FDA 483 - Mass General Brigham Inc. IRB - May 23, 2017

An FDA inspection conducted at Partners Human Research Committees, an Institutional Review Board (IRB), from May 16 to May 23, 2017, identified a significant observation regarding informed consent practices. The inspection report, issued to Dr. Elizabeth L. Hohmann, Director and Chairperson, highlighted that the IRB failed to ensure that information provided to study subjects as part of informed consent included all necessary elements. Specifically, during the review and approval process for an updated Informed Consent Form (ICF) related to an IRB protocol, the committee overlooked previously submitted and approved changes from prior versions of the ICF. This omission led to the approval of an ICF that did not incorporate all required modifications, necessitating enrolled subjects to re-sign the form. This observation indicates a lapse in maintaining complete and accurate informed consent documentation. The findings are reported pursuant to Section 704(b) of the Federal Food, Drug, and Cosmetic Act, which mandates reporting of observed conditions or practices that may indicate non-compliance. Partners Human Research Committees is expected to address this observation by implementing comprehensive corrective actions to ensure all elements of informed consent are consistently included and accurately maintained in their protocol review and approval processes, thereby safeguarding the rights and welfare of human subjects in clinical research.