Risks and benefits
Clinical trials involve risks, just as routine medical care and the activities of daily living. When weighing the risks of research, you can consider two important factors:
- the degree of harm that could result from participating in the study, and
- the chance of any harm occurring.
Most clinical studies pose the risk of minor discomfort, which lasts only a short time. However, some study participants experience complications that require medical attention. In rare cases, participants have been seriously injured or have died of complications resulting from their participation in trials of experimental therapies. The specific risks associated with a research protocol are described in detail in the informed consent document, which participants are asked to sign before participating in research. Also, a member of the research team explains the major risks of participating in a study and will answer any questions you have about the study. Before deciding to participate, carefully consider possible risks and benefits.
Well-designed and well-executed clinical trials provide the best approach for participants to:
- Gain access to new investigational drugs or devices 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.
Risks to participating in clinical trials include the following:
- There may be unpleasant, serious, or even life-threatening side effects to experimental drugs or devices.
- The study may require more time and attention than standard treatment would, including visits to the study site, more blood tests, more treatments, hospital stays, or complex dosage requirements.