Informed Consent
UTHSC Institutional Review Board (IRB)
Session Overview
 Process and Documentation
 Vulnerable Populations
 Informed Consent of Non-English Speakers
 Illiterate Subjects
 Alteration/Waiver of Informed Consent
Informed Consent Process
Informed Consent is not just a form; it is an ongoing process of information
exchange that may include:
 Recruitment materials;
 An ongoing, open discussion of the research study, including risks,
benefits, procedures, and alternatives, appropriate to the subject and
the study;
 Ample opportunity for the subject to ask questions and to have them
answered;
 An explanation that the subject’s participation is voluntary and that the
subject can decline to participate;
 Formally obtaining the subject’s consent or dissent; and
 Documentation of the consent process
Recruiting Study Subjects
 FDA considers direct advertising for study subjects to be
the start of the informed consent and subject selection
process
 Advertisements should be reviewed & approved by the
IRB as part of the package for initial review; however, if
a researcher decides at a later date to advertise for
subjects, the advertising may be submitted for IRB
review & approval
 FDA believes that any advertisement to recruit subjects
should be limited to the information the prospective
subjects need to determine eligibility and interest
Informed Consent Document
 A statement that the study involves research
 An explanation of the purposes of the research
 The expected duration of the subject's participation
 A description of the procedures to be followed
 Identification of any procedures which are experimental
 A description of any reasonably foreseeable risks or
discomforts to the subject
Informed Consent Document
 A description of any benefits to the subject or to others which may reasonably be expected
from the research
 A disclosure of appropriate alternative procedures or courses of treatment, if any, that
might be advantageous to the subject
 A statement describing the extent, if any, to which confidentiality of records identifying the
subject will be maintained
 For research involving more than minimal risk, an explanation as to whether any
compensation, and an explanation as to whether any medical treatments are available, if
injury occurs and, if so, what they consist of, or where further information may be obtained
 Research, Rights or Injury: An explanation of whom to contact for answers to pertinent
questions about the research and research subjects' rights, and whom to contact in the
event of a research-related injury to the subject
 A statement that participation is voluntary, refusal to participate will involve no penalty or
loss of benefits to which the subject is otherwise entitled, and the subject may discontinue
participation at any time without penalty or loss of benefits, to which the subject is
otherwise entitled
Additional Elements
 A statement that the particular treatment or procedure may involve
risks to the subject (or to the embryo or fetus, if the subject is or may
become pregnant), which are currently unforeseeable
 Anticipated circumstances under which the subject's participation may
be terminated by the investigator without regard to the subject's
consent
 Any additional costs to the subject that may result from participation in
the research
 The consequences of a subject's decision to withdraw from the research
and procedures for orderly termination of participation by the subject
 A statement that significant new findings developed during the course
of the research, which may relate to the subject's willingness to
continue participation, will be provided to the subject
 The approximate number of subjects involved in the study
Informed Consent Document
 Must be written in “lay language” (i.e., understandable to the
people being asked to participate)
 Use of the scientific jargon and legalese is not appropriate
 Do not use the first person (e.g., “I understand that…”)
 If the document is ungrammatical, it does not communicate; if
it does not communicate, it cannot serve its purpose
 The written presentation of information is used to document
the basis of consent and for the subject’s future reference
Documentation of Informed
Consent
 Informed consent shall be documented by the use of a written
consent form approved by the IRB and signed and dated by the
subject or the subject’s legally authorized representative (LAR)
 A copy of the consent document must be given to the subject or
(LAR)
 The original signed consent form should be retained in the research
record
 If applicable, a copy of the consent form should be included in the
subject’s medical record
 Document the proceedings of the informed consent interview in the
research record (sample on IRB website)
Legally Authorized
Representative (LAR)
 When prospective subjects lack adequate decision making capacity,
investigators may not involve them in clinical research without the legally
effective informed consent of the subject’s legally authorized representative
(LAR).
 The LAR must be an adult
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who has exhibited special care and concern for the subject,
who is familiar with the subject’s personal values,
who is reasonably available, and who is willing to serve.
No person who is identified in a protective order or other court order that
directs that person to avoid contact with the subject shall be eligible to serve as
the subject’s LAR.
