The U.S. Department of Health and Human Services (HHS) has announced plans to speed up approvals and monitoring for federally funded clinical trials. The planned revisions (the first since 1981) are intended to ease the regulatory burden faced by U.S. physicians acting as clinical investigators. HHS unveiled its “Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators” in the July 26 Federal Register.
Current federal rules require that each site where clinical trials occur must maintain its own institutional review board (IRB), which scrutinizes and approves the research protocol and informed consent procedures. Under the HHS proposal, all domestic sites in a multisite trial could name a single review board as the IRB of record. Such “central IRBs” are already common among privately-funded clinical trials. If the central IRB plan takes effect, it could make trials less costly.
At the same time, HHS wants to expand who is covered by federal rules. As American Medical News reports, “Currently, human-research subjects regulations apply only to studies funded by one of 15 federal agencies or to FDA-regulated trials. Under the HHS proposal, the rules would apply to all studies—regardless of how they are funded—that are conducted at a U.S. institution that receives any federal funding for human subjects research.”
Additional changes under the proposed rule include creating a single government website to allow electronic reporting of all clinical-trial adverse events, and an overhaul of informed consent requirements (including a requirement for written patient consent for any biospecimens for use in future research).
The deadline for public comment on the HHS advanced notice of proposed rule-making is Sept. 26. For a comparison of how the proposed guidelines stack up against existing regulations, visit the HHS website.