Initial Review Submission Form s1

Initial Review Submission Form Investigator Signature Page

Investigator Confirmation of Board Requirements
The Principal Investigator must assure the Board of the following by signing in the space provided below:
· The answers in this form are accurate.
· I will read and abide by all of the Board requirements listed on the Certificates of Approval (COAs) and other WIRB correspondence I receive.
· If one or more of the Board’s requirements are not acceptable, I understand that I may ask the Board to reconsider its requirements, but may not enroll subjects until the issue is resolved in a manner acceptable to the Board.
· For covered entities requesting WIRB approval of HIPAA partial waivers of authorization for recruitment: “By signing below I am providing written assurance that only information essential to the purpose of recruitment will be collected, and access to the information will be limited to the greatest extent possible. Protected health information will not be re-used or disclosed to any other person or entity.”
· For covered entities requesting WIRB approval of HIPAA full waivers of authorization: “By signing below, I am providing written assurance that only information essential to the purpose of this research will be collected and used, and protected health information will not be re-used or disclosed to any other person or entity except as permitted under the Privacy Rule found at 45 CFR 64. This written assurance is only applicable to research conducted under the jurisdiction of the Privacy Rule.”
Signature of Principal Investigator Date

IRSF Investigator Signature Page 07-2012 033109001