As many of you know, the NIH has issued a policy on single IRB review, effective September 25, 2017, “establishing the expectation that all sites participating in multi-site studies involving non-exempt human subjects research funded by the National Institutes of Health (NIH) will use a single Institutional Review Board.”
More substantially, January 19, 2018, is the effective date for the final revisions to the Common Rule. Significant changes in the regulations governing human subjects research involve its applicability to non-federal research, the definition of research and human subject, new categories of research that may be exempt from IRB review, additional requirements for informed consent for clinical trials, and a relaxation of requirements for continuing review. A single IRB mandate for “cooperative” research becomes effective in January, 2020.
IRB leadership and staff are working in concert with OMH leadership, Counsel’s Office, and ITS to adapt and revise our policies, procedures, and information systems to the new regulations and policies. We will keep you informed of actions you will need to take as implementation dates near.