Research Jeopardy: Understanding New NIH Conflict-of-Interest Regulations

Navigating the new Conflict-of-Interest rules can be extremely tricky

Don't let an innocent misstep cause you to get stuck in messy administration, or even, legal hassles.

Conflict-of-Interest regulations just got a lot tougher. What does it mean for your research?

In May 2010, the NIH released more stringent rules on financial conflicts-of-interest to ensure that researchers' personal financial interests do not influence the nature or outcome of publicly funded studies. What does this mean to your research? Many PIs are confused, uncertain, and even scared of how these new policies could affect their careers.

Upholding the public's trust and the integrity of your research

As part of the new regulations, you would be required to disclose substantially more information about your relationships with private industry. In the past, you needed to report on relationships that exceeded $10,000. That threshold has been lowered to $5,000. If you don't know how or what to report, you are likely jeopardizing your research and your reputation.

New regulations you need to be aware of:

• Cutting to $5,000 from $10,000 the level at which an NIH-backed researcher must report to their university a payment from an outside company

• Require universities to give the NIH details of plans of reducing COI, rather than merely asserting such plans exist

• Require universities to evaluate relationships between the researcher and the company

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Featured Presenter: Kristin West, J.D. Kris West is the Associate Vice President and Director of the Office of Research Compliance at Emory University. She has worked at Emory for over 20 years, first in the University’s Office of Vice President and General Counsel and then moving on to establish and manage the Office of Research Compliance. Kris provides regulatory advice and guidance for researchers involved in human and animal subjects, as well as basic research. She works very closely with committees that provide regulatory oversight, including the Institutional Review Board, Institutional Animal Care and Use Committee and Institutional Biosafety Committee. In the area of conflict of interest, she provides advice and counsel to the Emory’s central Conflicts of Interest Office. Recently, she played a key role in responding to government questions concerning conflicts matters at the University and in developing new policies and procedures to address conflict of interest matters. Kris holds a B.A. from the University of Maryland, Suma Cum Laude, and a J.D., Magna Cum Laude, from Mercer University. She is a practicing attorney and a member of the Georgia Bar. Kris is a frequent speaker for the Health Care Compliance Association (HCCA), and regularly participates as an instructor for HCCA’s Research Compliance Academies. This On-demand presentation is brought to you as a training tool by the Principal Investigators Association, which is an independent organization. The presentation, tools presented and their contents are not connected with the National Institutes of Health (NIH), nor are they endorsed by this agency. All views expressed are those personally held by the presenter and are not official government policies or opinions.

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