IRB minimal standards for informed consent
The minimal standards against which all informed consent protocols will be weighed include:
- Information. Subjects are to be given information on the purpose, procedures, possible benefits, risks, and investigators as necessary to make informed judgments about their participation.
- Understanding. Investigators must take appropriate measures to assure that subjects understand the consequences of participation in the research.
- Voluntariness. Subjects must be given opportunities to contemplate their decision to participate and to give or not give their consent without coercion and with the understanding that they may withdraw from participation at any time.
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