Nebraska S Health Science Center Office of Regulatory Affairs (Ora) s1

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NEBRASKA’S HEALTH SCIENCE CENTER OFFICE OF REGULATORY AFFAIRS (ORA)

Institutional Review Board (IRB)

Addendum M

Waiver of Requirement to Obtain Signed Consent

DATE:

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IRB:

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TITLE OF PROTOCOL:

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PRINCIPAL INVESTIGATOR:

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Instructions: The IRB may waive the requirement for the investigator to obtain a signed consent form in accordance with 45 CFR 46.117(c), equivalent sections of the Common Rule as adopted by other federal departments or agencies, and 21 CFR 56.109(c), if applicable, for some or all subjects.

To determine if a waiver of signed consent is permitted under the applicable regulations, the investigator must provide thorough and complete responses to the attached questions. This information must be submitted with the IRB Application.

A. WAIVER OF SIGNED CONSENT UNDER 45 CFR 46.117(C)(1) WHERE THERE IS RISK ASSOCIATED WITH A BREACH OF CONFIDENTIALITY

1. Are you requesting a waiver of written (signed) informed consent for all subjects or just a subset of subjects?

All subjects

Subset of subjects. Describe the characteristics of these subjects. Note: In some research projects, the waiver of the requirement to obtain a signed consent form is only applicable to a subset of subjects.

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2. Is the consent form the only record linking the subject with the research and is the principal risk of the research potential harm resulting from a breach of confidentiality?

No. Note: The IRB cannot grant a waiver of written (signed) informed consent unless the potential for a breach of confidentiality with resultant harm to the subject is linked to signed informed consent document

Yes. Note: Risk related to a potential breach of confidentiality would be dependent upon the sensitivity of the research data (e.g., a longitudinal study of domestic partner abuse) and the stringency of the procedures in place to protect the confidentiality of the data.

3. Attach a narrative of the information to be transmitted to the subject during the process of consent. All the elements of consent required by the IRB that are contained in the consent form template must be included.

Note: If written (signed) consent is waived by the IRB under this circumstance, then each subject must be asked whether he/she wants documentation linking the subject with the research, and the subject’s wishes will govern. If a subject elects to have documentation of his/her consent, he/she must be asked whether they agree to documentation in the form of a written notation in the secure research record maintained by the investigator. Before making this decision, the subject must be advised of the potential harm which may result from a breach of confidentiality. The decision of each subject must be documented in the research record.

Note: In accordance with 21 CFR56.109(c), a waiver of the requirement to obtain a signed consent form for FDA-regulated research is not permitted under item #2.

Note: It should be noted that a waiver of written (signed) consent does not imply a waiver of either the process of consent or the required elements of consent.

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B. WAIVER OF SIGNED CONSENT UNDER 45 CFR 46.117(C)(2); 21 CFR 56.109(C) WHERE THE RESEARCH IS NO MORE THAN MINIMAL RISK AND WRITTEN CONSENT IS NORMALLY NOT REQUIRED OUTSIDE THE RESEARCH CONTEXT

1. Are you requesting a waiver of written (signed) informed consent for all subjects or just a subset of subjects?

All subjects

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2. Does the research present no more than minimal risk of harm to subjects and involve no procedures for which written consent is normally required outside of the research context?

No. Note: The IRB cannot grant a waiver of written (signed) informed consent unless the research is no more than minimal risk.

Yes. Note: Minimal risk means "The probability (of occurrence) and magnitude (seriousness) of harm or discomfort (e.g., psychological, social, legal, economic) associated with the research are not greater than those ordinarily encountered in daily life (of the average person in the general population) or during the performance of routine physical or psychological examinations or tests." Minimal risk, therefore, is used to define a threshold of anticipated harm or discomfort associated with the research that is low.

Note: Examples of procedures that would normally meet the requirements of 46.117(c)(2) include 1) routine diagnostic procedures such as venipuncture, magnetic resonance imaging, electrocardiography, and vital sign measurements; and 2) routine psychological assessments or tests.

Note: In accordance with 21 CFR56.109(c), a waiver of the requirement to obtain a signed consent form for FDA-regulated research is only permissible under item #2 above.

3. Attach either a consent form which does not contain signature blanks or a written narrative of the information to be transmitted to the subject during the process of informed consent. Note: All the elements of consent required by the IRB that are contained in the consent form template must be included. Subjects should normally be given a copy of the unsigned consent form or written narrative.

Note: It should be noted that a waiver of written (signed) consent does not imply a waiver of either the process of consent or the required elements of consent.

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