When institutional review boards meet to discuss the ethics of human subjects in studies, they rely on the perspective of non-scientists to make sure that the test subjects will be able to understand what they are signing up for. Each IRB has six scientists and three non-scientist members. The main qualification for being one of the three non-scientists is that you are not a scientist.
Tanna MacReynold frequently serves on IRBs in addition to her role as senior director of IRB affairs at WIRB in Washington. “It’s very exciting. The members are quite the mix. We have physicians, pediatric oncology doctors, photographers, and engineers. I’m a non-scientist,” she says. It’s a paid job, but no one is an IRB member as a full-time career, since one person is usually on at most three IRBs a week.
IRBs meet just once to approve a study or to require modifications. The members have two days to prepare for each meeting, each of which is about three hours long.
“The scientists are there to present the scientific aspects of the study,” she says. “The scientists use the meeting as an opportunity to educate the non-scientists. We have a discussion about the rights and welfare of the subjects, and it’s one of the critical pieces for non-scientists to view it as a layperson, look at the consent form, make sure that we understand what is going on in the research, and go away as informed subjects.”
After the discussion, the board holds a vote about whether to approve the study, and the majority wins. “I’ve been on a jury, and I would say it’s kind of similar,” MacReynold says.
A board may approve a study, turn it down, or request changes or additional information. The researchers have an opportunity to respond, and can request another meeting for the IRB to reconsider.
Since IRBs are supposed to be impartial, WIRB has to be careful to avoid conflicts of interest. MacReynold says this is easier at an independent review company like WIRB than it is at small individual institutions such as hospitals or universities where the people who are on IRBs often have direct ties to the research being conducted.
Nevertheless, the for-profit IRB industry has attracted criticism because of the fear that IRBs will try to please clients instead of worry about the welfare of human subjects. MacReynold says the business personnel and the staff who run the IRBs are separate from one another. “Business discussions don’t ever come up in the boards,” she says. “Even as a staff person, I’m pretty much as removed from the business specs as possible. We don’t want to commingle those two things.”
For-profit IRBs are kept honest by FDA regulations in addition to the company’s scruples. Both of WCG’s main IRB companies, Copernicus Group and WIRB, have been awarded ISO9000 certification by an independent auditor, with WIRB earning the certification on March 16.