Human Subjects Research Alert

Revised Final Common Rule Web Resources and NIH Policy Changes on Human Subjects Research

There are a number of substantial recent changes to NIH funded research policies relating to Institutional Review Boards that investigators should be aware of. There are also a number of important changes to the Common Rule (45 CFR Part 46) that will take effect between 2018 and 2020.

The following web resources are listed to provide information and guidance once these new changes go into effect. Researchers should be aware that the NIH policies affect the grants that are due on or after Jan.25th, 2018, so  it is best to be proactive in the budget and details regarding single IRB review.

To increase transparency and stewardship for clinical trials, the NIH expanded the definition of a clinical trial. This website has important information regarding that definition and appropriate requirements. Some of these new requirements are highlighted below.

Good Clinical Practice (GCP) Training:

This policy was effective Jan.1, 2017 and all study team investigators and staff who conduct, manage or oversee or design clinical trials research are require to complete training on GCP.

NIH: Single IRB Review:

This policy applies to NIH funded multi-site human subjects studies, requiring a single IRB review. This policy goes into effect for all grants due on or after Jan. 25th, 2018. Options for methods of single IRB review include:

  • Cooperative (Reliance, Institutional Authorization) Agreements: These are negotiated by the sites that are engaged in a multi-site study where a central protocol is used. Collaborating sites elect to cede review to a single site, usually the institution of the PI receiving the award or a site best suited to be the IRB of Record.
  • Central IRBs: These are usually formed for a common purpose- CIRB (Central Institutional Review Board for NCICTN (National Cancer Institute Clinical Trials Network) is an example of a central IRB. Commercial IRBs or Independent IRBs can function as a central IRB. These are commonly used in industry sponsored studies and there are charges for the service. Commercial IRBs include Quorum, Copernicus Group/ Western IRB, Shulman/Advarra.
  • SMART IRB: This reliance system is set up by and utilizes a master agreement that is signed by each participating institution. SMART IRB is funded by the NIH Clinical and Translational Science Awards (CTSA) Program through grant number UL1TR001102-04S1.

Additional Resources on the Single Review Policy:

Clinical Trials Transformation Initiative (CTTI): Implementation tools for the use of a single IRB of record.

NIH Certificate of Confidentiality (COC):

This policy was effective October 1, 2017 and provides automatic coverage for all NIH funded human subjects studies that involve collecting or using identifiable sensitive information. Studies should include language in the Informed Consent Form (ICF) that explains the COC and what specifically is covered by the policy. The NIH COC kiosk has detailed information regarding the Certificate of Confidentiality. This policy covers all applicable NIH studies that were ongoing or funded as of Dec. 13th, 2016.

Changes to the Common Rule (45 CFR part 46):

The much awaited and discussed HHS Common Rule changes affecting Human Subjects Research were officially released January 19th, 2017. Some of the changes include expansion of the exempt research categories and the addition of a new “limited review” for applicable exempt research. Other changes include eliminating continuing review for some expedited studies, some additional required elements of informed consent such as details regarding biospecimens, return of results and commercial profit. The Collaborative Institutional Training Initiative (CITI Program) has some great resources detailing all the changes. The new regulations are slated to take effect Jan. 19th 2018 with the exception on the single review rule for cooperative research which is January 2020. There has been a request to postpone the effective date for a year. Check with either of the resources below for those updates.

Additional Resources: