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NIH Issues Guidance on Policies for Reporting “Foreign Activities”

July 19, 2019

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PRESS CONTACTS
Anurupa Dev, Lead Specialist, Science Policy
Heather Pierce, Sr. Director, Science Policy & Regulatory Counsel

The National Institutes of Health (NIH) July 10 issued a guide notice outlining responsibilities for institutions and investigators under the NIH Grants Policy Statement as well as other applicable federal regulations to “report foreign activities through documentation of other support, foreign components, and financial conflict of interest to prevent scientific, budgetary, or commitment overlap.”

This notice was published in the context of foreign activities but applies broadly, to all support and grants. While the NIH states in an accompanying Frequently Asked Questions (FAQ) that this notice serves as a reminder for the extramural community and does not expand the applicability of the existing Other Support policy, the FAQ also indicates that the NIH is expecting applicants to disclose paid or unpaid activities that are not only related to the research: Outside Activities such as teaching or consulting that may be compensated or uncompensated constitute Other Support if they are in any way related to the investigator’s research endeavors or expertise.”

The AAMC, along with higher education associations including the Association of American Universities (AAU), the Association of Public and Land-grant Universities (APLU), and the Council on Government Relations (COGR), expressed concerns to the NIH that these FAQs appear to vastly increase the amount of information included in grant applications, including unpaid consulting or activities unrelated to an investigator’s research. The NIH Office of Extramural Research has been receptive to these issues and agreed that the phrasing of the FAQs could result in the misperception that NIH wanted far more information to be included in grant applications than intended. The agency has confirmed that FAQ question number six, which focuses on when outside activities should be reported as “Other Support,” will be removed from the website and that in the coming days and weeks a number of other changes clarifying NIH’s requirements will be posted.

The issue of foreign government influence at U.S. research institutions has been an increasing area of concern for the NIH and other federal science agencies over the past several years. In August 2018, NIH sent a letter to over 10,000 grantee institutions highlighting threats to research integrity, including failure of grantees to disclose foreign support for NIH-funded projects. A working group of the Advisory Committee to the NIH Director subsequently released a report in December 2018 offering recommendations for institutions to address these issues [see Washington Highlights, Dec. 14, 2018].

As noted in testimony given by the NIH at a recent Senate Finance Committee hearing [see Washington Highlights, June 7], the NIH is currently communicating with over 60 grantee institutions that the agency believes have failed to disclose substantial financial ties to foreign agencies or have failed to uphold the confidentiality of the peer review process. Investigations conducted in collaboration with awardee institutions are ongoing and several institutions have returned grant funds to the NIH and in some cases dismissed researchers for violations of agency and/or institutional policies. In a blog post, NIH Deputy Director for Extramural Research Mike Lauer, MD, notes that noncompliance with agency policy may lead to withholding or termination of awards or a referral for investigator suspension or debarment.

The AAMC is developing a set of issue briefs on this topic, and the first communication focused on NIH policy is now available.

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