Guide :: Informed Consent :: Special Consent :: Documentation of Consent
Waiver of documentation of consent
In some studies, documenting consent is either inappropriate or even risky to a participant. The Board can grant a waiver of documentation of consent if:
- The only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality.
or
- The research is no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.
A waiver of documentation of consent does not mean that you do not need to consent the participant. Instead, it means that the Board does not require a participant to sign a consent document. You are still required to provide a consent session for the participant and explain all of the points of a consent form. You need to ask the participant if they consent to the study. This form of consent is called “oral consent.” Please see the Oral Consent section for more information.
Please note that the Board does not consider “inconvenience to the researcher” as a reason for granting a waiver of documentation of consent.
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Guide :: Informed Consent :: Special Consent :: Documentation of Consent |
