Exculpatory Language in Informed Consent

Administrative draft guidance, not enacted legislation. This captured publisher edition preserves the listed document and attachments; later developments are not independently consolidated.

Guidance on Exculpatory
Language in Informed Consent
DRAFT GUIDANCE
This guidance document is being distributed for comment purposes only.
Comments and suggestions regarding this draft document should be submitted within 60 days of
publication in the Federal Register of the notice announcing the availability of the draft
guidance. All comments should be identified with the docket number listed in the notice of
availability that publishes in the Federal Register.
Submit electronic comments to http://www.regulations.gov.
Submit comments on paper, disk, or CD-ROM by mail/hand delivery/courier to:
Office for Human Research Protections
Division of Policy and Assurances
1101 Wootton Parkway, Suite 200
Rockville, MD 20852
Food and Drug Administration
Division of Dockets Management (HFA-305)
5630 Fishers Lane, Room 1061
Rockville, MD 20852
U.S. Department of Health and Human Services
Office for Human Research Protections 	Food and Drug Administration
August 19, 2011

Guidance on Exculpatory
Language in Informed Consent
Additional copies are available from:
Division of Policy and Assurances
Office for Human Research Protections
1101 Wootton Parkway, Suite 200
Rockville, MD 20852
(Tel) 240-453-6900 or 866-447-4777
(Fax) 301-402-2071
http://www.hhs.gov/ohrp/newsroom/rfc/index.html
or
Office of Good Clinical Practice
Office of Special Medical Programs, Office of the Commissioner
Food and Drug Administration
10903 New Hampshire Avenue
WO32-5103
Silver Spring, MD 20993
(Tel) 301-796-8340
(Fax) 301-847-8640
http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ProposedRegulationsandDraftGuidances
/default.htm
U.S. Department of Health and Human Services
Office for Human Research Protections 	Food and Drug Administration
August 19, 2011

Contains Nonbinding Recommendations
Draft — Not for Implementation
Guidance on Exculpatory Language in Informed Consent
This draft guidance, when finalized, will represent the Office for Human Research Protections’ (OHRP’s)
and the Food and Drug Administration’s (FDA’s) current thinking on this topic. This guidance does not
create or confer any rights for or on any person and does not operate to bind OHRP, FDA or the public.
OHRP and FDA guidance should be viewed as recommendations unless specific regulatory requirements
are cited. The use of the word must in OHRP and FDA guidance means that something is required under
the Department of Health and Human Services (HHS) regulations at 45 CFR part 46 or the Food and
Drug Administration regulations at 21 CFR parts 50 and 56. The use of the word should in OHRP and
FDA guidance means that something is recommended or suggested, but not required. You can use an
alternative approach if the approach satisfies the requirements of the applicable statutes and regulations.
If you want to discuss an alternative approach, contact the OHRP or FDA staff responsible for
implementing this guidance.1
I. 	INTRODUCTION
This draft guidance has been prepared jointly by the Office for Human Research Protections
(OHRP) and the Food and Drug Administration (FDA). This document applies to non-exempt
human subject research conducted or supported by the Department of Health and Human
Services (HHS) and is intended for clinical investigators, institutional review boards, and
funding agencies that may be responsible for review or oversight of human subject research
conducted or supported by HHS. This document also applies to human subject research
regulated by FDA and is intended for clinical investigators, sponsors, and institutional review
boards conducting or reviewing such research.
This document provides guidance on the regulatory prohibition on the inclusion of exculpatory
language in informed consent. The document includes examples of language that OHRP and
FDA consider acceptable as well as examples of language that the agencies would consider
exculpatory. When finalized, this document will supersede OHRP’s November 15, 1996,
guidance entitled, “‘Exculpatory Language’ in Informed Consent” and question number 52 in
FDA’s January 1998 guidance entitled, “Institutional Review Boards Frequently Asked
Questions – Information Sheet Guidance for Institutional Review Boards and Clinical
Investigators.”
OHRP’s and FDA’s guidance documents, including this guidance, do not establish legally
enforceable responsibilities. Instead, guidances describe OHRP’s and FDA’s current thinking on
a topic and should be viewed only as recommendations, unless specific regulatory or statutory
requirements are cited.
II. 	DISCUSSION
1 Contact information for both OHRP and FDA can be found in Section III of this guidance.
1

