How do researchers make sure that participants are safe?

It’s a good idea to ask questions and gather information before you make a decision about participating in research. It’s also important to remember that strict rules protect participants in research studies. Researchers take these rules very seriously because they care about participants’ health. Additionally, researchers must follow the rules if they want to be allowed to do more research.

Below is information about how study participants are kept safe.

Federal agencies

• Protect the rights and well-being of clinical research participants. Federal agencies including the FDA and NIH oversee much of the medical research in the United States.

Informed consent

• Informed consent is the process of learning about a clinical research study before you decide if you want to participate. For more information about informed consent, see the “What is informed consent?” section in this guide.

Institutional review boards (IRBs)

• IRBs oversee the research centers where clinical studies are conducted. IRBs review and approve study protocols (plans) for scientific merit, participant safety, and ethical considerations. Participants who have questions may contact the IRBs at the research center they are considering. IRB members usually include scientific experts as well as community members.

Leaving the trial

• Participants who wish to leave the trial because they feel unsafe may do so without penalty.

Peer review

• Federal agencies may review individuals and institutions conducting research.

Primary health care

• If you participate in a study, talk with your regular doctor to be sure that medications you normally take are safe to use with any medications you may take for the study. Sometimes the researcher will ask for permission to speak with your regular doctors to make sure you get the best treatment.

Protocol

• A protocol is a plan that details what researchers will do during a study. Every study must have a protocol. The protocol includes information on how researchers will work to keep participants safe.

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