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When a research project involves any physical interaction or specimen collection at the University of Iowa Health Care (UIHC), it is UIHC policy (IM-MR-06.21) that a signed copy of the Record of Informed Consent (RIC) be placed in the subject’s medical record chart. All content added within the Record of Consent must be approved by the IRB prior to use. The Informed Consent Document signed by the subject (or a copy) is NOT placed in the medical record. The RIC provides a link between the UIHC patient and the study in which they participate, however, it protects the privacy and confidentiality by providing limited information about the research study. The RIC is signed by the research team member who obtained consent from the subject and documents that consent has been obtained.
A template Record of Informed Consent is available as a choice on the Consent/Assent attachments page of HawkIRB. The Record of Consent Policy applies to studies reviewed and approved by WIRB. The VAHCS does not recognize the Record of Informed Consent. Any research studies that occur under IRB-03 or at the VAHCS will be required to place the informed consent document in the medical record. The Record of Informed Consent will not be used at the VAHCS.