Single Institutional Review Board (sIRB)

Research supported by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (DHHS), strives to understand, treat, and ultimately prevent the myriad infectious, immunologic, and allergic diseases that threaten millions of human lives. The NIAID Division of Microbiology and Infectious Diseases (DMID) supports extramural research to control and prevent diseases caused by infectious agents, including research to counter bioterrorism. This includes basic and applied research to develop and evaluate therapeutics, vaccines, and diagnostics that is funded through a variety of research grants and contracts.

The evaluation of therapeutics, vaccines, devices, diagnostics and treatment strategies in clinical trials and studies is an essential element of the efforts of NIAID. Through multiple grant and contract research programs, NIAID supports a broad range of clinical research, including single-center and multi-center Phase 0-4 clinical trials of therapeutics and vaccines, including new vaccine formulations, schedules and modes of delivery; surveillance or natural history / cohort studies for pathogens of interest; and evaluation of novel diagnostics. Much of this research is devoted to addressing critical public health needs, such as those related to emerging and re-emerging infectious diseases (e.g., SARS-CoV-2, Ebola, influenza, etc.), as well as those supporting the evaluation of the safety and efficacy of vaccine and therapeutic candidates against potential agents of bioterrorism, including NIAID priority pathogens (https://www.niaid.nih.gov/research/emerging-infectious-diseases-pathogens). 

The recent COVID-19 pandemic has underscored the need for rapid IRB review to support critical and time-sensitive clinical studies. To that end, DMID requires the services of a single institutional review board (IRB), also known as an independent ethics committee (IEC), to review the methods proposed for select NIAID-supported clinical research activities to ensure studies subject to the Revised Common Rule Cooperative Research Provision (45 CFR 46.114(b)) are ethical and meet current Federal regulations.  Furthermore, NIH Policy requires the use of a single IRB for multi-site, non-exempt human subjects research using the same research protocol.

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