 Identification of an LAR should normally be made using the following order of
descending preference: conservator; guardian; attorney-in-fact; subject’s
spouse, unless legally separated; the subject’s adult child; the subject’s parent;
the subject’s adult sibling; any other adult relative of the subject; or any other
adult who is familiar with the patient’s personal values, who is reasonably
available, and who is willing to serve as LAR.
Legally Authorized
Representative (LAR)
 If the LAR loses the legal right to consent for the subject while
the subject is participating in a research study (e.g., loss of
Power of Attorney over healthcare), a new LAR must be
identified and consented for the subject’s continued
participation in the study.
 When consent has been obtained from the LAR due to the
incompetence of the subject at the time of entry in a study,
and the subject regains competence during study
participation, then the principal investigator or designee must
secure the subject’s non-objection to continued participation
in the study.
Legally Authorized
Representative (LAR)
 Adults who have the capacity to consent during study
enrollment, but who may lose the capacity to consent at
some point during study participation (due to Alzheimer’s
disease for instance) can name a future LAR upon study
enrollment. This should be done in writing, such as on a
healthcare proxy form, and be kept with the subject’s
research record. At the time when the investigator
determines the subject has lost the capacity to continue to
consent to study participation, the designated LAR should be
consented.
 If a research study will include the use of adults who do not
have the capacity to consent, assent of the adult subject
should be obtained if possible and documented on the adult
assent discussion page of the consent form.
Legally Authorized
Representative (LAR)
Appropriate signature line(s) on the UTHSC informed consent
document:
Appropriate initial lines on the UTHSC informed consent
document:
Pediatric Assent
 Assent is a child’s affirmative agreement to participate in a
research study
 A child’s passive resignation to submit to an intervention or
procedure must not be considered assent
 The assent process should be developmentally appropriate
give the ages and other characteristics of the children to be
approached and provide opportunities for children to
express and discuss their willingness or unwillingness to
participate
Pediatric Assent
Documentation of assent, varies by age of the minor:
 Research with very young children (<8 years old) requires only
that parental permission is secured and that appropriate
information is given to the minor about the research in the same
way that procedures would ordinarily be explained to a young
child.
 For minors between the ages of 8–13, documentation of assent to
participate is required using a “short form” assent document. The
“short form” assent document will be attached as the last page of
the consent form.
 For older adolescents (age ≥14 years), a single consent form that
both the minor and the parents sign is adequate unless the
Committee has specified differently in the approval letter.
Pediatric Assent
 If a minor between the ages of 14 and 17 is cognitively
capable of assenting to his/her participation in the
research study but cannot physically sign the assent line
on the consent page (e.g., due to paralysis), he/she can
verbally indicate that he/she assents and can have
his/her LAR sign the assent line for him/her.
 This situation should be explained and documented in
the assent/consent discussion notes in the research
record
Pediatric Assent
 When a child subject turns 8 years old while participating in
a research study, then the documentation of assent is
required utilizing the “short form” assent document
 When a child subject reaches the age of majority while
enrolled in research study, then the subject should reconsented as an adult.
 If the parent loses parental rights or a legal guardian loses
guardian rights while the child is participating in a research
study, a new LAR must be identified and consented for the
child’s continued participation in the study.
Pediatric Assent
 Appropriate signature line(s) on the UTHSC informed consent
document:
 Appropriate initial lines on the UTHSC informed consent
document:
 Include the “short form” assent document as the last page of
the consent form if the research study includes subjects 8-13
years of age
Assent Discussion for Subjects
8-13 Years of Age
A. Assent Obtained
 Date and time of assent
 Minor Subject’s name, date of birth, and signature
 Signature of person obtaining assent
B. Assent Not Obtained, but Minor Subject was Enrolled
 Assent of the minor subject was NOT obtained for the following reason:
 Minor is cognitively or emotionally unable to participate in an assent discussion (e.g.,
minor has either a psychiatric or developmental disorder; minor received narcotics
within the last 4 hours; minor is sedated; etc.).
 Minor refused to provide assent; however, the intervention or procedure involved in
the research holds out a prospect of direct benefit that is important to the health or
well being of the minor and is available only in the context of the research [45 CFR
46.408(a)].
