Is sharing results a moral obligation?
Take care: Not everyone wants to know
Are investigators morally obligated to provide research participants with the chance to see the results from the studies in which they enroll — and should IRBs require them to do so?
Some researchers argue that they should, calling it a matter of respect for the people who literally give of themselves — their time and their bodies — to help advance science.
But they say it’s not simply a matter of sending a letter with results to all participants in all studies. Some patients may not want to know the results. Some studies are so sensitive that they would require a carefully thought-out plan for approaching subjects with their results, perhaps through face-to-face interviews.
Ann Partridge, MD, MPH, an oncologist at Dana-Farber Cancer Institute and instructor in medicine at Harvard Medical School in Boston, has studied the attitudes of breast cancer patients regarding receiving results from clinical trials in which they’ve been enrolled.1
She says each study is different, and IRBs should approach the issue of results just as they would informed consent, tailoring the requirements to fit the study and the patient population involved.
"I think IRBs need to be sensitive to the varied nature of results," Partridge says. "Investigators need to think through beforehand what are the possible outcomes of this study and worst case scenarios, what’s the most sensitive, patient-friendly, and also practical way of sharing those results."
Few provide results now
Currently, few investigators provide results to their subjects, and it is not a common IRB requirement, says Conrad Fernandez, MD, FRCP, an associate professor of pediatric hematology and oncology at Dalhousie University in Halifax, Nova Scotia.
In a study published this summer in Blood, the journal of the American Society of Hematology, Fernandez surveyed 450 authors of abstracts presented at the society’s annual meeting in 2003.2
Of the nearly 200 respondents, only 30% had a formal plan for returning research results to participants, although nearly 70% supported the idea.
Only 7% of respondents indicated that their IRBs mandated that research results be returned to participants. Fernandez says the results were consistent among U.S., Canadian, European, and other international researchers.
When asked why they had no plans to return results, "a substantial proportion indicated that they had just never considered it something that was an obligation," Fernandez says.
Researchers also cite obstacles such as difficulty maintaining contact with subjects over time, and the potential cost of returning results.
Fernandez concedes that such an endeavor could be costly, depending on the type of plan required by a specific study.
For studies in which the results were expected to be uniformly good, the researcher could plan from the beginning to distribute results by letter, which could be relatively inexpensive, he says.
But Fernandez says other studies could raise issues that would require more careful treatment of results and subjects, particularly where individualized results are concerned. For example, genetic research could give a subject information such as a predisposition to illness that they might not want to know, for their own peace of mind or because of fears of losing insurance.
"Also results might be potentially harmful in other ways," Fernandez says. "They may cause distress in reliving the initial event of their diagnosis and research participation. There may be distress because they happened to have been randomized to an inferior arm and did more poorly.
"They also may know of individuals who participated in the same study and if they got randomized to the positive arm, there may be survival guilt," he says. "That’s very true for our pediatric patients — a lot of them know each other."
In these cases, he says, the return of results may need to be in a face-to-face, even in a one-on-one setting and researchers may need to refer them to counseling or other services as needed, he says.
As an example, Fernandez cites research done on pediatric patients with Hodgkin’s disease, which showed that those treated with radiation therapy have an increased risk of breast cancer later in life. "That kind of information probably shouldn’t come in a form letter to a research participant to say, Yeah, at 30 years everybody needs a mammogram’ and then sign off," Fernandez says. "I think that really needs to come in a face-to-face or at least verbal contact with a plan in place for follow-up, both medically as well as psychologically.
"It could be very involved and expensive and time consuming," he says. "However, there is cost from my point of view associated with getting informed consent for participation in studies, and that’s a moral requirement that we assume is part of the cost of doing business, so to speak, in research."
He argues that returning research results is also a moral obligation the research community is obligated to assume.
Guidelines for providing results
How then, should IRBs and researchers plan for the release of research results?
Fernandez and Partridge contend that IRBs should have a policy requiring researchers to provide a plan to return results to subjects who wish to see them, or to provide an explanation why it shouldn’t be done.
"The researcher probably will be able to inform that plan very well because they can often anticipate what the nature of the results would encompass," Fernandez says.
He suggests that subjects should be informed as part of the regular consent process that they will have an opportunity to receive results from the study when it’s completed, if they wish. The informed consent should lay out not just the benefits, but the potential risks of receiving the results. He says subjects probably should be informed more than once during the course of the study of this opportunity, as their attitudes about learning the results may change over time.
Results shouldn’t be released until the study has been closed and the results have undergone the normal peer review, he says. "You want to be providing results that have the same degree of veracity as you would to the scientific community," Fernandez says.
However, they should be provided in a form that is more understandable to the laypeople in the study. For this reason, he says the current push to provide a clinical trials registry will not satisfy the needs of informing subjects about results from clinical trials.
"Those results, while theoretically accessible, aren’t accessible to the average participant," Fernandez says. "The results need to be provided to participants in a format which they can understand — it’s not sufficient to just refer them to the journal and publication."
An IRB could provide for review of the materials given to subjects to ensure they are understandable, but Fernandez says it wouldn’t necessarily have to be a requirement.
Fernandez and Partridge both say the timing of releasing results to study participants is important. They say subjects should learn about the results from researchers before they’re disseminated to the public at large through media coverage.
"Patients shouldn’t feel like the only way they heard about it was when it came out in The New York Times or on the nightly news," Partridge says.
Fernandez says that results could be released to subjects after a manuscript is accepted for publication, which would still leave time to inform everyone before the article was actually published. A subject can only be informed of results if researchers know where to find him or her, which is seen by some as a significant obstacle to releasing results. But Fernandez says his studies have shown that subjects who want to see results believe it’s their obligation to make sure researchers can contact them when the time comes.
"You can inform the individual about the potential benefits and harms of receiving research results," Fernandez says. "You can then say, We anticipate the results to be ready in about a year’s time. Do you want to be contacted for that?’ And some people may already vote with their feet at that stage. For those who do want to be contacted, it becomes incumbent on them to retain the contact."
Both Partridge and Fernandez say they hope to see more interest among IRBs and researchers in providing this type of information to subjects, because the interest among subjects is already there.
"I think thoughtful people are concerned about the pros and the cons, so no one’s wanted to push this," Partridge. "But we are pushing it more and more because there is more and more data that we can do this in a safe, patient-friendly, research investigator-friendly way that improves the process and improves communication with patients after a trial."
References
- Partridge AH, et al. Offering participants results of a clinical trial: Sharing results of a negative study. Lancet 2005; 365:963-964.
- Rigby H, Fernandez CV. Providing research results to study participants: Support versus practice of researchers presenting at the American Society of Hematology annual meeting. Blood 2005; 106(4):1199-1202.
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