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:
- 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.
- 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.
- 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.