Waiver of Written Documentation of Consent

University and Federal regulations generally require written documentation of informed consent. The requirement for a written, signed consent form may be waived by a Human Subjects Review Committee if:

• the signed consent form itself might compromise the confidentiality of the data describing the subject and the subject prefers that no signed consent form be used; or
• the research presents no more than minimal risk and involves no procedures for which written consent is normally required outside the research context.

The requirement may also be waived on a case-by-case basis if there are other circumstances similar, hut not identical to, (a), above, and a clear and convincing case is made for granting such a waiver.

If a principal investigator wishes a waiver of the requirement for a consent form this should be indicated on Form UW 13-11 and complete justification of the request for the waiver showing compliance with the regulations governing waivers should be provided.

Waiving the requirement for a written form does not waive the requirement for informed consent. Subjects must be informed of the nature of the research, and their consent (or the consent of their legal representatives) must be obtained whenever appropriate. The Committees generally require the use of an Information Statement or Information Sheet when it waives the requirement for written documentation of informed consent.

An Information Statement is essentially a consent form, in standard format, up to and including the investigator's signature and date line, but not signed by the subject, and headed "Information Statement" rather than "Consent Form". The "Other Information" section should contain the statement, "If you have questions later on about the research you can ask one of the investigators listed above. If you have questions about your rights as a research subject, you can call the University of Washington Human Subjects Division at (206) 543-0098."