What are the risks?

The answer to this question depends on the type of study. Some studies involve little or no risk, while others may be very risky. Most studies are somewhere in between. The researchers doing the study will explain all of the risks to you. You should get answers to all of your questions about your risk before you agree to be in the study.

There are two risks that are particularly important for women:

Pregnancy - When a woman is pregnant, any drugs that she takes may have an effect on her fetus. Because the risks of new drugs and other treatments to the fetus are not always known, women who may become pregnant must take these risks into consideration. During the informed consent process, you may be asked if you are pregnant or are considering getting pregnant. If you are sexually active, the researcher will ask you to use a reliable form of birth control while you are in the study. You may also be asked to have regular pregnancy tests as part of the study.

Birth Control Pills and Hormone Replacement Therapy - Birth control pills, other hormonal contraceptives (such as Norplant or Depo-Provera), and hormone replacement therapy during and after menopause can affect how your body handles drugs. It is important to tell the doctor performing a medical research study about what hormones and other drugs you are taking, even "natural" hormones, herbs and dietary supplements.