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Institutional Review Board

Instructions for Creating
an Informed Consent Form and Process

Informed consent shall be documented by the use of a written consent form approved by the IRB and signed by the participant and/or their legally authorized representative. In the case of minors (17 years of age or younger), the parent or legal guardian must give consent, as well as the minor. A copy of the consent form shall be given to the person signing the form, and the original signed form must be maintained in a place designated in your project description. Sample consent forms are also included with Category 1, 2, and 3 proposal packets.

Please remember that informed consent is fully informed consent. It is a process, not just a piece of paper. A participant must know all information regarding the study that would be relevant to their decision in order to make an informed decision to participate.

Please note that the final form that you use must first be approved by the Institutional Review Board before it can legally be administered and the IRB must by law retain in its records a sample copy of that form. The approved consent form will be date stamped and sent with your approval letter. It is the copy you should use for your research project.

Conditions of Approval:
Approval by the IRB applies only to the procedures submitted in the proposal. The investigator must secure prior approval from the IRB for any changes in the procedures that will affect the use of human participants. The investigator must also report to the IRB any problems that arise in connection with the use of human subjects.

IRB approval is only valid for the period specified in the proposal up to one year. If a project continues beyond the specified completion date or beyond one year, the investigator must request a continuation of approval from the IRB (see appendix).

Next step - completing the appropriate packet for your project.

Questions? Please call Kim Remley at 585-395-2523 or