C. Assent was Obtained, but Minor Subject was Unable to Sign
 The minor assented to participation, but has an incapacity that prevents
applying a signature (e.g., the subject’s dominant hand is incapacitated, the
subject is illiterate, etc.) The assenting subject’s inability to sign the assent
document has been duly noted in the research record.
Children who are Wards of the
State
 Children who are Wards of the State or any other agency, institution, or entity
can be included in research involving greater than minimal risk with no prospect
of direct benefit or Research not otherwise approvable, but which presents an
opportunity to understand, prevent, or alleviate serious problems affecting the
health or welfare of children only if
 such research is related to their status as wards; or
 the research is conducted in schools, camps, hospitals, institutions, or similar
settings in which the majority of children involved as subjects are not wards.
 If research is approved under this section, the IRB shall require appointment of
an advocate for each child who is a ward, in addition to any other individual
acting on behalf of the child as guardian or in loco parentis.
 One individual may serve as advocate for more than one child. The advocate
shall be an individual who has the background and experience to act in, and
agrees to act in, the best interests of the child for the duration of the child’s
participation in the research and who is not associated in any way (except in the
role as advocate or member of the IRB) with the research, the investigator(s), or
the guardian organization.
Inclusion of Prisoners
 Individuals who are detained in a residential facility for court-ordered substance
abuse treatment as a form of sentencing or alternative to incarceration;
however, individuals who are receiving non-residential court-ordered substance
abuse treatment and are residing in the community are not prisoners
 Individuals with psychiatric illnesses who have been committed involuntarily to
an institution as an alternative to a criminal prosecution or incarceration;
however, individuals who have been voluntarily admitted to an institution for
treatment of a psychiatric illness, or who have been civilly committed to nonpenal institutions for treatment because their illness makes them a danger to
themselves or others, are not prisoners.
 Parolees who are detained in a treatment center as a condition of parole are
prisoners; however, persons living in the community and sentenced to
community-supervised monitoring, including parolees, are not prisoners.
 Probationers and individuals wearing monitoring devices are generally not
considered prisoners; however, situations of this kind frequently require an
analysis of the particular circumstance of the planned subject population.
Inclusion of Prisoners
 When a previously enrolled research subject becomes a
prisoner and the relevant research protocol was NOT
reviewed and approved by the institutional review board
(IRB) in accordance with the requirements of HHS regulations
at 45 CFR46, subpart C, the principal investigator should
promptly notify the IRB of this event.
 All research interactions and interventions with, and
obtaining identifiable private information about, the nowincarcerated prisoner-subject must cease until the
requirements of subpart C have been satisfied with respect
to the relevant protocol
Informed Consent of Non-English
Speakers
Informed consent must be presented in a language
understandable to the subject or legally authorized
representative [21 CFR 50.20/45 CFR 46.116 & §46.117] &
contain all the elements necessary for legally effective
informed consent
Informed Consent of Non-English
Speakers
Local Policy
 A non-English translation of the English version of the IRB approved
informed consent document + Translator's Declaration
 Person obtaining informed consent must be fluent in both English &
the language of the subject or legally authorized representative
(LAR) or be assisted by an interpreter, who must be physically
present during the informed consent interview.
 Family or friends of the prospective subject or LAR may not serve as
interpreters
 Verbal translation of the English informed consent document is not
acceptable
 After consent is obtained, the subject or the LAR must be given a
copy of the signed informed consent document
 Informed consent is an ongoing process, an interpreter must be
available for all research-related interactions involving subjects or
LARs who are non-English speaking
Informed Consent of Non-English
Speakers
Methodist Healthcare (MH) facilities only:
 A written translation of the informed consent document is required
 Language line service for MH is the Certified Languages International
800.237.8434 & the Patient Affairs Department
Regional One Health
 A written translation of the informed consent document is required
 Page an Interpreter or call via Vocera (Interpreters).
 Allow five (5) minutes for a response from an interpreter if paged.
 Medical Interpreters are available seven (7) days a week.
