Greg E. Manship, M.Div., MT(ASCP), CIM, CIP IRB Coordinator, University of Indianapolis

Co-Vice Chair, Community Health Network IRB

“Exculpatory” from “exculpate”

“Exculpate” (Latin) ex (from) + culpa (blame)

“to clear from alleged fault or guilt”*

*Merriam-Webster’s Online Dictionary (http://www.merriam-webster.com/dictionary/exculpate)

45CFR46.116 and 21CFR50.20

◦ “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.”

“Narrow Interpretation” “Broad Interpretation”

“. . . the subject or the representative is made to waive . . .or releases . . . ”

Restricts meaning to etymological definition of “to clear from blame or fault”

Limits prohibition to statements about release from liability

Meaning limited to not holding researchers at fault for wrongful acts

“ . . . 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 . . .”

Researchers many NOT use language whereby a subject waives actually or apparently any legal rights

The prohibition of exculpatory language is to preclude exploitation of voluntariness and vulnerability of participation in research.

Respect for autonomy◦ Rational human being has inherent value◦ A human being is not a means only to an end

Beneficence◦ Promotion and protection of human well being◦ Provide opportunity for subjects to seek legal relief

Justice◦ Fair and equitable treatment of all human beings◦ Protect rights to recover losses due to negligence

Tissue obtained from you in this research may be used to establish a cell line that could be patented and licensed. There are no plans to provide financial compensation to you should this occur.

By consenting to participate, you authorize the use of your bodily fluids and tissue samples for the research described above.

This hospital is not able to offer financial compensation nor to absorb the costs of medical treatment should you be injured as a result of participating in this research.

This hospital makes no commitment to provide free medical care or payment for any unfavorable outcomes resulting from participation in this research. Medical services will be offered at the usual charge.

Copyright © 2003 Georgetown University(http://www.ehcca.com/presentations/ressummit3/5_02.pdf)

I agree that the medical center will not pay me for any injuries I may sustain as a result of participating in this research.

You must provide blood samples that will be kept in a "bank" for future research. Once you have provided these blood samples, you cannot change your mind about being in the research and have the sample removed from the "bank.“

By agreeing to this use, you should understand that you will give up all claims to personal benefit from commercial or other use of these substances.

You volunteered to have your child be in this research study, so you cannot hold the hospital or the doctors responsible if anything bad happens to your child.

Federal regulations prohibit use of language that actually or apparently waives any legal rights of research participants.

Federal regulations prohibit use of language that actually or apparently releases investigators, sponsors, institutions and their agents from liability of negligence.

Sgt. Friday’s Rule of Thumb: Avoid ALL language that implies or requires understanding or agreement by subject. “Just the facts, ma’am.”

Banker, E. A., & Amdur, R. J. (2006). Institutional review board: Management and function (2nd ed.). Sudbury, MA: Jones and Bartlett Publishers.