Conflict of Interest for PHS funded researchers
The U.S. Public Health Service (PHS) amended its Financial Conflict of Interest (FCOI) Regulation effective August 24, 2012. Accordingly, UMass Amherst has adopted a new PHS Financial Conflict of Interest (FCOI) Policy effective August 24, 2012 (policy attached). In order to fully comply with PHS’s new regulation, UMass Amherst has created new PHS Financial Conflict of Interest (COI) Disclosure Forms. If you plan to apply for funding from a PHS (directly or flowing thru another agency) or have current PHS funding or plan to ask for no cost extension of an existing PHS award, you must comply with the new FCOI Regulations.
PHS defines "Investigator" as 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.
Investigator is broadly defined so that it may include any UMass Amherst personnel, post-doctoral associates, and students.
The FCOI regulation, effective August 24, 2012, requires that all persons applying for, receiving or being supported on PHS funds must be compliant with PHS rules on training, disclosure, and establishment of conflict of interest management plans prior to the awarding of funds. The rules apply to current interests and interests in the 12 months preceding the disclosure, rather than interests that are anticipated in the future.
The major changes to the PHS Financial Conflict of Interest Policy include:
Lower Financial Thresholds
Investigators must disclose the following as a significant financial interest if applicable to the Investigator, the Investigator’s spouse (or domestic partner), or dependent children:
- The value of any remuneration received from any publicly traded entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure that, when aggregated, exceeds $5,000.
- Please note that assets in or income from investment vehicles such as mutual funds and retirement accounts are not considered significant financial interests and do not need to be disclosed as long as you do not directly control the investment decisions made in these vehicles.
- The value of any remuneration received from any non-publicly traded entity in the twelve months preceding the disclosure that, when aggregated, exceeds $5,000, or any equity interest in non-publicly traded entities. Intellectual property rights and interests count toward the $5,000 received from the entity upon receipt of income related to such rights and interests.
Increased Transparency for Travel Reimbursement
- Any reimbursed travel or sponsored travel related to Institutional responsibilities must be disclosed as a Significant Financial Interest.
Please note that you are not required to disclose travel that is reimbursed or sponsored by a federal, state, or local government agency, an Institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education.
Please note that effective August 24, 2012, each Investigator must complete training prior to engaging in research related to any PHS-funded grant or contract and at least every four years, and immediately under the following circumstances:
- Institutional FCOI policies change in a manner that affects Investigator requirements; An Investigator is new to UMass Amherst; or
- UMass Amherst finds an Investigator noncompliant with the established COI policy or management plan.
Upcoming Training sessions
- All PHS/NIH investigators must participate in mandatory training required by the new policy before submitting any PHS/NIH proposals. Please see below for a current training schedule and click on the date to enroll.
- Slide presentation from UMass Amherst COI training session. Please note that this packet may serve only as a course refresher.
- Complete list of PHS agencies - U.S. Department of Health and Human Services Organizational Chart.
- NIH FCOI Webinar on Revised Regulation, November 30, 2011
- Town Hall Meeting on UMass COI Policies, April 26, 2012 (powerpoint)
- Implementing the NIH Final Rule March 2012
- NIH FCOI FAQs