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Monday-Friday
7:45 am – 7:30 pm
Saturday-Sunday
9 am – 5:30 pm
Interpreters can be contacted via pager: 242-9189
Language Services 5-7264
Illiterate English Speaking
Subjects
 A potential subject who speaks and understands English but does not read or
write, can be enrolled in a research study
 The consent form may be read to the prospective subject
 The individual will “make his/her mark” on the consent document in the space for
the subject’s signature
 Person obtaining consent should document in the research record the method(s)
utilized to communicate with the subject and the method(s) utilized by the subject
to communicate agreement to enter the study.
 A potential subject who can understand and comprehend English, but is physically
unable to talk or write (e.g., paralysis) can be entered into research studies.
 A subject can verbally indicate that he/she consents and can designate a
representative (e.g., a relative, hospital patient advocate, social worker, etc.) to
sign the consent line for him/her, provided the latter party is not involved in the
actual conduct of the study.
 This situation should be explained and documented in the consent discussion notes
in the research record, including a description of the identity of the person to
whom the authorization has been given.
Illiterate English Speaking
Subjects
 Upon verbal explanation, the potential subject should be able
to:
 describe the study procedures in lay terms and appreciate what
will be involved in participation in the study,
 understand the risk(s) and benefit(s) of being in the study, and
 indicate approval or disapproval regarding participation in the
study.
 After consent is obtained, the subject or the LAR must be
given a copy of the signed informed consent document
 Video and audiotaping of the process may be utilized with
permission of the individual and in accordance with the
institution’s policies
Alteration/Waiver of Informed
Consent
Federal regulations permit the waiver or alteration of informed
consent (45 CFR 46.116(d) if a protocol meets very specific criteria
 the research involves no more than minimal risk to the subjects;
 the waiver or alteration will not adversely affect the rights and
welfare of the subjects;
 the research could not practicably be carried out without the
waiver or alteration; and
 whenever appropriate, the subjects will be provided with
additional pertinent information after participation.
Waiver of Informed Consent
The UTHSC IRB may waive the requirement for the investigator to
obtain a signed consent form for some or all subjects if it finds
either:
 That the only record linking the subject and the research would
be the consent document and the principal risk would be
potential harm resulting from a breach of confidentiality. Each
subject will be asked whether the subject wants documentation
linking the subject with the research, and the subject's wishes
will govern; or
 That the research presents no more than minimal risk of harm to
subjects and involves no procedures for which written consent is
normally required outside of the research context. In cases in
which the requirement for written documentation of consent is
waived, the IRB may require the investigator to provide subjects
with a written statement regarding the research.
Alteration of Consent/Waiver of
Documentation of Consent
If you are conducting a survey, the following statements should be incorporated into an
introductory paragraph. Willingness of the subjects to complete the survey will serve as
adequate documentation of informed consent.
 A brief statement that the survey is part of a “research study.”
 A brief statement regarding the purpose of the research and who is performing it.
 A statement regarding research procedures. Explain that the study involves answering a
series of questions and will take a specific length of time.
 A statement regarding any foreseeable risks. These might include tiring from answering
questions or being asked sensitive questions. If there are no risks, this should be indicated.
 A statement regarding anticipated benefits. Describe the potential benefits of the
knowledge to be gained and any benefits for subjects. If there are no benefits to subjects,
this should be indicated.
 A statement that participation is voluntary and failure to participate will not adversely
affect the subject’s rights, medical care, grade in any course, or employment status.
 A statement regarding provisions to maintain the confidentiality of the data.
Telephone Consent
 A request to secure telephone consent must be submitted to the
UTHSC IRB as an alteration of informed consent.
 FDA guidance states that it is acceptable when necessary to send the
informed consent document to the subject or LAR by fax and to
conduct the consent interview over the telephone when the subject
or LAR can read the consent form as it is discussed.
 Study procedures may not be initiated until the signed consent form is
returned by fax to the investigative site. The consent form with the
original signatures must be mailed or brought to the investigative site
at the earliest opportunity.
 The UTHSC IRB will also permit the use of alternative communication
technologies in FDA-regulated study, i.e., email, mail, or
videoconference.
 Telephone consent is generally not allowed at Methodist Healthcare
facilities.
Reminders
 Use the UTHSC IRB consent form templates
http://www.uthsc.edu/research/research_compliance/IRB/co
nsent.php
 Document consent discussion in the research record
 Contact the IRB office (448-4824) if you have any questions!