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…
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COSSA Headlines | NIH Clinical Trials Policy: Implications for Basic Behavioral and Social Science Research
View the slides. Join COSSA for our monthly Headlines webchat to recap the most important social and behavioral science news from the past month and answer your questions. Stick around for a deep dive discussion with special guest Dr. William (Bill)…
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…
ACTION ALERT: Register Your Concerns About the Problematic NIH “Clinical Trials” Definition
October 17, 2018 As COSSA has been reporting, 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…
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…
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…