NIH Single IRB Policy
The NIH Single IRB policy will go into effect for all grants applied for after January 25, 2018. This policy requires a single IRB (sIRB) review for all NIH-funded multi-site research. One IRB will serve as the IRB of record while the other institutions rely on the review of the primary institution via a formal reliance agreement signed by both Intuition A, the IRB of record, and Institution B, the IRB relying on the IRB of record. Sites relying on the primary institution are still responsible for ethical conduct of research and for ancillary committee reviews, investigator training, and COI management. The decision of which site will serve as the IRB of record will be made during the grant submission period.
NIH Definition of Clinical Trial – Update
Recently, there has been a call from the research community for clarification of the NIH definition of clinical trial. In 2015, NIH added “behavioral outcomes” to their definition of clinical trial. The NIH definition of clinical trials is as follows: “A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.”
In September 2017, COGR sent a letter to NIH requesting revisions to the clinical trial case studies as these case studies, published in 2017, seemed to significantly expand the definition. Per an email from COGR on January, 24, 2018, “…on January 22, a dialogue on this topic between Jeremey Wolfe, immediate past president of FABBS, and Dr. Mike Lauer, NIH Deputy Director for Extramural Research, addressing related concerns that have been raised by the community was published in Nature Human Behaviour. The article provides information and clarifications that should be helpful to investigators.”
NIH has also created a decision tree to assist with determining whether a study meets the definition of a clinical trial. The decision tree can be found at: https://grants.nih.gov/policy/clinical-trials/CT-decision-tree.pdf. The decision of whether a study meets the definition will be determined during the grant submission.
Things to remember if YOUR study meets the NIH definition of a clinical trial:
- Good Clinical Practice (GCP) training is REQUIRED if the study meets the clinical trial definition. The principal investigator of the study will hold the responsibility for making sure everyone on the research team has completed GCP training. UNCG has social/behavioral/educational (SBER)-focused GCP training available through CITI. To complete the training, go to https://integrity.uncg.edu/citi-training/ – and click the document under “GCP – Social and Behavioral Research Best Practices for Clinical Research.”
- If a study meets the NIH definition of clinical trial, registration of the study on ClinicalTrials.gov will be required. Registration on ClinicalTrials.gov will be the responsibility of the principal investigator of the study or their designee. IRB approval of the study will be held until documentation of registration on ClinicalTrials.gov can be provided. Registration is required within 21 days of enrolling the first human subject. Information regarding the registration of the study on ClinicalTrials.gov must be included in the consent form.
- Reporting of study data on ClinicalTrials.gov is required within 12 months of completing data collection on the primary endpoint. Reporting this information to ClinicalTrials.gov will be the responsibility of the principal investigator or their designee. If the principal investigator is not compliant with this reporting requirement, NIH can hold funding for ANY investigator at the institution with NIH funding.
