clinical trials

NIH Further Extends Registration, Reporting Enforcement Delay for Some Clinical Trials

On March 23, the National Institutes of Health (NIH) issued a notice (NOT-OD-21-088) further delaying enforcement of the NIH Policy on Dissemination of NIH-Funded Clinical Trials Information for basic experimental studies with human participants (BESH). As previously reported, NIH established a revised definition of “clinical trials” several years ago, which now includes some basic behavioral and social science research and mandates new reporting requirements. The new registration and reporting requirements—specifically requirements to register and report in ClinicalTrials.gov—have presented challenges for some types of behavioral and social science projects that now fall under the BESH category. In response, NIH delayed enforcement…

NIH to Hold Webinar on Basic Experimental Studies with Humans

On December 7, the National Institutes of Health (NIH) will be holding a public webinar on the Basic Experimental Studies with Humans (BESH) classification of NIH-funded research. The webinar, which will be led by Acting Director of ClinicalTrials.gov Rebecca Williams and NIH Technical Specialist at ICF International Elisa Golfinopoulos, will discuss an analysis from the National Library of Medicine (NLM) on the challenges of reporting and registering results information of BESH on ClinicalTrials.gov and the broader implications of the NLM’s findings. The webinar will be streamed live on the NIH website.

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…

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…

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…

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…

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…

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…

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

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. 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…

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…

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