VCOM Institutional Policy and Procedure Manual

VCOM Policy and Procedure

Policy #R004

• Study-specific consent and comprehensive IRB review • IRB waiver of consent (as eligible) and comprehensive IRB review • Exemption #4 • De-identification to remove the research activity from Common Rule purview and not require IRB review or consent For all non-English speaking participants, written translation of informed consent documents must be performed by an independent qualified individual. Though there is no standard definition of what constitutes a “qualified individual,” the investigator should demonstrate due diligence in obtaining an adequate translation of the informed consent documents from an individual whose qualifications would appear adequate to a reasonable person. 14.2. Documentation Informed consent will be documented by the use of a written form signed by the subject (or the subject’s legally authorized representative). However, this requirement may be waived if the IRB finds either: • The research presents no more than minimal risk of harm to subjects and involves no procedures of which written consent is normally required outside the research context. • The only record linking the subject and the research would be the consent document, and the principle risk would be potential harm resulting from a breach of confidentiality. However, each subject must be asked whether they want documentation linking them with the research, and the subject’s wish will govern. • If the subjects or legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm, that the research presents no more than minimal risk of harm to subjects and provided there is an appropriate alternative mechanism for documenting that informed consent was obtained. In cases where the signed informed consent form is waived, PIs may be asked to provide the subjects with a simple written statement about the research. If the research does not meet the criteria for waiving signed consent documentation, a written consent document must be signed. The IRB must approve all consent forms prior to subject recruitment (consent forms will be reviewed during the review of the proposed research). A copy of the signed consent form must be given to the person signing it. The consent form must be either one of the following types of documents: • A written consent document that embodies the elements of informed consent noted in Section 14.1. General Requirements . This form may be read to the subject or his or her representative, but the PI will give either the subject or the representative adequate opportunity to read it before signing. • A “short form” written consent document stating that the elements of informed consent have been presented orally to the subject or the subject’s legally authorized representative. When this method is used, there will be a witness to the oral presentation. Furthermore, the VCOM IRB must approve a written summary of the oral presentation. The person obtaining consent will sign a copy of the summary. The witness will sign both the short

VCOM Institutional Review Board Policies and Procedures

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