Documentation of Informed Consent

Under federal regulations (Title 45 Code of Federal Regulations, Part 46 §46.116), informed consent must be documented by the use of a written form approved by the HSRB and signed by the subject or their legally authorized representative. The consent form may be one of the following; in either case, a copy must be given to the research participant or their representative.

  1. A written consent document that embodies the elements of informed consent. This form may be read to the subject or the subject's legally authorized representative, but in any event, the investigator should give either the subject or the representative adequate opportunity to read it before it is signed; or
  2. 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 should be a witness to the oral presentation. Also, the HSRB must approve a written summary of what is to be said to the subject or the representative. Only the short form itself is to be signed by the subject or the representative. However, the witness should sign both the short form and a copy of the summary, and the person actually obtaining consent should sign a copy of the summary. A copy of the summary should be given to the subject or the representative, in addition to a copy of the short form.

The HSRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either:

  1. That 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. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern; or
  2. That the research presents 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.

In cases in which the documentation requirement is waived, the HSRB may require the investigator to provide subjects with a written statement regarding the research.