Waiver of Documentation of Informed Consent

Investigators shall be responsible for insuring that informed consent is documented by the use of a written consent form approved by the CPHS/IRB and signed by the subject or the subject's legally authorized representative, unless this requirement is specifically waived by the CPHS/IRB. Each person signing the written consent form must be given a copy of that form.

Under certain conditions, the CPHS/IRB can waive the requirement that the subject sign the consent form. However, waiver of documentation of informed consent does not constitute waiver of informed consent. The CPHS/IRB may waive the requirement to obtain a signed consent form for some or all of the subjects if one of the following conditions exists:

  1. The consent document is the only record linking the subject and the research and the principle risk would be potential harm resulting from a breach of confidentiality. Subjects will be asked whether or not they want documentation linking them to the research, and their wishes will prevail.
  2. 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.
  3. For projects of minimal risk involving the use of questionnaires, the required elements of informed consent may be included in an introductory letter attached to the instrument, which includes a statement that completion and return of the questionnaire will constitute consent to participate.

In cases where documentation is waived, the CPHS/IRB may require the investigator to provide subjects with a written statement regarding the research.