Presented by Gail Paulsen, IRB Administrator during the March Clinical Research Coordinator’s Quarterly Updates.
UNMC Human Research Protection Program (HRPP) Policy 5.1 describes the Organization’s requirements for the process and documentation of informed consent. Legally effective informed consent must be obtained for all subjects or legally authorized representatives (LARs) prior to their participation in a study.
Informed consent must be documented on IRB-approved consent forms and only the currently approved and stamped Informed Consent Form (ICF) should be used. Coordinators should never rely on stock copies but should always download the current form from the eIRB Approved Consent section.
There are templates available for informed consents for Adults, Adults without capacity to consent, and minors. There are also special requirements when consenting non-English speaking subjects. In Nebraska age of consent or “majority” is 19 years of age. Subjects at or above the age of majority who have the capacity to consent for themselves should be consented on the approved Adult Consent form. When an adult is unable to provide consent a Legally Authorized Representative (LAR) can sign a consent form on behalf of the compromised adult. The IRB must approve enrollment plans for decisionally-impaired subjects as well as the LAR consent form. There may also be a requirement to provide an information sheet written at a level of understanding for the adult subject, i.e. patients with Alzheimer’s or developmental disabilities, etc. Subjects with diminished capacity may be able to assent based on the adult information sheet and this assent must be documented in the LAR ICF; however their assent is not a legally binding consent and the LAR must sign the ICF on their behalf. Tools to help determine capacity for consent can be found on the IRB website. In the instance of a temporary loss of capacity the use of an LAR ICF should be used and when the subject regains capacity they must sign the Adult ICF acknowledging their consent; both consent documents should be retained in the medical record. Coordinators of long-term studies which enroll minors (subjects under the age of majority, 19 years in Nebraska) need to be aware that when a subject reaches the age of majority a new Adult ICF must be signed by the subject. When consenting Non-English speaking subjects a certified translator must be utilized in addition to an IRB approved translated consent form in the language understandable to the subject. In certain instances the IRB may approve the use of a short form (i.e. unexpected encounters, prospect of direct therapeutic benefit, etc.). Each use of a short form must be approved by the IRB prior to use. Short forms are good for only a two week period, both the translator and the PI must sign the consent form.
Study personnel who are permitted to document informed consent must be: Authorized by the PI, listed by name in the documentation of consent section of the IRB application, and approved by the IRB. They must have the necessary expertise, sufficient knowledge of the protocol, any required medical/dental licensure, and authorization per hospital policy to perform the procedures in a non-research clinical care/diagnostic context.
Ultimately the PI is responsible for the development, obtainment, and documentation of valid informed consent.