Record of Informed Consent
For any research protocol occurring on the premises of the UIHC and involving a physical interaction or collection of physical specimens from a human subject, documentation must be made in the subject’s UIHC medical record and must include a record of informed consent. The physical interaction includes, for example, a cheek swab or a single blood draw, when occurring on the premises of the UIHC.
If the subject has a current UIHC medical record, the Record of Informed Consent must be scanned to the UIHC medical record. If the subject has no existing record, the subject must be registered as a UIHC patient and given a UIHC hospital number.
- A Record of Informed Consent is to ensure:
- Subject confidentiality. The record of consent will always be used in the medical record in place of the informed consent document.
- References to study drugs, potential complications, or any other pertinent information for emergency personnel. If questions arise, the research team’s contact information is included on the record of consent.
- A Record of Informed Consent is not required when:
- Participation involves ONLY a written survey or oral interview only
- Physical interaction or collection of physical specimens does NOT occur on UIHC premises
- The Record of Informed Consent template is on the following page. Note that it does not contain the project title or a description of the study. The record of consent will include the following information:
- Subject Name
- Hospital id#
- IRB ID number
- 24/7 contact information for the research team
- Date the subject signed the informed consent document
- If applicable, study drug indication, potential complications, and whether or not it is an investigational use
- Any other information that may be important to emergency personnel.
- Signature from the research team member who obtained the subject’s consent to participate.