3. The determination of a subject’s incapacity to consent to study participation by the physician making the determination must be documented and retained in both the medical and research records. This documentation must be retained as part of the permanent source documents for the IRB-approved study. II. IRB Responsibilities: A. In order to approve the use of a surrogate in a study, the IRB must make a determination and document that the research relates to the cognitive impairment, lack of capacity, or serious physical or behavioral conditions and life-threatening diseases of the research subjects and either: 1. offers the prospect of direct benefit to the subject, provided that the IRB has determined that the risk is justified by the anticipated benefits and that the relation of the anticipated benefit to the risk is at least as favorable to the subject as that presented by available alternative approaches. If a currently recognized treatment exists, the subject, guardian, or surrogate shall be presented with the choice of the recognized treatment and the research protocol; or 2. does not offer the prospect of direct benefit to the subject, provided that the IRB has determined that it: (1) is likely to yield generalizable knowledge about the subject’s disorder or condition; (2) by its very nature cannot be conducted without the participation of decisionally incapacitated persons; and (3) involves no more than a minor increase over minimal risk. risk” means that the probability and magnitude of harm or discomfort “Minimal anticipated in the research are not greater than those ordinarily encountered in daily life or during the performance of routine psychological exams or tests. B. The IRB must ensure that all of the following elements are specified in the approved Surrogate Consent Form in nontechnical terms and in a language in which the subject or the subject’s guardian or authorized representative is fluent: 1. an explanation of the procedures to be followed in the study and any drugs or devices to be utilized, including: a) the purposes of the procedures, drugs, or devices; b) the use of placebo controls, when applicable; c) the process by which persons will be assigned to control groups.
3. The determination of a subject’s incapacity to consent to study participation by the physician making the determination must be documented and retained in both the medical and research records. This documentation must be retained as part of the permanent source documents for the IRB-approved study. II. IRB Responsibilities: A. In order to approve the use of a surrogate in a study, the IRB must make a determination and document that the research relates to the cognitive impairment, lack of capacity, or serious physical or behavioral conditions and life-threatening diseases of the research subjects and either: 1. offers the prospect of direct benefit to the subject, provided that the IRB has determined that the risk is justified by the anticipated benefits and that the relation of the anticipated benefit to the risk is at least as favorable to the subject as that presented by available alternative approaches. If a currently recognized treatment exists, the subject, guardian, or surrogate shall be presented with the choice of the recognized treatment and the research protocol; or 2. does not offer the prospect of direct benefit to the subject, provided that the IRB has determined that it: (1) is likely to yield generalizable knowledge about the subject’s disorder or condition; (2) by its very nature cannot be conducted without the participation of decisionally incapacitated persons; and (3) involves no more than a minor increase over minimal risk. “Minimal risk” means that the probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during the performance of routine psychological exams or tests. B. The IRB must ensure that all of the following elements are specified in the approved Surrogate Consent Form in nontechnical terms and in a language in which the subject or the subject’s guardian or authorized representative is fluent: 1. an explanation of the procedures to be followed in the study and any drugs or devices to be utilized, including: a) the purposes of the procedures, drugs, or devices; b) the use of placebo controls, when applicable; c) the process by which persons will be assigned to control groups.
RowanSOMGuidelinesforSurrogateConsent.docx