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REGULATORY COMPLIANCE

Do You Expect Any Significant Change in the Proposed NIH Conflict-of-Interest Rules Before They Are Adopted?

Reader Question: We’re trying to get a head start on changing our policies and procedures to meet the requirements of the National Institutes of Health's (NIH) proposed financial conflict-of-interest rules. We’d rather not make decisions based on moving targets. How likely is it that the final rules will differ from what's been proposed?

Expert Comments: The following three key areas of the proposal are not likely to change:

• The transfer of responsibility from the principal Investigator to the institution to decide whether a Significant Financial Interest is related to the investigator’s government-funded research and, if so, whether it is a Financial Conflict of Interest in that it directly and significantly affects the design, conduct or reporting of the research;

• The Web site reporting requirements for PIs who have a Financial Conflict of Interest, i.e., the institution must post on a public Web site the investigator’s name and position, along with a description of the nature and dollar range of the Significant Financial Interest ; and

• The reduction of the dollar-amount thresholds that trigger the determination of a Significant Financial Interest.

However, PHS expected and received a large number of comments on the proposed regulations, even extending the public-comment period for one month (ended Aug. 19). It specifically requested comments regarding the following:

• The manner in which the regulations apply when a PHS-funded researcher transfers from one institution to another, or when a new institution gets involved in an ongoing PHS-funded project. Specifically, the agency wants comments on how the regulations should apply when there is a shift in the personnel or institutions involved and/or whether a PI's new institution must consider a prior institution’s determination that the PI had a Financial Conflict of Interest.

• Enforcement provisions, including whether the regulations should describe specific actions that the agency can take in response to Financial Conflicts of Interest or instances of non-compliance.

Based on PHS’s concerns, it seems the agency is planning to keep the proposed regulations intact, but clarify the specifics in response to comments.

Expert comments by Kristin West, associate VP and director, Office of Research Compliance, Emory University, Atlanta.

Kristen West recently presently a teleconference on Research Jeopardy: Understanding New NIH Conflict-of-Interest Regulations. If you are interested in obtaining a recording (MP3 or CD) or a PDF transcript, click here!

This eAlert is brought to you as an informational training tool by the Principal Investigators Association, which is an independent organization. Neither the eAlert nor its contents have any connection with the National Institutes of Health (NIH), nor are they endorsed by this agency. All views expressed are those personally held by the author and are not official government policies or opinions.