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Proposed HHS Regulations: Regarding Conflict of Interest and Objectivity in Research

Principal Investigators Association, July 2010, Pages: 90


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90 Minute Audio Conference presented by Kristen H West, JD, CIPP, CHRC

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

The Principal Investigators Association, an independent organization, brings you this product as a training tool. The content has no connection with the NIH or NSF, nor do these agencies endorse it. All views expressed are those personally held by the author and are not official government policies or opinions.



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