Study identifies barriers to use of central IRBs

A study conducted by the Clinical Trials Transformation Initiative (CTTI) identified some of the barriers IRBs may face when choosing a central IRB for multicenter studies. “Using Central IRBs for Multicenter Clinical Trials in the United States,” published in the journal PLOS ONE, gives recommendations for IRBs to overcome the barriers to choosing a central IRB and improve the efficiency of multicenter studies. CTTI is a public-private partnership established by Duke University and the Food and Drug Administration that comprises more than 60 member organizations to improve the quality and efficiency of clinical research.

The CTTI researchers conducted a literature review and interviewed IRB representatives from institutional IRBs, federal IRBs, commercial IRBs, industry, and regulatory agencies. “Our goal was to identify the range of perceptions and beliefs among diverse participants, and not to establish the prevalence of different views,” the study authors wrote.1

“To help with this, we developed a guide to support communication between a research institution and a central IRB as they develop an agreement about who will do what for a given trial,” says the study’s lead author, Kathryn Flynn, Ph.D., assistant professor of medicine at Medical College of Wisconsin. “We hope sponsors in a position to do so require the use of central IRB review for multisite trials, to allow stakeholders to gain experience that may foster greater comfort and trust with that model.”

Barriers the authors identified include:

  • The feasibility of working with multiple outside IRBs, each having its own protocol submission process.
  • loss of revenue generated from fees for review of commercial-sponsored studies;
  • concern for noncompliance and regulatory liability;
  • concern for legal liability in the event of litigation secondary to errors, omissions, or negligence of an IRB not directly affiliated with the IRB conducting research;
  • quality of review;
  • potential loss of local context (for example, unique patient populations, local knowledge of investigators, or a center’s resources for conducting the research).1

The authors of the study developed a list of solutions for the identified barriers, including establishing liability protections, clarifying policy to take action against the IRB of record in the case of noncompliance, conducting standardized quality tests of IRBs, and developing a detailed communication guide with information on the study site, investigators, and other local data.

The study also uncovered confusion over the responsibilities of institutions and central IRBs.

“A major finding was that many of the perceived barriers to using central IRBs arise from the fact that most or all of the tasks related to protecting the institution (e.g., conflict of interest review) are often coordinated through the institution’s IRB office and incorporated into their review process,” the study authors wrote. “What evolved as bureaucratic convenience in most institutions — locating certain institutional review processes in the IRB office — seems to have altered perceptions of what is entailed in the ethical review of research. This conflating of institutional responsibilities with the ethical review responsibilities of the IRB leads to confusion about how institutional responsibilities would be handled in the context of a central IRB review, creating resistance to using central IRBs.”1

To address the problem, the authors developed a guide to assist IRBs in breaking down which responsibilities go to the central IRB, individual institutions, or both.

“The clinical trials community has an opportunity to significantly improve the quality and efficiency of one essential aspect of the clinical research enterprise, as there is good reason to believe that central IRB review would be beneficial to clinical research,” the authors stated.1

Reference

  1. Flynn KE, Hahn CL, Kramer JM, Check DK, Dombeck CB, et al. (2013) Using Central IRBs for Multicenter Clinical Trials in the United States. PLoS ONE 8(1): e54999. doi:10.1371/journal.pone.0054999