IRBs tasked with reviewing xenotransplantation study protocols likely will need to consult with outside experts. “IRBs must have the expertise in order to review the protocols from a scientific, ethical, and patient welfare perspective,” says Daniel J. Hurst, PhD, ThM, MSc, director of medical professionalism, ethics, and humanities at Rowan University School of Osteopathic Medicine in Stratford, NJ.
Hurst and colleagues previously recommended IRBs consider using an expert consultant who is external to the IRB to review the submission and offer recommendations before the committee actually votes.1 “For example, the International Xenotransplantation Association has an ethics committee with varying expertise on a number of matters. The committee allows for protocols to be submitted to them for review,” Hurst suggests.
At some hospitals, there may be one or two enthusiastic physicians or surgeons who want to initiate a clinical trial for xenotransplantation. “They may, in their enthusiasm, minimize the potential problems to the IRB,” says David Cooper, MD, PhD, a senior investigator in transplant surgery at Mass General Research Institute.
Thus, the person requesting the clinical trial might convince the IRB everything they are going to do will be fine, and win protocol approval. “The local IRB probably doesn’t have the expertise to know if they’re being given all of the facts to consider,” Cooper notes.
Cooper would like to see the FDA require IRBs reviewing these study protocols to include a member with expertise in the xenotransplantation field. This expert could be someone outside the IRB’s institution. Possibly, there could be a national IRB with multiple experts in the field to review the study protocols. “I am doubtful that the standard local IRB at most centers is sufficiently knowledgeable to make a decision about whether a particular xenotransplantation clinical trial is realistic,” Cooper observes.
In the complex field of xenotransplantation, specialized expertise is needed in multiple areas, including immunology and infectious disease.
“You may need more than one expert, because the field is very wide. The IRB would need at least one expert who knows when another expert opinion is required,” Cooper asserts.
One important example relates to clinical trials involving brain-dead subjects. In these subjects, after an organ transplant, it may be impossible to determine the cause of graft failure. The FDA will ask: Was it because of the pig graft, or was it because of the effects of brain death? The researcher may have no way to know for sure. “It complicates everything. It’s not a valuable exercise, because the results are difficult to interpret and may be misleading — and you don’t learn anything new,” Cooper says.
IRBs may approve these study protocols simply because they lack sufficient expertise on both brain death and xenotransplantation to realize the trial is weak and should not go forward as proposed.
“We should have people on the IRB who know the topic well — and they are not easy to find,” Cooper says.
REFERENCE
1. Hurst DJ, Padilla LA, Trani C, et al. Recommendations to the IRB review process in preparation of xenotransplantation clinical trials. Xenotransplantation 2020;27:e12587
An enthusiastic surgeon who wants to initiate a clinical trial for xenotransplantation may, in their enthusiasm, minimize the potential problems to the IRB. The surgeon might win approval, but the IRB might lack the expertise to know if they are receiving all the facts.
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