Revisions to the 1995 Public Health Service regulations regarding financial conflict of interest in publicly funded research, enacted by the Department of Health and Human Services in 2011, will be effective as of August 24, 2012.
- These regulations affect all agencies funded under D.H.H.S.; not just NIH. Know that the NIH guidance is probably a good one to follow for sister agencies that are smaller and less structured. Also, as goes D.H.H.S., goes the federal government. The NSF has similar guidelines, so don’t think you’re off the hook.
- Check the NIH website FCOI page for new information at least weekly!
- There is a new module to be added to Commons, and a PowerPoint with case studies for guidance that were added this week. They add information at least every 2 weeks, and as we get closer this will change.
- Bookmark the NIH frequently asked questions section about the regulations – they are adding new questions regularly. You can find it here.
- Be prepared to ask your PIs in your regular meetings about their planned travel, and the purpose – creating a checklist of items to ask about, depending on your investigator’s type of research activity is going to be key as the reporting needs to occur on a timely basis.
- Your institution will likely have an office within its Office for Research to serve as a resource on these issues. Find out who that contact is for questions so that you can be proactive if a question or a concern were to arise. Gray areas exist – it’s best to ask questions, assume the best and get them answered up front.
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. Find out more by revisiting what I’ve already posted and checking out these sites – and get ready!