Search Results: clinical

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…

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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…

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December 2018 Headlines & Deep Dive on NIH Clinical Trials Policy

View the slides. COSSA’s December 2018 Headlines webchat featured a deep dive discussion with special guest Dr. William (Bill) Riley, Director of the Office of Behavioral and Social Sciences Research (OBSSR) at the National Institutes of Health (NIH), who gave an update on what’s new and exciting at OBSSR and discuss the next steps for NIH’s controversial clinical trials policy.

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Letter on NIH Clinical Trials Policy

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Statement on the NIH Definition of “Clinical Trials”

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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…

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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…

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OHRP Releases Information on Clinical Trial Consent Form Posting, GDPR Guidance

As part of the revisions to the Common Rule (the set of regulations that govern research involving human participants) going into full effect in January 2019 (see COSSA’s coverage for more details), clinical trials covered by these regulations must publicly post copies of the consent forms used to enroll participants. The Office of Human Research Protections (OHRP) has announced that these consent forms must be posted either on clinicaltrials.gov or to a docket folder on regulations.gov (docket ID: HHS-OPHS-2018-0021). OHRP has also made available guidance related to the European General Data Protection Directive (GDPR) to assist stakeholders conducting human subjects…

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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…

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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…

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Letter to NIH Director on Clinical Trial Policy

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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…

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

Summary 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. Read more.

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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…

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SBM Hosts NIH Good Clinical Practice for Social and Behavioral Research Training Course

The Society of Behavioral Medicine (SBM), a COSSA member, is hosting a free National Institutes of Health (NIH) training and certification course for good clinical practice in behavioral and social science research at the request of the NIH Office of Behavioral and Social Sciences Research. The Clinical and Translational Science Awards (CTSA) Program, funded by the NIH National Center for Advancing Translational Sciences, developed the training material which is comprised of nine video modules. As previously reported, all NIH-funded investigators and staff who are involved in applying for, conducting, overseeing, or managing clinical trials are required, effective January 1, 2017, to…

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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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NIH: Collaborative Innovation Award, Clinical and Translational Science Award Program

The National Center for Advancing Translational Sciences (NCATS) within the National Institutes of Health (NIH) is inviting applications to stimulate innovative collaborative research in the NCATS Clinical and Translational Science Award (CTSA) consortium.  Because translating biomedical discoveries into clinical applications is essential to improving health and at the same time a complex process with high costs and substantial failure rates, the CTSA hubs are designed to promote advances in translational research and training at participating medical research institutions.  NCATS recently released a funding opportunity announcement (FOA), Collaborative Innovation Award, Clinical and Translational Science Award Program (PAR-15-172), to enable collaboration among…

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NIH to Use Single IRB to Speed the Initiation of Clinical Research, Seeks Comments

On December 3, the National Institutes of Health (NIH) issued a draft policy to promote the use of single institutional review boards (IRB) in multi-site clinical research studies. The draft policy proposes that all NIH-funded multi-site studies carried out in the U.S. utilize a single IRB regardless of the funding mechanism. Hence, the agency is seeking public comments on the draft policy through a 60 day comment period closing January 29, 2015. According to the release announcing the draft policy, exceptions would be allowed if local IRB review is necessary to meet the needs of special populations or where it…

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NIH Seeks Comments on Draft NIH Policy on Dissemination of NIH-Funded Clinical Trial Information

The National Institutes of Health (NIH) is seeking comments on its draft policy “to promote broad and responsible dissemination of information on clinical trials funded by the NIH” through registration and submission of summary results information to ClinicalTrials.gov. NIH has a number of policies designed to promote the distribution of research results and guide funding recipients in disseminating their results, including the NIH Data Sharing Policy, the NIH Public Access Policy, the NIH Research Tools Policy, and the NIH Genomic Data Sharing Policy. According to the NIH, a recent study found that the results of less than half of NIH-funded…

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NIH: IDeA Program Infrastructure for Clinical Translational Research

The National Institutes of Health (NIH) established the Institutional Development Award (IDeA) program in 1993 to enhance biomedical research in states that have had historically low NIH grant funding success rates. The program currently supports competitive research in 23 states and Puerto Rico through the Centers of Biomedical Research Excellence (COBRE) and IDeA Network of Biomedical Research Excellence (INBRE) initiatives.

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