significant financial interests. On 12/1, the PI’s wife inherits $40,000 of stock in a pharmaceutical company. The PI would be responsible for notifying the Grants & Special Gifts Officer of this change in his or her financial circumstances.)
3. In the event that a PI’s financial circumstances change and a significant financial interest is reported, the Grants & Special Gifts Officer shall complete steps 5-8 in Part A, “Requirements,” above.
C. Management of Financial Conflicts of Interest
1. In the event that a Financial Conflict of Interest is identified, the Vice-President/Treasurer (also referred to in this policy as “Institutional Official”) shall, in consultation with the Dean of Faculty and the investigator, be responsible for creating a management plan to ensure that the significant financial interest does not affect the conduct, design, or reporting of NIH-funded research.
2. Written plans will manage, reduce, or eliminate any Financial Conflict(s) of Interest. Such plans will be designed to meet applicable legal requirements, facilitate the local resolution or management of any conflict, and protect the sensitivity of disclosed information. If the Institutional Official determines that there is a Financial Conflict of Interest, he or she must approve a written management plan before any related research goes forward. The affected investigator is responsible for developing and submitting a proposed management plan to, and in consultation with, the Institutional Official. Management plans may include one or more elements, such as the following:
of the sponsored program by independent researchers or reviewers, the
Institutional Official, an FCOI Committee, or a designee.
b. Modifications to the research or program plan.
c. Appointment of an oversight panel or person to review research/scholarship.
d. Limitations on the employee’s involvement in personnel or other decisions on behalf of the College.
e. Divestiture of Significant Financial Interests and/or
f. Other arrangements that manage, reduce, or eliminate a potential Financial Conflict of Interest.
1. Faculty training will take the form of an individual session with the Grants & Special Gifts officer, and a computerized training session.
2. Prior to submitting a proposal, the PI is required to complete Reed College’s FCOI form. To assist them with this process, the Grants & Special Gifts Officer will meet with the PI, provide them with a copy of the college’s FCOI policy, provide them with a copy of the FCOI form, and will discuss the college’s policy with them. This will give each PI a chance to ask questions about the policy, inquire about FCOIs, etc.
3. Should a proposal be funded, the PI will be responsible for completing the FCOI tutorial available on the NIH’s FCOI website.
4. This combined training must be completed prior to the start date of a grant, and then every four years thereafter. Should a grant terminate before the fourth year of this period, the PI shall not be required to complete additional FCOI training.
1. Reed College will comply with all requirements of the NIH Financial Conflict of Interest Policy related to providing timely and accurate reports to NIH. The Grants & Special Gifts officer is tasked with providing NIH with initial and annual reports in the event that a SFI is identified and determined to be a FCOI.
a. Retrospective Review
In some cases the Institutional Official may determine that a Financial Conflict of Interest was not identified or managed in a timely manner, including but not limited to an Investigator’s failure to disclose a Significant Financial Interest that is determined to be a Financial Conflict of Interest, or an Investigator’s failure to materially comply with a management plan for a Financial Conflict of Interest. In such cases a committee appointed by the Institutional Official will complete a retrospective review of the Investigator’s activities and the research project to determine whether the research conducted during the period of non-compliance was biased in the design, conduct or reporting of the research.
Documentation of the retrospective review shall include the project number, project title, PI, name of Investigator with the Financial Conflict of Interest, name of the entity with which the Investigator has the Financial Conflict of Interest, reason(s) for the retrospective review, detailed methodology used for the retrospective review, and findings and conclusions of the review.
The Institutional Official will update any previously submitted report to the funding agency, specifying the actions that will be taken to manage the Financial Conflict of Interest going forward. If bias by the investigator is found, the report will include a mitigation report in accordance with the applicable regulations, including a description of the impact of the bias on the research project and the plan of action to eliminate or mitigate the effect of the bias.
2. The Grants & Special Gifts Officer will be responsible for ensuring that a copy of this policy is available on the Reed College website.
3. Reed College will provide information on investigators with conflicts of interest, within 5 business days, to any member of the public who requests that information in writing.
4. Information provided to the public shall consist of the following information:
2. Grant title
3. Grant amount and project period(s)
4. Type of FCOI reported
5. Measures taken to ensure that the FCOI is mitigated
If no faculty have financial conflicts of interest, Reed will provide a statement to this effect to any member of the public who makes a request of the college.
This policy implements the requirements of 42 CFR 50 and 45 CFR 94; where there are substantive differences between this policy and the requirements, the requirements shall take precedence.
When the College works with subrecipients or subawardees of grant funds from the federal agencies to which this Policy applies, it will enter into written agreements specifying whether the subrecipient institution will follow College’s FCOI Policy or its own. Subrecipients and subawardees will be required to comply with any applicable federal regulations.
Reed College will retain all documents related to financial conflicts of interest for awarded and submitted grants for a period of at least 7 years following the termination of the grant.
This policy was approved by the Dean of Faculty and Vice-President/Treasurer on August 22, 2012
For questions related to this policy, please contact David Frazee Johnson, Grants and Special Gifts Officer.