Fairness and common sense can ease tensions
Fairness and common sense can ease tensions
PIs admit to deceit when IRBs are thought unjust
An anonymous survey of principal investigators (PIs) suggests that IRBs that are heavy-handed with research protocols might unwittingly encourage deceit among researchers.1
"Our goal was to keep the survey sanitized and anonymous, but we were surprised at the candor of replies that came back," says Gerald Koocher, PhD, dean of the school of health studies and professor of psychology at Simmons College in Boston.
The study concludes that IRB policies and treatment of investigators can impact PIs' behavior and morale. Koocher and co-investigator Patricia Keith-Spiegel used the Computer Retrieval of Information on Scientific Projects (CRISP) database of federally funded biomedical research projects conducted at universities, hospitals, and other research institutions to obtain names of PIs to survey.
CRISP is maintained by the Office of Extramural Research at the National Institutes of Health, includes projects funded by NIH, Substance Abuse and Mental Health Services, Health Resources and Services Administration, the FDA, CDC, Agency for Health Care Research and Quality, and Office of Assistant Secretary of Health.
The investigators surveyed PIs from the CRISP database and also sent questionnaires to psychologists found through the Association of Scientific Psychology, Koocher says.
"The questionnaire went out by mail, and we specifically asked people to not identify themselves and to just send us an e-mail message to receive a copy of the report," Koocher says. "We didn't want any identifying information on the questionnaires other than gender and age."
More than 1,000 questionnaires were sent out, and about 400-600 people replied. Some respondents called the researchers to offer narratives in response to the questions, Koocher says.
The narratives, published in Ethics and Behavior, offer striking examples of ethical and regulatory infractions. For example, one adapted scenario included in the published study described an investigator who felt mistreated by the IRB, so when his research protocol did not gain approval after two appeals, he submitted a paper for publication and reported the procedures as conforming to IRB mandates although he use used contrived data.1
In other examples, investigators loaded protocol descriptions with boring details and omitted controversial elements in order to gain smoother IRB approval, and another investigator routinely begins data collection before receiving IRB approval in response to frustrations over what she views as too-lengthy IRB reviews.1
Helping hand or conflict of interest?
While IRBs are not responsible for investigator malfeasance, they can address the perceptions of unfairness, which relates to the organizational justice theory, Koocher says. Koocher has spoken before audiences of investigators and IRB members or staff about the perceptions of PIs, and he's received some interesting feedback.
"One of the IRB administrators came up to me afterwards and said she felt such empathy for the desperation of some investigators," Koocher recalls. "At her facility, there might be an investigator who has a large lab and is supporting dozens of people and he feels pressure that if funding isn't continued in a certain way then he will be forced to lay off people."
These human pressures, along with institutional pressures, can lead to unethical behavior, Koocher notes.
"In our experience, IRBs have fallen into three different categories, although obviously in a continuum," Koocher says. "At one end are the tight regulators, and their goal is to protect human subjects at all costs, which is fine, but the real purpose of the IRB was not to block research simply because one person might object to it."
Some IRB's are so risk averse in their approach to protocol reviews that they limit the amount of research that could be done, Koocher says.
"Some reasonable research is not done because of high barriers predicated on local standards," he explains.
"A the other end of the continuum are some lax IRBs that want more research at their institution," Koocher says. "Their attitude is, 'We know what we're doing, and we know everyone here,' and so maybe some studies slide through."
In the middle are the IRBs that Koocher and others might term an ideal IRB, which is one that assists researchers in doing what they want to do, but keeping the research consistent with the protection of human subjects, Koocher says.
"So if you have a protocol that raises hackles about whether human subjects are adequately protected, the IRB should be in a position to help you tweak the study so it can rise to the level of acceptability and be done," Koocher says.
This is preferable to having an IRB simply create roadblocks, he adds.
"Some IRB administrators and members feel as though they are not allowed to help investigators, but it's not true," Koocher notes. "They have to have the integrity and protection of human subjects as their primary mission, but that's not to say they can't be helpful to investigators, especially if the research could be done ethically with some tweaking."
To IRB staff and members who say they can't help investigators because that would be a conflict of interest, Koocher responds, "You're job is to ensure good safe research, so why is helping them a conflict of interest?"
Another reason IRBs may not assist investigators in improving human subjects protection in their protocols is their institutions do not adequately staff the IRB, so they are too overwhelmed with the workload to provide extra help, Koocher adds.
So when IRBs create unnecessary barriers through misunderstanding or work overload, investigators may feel they are being unfairly treated and respond accordingly, Koocher says.
"There always are a few arrogant apples in the barrel, but most people get angry at an IRB that delays or doesn't seem responsive or which gives ambiguous feedback or raises objections without a clear basis for it," he explains.
Who's minding the store?
Another problem is the way IRBs are run, Koocher says. "In general, institutional review boards should vote on whether or not to approve a study," he says. "There are many places where an IRB chair or administrator decides they want to reach a consensus, and the problem with that approach is it allows one outspoken person to block a study."
The most outspoken person could be an ideologue who is misguided, and if that person holds sway then the result is like a criminal trial where there must be a unanimous decision, Koocher explains.
"You wouldn't want an IRB to pass something by a five-to-four vote, but by the same token, one strident voice shouldn't derail an otherwise acceptable protocol, especially if the strident voice comes from someone who doesn't have a strong knowledge of the study topic," he says.
With human subjects research review, the standard should be a preponderance of evidence, not a "beyond a reasonable doubt" standard, as used in the criminal justice system, Koocher adds.
This especially is true when research involves social-behavioral science and the worst risks are emotional, rather than physical, he suggests.
For instance, Koocher once was involved in a study about death and adolescents, and one of his questions was "Do you ever worry about dying?" This question had been standardized with normal adolescents, and he wanted to administer the test on adolescents who had serious illnesses, but only with their permission.
"One physician on the IRB said, 'You can't ask questions like that of kids,'" Koocher recalls. "But the test had been administered to hundreds of kids at other sites, and there were no ill effects reported."
Nonetheless, the doctor had a gut reaction to the study question, and his doubts caused other IRB members to question it too, Koocher says.
"We politely pointed out that this instrument had been used many years with no ill after-effects, so the IRB needed to consider whether there was significant evidence rather than an emotional reaction, and the IRB told us to go ahead with the study," Koocher concludes.
Reference:
- Keith-Spiegel P, Koocher GP. The IRB paradox: could the protectors also encourage deceit? Ethics & Behavior. 2005:15(4):339-349.
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