Contains Nonbinding Recommendations
Draft — Not for Implementation
Section 46.116 of 45 CFR and section 50.20 of 21 CFR state: “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.” Thus, for particular language in a consent document to be impermissible under this
provision, not only must the language involve a waiver, release, or the appearance of a waiver or
release, but it must also be “exculpatory.” OHRP and FDA consider exculpatory language to be
language which has the general effect of freeing or appearing to free an individual or an entity
from malpractice, negligence, blame, fault, or guilt. Therefore, a waiver in an informed consent
document of any legal right a subject may have may be permissible so long as that waiver does
not have the general effect of freeing or appearing to free an individual or an entity from
responsibility for malpractice or negligence, or from blame, fault, or guilt (i.e., the waiver is not
exculpatory).
For example, if an informed consent document contains language by which a subject waives his
or her right to be compensated for injuries arising from participation in the research, such
language would meet the definition of exculpatory language because it has the general effect of
freeing or appearing to free the investigator, sponsor, and/or the research institution from
malpractice, negligence, blame, fault, or guilt. For that reason, such language would violate 45
CFR 46.116 and 21 CFR 50.20.
On the other hand, a subject’s waiver of any rights he or she may have with respect to a
biospecimen obtained by investigators for research purposes would not be exculpatory because it
does not have the effect of freeing the investigator, sponsor, institution, or others involved in the
research from malpractice, negligence, blame, fault, or guilt. Accordingly, including such
waiver language in an informed consent document would be permissible under 45 CFR 46.116
and 21 CFR 50.20. OHRP and FDA understand it has long been common practice of
investigators and sponsors not to compensate research subjects who agree to provide
biospecimens for research purposes even if those biospecimens are later used for commercial
purposes. Moreover, OHRP and FDA are not aware of any federal or state laws or policies that
suggest that research subjects would have any legal right to such compensation if they
voluntarily signed an informed consent form which clearly stated that they would not be paid or
otherwise compensated for providing their biospecimens.
Given these circumstances, OHRP and FDA have concluded that language in an informed
consent form is not exculpatory if it informs subjects that, by agreeing to allow the use of their
biospecimens for research purposes, they are giving up any legal right to be compensated for the
use of the biospecimens.2 In other words, such releases or waivers of rights to biospecimens
would be permissible when the waiver does not have the effect of freeing the investigator,
sponsor, institution or others involved in the research from malpractice, negligence, blame, fault,
or guilt. 	Such language may be considered an acceptable way to accurately inform subjects that
they will not be receiving any financial compensation, now or in the future, for the use of those
2 While this guidance focuses primarily on biomedical research conducted in a healthcare setting, its application is
not limited solely to those circumstances.
2

Contains Nonbinding Recommendations
Draft — Not for Implementation
biospecimens. Such language may, therefore, be appropriately included in an informed consent
form without violating 45 CFR 46.116 or 21 CFR 50.20.3
In an effort to help the research community understand what may or may not constitute
exculpatory language in violation of 45 CFR 46.116 and 21 CFR 50.20, we provide the
following examples below:
Examples of Acceptable Language
 	Although future research that uses your samples may lead to the development of new
products, you will not receive any payments for these new products.
 	By agreeing to this use, you are giving up all claims to any money obtained by the
researchers from commercial or other use of these specimens.
• 	I voluntarily and freely donate any and all blood, urine, and tissue samples to the [name
of research institution] and hereby relinquish all property rights, title, and interest I may
have in those samples.
 	By consenting to participate in this research, I give up any property rights I may have in
bodily fluids or tissue samples collected during this research.
 	Although the results of research, including your donated materials, may be patentable or
have commercial value, you will have no legal or financial interest in any commercial
development resulting from the research.
 	Tissue obtained from you in this research may be used to establish a cell line that could
be patented and licensed. No financial compensation will be provided 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.
 	Because of hospital policy, the hospital is not able to offer financial compensation should
you be injured as a result of participating in this research. However, you are not
precluded from seeking to collect compensation for injury related to malpractice, fault, or
blame on the part of those involved in the research, including the hospital.
 	Because of hospital policy, the 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. However, you are not
precluded from seeking to collect compensation for injury related to malpractice, fault, or
blame on the part of those involved in the research, including the hospital.4
3 This guidance document is not intended to address the issue of subject withdrawal from
research.
4 As discussed in the guidance entitled, “Guidance for Industry: Investigator Responsibilities—
Protecting the Rights, Safety, and Welfare of Study Subjects,” FDA expects that the hospital will
3

Contains Nonbinding Recommendations
Draft — Not for Implementation
4
 	In the event that you suffer a research-related injury, your medical expenses will be your
responsibility or that of your third-party payer, although you are not precluded from
seeking to collect compensation for injury related to malpractice, fault, or blame on the
part of those involved in the research.5
The above examples are permissible under 45 CFR 46.116 and 21 CFR 50.20 because in each
example, the waiver or release does not have the general effect of freeing or appearing to free an
individual or an entity from malpractice, negligence, blame, fault, or guilt.
Examples of Exculpatory Language
The examples below would be in violation of 45 CFR 46.116 and 21 CFR 50.20 because in each
example, the waiver or release has the general effect of freeing or appearing to free an individual
or an entity from malpractice, negligence, blame, fault, or guilt.
 	I waive any possibility of compensation, including any right to sue, for injuries that I may
receive as a result of participation in this research.
 	If you suffer a research-related injury, neither the institution nor the investigator can
assume financial responsibility or liability for the expenses of treatment for such injury.
 	In the event that you suffer a research-related injury, your medical expenses will be your
responsibility or that of your third-party payer.
III. 	CONTACTS FOR QUESTIONS
For questions regarding this draft document contact:
OHRP
By phone at:
(866) 447 – 4777 (toll-free within the U.S.) or
(240) 453-6900, or
Email at ohrp@hhs.gov
FDA
Sara F. Goldkind, M.D., M.A.
Sara.Goldkind@fda.hhs.gov
(301) 796-8342
make efforts to ensure that the investigator provides reasonable medical care for any adverse
events, including clinically significant laboratory values, related to the trial participation. If the
investigator does not possess the expertise necessary to provide the type of medical care needed
by a subject, the investigator should ensure that the subject is able to obtain the necessary care
from a qualified practitioner. This guidance is available at:
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U
CM187772.pdf
5 This sentence as used in this example, as well as in the previous two examples, is only one
potential way of explaining in an informed consent document that a subject's legal right to seek
to collect compensation for research-related injuries in certain situations is not being waived.
Other language that similarly conveys this concept would also be acceptable.