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Do research participants always have to sign an informed consent?

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Do research participants always have to sign an informed consent?

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No. There are several research situations, all involving no more than minimal risk, where the IRB can authorize you to obtain consent orally. For example, if your participants cannot write, the IRB will waive this requirement, provided that the study presents no more than minimal risk. Otherwise, you would have to obtain written consent from someone authorized to act on behalf of the participant. As another example, if the risk to your participants would increase markedly because they signed a consent form (as in an interview or survey that addressed the participant’s HIV status), then the requirement could also be waived. You would still need to obtain informed consent, but it could be obtained orally.

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