On September 16, 2016, the Department of Health and Human Services (HHS) issued a new regulation and the NIH has issued a new policy to increase the availability of information about clinical trials. The HHS Final Rule describes requirements for registering and submitting summary results information for certain clinical trials to ClinicalTrials.gov. A complimentary NIH policy that applies to all clinical trials funded by NIH, regardless of whether they are subject to the Final Rule was also published today. The Final NIH Policy was also published in the NIH Guide for Grants and Contracts.
NIH has made available a number of resources to help explain these changes. These resources include:
§A summary of the Final Rule and NIH policy
§A table of the key elements of the Final Rule and NIH policy
§A summary table of changes from current practice described in the Final Rule
In addition to these resources, ClinicalTrials.gov will be offering a series of three live webinars to provide responsible parties with information about the Final Rule. Each webinar will cover a different aspect of the Final Rule, including an overview of which applicable clinical trials are covered, what clinical trial registration and results information is required under the “expanded” requirements, and when the requirements take effect.
For a more in-depth examinationof these issues, we encourage you to read two new “Under the Poliscope” blogs authored by Dr. Carrie D. Wolinetz, NIH Associate Director for Science Policy and Dr. Michael Lauer, NIH Deputy Director for Extramural Research. The blogs can be accessed here and here.
All of the above referenced information, as well as additional information can be found on theOffice of Science Policywebsite under the “Sharing Clinical Trial Information” tab.