Is it safe to participate in a clinical research study?
A clinical research study involving an investigational product is an experiment to test the safety and effectiveness of the product. As a result, there may be risks to your health if you decide to participate. The risks to your health will depend on the type of study and how much is already known about the product. The risks may be no more than an unpleasant side effect that goes away quickly, or they may lead to a life-threatening condition. The risk may be that the product is ineffective and does not help your condition. The clinical investigator or study staff member should talk to you about all the reasonably foreseeable risks of participating in the clinical research study.
While it may not be possible to eliminate all risks associated with participation in a clinical research study, steps should be taken in all such studies to reduce possible risks. These steps should include the development of a study protocol that explains exactly how the clinical investigator is to conduct the clinical research study, and review and approval of the study by an institutional review board.