Appendix E: Regulatory Support for Consent Process Review Criteria
- How will consent be obtained (written, verbal, electronic)?
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Is a waiver or alteration of written informed consent being requested? If yes:
- Does the research involve no more than minimal risk?
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Is the waiver or alteration appropriate and justified?
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Is the consent document the only record linking the subject and the research, and is the principal risk the loss of confidentiality?
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Would it be impractical for the research to be conducted without a waiver or alteration of signed consent?
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- Will an information sheet be used in lieu of a consent form?
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Are subjects capable of providing informed consent? If no:
- Is the party being authorized to provide consent appropriate?
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Will assent be obtained from subjects? If no:
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Is lack of assent appropriate and justified?
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- Is the consent form and process comprehensible for the subject population or those authorized to provide consent?
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Does the consent form/information sheet include all necessary elements?
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Does the consent process provide for adequate discussion to ensure consent is truly informed?
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Is the consent process devoid of any appearance of coercion or undue influence?
Informed consent is the direct application of the ethical principle of respect for persons. A discussion of the principle of respect for persons can be found in the Belmont Report (Part B, Section 1), as well as a discussion of the requirements of informed consent (Part C, Section 1).
Two of the criteria for Institutional Review Board approval of research, as listed in the regulations, include the requirement for obtaining informed consent (§46.111, section a4) and its documentation (§46.111, section a5). The regulations include, as well, general requirements for informed consent (§46.116), and the requirements for its documentation (§46.117).
See, as well, Appendix F: Elements of Informed Consent sheet.