Risks are involved in clinical research, as in routine medical care and activities of daily living. In thinking about the risks of research, it is helpful to focus on two things: the degree of harm that could result from taking part in the study, and the chance of any harm occurring.
The specific risks associated with any research protocol are described in detail in the informed consent document, which you are asked to sign before taking part in research.
Any major risks of participating in a study will be explained to you before you decide to participate. You may always ask questions to the research team about participating, either before, during, or after your participation in the research study.
Participating in a research study may have benefits to you as a participant. Well-designed and well-executed clinical trials provide the best approach for participants to:
- Play an active role in their health care.
- Gain access to new research treatments before they are widely available.
- Receive regular and careful medical attention from a research team that includes doctors and other health professionals.
- Help others by contributing to medical research.
(Adapted from the NIH Clinical Center: http://clinicalcenter.nih.gov/participate/faqaboutcs.shtml and http://www.nih.gov/health/clinicaltrials/basics.htm)