The document discusses the National Institutes of Health (NIH) draft policy mandating the use of a single Institutional Review Board (IRB) of record for multi-site NIH-funded research conducted at domestic sites, while foreign sites are given the option to comply. The policy aims to streamline IRB review processes, shifting regulatory compliance responsibilities—from IRB oversight to obtaining informed consent and reporting adverse events—to a centralized IRB which must still consider local context and meet other regulatory requirements. Selection of the IRB of record will fall to the project lead, and associated costs, including those for fee-based IRB services, are to be included in grant budgets. Limited exceptions to the single IRB mandate are permitted, particularly where specific populations or legal requirements necessitate local review.
The document evaluates several implementation strategies, including ceding oversight to independent (commercial) IRBs, using or modifying existing IRB structures at the lead institution, establishing virtual IRB infrastructures, and direct-charging IRB costs while raising potential compliance concerns under federal costing guidelines. Each option presents distinct advantages and challenges: independent IRBs offer specialized infrastructure and experience with external sites but raise concerns about consideration of local context; leveraging internal IRBs utilizes established processes but may lack flexibility and local representation; virtual IRBs facilitate adaptability and expertise-sharing but introduce new complexities in coordination and financial management. The summary also addresses concerns about the policy’s “one-size-fits-all” approach, which may impose administrative burdens, affect investigator timelines, and challenge traditional notions of local context in IRB reviews, ultimately encouraging institutions to weigh the administrative, operational, and financial implications before implementation.
