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Nurses can add ethical focus to IRB deliberations
Researcher, IRB chair say adding one won't do the trick
For years, IRBs have been urged to improve the diversity of their memberships by adding unaffiliated and nonscientist members; the theory being that lay members bring a greater emphasis on the subject's perspective, and can more easily ensure that subjects understand informed consent.
Now, one sociologist who has studied the activities of IRBs has a provocative suggestion: Stop worrying so much about unaffiliated members. Instead, focus on adding more nurses.
William G. Rothstein, PhD, a professor of sociology at the University of Maryland, Baltimore County, MD, says his survey of IRB members shows nurses were more likely than other groups to rate ethical issues, such as adequate informed consent and protecting subject confidentiality, as "very important" to them personally.
He says nurses were the only group looked at that rated such issues higher than the average of all IRB members. Physicians surveyed consistently rated ethical issues lower in importance than the average, and responses of unaffiliated IRB members were similar to those of other groups represented on the boards, including administrators and pharmacists.
Ironically, both the nurse members and the IRB members, as a group, rated nurses among the least influential groups in committee deliberations, which could dilute their ability to press ethical issues on boards. Rothstein says the answer may lie in adding enough nurses to a board to give them critical mass to make their case.
Rothstein, who himself serves on an IRB, says that when his team began surveying IRB members about their ethical attitudes, he didn't know what to expect.
"We were surprised [by the results], but then we looked at the literature on nurses and their attitudes toward ethical issues, and the two matched very nicely," he says. "The types of ethical issues that IRBs consider are ones that nurses have been shown to be sensitive to in other issues. If the ethical issues had involved sampling or dosage, or types of drugs, I'm not sure nurses would have come out as differently as they did. But IRBs rarely look at issues like that."
Responses from members rated
Rothstein surveyed 284 members of 27 IRBs across the United States. Questionnaires were administered at IRB meetings.
Members were asked for demographic information, as well as to rate the importance of 11 issues, including:
For every issue, the nurse members rated it as more important than any other group. For example, on informing subjects of risk, 100 percent of nurses found the issue "very important," compared with 86.6 percent of physicians, 86.8 percent of unaffiliated members and 88.7 percent of all members surveyed.
Rothstein says the disparity isn't based on dissimilar ethical values, because each group had nearly identical rankings of all the ethical issues by importance. He says no differences were found between nurses who did or did not submit research proposals themselves.
Based on these results, Rothstein says it would be more useful for IRBs to recruit more nurses than to spend energy trying to increase the number of unaffiliated members on an IRB.
"It's a waste of time [putting more unaffiliated members on a board]," he says. "First of all, it's hard to find them, and second, they tend to be ignorant of the issues involved. They tend to defer to others, and the others who speak most often and most forcefully are physicians. So I really don't feel it has much of an impact."
Rothstein says that in his experience, researchers on IRBs look at the review process with an eye toward how it might affect their own research in the future.
"They don't want the bar raised higher for any research because it may affect their research," he says. "I've heard this said many times: 'We don't require that,' the implication being if you require it for this other study, then you could come back and demand it for my research.
"I think it's the general standards they are concerned with — they want standards that won't have an adverse impact on them."
Nurses can provide balance
Elaine Larson, RN, PhD, FAAN, CIC, professor of pharmaceutical and therapeutic nursing and IRB chair at Columbia University Medical Center, New York, NY, says she was not at all surprised by Rothstein's findings.
"Nurses see themselves much more as patient advocates for the individual patient, whereas researchers often see themselves as generating new knowledge and maybe not so attentive to the interests of the individual patient," she says. "There may be a little bit of a perspective or cultural difference."
However, she says that when taken to extremes, a patient advocacy role can have a downside, causing nurses to act as gatekeepers who view researchers as the enemy. On the other hand, researchers may demonstrate an opposite extreme, showing less concern about individual subject welfare.
"In the IRB, we do sometimes get [proposals] like, 'Let's do a muscle biopsy in a healthy child,'" she says. "We would say no to that, because it's somewhat painful, it's not free of risk and there's no individual benefit, nor is there a clear rationale for what it adds to generalizable knowledge."
She says both extremes — too much protectiveness, or too little — are harmful.
"The one extreme is 'Nobody's going to touch my patient to do anything unless it's therapeutically and directly beneficial.' That's a problem, because how in the world are we supposed to know what's beneficial unless we try it in some systematic way? And that requires research," Larson says.
"On the other extreme, from the researcher's end, is the idea that our main goal is to increase knowledge, and if it's not pleasant for a few people, it's worth it. That's not good either.
"I think there needs to be a better team approach to research, where the clinicians and researchers understand that, together, they're trying to make it better for patients."
Larson notes that for most of her career, she has been the only RN on her IRB. But she says nurses aren't the only professional group that advance the patient advocacy end of the spectrum, pointing to social scientists and public health workers as examples.
"So I have a feeling that it's probably not nurses, it's probably people who are primarily in the social sciences," she says. "Nursing is sort of standing between two worlds — certainly the biologic sciences, but we're also interested in some of the sociological and cultural factors that have to do with illness."
She agrees with Rothstein that it would be beneficial to add more nurses to provide that essential counterbalance to the researcher perspective — even to the extent of not focusing so much on adding unaffiliated members.
"We have wonderful lay members, but they really can't say a lot," Larson says. "What they do say is to tell us that the consent form isn't understandable. That's a very good perspective. But honestly, there needs to be members who are of the patient advocacy end of the spectrum who also understand the biology of what's going on."
Both Rothstein and Larson say having one nurse on an IRB is not enough to ensure a robust discussion about ethical issues.
"When they're on their own, it takes a lot of bravery to say something in an IRB with all these very strong researchers and mature people who have a lot of clout in the organization," Larson says.
Rothstein advises limiting the number of MDs on an IRB and trying to recruit more non-MDs. "You have to think in those terms," he says.