Do research participants always have to sign an informed consent document?
No. In certain research situations, all involving no more than minimal risk, the IRB can waive the requirement that you obtain the participants signature on a paper consent form. For example, if your participants cannot write, the IRB will authorize you to obtain consent orally. In some situations the IRB might authorize you to obtain consent over the telephone or by e-mail. Sometimes the documentation requirement is waived if “implied” consent is sufficient. An example of this would be including a statement at the top of a survey or questionnaire informing participants that their completion and return of the survey implies their consent to participate. (For more information refer to the Application for Alteration of the Requirement to Obtain Written Informed Consent.) The requirement to obtain written consent can also be waived if the risk to your participants would increase markedly because they signed a consent form (as in an interview or survey that addressed the participant’s HIV
