Exculpatory Clauses
Federal regulations, as well as our IRB policies and procedures, require
that consent forms and processes be free from any exculpatory language
which waives or appears to waive any legal rights the participant may have
or which releases or appears to release the PI, UAMS or Sponsor from
liability for negligence. You might now be wondering what an exculpatory
clause looks or sounds like.
Examples of Language That Would Not Be Acceptable:
“In the event of complications, physical injury, or illness resulting from the research, only acute and essential medical treatment is available. This institution will not provide monetary compensation for wages lost as a result of injury, hospitalization or professional services.”
“By agreeing to this use, you should understand that you will give up all claim to personal benefit from commercial or other use of these substances.”
“I voluntarily and freely donate any and all blood, urine, and tissue samples to the Sponsor and hereby relinquish all right, title, and interest to said items.”
“By consent to participate in this research, I give up any property rights I may have in bodily fluids or tissue samples obtained in the course of the research.”
“I waive any possibility of compensation for injuries that I may receive as a result of participation in this research.”
Examples of Acceptable Language:
“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.”
Jennifer Sharp, J.D.
April 11, 2005