For hundreds of thousands of subjects in clinical trials, when their participation in a study ends is usually when their contact with investigators is over, too. Researchers rarely share their results with their study subjects. What’s more, they don’t reveal any findings they might have discovered to individual participants about their own health.

 

Because investigators and institutional review boards haven’t often discussed the results-sharing issue, policies and guidelines of various institutional review boards vary widely. David Shalowitz, a medical student at the University of Michigan, and Franklin Miller, a bioethicist with the National Institutes of Health, decided to see if investigators’ claims about why they don’t share results were justified, and if any consensus emerged.

 

In article published in the journal Public Library of Science Medicine in May, the two reviewed previous studies of communications between investigators and research participants. As part of their research, they examined commentaries on the potential positive and negative impacts of sharing results, as well as data from studies that evaluated the desires and reactions of research volunteers in specific clinical trials. The bombshell? More than 90 percent of trial participants want access to aggregate study results, says Shalowitz, the lead author on the study. And a slightly smaller percentage of subjects want to know their individual results if they have relevance to their lives.

 

In recent years, the results-sharing issue has started to get more attention. The visibility comes with the increase in genetics research and the potential that an investigator could discover something that could have immediate or future repercussions on a participant’s life. In fact, the U.S. Department of Health and Human Services’ Office of Human Research Protections was expected to issue a request for information in August 2008 about the need for researchers to keep subjects informed about adverse events or other developments that might arise after a study ends.

 

Though some researchers make efforts to provide information to research subjects about their findings, informed consent documents often explicitly state that test results will not be made available, even if participants request them. Research participants often feel that if investigators are finding out information about them, then they’re entitled to the same information.

 

“This is something the ethics community certainly feels is long overdue,” says Joan Rachlin, executive director of the education and policy group Public Responsibility in Medicine and Research. “It is really a moral imperative. If people contribute their time, their DNA, their tissue, their blood, their fluids—if they volunteer in whatever capacity to participate in a clinical trial—at the very least, they are entitled to know the upshot of the trial in which they participated.”

 

One of the biggest hurdles to sharing results, Shalowitz says, was the cost of contacting research volunteers and presenting trial results to them. Discussing aggregate results in layman’s terms is not as difficult, he notes, as preparing individual reports for each volunteer. That’s a task than can end up being very labor-intensive in a large study with hundreds or thousands of participants.

 

Another challenge: Investigators are concerned about the impact on participants receiving research data about themselves, the researchers found. Investigators wondered whether disclosure would make people happy, distressed, and more or less likely to enroll in future research studies. “Expense alone is not a sufficient reason to abrogate an ethical responsibility to offer participants information that they voluntarily helped generate,” says Shalowitz. “There’s a reasonable exception to be made if investigators can establish that the offer to communicate research results would substantially compromise the feasibility of the research itself. We expect those situations would be few and far between.”

 

Many investigators fear they would need to call hundreds of people they enrolled and have a face-to-face discussion with each about the results. But the study found a majority of participants consider written communications acceptable, Shalowitz says.

 

To fix the problem, Shalowitz says standards for measuring communications between investigators and research volunteers is needed in order to evaluate these interactions. In the absence of that, he says, there will continue to be plenty of arguments about the risks and benefits of sharing results without data to back them up.