30
Jun2021

In an earlier post this year, we heard from Stephen Rosenfeld, MD, about a new nonprofit “learning IRB.” This post features Michele Russel-Einhorn, JD, the Chief Compliance Officer at Advarra, on how independent, private IRBs learn and evolve.

The review criteria utilized by IRBs possess an inherent flexibility that has allowed them to adapt to a wide range of research over the past several decades. Over that time span, many questions have arisen as to whether the IRB regulations can adequately apply to such innovations as organ transplants, Car-T cell therapies, and research using digital technology.  In the face of such rapid change, in all cases, however, we have seen the wisdom of those who drafted the regulations vindicated, as the IRB review criteria have continued to protect participants in all types, styles, and manner of research.

Clearly, the IRB review criteria are not unambiguous, either in their implementation or interpretation. Perhaps the most categorical provision of the regulations relates to the requirement that no fewer than five individuals must serve on an IRB. Other than that, many of the regulations are written quite broadly and can be interpreted differently depending upon the specifics of the research in question. Every IRB should be functioning in an environment in which all interpretations, guidance, and applications are subject to ongoing review, dialogue, and analysis.

IRBs across the country can have different policies and/or interpretations related to regulatory requirements that fall into potential gray areas, including, for example:

  • What the phrase “reasonably available” means when two parent signatures are required;
  • Whether monitoring constitutes a benefit in research;
  • How much time should be allocated for the consent process to meet the ethical and regulatory requirement for sufficient opportunity for an individual to consider whether to participate in research; and
  • What compensation offered in research might be considered coercive or unduly influencing of participants.

These are but a few of the numerous issues that arise in IRB review that can trigger deeply held, subjective, but considered views by the individuals who serve as IRB members. An institutional review board is, after all, a collective—a committee that, in applying regulatory criteria in a deliberative fashion, should always be focusing on the research under review, the protections and values informing the regulatory provisions, and their appropriate application in each particular context.

Most IRBs, whether independent or housed within an institution, hold regular meetings with chairs and board members to discuss recurrent issues arising in the implementation of the IRB review criteria. This often includes a review of recent articles, presentations and webinars from external experts, and discussion of the specific facts associated with certain types of research under review. In addition, regular in-service training and education tends to be commonplace at most IRBs. This is true of Advarra and many of our colleague IRBs, as we each strive to apply best practices and interpretations that can help guide the individual board members who bring independent and diverse perspectives to the IRB review process.

While some IRBs draw members primarily from within their institution, and review research submitted by their faculty and staff, Advarra does not conduct research and our IRB is comprised of both employees and over 140 members who are not affiliated with Advarra and who bring to the IRB meetings viewpoints and a frame of reference from their own professional lives.

Beyond the diversity of its IRB memberships, as an independent IRB, Advarra has firewalls and policies to guarantee the decision-making independence of these panels. AAHRPP Accreditation requirements, periodic FDA IRB inspections, and ongoing audits from clients serve as additional oversight over the IRB. These structural safeguards and corporate policies—which should be in place at any independent or institution-based IRB—ensure the open deliberation that embodies the spirit of the regulations. This goal of unfettered, constantly evolving dialogue is similar to the process by which the Secretary of Health and Human Services Secretary’s Advisory Committee on Human Research Protections iteratively identifies and debates the various complex issues that arise in the application of the regulations to new or complex circumstances. This is ultimately the beauty and challenge of IRB review: arriving at a reasonable balance between the words in the regulations, the broad ethical considerations underpinning them, and the practical limitations of locating consensus among diverse and knowledgeable IRB members.

Michele Russell-Einhorn is the Chief Compliance Officer at Advarra

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