Conflict of Interest for Public Health Service Agencies (NIH, CDC, FDA)
Researchers, who are funded by a Public Health Services Agency (http://nrc59.nas.edu/pub/fcoi_agencies_phs_regs.html) such as NIH, must comply with newly issued financial conflict of interest regulations. The regulations (http://grants.nih.gov/grants/policy/coi/fcoi_final_rule.pdf), governs research sponsored by Public Health Services (PHS) agency, applies to all investigators who are involved in the design, conduct or reporting of the PHS research project and applies to new proposals, new awards, non-competing renewals, and new no cost extensions.
New requirements that differ from WHOI’s current COI policy include
- Mandatory training
- Broader disclosure requirement of all financial interests that relate to an individual’s institutional responsibilities, including remuneration from non-profit entities and sponsored travel.
- A threshold of $5,000 for “significant financial interests” as defined in the policy addendum “WHOI Addendum to COI for PHS research (pdf)”.
- Prior to submitting Public Health Services (PHS) (e.g. NIH) proposals or to dispersal of funds from PHS award, WHOI is required assure that all training and financial interest reports are up to date and completed, review and manage as necessary any financial conflict of interest, report financial conflict of interest and management plan to the PHS agency.
- Institution is required to have policy and procedures that is in compliance with the PHS regulations.
Investigators are required to
- Take the training found at http://grants.nih.gov/grants/policy/coi/tutorial2011/fcoi.htm
- At the end of the training session, print a certificate with their name and send a pdf scan of the certificate to their Department Admin.
- Read the addendum policy “WHOI Addendum to COI for PHS research (pdf)”.
- Fill out the Addendum Financial Interest Report (pdf).
- Print a hard copy of the filled out report, sign the report to certify that the investigator has correctly reported their financial interests, and that the investigator has read the WHOI addendum policy.
- Scan the signed report, creating a PDF with the file name
Last name_PHS FI Report 2012
e.g. Hahn_PHS FI Report 2012
where the last name and year are specific to the person and to the year the report is submitted. Note that the reporting year is 12 months prior to the year the report is signed and submitted.
- Send this pdf to your Department Admin.
- Department Admin will send the scan of the training certificate and the signed financial interest report to DoR (firstname.lastname@example.org) and GCS (email@example.com) and will notify them if any financial interest is reported.
- Take training and update the Addendum Financial Interest report as specified in the Policy, “WHOI Addendum to COI for PHS research (pdf)”.
NIH References and Sources for Addendum Policy:
NIH Financial Conflict of Interest Web Page (http://grants.nih.gov/grants/policy/coi/)
NIH Frequently Asked Questions (http://grants.nih.gov/grants/policy/coi/coi_faqs.htm)
Federal Register: Responsibility of Applicants for Promoting Objectivity in Research. (42 C.F.R. Part 50, Subpart F)
Federal Register: Responsible Prospective Contractors. (45 C.F.R. Part 94)
NIH Financial Conflict of Interest FCOI Requirement and Demo Webinar 14 Aug 2012 (http://videocast.nih.gov/summary.asp?live=10752)
Federal Register Notice (pdf) (08/25/2011) (http://grants.nih.gov/grants/policy/coi/fcoi_final_rule.pdf)
Last updated: August 9, 2015