It is ethically necessary to ensure that subjects are fully informed about the nature of the research project so they can make an informed decision about participation. Consent for Research that may be Determined Exempt Research May be used for: Situations in which it may be approved include deception or analysis of existing data. It is rare that the IRB will approve a complete waiver of informed consent. Food and Drug Administration (FDA) regulations at 21 CFR part 50Ĭonsent will not be obtained or consent will not contain all of the information that is typically required.Department of Health & Human Services (HHS) regulations at 45 CFR part 46.The requirement for informed consent is one of the central protections defined by the: Any exceptions must be reviewed and approved by the IRB beforehand. With few exceptions, researchers must obtain and document consent from the prospective research subject before initiating any study procedures. For more information regarding the procedures for obtaining and documenting informed consent, please see HRP-90 and HRP-91. Voluntary informed consent is not a one-time event, but rather is an ongoing process. Individuals should be given the opportunity to make the choice to be in a study without pressure or undue inducement to participate. Based on the governing principles of human research outlined in “ The Belmont Report,” investigators have key responsibility for ensuring voluntary participation of research subjects.Īny prospective research subject (or his/her legally authorized representative) should be able to understand as completely as possible the procedures to be performed, risks, benefits, alternatives, and confidentiality measures.
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