The Association of Clinical Research Organizations (ACRO) and others are cautioning the FDA against issuing guidance that could muddle or duplicate the responsibilities of institutional review boards (IRBs) and trial sponsors or CROs.
ACRO expressed concern that the draft guidance on IRB responsibilities from November could create overlap between sponsors and IRBs, according to its comments. The draft guidance says it is the responsibility of IRBs to check investigator qualifications, site codes and inform sponsors if an IND is necessary.
But ACRO says that in commercially-sponsored research, “determinations about clinical investigators’ qualifications, the adequacy of research sites, and determining whether an IND or IDE is necessary certainly are among the responsibilities of the sponsor of the clinical investigation.”
Similarly, the Association of Clinical Research Professionals (ACRP) says that a number of the recommendations in draft “bridge over into the sponsor’s responsibility and are not currently, nor should be, in the IRBs domain for approval of research.”
The Biotechnology Industry Organization (BIO) also warns that connections between this draft guidance and previous guidance on Using a Centralized IRB Review Process in Multicenter Clinical Trials “may be lost.” BIO says the use of a single, centralized IRB for a clinical study as it can enhance a sponsor’s ability to more efficiently conduct studies.
ACRO calls on the FDA to ensure the final guidance encourages “IRBs to work in consultation with study sponsors in reviewing certain aspects of clinical studies.”
While such shared responsibility “might be difficult to coordinate at times,” it could help sponsors and CROs “avoid duplication of effort and the creation of new regulatory burdens and inefficiencies,” according to ACRO.
The ACRP also recommends clearer distinctions in the draft between local/affiliated IRBs, off-shore IRBs/Ethics Committees and non-affiliated IRBs when providing recommendations on how to qualify a clinical investigator.
The agency also should “avoid releasing a final guidance that potentially creates confusion by failing to distinguish between investigator-initiated and commercially-sponsored research,” according to ACRO.