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Waivers of Informed Consent and HIPAA Research Authorization Ellen Patricia, MS, CIP Erin Odor, MA, CIP Office of Responsible Research PracticesOffice of Responsible Research PracticesSession Objectives
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Step 1: Read and understand the purpose of the waiver of informed consent.
02
Step 2: Collect all necessary information regarding the study or procedure the waiver is for.
03
Step 3: Clearly state the risks and benefits involved in participating without informed consent.
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Step 4: Provide a section for the participant to provide their signature, indicating their agreement to waive informed consent.
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Step 5: Ensure the waiver form is easily accessible and understandable.
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Step 6: Store the completed waivers securely and confidentially.

Who needs waivers of informed consent?

01
Researchers conducting studies or procedures that involve human subjects and require a waiver of informed consent.
02
Medical professionals or institutions performing emergency medical interventions where obtaining informed consent is not feasible.
03
In certain legal situations where obtaining informed consent would obstruct justice or harm public interest.
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Waivers of informed consent are provisions that allow researchers to exclude the requirement of obtaining informed consent from participants under certain circumstances, typically when the research poses minimal risk and does not adversely affect the rights and welfare of participants.
Researchers conducting studies that qualify for a waiver of informed consent are required to file such waivers with the Institutional Review Board (IRB) or ethics committee overseeing the research.
To fill out waivers of informed consent, researchers must provide detailed information about the study, the rationale for the waiver, the nature of the involvement of participants, and how their rights and welfare will be protected.
The purpose of waivers of informed consent is to facilitate research that may not be possible if informed consent requirements would hinder data collection, particularly in studies involving minimal risk to participants.
Information that must be reported includes the study's purpose, the population involved, any potential risks and benefits, measures taken to protect participants' confidentiality, and justification for why informed consent cannot be obtained.
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