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With changes to how gene therapy research is reviewed and regulated, IRBs will need to do more on their own to ensure study participant safety.
The Final Action Under the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) eliminates the Recombinant DNA Advisory Committee (RAC) and its pre-review of gene transfer trials. It also closes a national database of these studies, and stops study subject reviews by local institutional biosafety committees (IBCs).
The changes mean that IRBs must be prepared to assess risks and benefits of gene therapy studies without the benefit of a RAC review and an IBC review.
Here is what IRBs and IBCs can do to fill the gap:
• Collaborate. “With the RAC being removed from the picture, essentially, IRBs and IBCs need to work together on this,” says Nancy M.P. King, JD, professor in the department of social sciences and health policy at Wake Forest School of Medicine in Winston-Salem, NC. King also is the co-director of the Center for Bioethics, Health, and Society and graduate program in bioethics.
IRBs should think of IBCs as consulting specialists. When an IRB receives a gene therapy protocol, the IRB office could call the IBC and ask for its opinion on the study’s safety and proceed from there, King suggests.
• Network. IRBs lack a good mechanism for talking to each other about new types of studies, King says.
“They go to the PRIM&R meetings and have informal networks with other IRBs, but there is no mechanism for formal coordination. That’s a general problem with any potentially controversial or risky research,” King explains. “What you want is an opportunity to talk together about those studies.”
IRB members and directors should develop relationships with their peers so they can contact them when a new question or need arises, she says.
• Seek experts. Before the NIH’s changes to gene transfer research regulation, there were multiple eyes looking at each protocol, says Daniel Kavanagh, PhD, senior scientific advisor, gene therapy, WIRB-Copernicus Group (WCG) of Madison, WI.
“First, there was the federal level with the RAC, and then the IBC and IRB would look at it from a patient safety perspective,” he says. “Now, there’s just one set of eyes, which is the IRB, for subject safety.”
Ideally, IRBs will have gene therapy research experts on the board or available to consult with the board. They also could seek expert advice when they receive a gene transfer study protocol, Kavanagh adds.
For instance, WCG has strong gene transfer research expertise and frequently consults with the IBC, he says.
Financial Disclosure: Author Melinda Young, Medical Writer Gary Evans, Editor Jill Drachenberg, Editor Jesse Saffron, Editorial Group Manager Leslie Coplin, Physician Editor Lindsay McNair, MD, MPH, MSBioethics, and Nurse Planner Kay Ball, PhD, RN, CNOR, CMLSO, FAAN, report no consultant, stockholder, speaker’s bureau, research, or other financial relationships with companies having ties to this field of study.