What do I need to know about informed consent?

Documentation of informed consent

Informed consent should contain certain required elements and be documented by a written form that is signed by the subject or the subject’s legally authorized representative (unless a waiver or alteration of consent or waiver of documentation of consent is requested and approved). The researcher should keep the signed consent forms for at least three years after the research has ended.

A written consent document that embodies the required 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.

Waiver of documentation of informed consent (unsigned consent)

The required elements of informed consent have been presented to the subject or the subject's legally authorized representative (e.g., orally, visually, etc.) but the subject does not sign the document. A copy of the summary may be required be given to the subject or the representative by the IRB.

An IRB 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.

Waiver or alteration of informed consent (no consent or some elements missing)

An IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth in this section, or waive the requirements to obtain informed consent provided the IRB finds and documents that:
  1. The research involves no more than minimal risk to the subjects;
  2. The waiver or alteration will not adversely affect the rights and welfare of the subjects;
  3. The research could not practicably be carried out without the waiver or alteration; and
  4. Whenever appropriate, the subjects will be provided with additional pertinent information after participation.