Time for major changes in meeting mandates
Things have changed; IRBs should too
Human subjects research has evolved and grown dramatically in recent decades, fueled by advances in medical technology, research globalization, and financial and professional incentives, a researcher and health science expert says.
"This situation creates increasing opportunities for ethical errors with devastating effects," says Barry Bozeman, PhD, Ander Crenshaw professor of public policy and regents' professor of public policy at the University of Georgia in Athens, GA.
"The typical professional and policy response to calamities involving human participants in research is to layer on more ethical guidelines and strictures," Bozeman says.
"In our paper we used a recent case, the Johns Hopkins University/Kennedy Krieger Institute Lead Paint Study, to examine lessons learned since the Tuskegee Syphilis Study about the role of institutionalized science ethics in the protection of human participants in research," Bozeman says. "We address the role of the institutional review board as the focal point for policy attention."
The 1992 Kennedy Krieger Institute Lead Paint Study was designed to assess cost-effective methods of household lead paint abatement. The study enrolled minority children who were exposed to lead in their homes and measured their blood lead levels, comparing children who lived in houses that had one of three lead abatement measures.1
Most of the children had reductions in blood lead levels, but two mothers of children whose blood lead levels increased filed a lawsuit. The case revealed that investigators encouraged landlords participating with the study to rent their houses to families of young children. The Maryland Court of Appeals terminated the study, describing it as a new Tuskegee.1
The Kennedy Krieger Institute study had followed all IRB and regulatory requirements, yet still fell far short of ethical goals.
While it's an extreme example, it highlights the problem of IRBs spending too much time and focus on more trivial matters and not enough on potentially serious issues, Bozeman says.
"In my judgment, IRBs spend 75% of their time on projects that should be expedited, but aren't, and 25% of their time is taken up with things where there's a real palpable danger to human beings and not just some theoretical worst-case scenario danger," Bozeman says.
For instance, much behavioral science research does not pose tangible risk.
"I know there is work in psychology where there's real potential for psychological harm, but most behavioral scientists would say the line is drawn in the wrong place," Bozeman says.
Not a vulnerable population
"I've been doing research for 30 years, and there has never been any harm committed and never any real potential for harm in any study I've done," Bozeman says.
Yet, IRBs have spent considerable time debating some of these studies.
For instance, Bozeman had a study that would enroll PhD-level scientists, many of whom were from other countries and did not speak English as a first language. The IRB considered this a vulnerable population based solely on this fact, he says.
"This is not a vulnerable population," Bozeman says. "If they do not want to participate in my study they have the sophistication to tell me 'No.'"
This attitude on the part of the IRB is indicative of the amount of energy IRBs spend on unnecessary distractions, he notes.
"The IRBs' resources should be focused on real possibility of probable harm," he adds.
Also, there should be more research conducted on IRBs and their practices, and then there should be process changes based on what's discovered, Bozeman says.
"Right now the process is for the most part one in which the researcher proposes and the IRB disposes, and that process would need to change," Bozeman says. "We have this sole responsibility [for ethical review] put on this institutionalized body, and that responsibility is too much for that body."
Researchers and potential subjects also need to be more involved in ethical considerations of studies.
For example, one solution is to engage participants in the protocol review process, Bozeman suggests.
"In my judgment that would make all the difference," Bozeman says.
It is impractical and would be very expensive, but human subjects research protection people should find a more feasible way to involve participants in judging protocols' ethical implications, he says.
"If we had people who were expecting to experience whatever occurs in research then they might have a different judgment about the research than people operating on theoretical involvement," Bozeman says. "In the Kennedy Krieger case you can imagine a different outcome if people said to IRB members, 'By the way, your children are going to be exposed to lead paint.'"
One model is the community advisory board, which is a big improvement over standard practice, he notes.
"Community advisory councils have representatives of the poor who take actions on behalf of the poor, and in some cases this is helpful," Bozeman says. "But in other cases these councils become a group of people who are professionalized agents of the poor without having much interaction with the poor."
To engage input from potential subjects, investigators could meet with members of the targeted population and ask one simple question, Bozeman suggests.
"Are you likely to be a subject in this experiment, and, if yes, can you help us decide about the ethics and appropriateness of this research?" he says. "This might not always be practical, but it could be used in cases of extreme potential risk."
Reference
- Bozeman B, Slade C, Hirsch P. Understanding bureaucracy in health science ethics: toward a better institutional review board. Am J Pub Health. 2009;99(9):1-9.
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