IRB - Sample Format for Informed Consent Form

NOTE: An "Informed Consent Form" must be included with your application for the use of human subjects in research. Below is a sample of the format that you should adapt to your specific requirements. Please follow the guidelines for informed consent as set forth in 45 C.F.R. § 46.116.

*** Begin Sample ***

I hereby consent to my participation in the following research project:

(Title of Project)
(Project Director)
(Department/Agency)
(Address)
(Telephone) (Fax) (E-mail)
(Sponsor)

State the purpose of the research in lay terms, the procedures to be followed and their purposes, including any which are experimental

• Describe anything that may cause embarrassment or discomfort to the participants.
• Describe any benefits to be expected from the project to the participants or society in general.
• Describe any alternative procedures (if appropriate) which may be available.
• Provide the name(s) and the telephone number(s) of the individual(s) who would be prepared to answer questions concerning the project.
• State that the participant is free to withdraw consent and to discontinue participation in the project at any time, without prejudice.

Signature of Subject (including children over 7 years of age) Signature of Parent or Guardian (if subject is under 18 years of age) Signature of Person Obtaining Consent	Date Date Date
*** End Sample ***