New PHS Research Conflict of Interest Regulations
Revisions to the 1995 Public Health Service (PHS) regulations regarding financial conflict of interest (COI) in publicly funded research, enacted by the Department of Health and Human Services (HHS) in 2011, will be effective on August 24.
Among the most impactful changes are revisions to the definition of “significant financial interest,” extent of investigators’ disclosure of information to institutions regarding their financial interests, institutions’ management of financial conflicts of interest, information reported to NIH and other funders, information made available to the public, and investigator training.
Ahead of these revisions, Northwestern University Provost Dan Linzer recently sent a statement informing the community that as of Monday, July 23, Northwestern had implemented its own new COI policy. He noted that the last time the Northwestern policy and procedures were rewritten was over a decade ago, and that much has changed in the intervening years.
“The new PHS requirements, which we hear may be adopted in part or wholly by other agencies, provided impetus to revisit our COI policies and procedures,” he said in the statement. “The policy changes are being implemented to comply with new federal regulations governing Financial Conflict of Interest (FCOI) policies at all institutions accepting PHS research funds.”
The new Northwestern policy and process will apply to all individuals involved in the design, conduct, or reporting of research for all proposals submitted and current awards received on or after August 24. While all research investigators will be affected by the new Northwestern COI policy, PHS funded researchers and staff working on PHS-funded studies will have additional disclosure requirements.
Further information about the new Northwestern University COI policy can be found on the Conflict of Interest Office (NUCOI) website.
What you need to know about the PHS regulations
- As Linzer noted, the PHS regulations may affect all agencies funded under HHS. Says Michelle Melin- Rogovin, manager of research administration at Northwestern University Feinberg School of Medicine, “The NIH guidance is probably good for sister agencies that are smaller and less structured to follow. Also, as goes PHS, goes the federal government; the National Science Foundation has similar guidelines, so don’t think you’re off the hook.” Melin-Rogovin has been writing about the new guidelines in her blog, “Research Administration Nation.”
- The Feinberg Research Office recommends checking the NIH website FCOI page for new information at least weekly.
- Melin-Rogovin also recommends bookmarking the NIH frequently asked questions section about the regulations – new questions are added regularly.
- Research administrators should be prepared to ask PIs about planned travel and its purpose – creating a checklist of items to ask about, depending on the investigator’s type of research activity, will be important.
Melin-Rogovin adds, “Collaboration between industry and academia is needed in order to fund advancement in science. Not every relationship is a conflict of interest, and these relationships can be extremely complicated. If you have a question, it’s perfectly appropriate to ask about it in order to receive additional information and to understand that the project you’re working on is meeting your university guidelines and the new regulations.”
Presentation slides and a handout from the July town hall meeting regarding the new PHS regulations and Northwestern COI policy are available on the NUCIO website. General questions and inquiries about the new policy should be directed to firstname.lastname@example.org.
This page last updated Aug 24, 2012