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NIH Policy Changes for Human Subjects Research and Clinical Trials

On January 25, 2018 the National Institutes of Health (NIH) will implement new policies related to human subjects research and clinical trials. Researchers whose proposed work meets the expanded definition of 鈥淐linical Trials鈥 will be required to meet additional proposal and compliance requirements. The following provides information and resources for PIs and Department Research Administrators related to the policy changes.

Training

IRB and OCG provided an in-person training on the changes and new compliance and proposal requirements on Tuesday, December 5. An additional training will be offered in January. Details to be provided soon.听

Resources

Resources for upcoming changes and new compliance and proposal requirements:

All Researchers Who Conduct Human Subjects Research

For all projects with proposal due dates on or after January 25, 2018 that include human subjects research:

  • Is the study a clinical trial? Review the new NIH definition of a clinical trial and whether the research is considered a clinical trial. The new definition of clinical trials encompasses a wide range of trial types: mechanistic, exploratory/developmental, pilot/feasibility, behavioral, and more. Some Human Subjects Research previously not considered to be clinical trials will be considered clinical trials.
  • Apply to the correct Funding Opportunity Announcement (FOA). With the new policy, FOAs will indicate if they allow, don鈥檛 allow or require a clinical trial.
  • Complete required humans subjects and clinical trials forms, as applicable. The new policy includes new forms for human subjects research.

For Clinical Trials Research

The following applies to all projects with proposal due dates on or after January 25, 2018 that include a clinical trial:

  • Apply for funding via Funding Opportunity Announcements (FOA) specifically for clinical trials.
  • Provide additional information in proposals, including a new Human Subjects and Clinical Trial Information form.
  • Register and maintain studies in ClinicalTrials.gov no later than 21 days after enrollment of the first participant.
    • Complete Good Clinical Practices (GCP) education. This is effective as of January 1, 2017 for all active grants and contracts with clinical trials.

More Information and Resources

NIH provides guidance on the policy changes, including a tool to help determine whether a study is considered a clinical trial. NIH resources are:

  • Video
  • for clinical trials
  • Video walkthrough of

麻豆免费版下载Boulder resources include:

  • IRB听to assist researchers in determining if their study is a clinical trial. 听Determinations need to be made prior to proposal submission so this analysis should be completed well in advance of submission deadlines.
  • OCG Proposal Analysts can provide guidance for proposal requirements. See the OCG Directory to find your Proposal Analyst.
  • Contact Kathryn Snider in OCG at kathryn.snider@colorado.edu for information on Registration for ClinicalTrials.gov.
  • Contact IRB for information on Education on Good Clinical Practices.听

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