What are the risks and benefits of participating in research?

Clinical research can involve risk, but it is important to remember that routine medical care also involves risk. It is important that you weigh the risks and benefits of participating in research before enrolling. When thinking about risk, consider two important questions:

1. What is the chance that the study will cause me harm?
2. If there is a chance of harm, how much harm could I experience?

If you are interested in participating in a study, ask the researchers any questions that will help you decide whether to participate. Taking time to share your concerns will help you feel safe if you do decide to volunteer. (You can find sample questions at the end of this booklet.) It may be helpful to involve close family members, your doctors, or friends in this decision-making process.

Risks

The nature of the risks depends on the kind of study. Often, clinical studies pose the risk of only minor discomfort that lasts for a short time. For example, in some mental health studies, participants take psychological tests; this is obviously a different kind of risk from undergoing surgery as part of a study. A participant in a study requiring surgery may risk greater complications. Risk can occur in many different ways, and it is important to speak with the research team to understand the risks in a particular study.

Keep in mind that all research sites are required to review their studies for any possible harm, and to share any potential risks with study volunteers. Possible risks include the following:

• The treatment involved may have health risks for you, such as unwanted side effects.
• The study may require more time and attention than standard treatment. You may need to visit the study site, take additional blood tests, stay in the hospital, or manage complex dosage requirements for medication.
• The treatment may not make you or other participants better.
• You may enroll in the study hoping to receive a new treatment, but you may be randomly assigned to receive a standard treatment or placebo (inactive pill).
• Whether a new treatment will work cannot be known ahead of time. There is always a chance that a new treatment may not work better than a standard treatment, may not work at all, or may be harmful.
• The treatment you receive may cause side effects that are serious enough to require medical attention.

Benefits

Benefits to participating in a study include:

• Treatment with experimental or study medications not widely available elsewhere.
• Care from a research team that includes doctors and other health care professionals who are familiar with the most advanced treatments available.
• Treatment that has been reviewed by many people, including other doctors and researchers.
• Research-related care or medicine at no cost.
• The opportunity to learn more about an illness and how to take care of it.
• The satisfaction of helping others by contributing to medical knowledge, or helping to identify possible new treatments.

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