Joining a research study is an important choice and one that should be based on having clear and complete information about how the study works and how it might affect you. Here are some questions for you to consider asking as you are making this important decision:
The answer to this question depends on the type of study you are thinking about joining. Some studies have no impact on your health care and are separate from where your health care provider works. Other studies might be about health care itself, or comparing different ways health care is given. This second type of study could affect your health care. If you have concerns about whether being in a study will affect your health care, ask the study staff directly so that you can make an informed decision.
Before you join a research study, the staff will explain what the study is about and what study participants will do. They will also share the risks and benefits of the study, if there are any.
The study might provide you with written material like a pamphlet, a letter, or a consent form. It’s a good idea to read anything they give you very carefully. It is the research team’s job to make sure you understand what study participation involves before you decide whether to join. Once you feel your questions have been answered and you feel comfortable participating, the staff will ask you whether you agree to be in a study. If you have concerns or unanswered questions about a study, you can always say “no.”
You can quit a research study at any time. The research staff might ask you for your reason for leaving the study, but you are not required to provide a reason. You should never be made to feel badly if you want to stop before the study is over. There are cases when quitting could affect your health, depending on what type of study you are in. For instance, you may be given instructions on how to safely stop using study medications. If this happens, you might consider talking to your health care provider before stopping the study.
There are many ways that study teams protect participant privacy. Some examples include:
However, a study team can never promise that your information is totally protected. No matter how hard they try, there may be cases, such as running into someone you know in the study clinic, that accidentally share that you are in a study. If you have concerns about how your privacy will be protected, talk about these concerns with the study staff so you can make a decision that is right for you.
Every research study involves certain benefits and risks to study participants, depending on the study’s purpose and procedures. It is the study team’s responsibility to explain what these risks and benefits are before you decide whether to join. You should only decide about joining once you feel you fully understand these risks and benefits.
Genetic research, which is also sometimes called “genomic research”, is different than other types of research because the tests that are done could reveal health information that you might have in common with your family members.
For example, there are studies that test whether participants have a gene that puts them at higher risk for developing a certain health condition. Having a genetic risk like this could mean that your relatives have it too. While some people find learning this information helpful, others may find it to be surprising or even scary.
Before joining a genomics study, talk to the family members who might be affected by learning these test results. It is important that study participation does not cause disagreements or bad feelings between family members. If you are concerned about this type of family sharing of medical information, you should consider this as you make your decision to join, or not join, a study.
This video from the U.S. Office for Human Research Protections provides basic information about social and behavioral health research and what makes it different from clinical research.
Watch video. (YouTube, 6:05).