News for Investigators

The Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) have issued guidance titled, “Minutes of Institutional Review Board (IRB) Meetings: Guidance for Institutions and IRBs.” This guidance was prepared jointly by OHRP and FDA and is intended for institutions and IRBs responsible for oversight of human subject research under HHS and FDA regulations.

To enhance human subject protection and reduce regulatory burden, OHRP and FDA have been actively working to harmonize the Agencies’ regulatory requirements and guidance for human subject research. This guidance document was developed as a part of these efforts. In addition, on December 13, 2016, the 21st Century Cures Act (Cures Act) (Pub. L. 114-255) was signed into law. Title III, section 3023 of the Cures Act requires the Secretary of HHS to harmonize differences between the HHS human subject regulations and FDA’s human subject regulations. This guidance document is consistent with the goals of section 3023 of the Cures Act.

The purpose of the guidance is to assist institutions and IRBs in preparing and maintaining minutes of IRB meetings that meet the regulatory requirements for minutes set forth in HHS and FDA regulations. The guidance also provides general recommendations on the type and amount of information to be included in the minutes.

This joint guidance is now available on OHRP's website at https://www.hhs.gov/ohrp/regulations-and-policy/guidance/alphabetical-list/index.html and on FDA's website at https://www.fda.gov/RegulatoryInformation/Guidances/ucm470046.htm.

The NIH is in the process of updating its policies and procedures regarding applying for and administering NIH-funded clinical trials – see the following two links for more details.
https://grants.nih.gov/policy/clinical-trials.htm and
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-015.html.

This would mean that research projects that would not formerly have been classified as clinical trials would now fall under that definition and be subject to all the NIH’s clinical trial requirements, including but not limited to reporting and registration. Also, “clinical trials” under the new definition would need to be submitted using additional clinical trial application forms and could not be submitted using the generic “parent” NIH funding announcements.