Office for Protection from
Research Risks (OPRR)
Cooperative Oncology Group Chairpersons Meeting
November 15, 1996
"Exculpatory Language"
in Informed Consent
No informed consent, whether oral or written, may include
any exculpatory language through which the subject 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
Examples of Exculpatory Language:
- 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 U.S. Government 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.