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 “Clinical Trials” 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.
Resources
Resources for upcoming changes and new compliance and proposal requirements:
- Human Subjects Research and Clinical Trials: 2018 Policy and NIH Proposal Changes - slide deck from 12/5/2017 OCG and IRB training
- CU Boulder Institutional Review Board (IRB)
- General Instructions for NIH and other PHS Agencies: Forms E
- NIH: Research Involving Human Subjects
- NIH: Clinical Trials Requirements
- Video: Overview of New NIH Policies on Human Subjects Research
- Video: Tour of New Forms
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’t 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:
- NIH Definition of a Clinical Trial
- Video Overview of new NIH Policies on Human Subjects Research
- Decision Tree for clinical trials
- FAQs
- Case Studies
- Video walkthrough of PHS Human Subjects and Clinical Trials Information Form
CU Boulder resources include:
- IRB to assist researchers in determining if their study is a clinical trial. 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.