Appendix A: Documentation of Informed Consent Checklist

(adapted from the Office for Human Research Protections, U. S. Department of Health and Human Services)

a. Except as provided in paragraph "c" below, informed consent shall be documented by the use of a written consent form approved by the HSC, and signed by the participant or the participant’s legally authorized representative. A copy shall be given to the person signing the form.
WRITTEN	b. The consent form may be either of the following: 1. A written consent document that embodies the elements of informed consent as outlined in the HSC APPROVAL CHECKLIST ITEM 4. This form may be read to the participant or the participant's legally authorized representative, but in any event, the investigator should give either the participant or the representative adequate opportunity to read it before it is signed.
DONE ORALLY	2. A short form written consent document, stating that the elements of informed consent required have been presented orally to the participant or the participant's legally authorized representative. When this method is used, there shall be a witness to the oral presentation. Also, the HSC shall approve a written summary of what is to be said to the participant or the representative. Only the short form itself is to be signed by the participant or the representative. However, the witness shall sign both the short form and a copy of the summary, and the person actually obtaining consent shall sign a copy of the summary. A copy of the summary shall be given to the participant or the representative, in addition to a copy of the short form.
WAIVER of req't for signed form	c. The HSC may waive the requirement for the investigator to obtain a signed consent form for some or all participants, if it finds either: 1. That the only record linking the participant and the research would be the consent document, and the principal risk would be potential harm resulting from a breach of confidentiality. Each participant will be asked whether the participant wants documentation linking the participant with the research, and the participant's wishes will govern; or 2. That the research presents no more than minimal risk of harm to participants, and involves no procedures, for which written consent is normally required outside of the research context. In cases in which the documentation requirement is waived, the HSC may require the investigator to provide participants with a written statement regarding the research.

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