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DRAFT GUIDANCE
 
 
  This guidance document is being distributed for comment purposes only.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publication in the Federal Register of the notice announcing the availability of the draft 
guidance.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  Food and Drug Administration 
Division of Policy and Assurances  Division of Dockets Management (HFA-305) 
1101 Wootton Parkway, Suite 200  5630 Fishers Lane, Room 1061 
Rockville, MD 20852  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Draft  Not for Implementation 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This draft guidance, when finalized, will represent the Office for Human Research Protections (OHRPs) 
and the Food and Drug Administrations (FDAs) 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 OHRPs November 15, 1996, 
guidance entitled, Exculpatory Language in Informed Consent and question number 52 in 
FDAs January 1998 guidance entitled, Institutional Review Boards Frequently Asked 
Questions  Information Sheet Guidance for Institutional Review Boards and Clinical 
Investigators.   
 
OHRPs and FDAs guidance documents, including this guidance, do not establish legally 
enforceable responsibilities.  Instead, guidances describe OHRPs and FDAs 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 subjects 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 subjects 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 
  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   FDA 
By phone at:  Sara F. Goldkind, M.D., M.A. 
(866) 447  4777 (toll-free within the U.S.) or  Sara.Goldkind@fda.hhs.gov 
(240) 453-6900, or  (301) 796-8342 
Email at ohrp@hhs.gov 
 
                                                                                                                                                             
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. 
  4