Waivers of Written Informed Consent

There are two categories where the Institutional Review Board (IRB) may waive all or part of the normal consent requirements:

1. The IRB may waive part or all of the normal consent requirements if:

a) the research involves no more than minimal risk to the subjects;
b) the waiver or alteration of normal consent procedures will not affect adversely the rights and welfare of the subjects;
c) the research could not be carried out effectively without the waiver or alteration; and
d) whenever appropriate, the subjects will be provided with additional pertinent information after participation.

This category of waiver includes those cases in which the researcher desires to withhold from the subject some information about the project that, if known by the subject, would bias the results of the study.

Ordinarily, the researcher would plan a debriefing session after completion of the subject's participation in order to provide the subject with the missing information, and give the subject the option of including his/her data in the study or having it destroyed.

In no case should a researcher seek to withhold information about the research or the subject's role in the research solely to reduce the chance that the subject will refuse to participate.

2. The IRB may waive the requirement for written consent if it finds that:

a) the only record linking the subject and the research would be the consent document and the principal risk would be the potential harm resulting from breach of confidentiality; or
b) the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside the research context.

This type of waiver applies especially to anonymous interviews (including face-to-face and telephone interviews) where the researcher's sole knowledge of the identity of the subject would come from the consent document.

Researcher's Responsibility

Waiver of written consent procedures does not imply waiver of the researcher's responsibility to obtain consent from the subject.

In all cases, the researcher must provide the subject with a statement describing the research that includes all relevant elements of informed consent. The IRB requires that when the use of written informed consent is waived, a cover letter be given to the subjects outlining the purpose and procedures of the project and containing a statement such as "Completion and return of the survey [questionnaire, interview, etc.] indicates consent to participate in the study."