Clinical Research Glossary

risks of a research study risks of a research study


The possible harms of being in a research study.

Example of risks of a research study in a sentence

Learning about the risks of a research study can help a person decide whether or not to join.

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The risks of a research study depend on the study and study procedures. The risks are listed in the consent form.

A potential participant should talk about the risks with the study team and anyone else who can help with deciding whether to participate.

Some risks may not be known when a person signs the consent form. The study team will keep the participant updated if important new risks are identified.

Sometimes there are also risks to other people to consider so these should also be reviewed and understood. For example, if a study shares genetic information that could impact other family members.

Other info to think about when joining a study

You might see the term “risks of the research study” when the study team gives you a consent form to review and tells you about the study. They will explain the risks that you may experience if you join the study.

Ask questions about any of the risks you don’t understand before agreeing to take part in a study. Risk may involve harm to the body but it may also include things like your personal information that is collected during the study potentially being leaked.

To learn more about the risks of a research study, you can ask things like:
– How much do the researchers know about the risks of the study treatment – especially if it is new or experimental?
– Does the study treatment have FDA approval or oversight?
–What are the short- or long-term risks, discomforts, or unpleasant side effects? How likely are they to occur, and are any of them severe?
-What are the researchers doing to decrease risks, discomforts, or unpleasant side effects?
– Is there anything a participant could do to minimize their risks during the study?

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