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Special Coverage: 2003 PRIM&R/ARENA Conference
Subjects often don’t understand benefits
Biomed and social-behavioral each pose challenges
While IRBs often pay close attention to a protocol’s potential risks and may hold discussions on the risks vs. benefits ratio, the benefits side of the equation often is poorly explained and less well examined, experts say.
"There’s a lot of discussion about how to talk about the risks of harm and what kinds of risks you may be undertaking when you join a study," notes Nancy King, JD, professor of social medicine at the school of medicine, University of North Carolina in Chapel Hill.
"Very often, you see consent forms that say you may or may not benefit," she says. "What does this mean in terms of people’s expectations of how they might benefit, and what do IRBs, study coordinators, and others think about benefits in addition to risk?"
King spoke about beneficence at a medical sciences panel presented at the PRIM&R and ARENA meeting and conference held Dec. 5-7, 2003, in Washington, DC.
She was involved in a study that looked at research consent forms and conducted interviews of study coordinators and research subjects about risks and benefits.
"We are in the process of analyzing data, but one [finding] we think is really important is that it’s a lot harder to talk about benefits of research in the early stage than it is to talk about risks, and people aren’t experienced doing it," King says.
For example, the classic phase one drug research study is conceived to test for safety in healthy volunteers, who because they do not have the disease for which the study is being conducted do not stand to personally benefit from any positive effects of the drug. On the other hand, some phase one drug studies use volunteers who have the disease that is being investigated; and with these individuals, there is a potential for a medical benefit from their participation, she says.
"So does that mean if a benefit is possible that you can talk about it with the volunteer?" King asks. "There’s a lot of disagreement about the answer to that question."
On the one side, the IRB and investigator may decide not to raise volunteers’ hopes by mentioning a potential benefit, and then if there is a benefit, it will be a surprise and bonus, she says.
"But one of the problems with that approach is that people who have a disease or condition go into a study in the first place because they want to benefit," King says. "So you may give rise to under-the-table conversations where investigators say, We have to say that in the consent form, but really we think you might benefit.’"
In the study about consent forms, she and colleagues found that the consent forms tend to be vague in their discussion of benefits, and this makes it difficult for participants to understand. Investigators tend to be vague about benefits because they don’t fully understand the issue themselves, King notes. "A more thorough discussion of what can and cannot be expected from a study would be very helpful to volunteers," she adds.
Improving the way investigators and IRBs look at potential benefits is one challenge that may require additional education and training. "Let’s see if there aren’t ways we can be more helpful to IRBs and investigators and talk to them about what potential benefits might be more realistically expected in a given study," King says. "That’s the focus of my colleagues and my research."
If benefits to subjects involved in biomedical science are little understood, then the problem may be even more pronounced when it comes to explaining the individual and societal benefits to participation in social-behavioral research.
"There are lots of challenges facing social scientists when it comes to appreciating research they do," says Moira Keane, MA, CIP, director, Research Subjects Protection Programs of the University of Minnesota in Minneapolis. She participated in a social and behavioral sciences panel on beneficence at the PRIM&R conference.
"We hear far more frequently about breakthroughs in medicine and challenges in medicine that are overcome by research," Keane says. "It’s difficult for social and behavioral sciences to garner the same kind of exposure for advances they are making, because sometimes they are subtle and sometimes they are based on broad population trends, things like crime prevention, risky adolescent behavior."
Likewise, it the potential benefits to an individual research subject are more difficult to pinpoint and communicate, she notes. "In medical science, it’s much easier to say we fixed this broken leg due to a new procedure; but on the social-behavioral side, it’s more difficult to link the benefits to society," Keane says.
One solution to the obstacles social-behavioral research poses to understanding benefits would be to present what is known to participants in a straightforward manner, she suggests.
"We have to be honest with our research subjects and participants and tell them what we know and think we can predict and often say what we don’t know," Keane says. "There are unseen risks, and we don’t know what your experience will be."
Benefits in such cases may be experiences that are difficult to identify and explain. For instance, an investigator who has worked extensively with a particular population may find that some subjects experience relief when they discuss a part of their past with investigators, and this could be a type of individual benefit, she explains.
"But we can’t generalize that to the entire population because there may be people who don’t want to talk about it," Keane says. "We often have to be honest with people and say, We really don’t expect that you will benefit, but it’s possible other people will benefit in the future.’"
Adult research participants have the choice to make altruistic choices, including giving their time and experience to research for the greater good, although they might not receive a personal benefit from participation, Keane adds.
The challenge to IRBs is to weigh research participants’ decision to forgo a potential personal benefit and see if there is a potential benefit to the greater society for which it would be worth asking individuals to make a sacrifice, Keane says. "IRBs are somewhat conservative to their approach to risks and benefits."