Should medical researchers share their results with the volunteers in their studies?

June 06, 2008

ANN ARBOR, Mich. -- Every year, hundreds of thousands of Americans volunteer to take part in medical research studies, from simple health surveys to detailed analyses of their DNA or tests of experimental medicines.

But what happens after their participation is over? In many cases, volunteers won't ever hear from the researchers about what the study revealed. But other studies make a special effort to keep volunteers informed, via newsletters or Web sites.

A new review of the issue, published recently in the journal Public Library of Science Medicine, suggests that participants' desire to know the results of studies outweighs concerns by some bioethicists about the potential negative psychological consequences of sharing some results. Even when it's bad news, most study volunteers want to know.

So, should all medical researchers make an effort to communicate about their results with the volunteers who are so vital to their research? If they try to do so, what hurdles -- ethical, privacy-related, financial or logistical -- might complicate their efforts? Could sharing clinical research results with some volunteers actually upset them?

Such questions are addressed in the new paper, which was written by University of Michigan medical student David Shalowitz and Franklin Miller, Ph.D., of the Department of Bioethics at the National Institutes of Health. The research was funded by a grant from the U-M President's Initiative for Ethics in Public Life.

The paper reviews the landscape of knowledge on this issue, including commentaries on the potential positive and negative impacts of sharing results, and data from studies that evaluated the desires and reactions of research volunteers in specific clinical trials.

All in all, the article says, better data are needed on the ins and outs of sharing study results with research volunteers.

"It's a mixed bag," says lead author Shalowitz. "We found overwhelmingly that participants do want access to aggregate study results, and that to a lesser extent they want to know their individual results if they have relevance to their lives."

For instance, volunteers in a study looking for genes related to a particular disease might appreciate the opportunity to find out what their individual genetic test revealed. And they may be interested in learning what the entire study found.

But other people in the same study might not want to know their individual results, for fear of finding out that they have a higher risk of developing a particular disease.

One of the biggest hurdles that the authors found in both commentaries and studies of this issue, Shalowitz says, was the cost of contacting research volunteers and presenting trial results to them.

Presenting aggregate results in layman's language is not as difficult, he notes, as preparing individual reports for each volunteer, which can be very labor-intensive in a large study with hundreds or thousands of participants.

Then there's the ethical issue of whether and how to offer participants a way to communicate with the researchers about what they've been told - for instance, by phone or e-mail if they're concerned about their individual test results.

And, for those who simply don't want to know their individual results or even the aggregate results, a system for opting out is needed.

These considerations might be addressed if researchers consider participant communications during the earliest planning of their study, including the funding request, Shalowitz says.

If the NIH and local Institutional Review Boards were to demand a plan for such communications as part of each study proposal, and perhaps provide staff who could facilitate such efforts, it would help researchers greatly, he adds.

In the end, the authors say, more research on the best approaches for contacting research volunteers, and the actual responses of volunteers to this issue, is needed.

"There's a need to develop a standard way of measuring these domains, so that systematic evaluations can be done," says Shalowitz. "We also need better evaluations of the best ways to communicate data to research participants. We need to change the current situation in which claims are being made about the benefits and risks of sharing results without data to back them up."
-end-
For more information on participating in clinical research trials at the University of Michigan, visit the U-M Engage web site, www.umengage.org.

Reference: PLoS Medicine, May 13, 2008 medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371%2Fjournal.pmed.0050091

University of Michigan Health System

Related Health Articles from Brightsurf:

The mental health impact of pandemics for front line health care staff
New research shows the impact that pandemics have on the mental health of front-line health care staff.

Modifiable health risks linked to more than $730 billion in US health care costs
Modifiable health risks, such as obesity, high blood pressure, and smoking, were linked to over $730 billion in health care spending in the US in 2016, according to a study published in The Lancet Public Health.

New measure of social determinants of health may improve cardiovascular health assessment
The authors of this study developed a single risk score derived from multiple social determinants of health that predicts county-level cardiovascular disease mortality.

BU study: High deductible health plans are widening racial health gaps
The growing Black Lives Matter movement has brought more attention to the myriad structures that reinforce racial inequities, in everything from policing to hiring to maternal mortality.

Electronic health information exchange improves public health disease reporting
Disease tracking is an important area of focus for health departments in the midst of the COVID-19 pandemic.

E-health resource improves men's health behaviours with or without fitness facilities
Men who regularly used a free web resource made significantly more health changes than men who did not, finds a new study from the University of British Columbia and Intensions Consulting.

Mental health outcomes among health care workers during COVID-19 pandemic in Italy
Symptoms of posttraumatic stress disorder, depression, anxiety and insomnia among health care workers in Italy during the COVID-19 pandemic are reported in this observational study.

Mental health of health care workers in china in hospitals with patients with COVID-19
This survey study of almost 1,300 health care workers in China at 34 hospitals equipped with fever clinics or wards for patients with COVID-19 reports on their mental health outcomes, including symptoms of depression, anxiety, insomnia and distress.

Health records pin broad set of health risks on genetic premutation
Researchers from the University of Wisconsin-Madison and Marshfield Clinic have found that there may be a much broader health risk to carriers of the FMR1 premutation, with potentially dozens of clinical conditions that can be ascribed directly to carrying it.

Attitudes about health affect how older adults engage with negative health news
To get older adults to pay attention to important health information, preface it with the good news about their health.

Read More: Health News and Health Current Events
Brightsurf.com is a participant in the Amazon Services LLC Associates Program, an affiliate advertising program designed to provide a means for sites to earn advertising fees by advertising and linking to Amazon.com.