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Issue date: March 12, 2000


Getting truly informed about clinical trials

By Ruth Levy Guyer

Mary Wileden has never suffered from seasonal affective disorder, or SAD, a depression that intensifies as summer's light wanes. But a dear friend does. That's why Wileden was willing to spend 24 hours in a dim room as researchers studied how darkness affected her mood.

"It seemed important," says Wileden, of Silver Spring, Md., reflecting on her volunteering in a clinical trial to investigate causes of SAD. It was "a way to contribute to my friend's life and to the lives of others."

Clinical trials make no promises. They are experiments, not cures. Tragedies like the death last September of an 18-year-old participant in a University of Pennsylvania gene-therapy trial are rare. But each trial is unique. So ask these questions before volunteering:

What is the purpose of the study? A sense of the sponsors and their intentions is helpful.

Are the drugs involved in this trial "approved," "experimental" or "investigational"? Approved drugs have been proved effective. Experimental or investigational drugs are just being tested.

How private are the medical records? You'll want to know who will have access to information about you and how secure that information is.

Whom do I call if something goes wrong? Every "informed consent" form should include a 24-hour contact number. That form should explain the study as well as your rights and those of the researchers.

To learn more about volunteering, visit clinicalstudies.info.nih.gov or call 1-800-411-1222.


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