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Potential Risks and DiscomfortsThe Consent Form should clearly describe the immediate and latent risks of each procedure/intervention to be carried out for research purposes.
The Consent Form should clearly describe the immediate and latent risks of each procedure/intervention to be carried out for research purposes.
A risk is a potential harm or injury associated with the research that a reasonable person would be likely to consider significant in deciding whether or not to participate in the study. The concept of risk includes discomfort, burden, or inconvenience a subject may experience as a result of the research procedures.
The Potential Risks and Discomforts portion of the Consent Form should clearly describe each procedure/intervention and each associated risk. For example, if your project involves psychological testing, subjects should be told that some aspects of the psychological testing could be stressful. Or, depending on the topic of a survey, it is possible that subjects may experience discomfort or embarrassment when answering some of the questions on the survey.
Base your disclosure of the potential risk on what a reasonably prudent prospective subject might want to know. Risks should not be understated or overstated. In some cases, it is appropriate to cite statistical probability of the risk occurrence, and/or risk prevention measures.
Do not use the terms “less than minimal risk,” “minimal risk,” and “greater than minimal risk” in the Consent Form because research subjects are not likely to understand the meaning of these terms.
If there are no known risks (including discomfort, burden, inconvenience) this should be stated in the Consent Form (for example, “there are no known risks associated with this research”).
