IRB Committee Member Help: Does the process of consent, including advertisements and recruitment materials, include exculpatory language where the participant waives, or appears to waive their rights?
| Belmont principle | Respect for Persons |
| Where to start: initial application | Read all advertising and recruitment materials, the description for the process of consent, and the consent documents |
| Where to start: continuing review application | Read all advertising and recruitment materials, the description for the process of consent, and the consent documents |
| Required IRB determinations | No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence. (45 CFR §46.116; 21 CFR §50) |
“Exculpatory language” means language in the consent where the participant in research appears to waive certain legal rights, or to indemnify the researcher in the event the participant is injured. To “indemnify” means to release, or appear to release the investigator, the sponsor, the institution or its agents from liability for negligence.IRB committee members may not approve a consent process that includes exculpatory language. Federal regulations specify that “No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence.” (45 CFR §46.116; 21 CFR §50)Recruitment methods, including advertisements and payment or reimbursement arrangements are part of the consent process. IRBs should evaluate the entire process and documentation of consent, from advertising and recruitment, to the documentation of consent, to insure that participants or their legally authorized representatives are not asked to waive their rights, or indemnify the sponsor.Examples of language where the participant appears to waive their rights include:
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| Accreditation Element | Element II.3.C.1. The IRB or EC has and follows written policies and procedures to review proposed participant recruitment methods, advertising materials, and payment arrangements and determines whether such arrangements are fair, accurate, and appropriate. |
| Regulations | 45 CFR §46.116; 21 CFR §50; |
| Guidance | FDA Information Sheets: Frequently Asked Questions: Informed Consent |
| OHRP Guidebook | Chapter 3: Basic IRB Review, Consent |