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.
Remit to: IRB Chair, c/o Research Services Interoffice: GranadaCenter, Suite 400, LSC
U.S. Mail:Express Mail: / LoyolaUniversity of Chicago
6525 N. Sheridan Road
Chicago, IL60626
6439 N. Sheridan Rd., Chicago, IL60626
Form A
Request for Waiver of Documentation of Informed Consent
Investigator’s name:
Title of Project:
A. Waiver of Documentation of Consent
Documentation of consent means that participants are required to sign a consent form, thereby documenting their consent. A waiver of documentation means that the IRB is waiving the requirement to obtain the participant’s signature. Even if this waiver is granted, a consent process must still be in place. The consent process must contain all the required elements of consent and usually consists consent form or a verbal script that is read aloud to them.
For the IRB to grant this waiver, your project must meet one of the following conditions. Check the appropriate condition and explain why your research meets the condition in the space provided.
Condition 1-The only record linking the participant and the research would be the consent document and the principal risk would be the potential harm resulting from a breach of confidentiality. This refers to instances where participants could be seriously harmed if it became known that they were participants in the research.
Explanation:
OR
Condition 2-The research presents no more than minimal risk of harm to participants and involves no procedures for which written consent is normally required outside of the research context. This refers to procedures such as mail surveys or brief interviews over the telephone or at public events/venues that elicit non-sensitive information.
Explanation:
Signature of Researcher ______Date ______
If requesting this waiver, please attach this document to the end of the “Application for IRB Review”(after question #9).
Remit to: IRB Chair, c/o Research Services Interoffice: GranadaCenter, Suite 400, LSC
U.S. Mail:Express Mail: / LoyolaUniversity of Chicago
6525 N. Sheridan Road
Chicago, IL60626
6439 N. Sheridan Rd., Chicago, IL60626
Form B
Request for Waiver of Informed Consent
Investigator’s name:
Title of Project:
B. Waiver of Informed Consent
Informed consent refers to a process whereby the researcher obtains the willingness of the participant to be included in research once all the necessary elements of consent (specified in federal regulations) have been disclosed. All elements must be fully disclosed for the decision to participate to be truly informed, thus when the IRB grants a waiver of informed consent it is either waiving the requirement of a consent process entirely or the requirement to fully disclose all elements of consent.
Please check the appropriate box:
I am requesting waiver of a consent process.
OR
I wish to refrain from fully disclosing certain elements of consent? If so, specify which element(s) and why?
In order for the IRB to grant this waiver, all of the following conditions must be met. Explain why your research meets each condition in the spaces provided.
Condition 1-The research involves no more than minimal risk to the participants.
Explanation:
Condition 2-The waiver will not adversely affect the rights and welfare of the participants.
Explanation:
Condition 3-The research could not practicably be carried out without the waiver. “Practicably” means there is no practical way to either implement a consent procedure or disclose all the elements of consent without jeopardizing the validity of the study.
Explanation:
Condition 4-Whenever appropriate, the participant will be provided with additional pertinent information after participation.
If appropriate, explain how this will be done:
Investigator’s Signature ______Date: ______
If requesting this waiver, please attach this document to the end of the “Application for IRB Review” (after question #9).