What Does the Witness Signature Line Signify for the Informed Consent?
Even though the federal regulations do not require it, the IUPUI/Clarian Institutional Review Boards (IRBs) require a witness signature for those studies utilizing written consent. The witness may be the PI or the person obtaining consent. Because the witness is signifying that the consent process occurred, the IUPUI/Clarian IRBs do not require the witness to be impartial. An impartial witness need only be utilized if the subject or their legal representative is unable to read or if there is some concern about the subject’s level of understanding. For additional information, refer to the online IRB Packet Consent Checklist at http://www.iupui.edu/~resgrad/ spon/download.htm. Revised Statement of Appointment Form PHS 2271 Now Available The “Statement of Appointment Form” (PHS 2271, Rev. 5/01) has been revised and will be required for appointments beginning on or after June 1, 2002. The National Institutes of Health (NIH) must implement use of this revised form in order to maintain compl