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Your Rights with Regard to Clinical Trials

From POZ Magazine; originally published August 1997

Spring 2000

The following rights are guaranteed by federal regulations with the force of law:

1. You have the right to truly informed consent, including a signed and dated copy of the form (which you should keep), in language you can understand. This means not simply signing a release, but fully comprehending the release and the trial by asking any questions and thoroughly discussing the decision with your advisor. As one activist says, informed consent is not just a signed paper, it's a thoughtful process.

2. You have the right to know the trial's "endpoint," or stopping point for your role in the experiment. Depending on your health, some endpoints -- such as opportunistic infections or death -- may be unacceptable.

3. You have the right to be told the other treatment options -- approved and experimental -- you have for this condition and how they may be better or worse than being in the study.

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4. You have a right to be informed not only at the outset about side-effects found in previous studies, but also about "significant findings" discovered during the current study that may affect your health. This includes additional side-effects of the drug you're taking and benefits of treatment that could be alternatives to the one you're taking.

5. You have the right to leave the trial at any time for any reason. You may solicit informed counsel from your own adviser, the patient advocate, the study coordinator, and the IRB (contact numbers for all but your adviser should be attached to every consent form.)

Reprinted again from Positives for Positives, a quarterly publication to inform the HIV/AIDS Community
Wyoming: Positives for Positives, 1714 1/2 Capitol Ave., Cheyenne, WY 82001. 307.635.0566 / 800.492.2203.





  
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This article was provided by Women Alive. It is a part of the publication Women Alive Newsletter.
 

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