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…
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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…
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…
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…
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…
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…
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…
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…
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…
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…