Documentation of Research

The federal regulations require that non-exempt research be documented; documentation means you’re getting a signature from the subject or their representative. A copy of the consent form is given to each participant. Documenting informed consent can be accomplished in one of two ways:

  1. A written consent document that contains all of the elements required by the Federal Guidelines. The form may be read to or with the subject or their representative, but in any case the subject or the representative must have time to read the form and ask questions before it is signed, OR
  2. A short form written consent document; this document states that the elements of informed consent required by the Federal Guidelines have been orally presented to the subject or their representative. There must be a witness to the oral presentation and the IRB must review and approve a written summary of what was said to the subject or representative. The subject or representative signs the short form and the witness signs both the short form and a copy of the summary, and the person obtaining informed consent (usually the Investigator) signs a copy of the summary. Copies of the summary and short form are given to the subject.

Exceptions

There are three situations where the regulatory requirement may be waived for written documentation of consent:

  1. The principal risks are those associated with a breach of confidentiality concerning the subject’s participation in the research (e.g., studies on sensitive topics such as drug abuse or sexual deviance); and (2) the consent document is the only record linking the subject with the research, OR
  2. The research presents no more than minimal risk and involves no procedures for which written consent is normally required when they are performed outside of a research setting, OR
  3. If the subjects are members of a distinct cultural group or community in which signing forms is not the norm, the research involves no more than minimal risk, and there is an alternative method for documenting that consent was obtained.

If the documentation requirement is waived, the investigator should provide subjects with a written statement regarding the research.