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Thursday, August 25, 2016
When you are deciding whether or not to take part in a research study, you will need to remember that becoming involved usually has both benefits and risks.
Sometimes the person who joins a research study will benefit directly, and their disease or problem will be helped. However, the possibility of receiving benefit varies from study to study, just like the risks.
There are many reasons why a person may choose to be in a research study. If you are considering joining a research study, you should think about what your reasons and goals are for joining and discuss these with your friends, family, health care provider and the principal investigator or other study personnel. Talking with these people and asking them questions should help you determine if your reason(s) for joining the study agree with what may happen as a result of your participation and the question the research is trying to answer.
Reasons that people join research studies include:
By participating in a research study, you may benefit in a number of ways:
Joining a research study may involve 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 physical complications. Remember that there can always be risks for research participants that were not expected and that risk can occur in many different ways. It is important to speak with the research team to understand the risks in a particular study. The risks should be clearly explained in the consent form.
There are generally known and unknown risks that go along with taking part in research studies. Researchers must tell you how they will keep these potential harms to a minimum. In addition, there are protections in place to keep you safe. As part of the informed consent process, researchers should make you aware of any possible stressful experiences before you agree to take part. Make sure to ask about the steps that will be taken to protect your confidential information as well as what help will be available if the study has the potential to be distressing.
Some potential risks of being part of a research study include:
It is important that you understand what risks are anticipated in the particular study you are considering and that you weigh the risks and benefits of participating in research before enrolling. When thinking about risk, consider these 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?
3. Are the benefits of taking part in the study more important to me than the risks?
If you are considering joining a study, ask the researchers any questions that will help you decide whether to participate. This includes asking for more information about parts of the conversation or written materials. Taking time to share your concerns will help you feel safe if you do decide to volunteer. You can find example questions to ask at Research Studies: Learn More Before You Take Part. It may be helpful to involve close family members, your doctors, or friends in this decision-making process. Remember that joining a research study is voluntary and that even after joining, if you change your mind, you can stop taking part at any time. The research staff will help you do this safely.
Regardless of whether you decide to take part in the study or not, it is important to make a decision that is right for you.
This article is a NetWellness exclusive.
Last Reviewed: May 15, 2011
Nicole M Deming, JD, MA
Assistant Professor of Bioethics
School of Medicine
Case Western Reserve University