Observing Informed Consent Presented by: David Rickaby, PhD Research Compliance Officer Milwaukee VAMC

IRB Responsibilities For studies recruiting human subjects, once recruiting has begun, the study must be audited for compliance with the applicable regulations and policies related to research informed consents. VHA Handbook § 9h. [Draft]

IRB Authority The IRB must have authority to observe, or have a third party observe, the consent process and the research. VHA Handbook § 7b. [Draft]

Informed Consent Process Given “under circumstances that…” provide sufficient opportunity for consideration of participation minimize the possibility of coercion provide information in understandable language do not include any exculpatory language 45 CFR

Minimize Coercion What is the setting in which the consent process is being conducted?

Informed Consent The person delegated [to conduct the interview and obtain consent from a subject] must be knowledgeable about the research to be conducted and the consenting process, and must be able to answer questions about the study. VHA Handbook § 14 a.(4) [Draft]

Required Elements It is research Risks/discomforts Expected benefits Alternatives Privacy and confidentiality Injury Study Contacts It is voluntary 45 CFR and 21 CFR 50.25

It is Research The subject may think he/she is making an appointment for treatment. The interviewer needs to make sure the subject understands what it means to take part in a clinical research study.

Required Elements [as needed] Unforeseeable risks Termination of participation Costs to Subjects Consequences of early withdrawal Provided with findings Number of participants 45 CFR and 21 CFR 50.25

VHA Required Elements Elements related to verifying the validity of the study VA treatment of research injuries payment made to subjects co-pays for non-research procedures VHA Handbook § 14 b. [Draft]

Required Elements The IRB may require that information in addition to that mentioned be given to subjects when, in the IRB’s judgment, the information would meaningfully add to the protection of the rights and welfare of subjects. 45 CFR (b)

Informed Consent Process Did the interviewer honor the subject’s right to privacy? Did the interviewer solicit feedback to assess the subject’s understanding?

Informed Consent Process What kinds of questions did the subject ask?

Informed Consent Process Was the consent document properly signed, dated and witnessed? Were any study-related procedures performed before signing the consent form?

Observation Process Coordinate with the interviewer Ask permission of the subject Ask for a blank consent form Observe; don’t participate Provide the interviewer with feedback Report findings to the IRB

In Conclusion… “Most codes dealing with human experimentation start out with the bland assumption that consent is ours for the asking. This is a myth. The reality is that informed consent is often exceedingly difficult to obtain in any complete sense. Nevertheless, it remains a goal toward which one must strive for sociological, ethical and legal reasons.” Henry Beecher, MD