Give research results to study participants
Research shows participants want it
For years, the debate has continued about returning the results of research to the study participants who made it possible. Would such a process be expensive and unwieldy? Could it cause more harm than good, when participants receive bad news?
Many studies have looked at the attitudes of participants and investigators toward disclosing research results to participants.
Now researchers have looked at that body of research, to see what lessons it may hold for investigators and IRBs on this issue. What they found, says David Shalowitz, AB, a student at the University of Michigan Medical School, Ann Arbor, was strong support among participants for offering results, good or bad.
"I think the most surprising conclusion was that despite the fact that participants tend to have mixed psychological reactions to receiving research data, they overwhelmingly want to receive it," he says.
"I think one of the stumbling blocks for investigators is a worry that they don't know how participants would react to receiving this kind of information — they don't want to do anything that would be taken the wrong way, that would be upsetting. But in the end, it looks like participants do want to at least get the chance to receive them if they want them."
IRBs should ask: Given that interest, he says IRBs should ask investigators upfront what they plan to do about offering research results when the study is completed.
"It shouldn't be an ad-hoc decision that's made later on down the road, when investigators discover that the results had meaning that they didn't think they would, or people were requesting their information and they hadn't planned for a procedure to deal with communication of the research results," Shalowitz says.
Shalowitz looked at 28 studies concerning communication of research results, some dating as far back as 1985.1 The studies covered a range of different types of research, but more than half (16) dealt with cancer or genetics research.
In some, the results discussed were aggregate results, but others dealt with individual results, such as a person's individual risk for developing a disease. Eighteen studies asked whether participants wanted results (nine studies asked about aggregate results, eight about individual results, and one asked about both).
The median percentage of respondents who did wish to see results was 90%. "Given that, I think it's safe to say that probably everybody should get the offer," Shalowitz says.
Written results may suffice: His review of the studies found another interesting point — participants generally were open to the idea of receiving results in a written format.
This is important, Shalowitz says, because one stumbling block to returning research results has been the assumption that it would require costly and time-consuming personal interviews.
"It seems like participants are OK with receiving cost-effective methods — written communiqués, for example, newsletters, a phone call, the sort of methods that are not as cost- and time-intensive as, say, bringing in participants for a genetic counseling session," Shalowitz says.
"I don't want to say that there would never be a situation in which one-on-one counseling is necessary, but for the vast majority of studies, it seems that participants will accept a written communication of results with a phone number or some other means of contacting investigators if they have more questions."
Studies that looked at the impact of receiving results did report some negative reactions, including anxiety, anger, guilt, or upset, and beneficial reactions, including satisfaction and relief.
Shalowitz says the vast majority of participants believed it was important to receive the results, despite the potentially negative impact.
He says his study was limited by the lack of standardization in how the issue is researched. However, the studies done to date show IRBs should be discussing the possibility with researchers.
"There will be some expense, but that isn't really a good ethical argument against offering participants the opportunity to receive research results, unless investigators and IRBs decide that the offer itself would substantially compromise the feasibility of the research from the scientific perspective," Shalowitz says. "And I expect that that's going to be more of a rare circumstance than people fear it will be."
Reference
- Shalowitz DI, Miller FG. Communicating the results of clinical research to participants: Attitudes, practices and future directions. PLoS Med 2008;5:e91.
You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
- Award-winning Medical Content
- Latest Advances & Development in Medicine
- Unbiased Content