Because of guidance updates from federal regulatory agencies and the Internal Review Board (IRB) accreditation process, the UNMC IRB is making many changes to the process of human subject protection at UNMC, The Nebraska Medical Center and UNO. Continuing education of the research community is an important part of the IRB accreditation process. Today’s article covers important reminders about informed consent.
Important Reminders about the Process of Informed Consent
- Informed consent is an educational, on-going process – not just signatures on the document. Also consider that subjects must be told new information that may affect their willingness to continue participating in a study – often by revising the consent form and obtaining new consent from subjects.
- IRB policy states that only physicians are permitted to obtain and document consent for subjects enrolling in IND (pre-marketed drug) studies and trials involving significant risk (such as IDE significant risk studies and other trials involving chemotherapy and surgery). While other study personnel (such as an RN, NP, PA, or study coordinator) can be involved in the process, the physician must be present to certify that the subject understands the study and has all questions answered.
- The IRB may allow participating personnel with appropriate licensure (such as RN, NP, PA, and Pharm.D.) to obtain and document consent for all other studies (such as marketed drug and greater than minimal risk studies). However, please understand that the PI and/or IRB may administratively decide that some studies will require that only physicians can obtain and document consent (such as studies involving vulnerable subjects.)
- The signature of a witness is required for all research studies involving greater than minimal risk. The witness must be someone who is not listed on the IRB application or consent form.
- When the PI is not the individual consenting a subject in a greater than minimal risk study, the PI must sign and date the consent form on the PI signature line within 10 business days of the time the subject signed the consent form.
[Note: If the PI is the person obtaining consent from the subject, the PI should sign and date the Investigator signature line only.]
- When a potential adult subject has a court appointed legal guardian, the proxy assent/guardian consent process must be used. The presence of a guardianship takes priority over an investigator’s determination of the subject’s competence.
- Because investigators often revise the consent documents during the course of a study, we strongly recommend that version number and date be indicated on the consent form (such as the on the bottom left of each page, opposite from the participant’s initials.) This will more easily help identify the most current version of the consent form and ensure that the current approved consent form is used. (FDA regulated studies are required to include a version date on the consent forms.)