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NIH Extends Enforcement Delay of Clinical Trials Policy Until September 2021

On July 24, the National Institutes of Health (NIH) released a notice announcing a further delay of enforcement of clinical trials reporting requirements for NIH-funded research designated as “basic experimental studies with humans.” The enforcement date, originally extended to September of this year, has been pushed to September 24, 2021. A blog post from the NIH Office of Science Policy describes the extension as necessary to address the challenges of reporting requirements for some researchers by continuing to search for common ground with the basic science community.

The notice is the latest iteration of NIH statements relating to changes to NIH’s clinical trial policy. As previously reported, NIH has established a new definition of “clinical trials” which includes some basic behavioral and social science research and mandates new reporting requirements. COSSA previously authored a Hot Topic piece detailing how the changes would affect basic research. Due to negative reactions from the basic science community on concerns of undue burden on the researchers, NIH announced a delay in the enforcement of the clinical trials policy and issued a Request for Information (RFI) to the community on best practices for implementing the policy. Read COSSA’s previous coverage for more details.

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Posted in Issue 16 (August 6), Update, Volume 38 (2019)

COSSA Encourages Response to NIH Clinical Trials RFI

As previously reported, the National Institutes of Health (NIH) has been taking steps in recent years to enhance its stewardship of and increase transparency over the clinical trials it funds. This has included the development of a new, expanded definition of the term “clinical trial,” which now applies to all research involving human subjects that involves a prospective experimental manipulation of an independent variable, and triggers the need for researchers to adhere to a number of new registering and reporting requirements using clinicaltrials.gov (see COSSA’s Hot Topic piece for details). Many basic behavioral and social science studies will be caught up in these new requirements.

NIH released a Request for Information (RFI) (NOT-OD-18-217) in September seeking input on the standards NIH should use in registration and results reporting for prospective basic science studies involving human participants (see COSSA’s previous coverage of the RFI). COSSA has issued an Action Alert to assist stakeholders concerned about this revised “clinical trials” definition in responding to the RFI. The alert includes additional context on the NIH clinical trials policy, a step-by-step guide to responding to the RFI, and sample text respondents can use in submitting their comments. Responses to the RFI are due by November 12, 2018. COSSA encourages individuals concerned about this policy to respond and share the action alert widely.

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Posted in Issue 21 (October 30), Update, Volume 37 (2018)

NIH Releases RFI, Delays Enforcement of New Clinical Trials Policy

On July 20, the National Institutes of Health (NIH) issued a Guide Notice (NOT-OD-18-212) outlining its plans to delay enforcement of key clinical trials reporting requirements for projects traditionally considered basic research.

The Notice, Delayed Enforcement and Short-Term Flexibilities for Some Requirements Affecting Prospective Basic Science Studies Involving Human Participants, follows months of feedback and pressure on NIH from the external research community, including COSSA and several COSSA members, to rescind or at least delay implementation of NIH’s clinical trials policy announced in 2016. As previously reported, in an effort to enhance its stewardship of and increase transparency over the clinical trials it funds, NIH established a new definition of “clinical trials,” which now captures some basic behavioral and social sciences research and comes with new reporting requirements (see COSSA’s Hot Topic piece for details).

NIH has now released a Request for Information (RFI) (NOT-OD-18-217) seeking input on the standards NIH should use in registration and results reporting for prospective basic science studies involving human participants. A blog post from the NIH Office of Extramural Research outlines the following specific topics for which the RFI is seeking comments:

  • “Examples of prospective basic science studies involving human participants that pose the greatest challenges in meeting the registration and results information submission requirements at ClinicalTrials.gov, including specific reasons for these challenges (e.g., specific data elements);
  • Strengths and weaknesses of potential alternative platforms that might function as conduits for timely registration and reporting of prospective basic science studies involving human participants;
  • Additional data elements or modification to existing data elements that could be applied to ClinicalTrials.gov to better meet the needs of the public and of researchers in assuring timely registration and results information submission of prospective basic science studies involving human participants;
  • Other existing reporting standards for prospective basic science studies involving human participants and how such standards would fulfill the aims described in the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information; and
  • Any other point the respondent feels is relevant for NIH to consider in implementing this policy for timely registration and reporting of prospective basic science studies involving human participants.”

Responses to the RFI must be submitted by November 12, 2018.

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Posted in Issue 17 (September 4), Update, Volume 37 (2018)

NIH “Clinical Trials” Definition Moving Forward: Researchers Take Notice

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. In a recent blog post, Mike Lauer, Deputy Director for Extramural Research, explained that while no changes have been made to the definition of a clinical trial, which is the primary area of concern for the social science community, the case studies developed by NIH to help investigators determine whether their research would now fall under the new definition have been updated and clarified.

COSSA described the planned changes and their impacts on the social science research community in a Hot Topic piece last year. All social and behavioral science researchers who have received NIH funding in the past, or who are looking to apply in the very near future, are strongly encouraged to review this information as your research may now fall under NIH’s revised definition of a “clinical trial” and require new steps to be taken. This policy impacts funding opportunity announcements with due dates of January 25, 2018 and beyond.

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Posted in Issue 1 (January 9), Update, Volume 37 (2018)

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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