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Human Subjects

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Informed Consent Waivers

Instructions:
Federal regulations require that investigators obtain the informed consent of each research participant (or the participant’s legally authorized representative) and document consent with a written consent form.  This requirement must be met in all cases, except in very specific circumstances in which the IRB is authorized to grant a “waiver”.  

The IRB can grant two types of waivers: a) waiver of documentation of informed consent or b) waiver of informed consent.  If a researcher believes that either waiver is necessary to the conduct of the research, then he/she may request a waiver, but a compelling case must be made that the waiver is necessary.   

If you believe a waiver is necessary to conduct your research, select the appropriate waiver form, and provide the information necessary to make your request.  Submit “Form A” or “Form B” (not both) as the final page of the “Application for IRB Review.” 


EXAMPLES

Below are examples of the kinds of projects which might be appropriate for a waiver:

Form A - Waiver of Documentation of Consent:  
Example falling under condition 1:  You are doing interviews with gay men in the military and you are concerned that knowledge of their participation in your study could jeopardize their position in the military and potentially harm them socially and financially.  You will prepare a consent form containing all the elements of consent, review it with participants prior to the interview, and give them the option of signing the form or consenting verbally.

Example falling under condition 2: You are conducting a mail survey of executives about job satisfaction.  You will send the survey accompanied by a cover letter containing all the elements of consent.  Return of the survey implies consent.

Form B - Waiver of Informed Consent:
Example 1: You are reviewing archival medical records at a psychiatric clinic to assess changes in psychiatric diagnosis and treatment over the last 20 years.  You will retrieve data from 1000 medical records, but no identifying information will be recorded.  Given the large number of patient records it would be impracticable to obtain the consent of each patient.

Example 2: You are doing a study where you deceive people about the purpose of the study and thus request a waiver of that particular element (explanation of purpose of study) of consent.  You plan to provide a full explanation of the purpose in a debriefing at the conclusion of the study.


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