When studies are approved by the IRB, the PI shall receive from the HSRO written notification together with a copy of the approved consent form containing the stamped/watermarked date of approval and the expiration date of the study's approval on each sheet. The Principal Investigator may make copies of the stamped/watermarked consent form for use in obtaining informed consent from each research subject. A copy of the stamped/watermarked approved consent form shall also be filed in the study files maintained in the HSRO. Only informed consent documents bearing the HSRO approval stamp/watermark may be used in the conduct of research.
Consent forms signed by research participants and others should be retained by the Principal investigator for a period of at least three years after the study is completed and a final report is approved by the IRB.