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 1200.05 §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 1200.05 §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 46.116

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 1200.05 §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 46.116 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 46.116 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 1200.05 §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 46.109(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