Principal Investigator's Name

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Principal Investigator's Name

Principal Investigator's Name:

Title of Investigation:

A. Waiver of Documentation of Consent (in accordance with 45 CFR part 46.116-117)

Documentation of consent means that participants are required to sign a consent form, thereby documenting their consent. A Waiver of Documentation of Consent means that the CCGA IRB is waiving the requirement to obtain the participant's signature. Even if this waiver is granted, a process of informed consent must still be in place. The consent form must still contain all the required elements of consent . Participants must indicate their informed consent by checking a box on paper or on an electronic form.

In order for the CCGA IRB to grant this waiver, your investigation much meet one of the following conditions. Check the appropriate condition and explain why your research/class project meets the condition in the space provided below:

______Condition 1- The only record linking the participant and the research/class project would be the consent document and the principal risk would be the potential harm resulting from a breach of confidentiality. Each participant will be asked whether she/he wants documentation linking the participant with the research, and his/her wishes will govern. Explanation:

OR

______Condition 2- The research/class project 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 electronic surveys or brief interviews over the telephone or at public events/venues that elicit non-sensitive information. Explanation:

______Principal Investigator (Print Name)

______Signature of Principal Investigator Date

______Signature of Faculty Advisor (if applicable) Date

If requesting this waiver, please attach this document to the CCGA IRB Application for Approval of Research or the Student Application for Approval of Class Projects with Human Participants.

1Rev. 1 October 2014 (Modeled after Georgia Southern University IRB policy materials)

2Rev. 1 October 2014

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