Should Medical Researchers Share Their Results With Volunteers In Their Studies?

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Should Medical Researchers Share Their Results With Volunteers In

Their Studies?

http://medicalnewscenter.com/out/out.cgi?

http://www.sciencedaily.com/releases/2008/05/080513054836.htm

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 Shalowitz and lin

, 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. "