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COSSA Joins Societies in Requesting Changes to NIH Clinical Trial Policy

In a letter sent to National Institutes of Health (NIH) Director Francis Collins on October 27, COSSA and 21 other scientific societies and associations requested that NIH revisit a new policy that alters the definition of “clinical trials” funded by the agency and institutes new reporting requirements for such research (see COSSA’s coverage of this issue). While the letter is supportive of the goal of enhancing transparency of NIH-funded research, including introducing registration and reporting requirements, the signatories express concern that “basic science research is being redefined as a clinical trial at NIH and that “basic science investigators will be unnecessarily burdened with requirements relating to conducting clinical trials that have nothing to do with their own research.” The organizations hope to work with NIH leadership to find a solution that addresses the concerns of the basic science community while still improving transparency for true clinical trial research.

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Posted in Issue 21 (October 31), Update, Volume 36 (2017)

NIH Provides Guidance on New Human Subjects, Clinical Trials Form

As previously reported, the National Institutes of Health (NIH) has been working for the last few years to enhance its stewardship of and increase transparency over the clinical trials it funds. COSSA described the planned changes and their impact on the social science research community in a Hot Topic piece earlier this month. All social and behavioral science researchers who have received NIH funding in the past, or who are looking to apply in the future, are strongly encouraged to review this information as your research may now fall under NIH’s revised definition of a “clinical trial.”

NIH released a blog post and short video on October 11 that provides specific guidance on how to complete the new PHS Human Subjects and Clinical Trial Information form, which will now be required for all grant applications submitted on or after the January 25, 2018 due dates. All researchers are encouraged to familiarize themselves with the new form.

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Posted in Issue 19 (October 3), Update, Volume 36 (2017)

HOT TOPIC: New NIH “Clinical Trials” Definition to Impact Basic Social and Behavioral Science Research

Hot Topic LogoThe National Institutes of Health (NIH) has been working for the last few years to enhance its stewardship of and increase transparency over the clinical trials it funds. The agency, which is the largest funder of clinical trials in the U.S., issued a Notice of Revised NIH Definition of “Clinical Trial” (NOT-OD-15-015) in late 2014 laying out a new, expanded definition to govern which research projects are to be categorized as a “clinical trial” from here on out.

While this change has been in process for the last few years, it wasn’t until more recently that the biomedical and behavioral research community started to take notice of the potentially significant impacts this new definition could have on a variety of basic research activities funded by the NIH, which will now be considered clinical trials. Although it was developed with the traditional NIH biomedical research clinical trial in mind and in response to concerns about study results going unreported, the social and behavioral sciences are impacted as well.

The 2016 notice states that “the revision is designed to make the distinction between clinical trials and clinical research studies clearer and to enhance the precision of the information NIH collects, tracks, and reports on clinical trials.” While it further states that the intention is not to “expand the scope of the category of clinical trials,” the resulting policy does just that.

Read on for COSSA’s full analysis of the changes.

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Posted in Issue 19 (October 3), Update, Volume 36 (2017)

OBSSR Director Discusses Implications of the New NIH Clinical Trials Policies for Behavioral and Social Sciences Research

In September 2016, the National Institutes of Health (NIH) issued a new NIH policy that requires the submission of grant applications requesting support for clinical trials in response to clinical trial-specific funding opportunity announcements (FOAs). According to the NIH, the purpose of the new is policy is to improve the NIH’s “ability to identify proposed clinical trials, ensure that key pieces of trial-specific information are submitted with each application, and uniformly apply trial-specific review criteria.” The new policy goes into effect September 27, 2017. Subsequently, all applications must be submitted in response to a clinical trial-specific FOA. Any applications not directed to a non-clinical trial FOA will be returned without review.

In an October 16 blog post, NIH Office of Behavioral and Social Sciences Research (OBSSR) Director Bill Riley noted that “although these policies and efforts were developed primarily with the traditional biomedical clinical trial in mind, they are applicable to social and behavioral trials as well.” Riley’s blog post is designed to assist the social and behavioral community in adhering to the policies and “highlight OBSSR’s efforts to make these policies and efforts fit better with the typical social or behavioral intervention trial.” In addition, NIH Director Francis Collins et al. authored a Viewpoint Essay describing the new policy in the Journal of the American Medical Association (JAMA).

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Posted in Issue 2 (January 24), Update, Volume 36 (2017)

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