Study shows that most research participants want their results

Debate continues over ethics of decision

As research ethicists and others debate the merits of giving clinical trial participants the personal and aggregate results of studies, recent research suggests that participants want this information.

"We had done work on the ethics side of this issue, and the debate rages on," says David J. Shalowitz, a medical student and member of the Bioethics Program at the University of Michigan Medical School in Ann Arbor.

"But we realized that in looking at ethics literature and debate surrounding the issue, there are many claims being made that depend on empirical data," Shalowitz adds. "For example, many commentators will make references to participants' desires."

So Shalowitz and co-investigator Franklin G. Miller, PhD, of the department of bioethics at the National Institutes of Health in Bethesda, MD, decided to study available data on participants' desires with regard to disclosure of study results. Their study, titled, "Communicating the results of clinical research to participants: Attitudes, practices and future directions," has been accepted for publication in PLoS Medicine and will be published on-line at www.plosmedicine.org.

"Overwhelmingly, participants want to know aggregate results of research, as well as clinically relevant individual results," Shalowitz says. "We reported a median of 90% based on a review of available literature."

Investigators reviewed studies from between 1950 and 2007, selecting those that provided qualitative or quantitative data on communicating research results with respect to participants' preferences, investigators' attitudes and practices, psychological or behavioral impact on participants, costs, and effect on participants' perceptions of research or investigators.

While a median of 69% of investigators support disclosing study results, fewer than half of the cases involved disclosure, Shalowitz notes.

There is a presumptive responsibility of investigators to report empirical results, Shalowitz notes.

"In the past, we've argued that the responsibility can come from different sources," he explains. "For one, investigators depend on the voluntary contributions of participants in order to get their data, and, in some ways, it shows respect and gratitude to those participants when investigators make the data available to them."

Other arguments concentrate on whether participants want to know the information and whether it will change the way they behave with regard to health care decisions, he adds.

"Many investigators are concerned with the costs of disclosing results," Shalowitz says.

There are time demands too, he adds.

"And there are discussions of whether communication with participants will increase transparency as a whole and whether it will increase trust or enrollment," Shalowitz adds. "These are empirical questions that need to be answered."

The disclosure research found that only a minority of investigators currently disclose results to participants, Shalowitz adds.

Barriers to disclosure

Despite the evidence that participants want to know study results, there still are barriers to investigators reporting aggregate results, Shalowitz notes.

One barrier involves resources, he says.

"If it turns out that it would be very costly in terms of time and money to make those results available to participants, then there's an argument that given the [paucity] of grant funding and the demands on researchers, this is low on the list of what needs to be done," he explains.

A second barrier could be institutional, including policies and procedures that discourage or prohibit the communication of research results, Shalowitz says.

"Some institutions have policies that say, 'We don't do that sort of thing, and disclosure is not the rule,'" he explains.

Another argument is that the line between aggregate and individual results can be blurred.

"You can show that the gene is associated with the condition, so what is the impact of aggregate results when these have many similarities with individual results?" Shalowitz says.

The ethical barriers are more apparent with the disclosure of individual results.

"Investigators' No. 1 concern tends to be the impact on participants when they find out information that is still in development about themselves," Shalowitz says. "Many research interventions have not been clinically vetted, and many investigators are worried that participants will misinterpret information."

For instance, a research participant might pursue an intervention based on research results, and this could be unnecessary or an overreaction.

One example is how some women who discovered they carry the gene that leads to early breast cancer pursued prophylactic surgery by having their breasts removed, Shalowitz says.

Also, investigators sometimes are concerned that disclosure of individual results will require genetic counseling in an intensive, one-on-one setting, he notes.

But research suggests that participants typically are happy to receive written disclosure communication and only a minority of sensitive information would require more labor-intensive disclosure, Shalowitz says.

Consider participant reaction to results

Shalowitz and Miller researched the reactions of participants when they were given individual information from a research study.

"We found that researchers can be guaranteed that some portion of participant population will have a positive psychological response, and some portion will have a negative psychological response," Shalowitz says.

"They might feel satisfaction, relief on the positive side," he says. "Negative reactions might include anxiety, anger, guilt, and being upset."

The take-home message is that participants overwhelmingly want to receive the research results, regardless of the potential for negative reactions, Shalowitz adds.

"When asked, 'Do you want to receive research results if it makes you feel XYZ,' they overwhelmingly say, 'Yes,'" he explains.

It remains important that researchers ask the question about how disclosure will impact subjects, Shalowitz notes.

"They need to make sure they're minimizing the risk and harm to participants," he says. "And they need to make sure that overall they're doing well by participants."

The next issue is how to disclose results.

It's important to give each participant a choice of whether to receive the results, Shalowitz says.

"There is widespread belief that they should not be told results they don't want to know," he says. "The vast majority of information is disclosed on a request basis."

For aggregate results, investigators could give participants a telephone number to call for information or a web site to visit to find out the results, he suggests.

"It turns out that many participants think a written communication with results and a number provided for additional questions is a more acceptable way of receiving research data," Shalowitz says.

Disclosure likely will increase as health consumers become more accustomed to medical transparency and finding information on-line.

"It should be established empirically, but it's likely that if investigators are more open and transparent about what's going on in research that participants will be more likely to be open and trusting in researchers," Shalowitz says.