The Informed Consent document contains the basic elements of informed consent as identified in and required by the United States regulations regarding the protection of human subjects (45 CFR 46). As required by this regulation, the informed consent document must be reviewed and approved by an Institutional Review Board.
The application must state specifically what information will be provided to the subjects about the investigation. Is any of this information deceptive? Further, the application must state how the subjects’ informed consent will be obtained. The sample consent form included in the application may be used as a guide. The final application must include a final draft of the consent form which the researchers propose to use.
Confidentiality
Adequate provisions must be made to protect the privacy of subjects and to maintain confidentiality of identifiable information. The protocol application must explain how procedures accomplish this objective; such as means of data storage, data location, and how long the data will be saved, description of persons with access to the data, and method of destroying the data when the study is completed.
Protocol Application Submission
All proposed research involving the use of human subjects requires review and approval by the Institutional Review Board (IRB) prior to the initiation of the research. Each proposal must include a brief description and address the seven criteria listed on the IRB Application Form. (You will need Acrobat Reader to view and use this form in its pdf format.)
