INDIANA UNIVERSITY HEALTH
BLOOMINGTON
TITLE: Informed Consent General
Requirements and Documentation
APPROVED: Wanda Katinszky
ORIGINATION: 09/26/2003
IRB – INSTITUTIONAL REVIEW BOARD
POLICY NUMBER: IC 601
PAGE 1 OF 18
REVIEW WITH REVISION: 08/05/2013
REVIEW ONLY:
1. POLICY
Informed consent must be legally effective and prospectively obtained informed consent.
Pursuant to 45 CFR 46.116 and 21 CFR 50.20, unless waived or altered, no Investigator may
involve a human being as a research subject unless he or she has obtained legally effective
informed consent of the subject or the subject's legally authorized representative. The
informed consent process provides a meaningful exchange of information between the
clinical investigator and the study subject that may include, in addition to reading and signing
the informed consent document, subject recruitment materials, verbal instructions,
question/answer sessions and measures of subject understanding. . Consent shall be sought
only under circumstances that provide the prospective subject or the representative sufficient
opportunity to consider whether or not to participate and that minimize the possibility of
coercion or undue influence. All questions about the trial should be answered to the
satisfaction of the subject or the subject’s legal authorized representative (LAR). The
information that is given to the subject of the LAR must be language understandable to the
subject or LAR. The purpose of the informed consent process is to provide potential
research subjects with sufficient information so they can make fully informed, uncoerced
choices about whether to begin or continue participation in a clinical trial. It is an ongoing
exchange between the subject and the research team throughout the research study. No
informed consent, whether or written, may include or have the appearance of including any
exculpatory language through which the subject or the LAR 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.
Unless waived by the IRB, the informed consent process must be appropriately performed
and documented. The documentation must be done in the source documents for each
subject. It is the responsibility of the principal investigator to obtain IRB approval or waiver
for the informed consent process to be used and to ensure that all federal and state
regulations and IUHB policies have been satisfied in the language of the informed consent
documents, as well as by the process and that any informed consent documents have been
approved by the IRB prior to being presented to potential subjects.
The IRB requires documentation of informed consent by use of a written informed consent
form approved by the IRB and signed and dated by the subject or the subject's legally
authorized representative.
DEFINITIONS:
Assent: An individual’s (not authorized to give legal consent) affirmative agreement to
participate in research obtained in conjunction with permission of the individual’s parents or
legally authorized representative. Mere failure to object should not be construed as assent.
Children (minor): According to the federal regulations, children are “persons who have not
attained the legal age for consent to treatments or procedures involved in the research,
TITLE: Informed Consent General
Requirements and Documentation
REVIEW WITH REVISION: 08/05/2013
POLICY NUMBER: IC 601
PAGE 2 OF 18
under the applicable law of the jurisdiction in which the research will be conducted.” Per
Indiana State law, “minors” are defined as “persons less than 18 years of age;” therefore, are
considered “children” for purposes of the regulations.
Exception: According to Indiana State law, a minor may consent for himself/herself if any of
the following are true:
a. By law, the minor is considered emancipated;
b. The minor is at least fourteen (14) years of age, not dependent on a parent for
support, is living apart from parents or from an individual in loco parentis; AND has
management of his/her own affairs;
c. The minor is or has been married;
d. The minor is in the military service of the United States; OR
e. The minor is authorized to consent to the health care by any other statute.
Cognitively Impaired: Having a psychiatric disorder (e.g., psychosis, neurosis, personality or
behavior disorder), and organic impairment (e.g., dementia), or a developmental disorder
(e.g., mental retardation) that affects cognitive or emotional functions to the extent that
capacity for judgment and reasoning is significantly diminished. Others, including individuals
under the influence of or dependent on drugs or alcohol, those suffering from degenerative
diseases affect the brain, terminally ill patients, and individuals with severely disabling
physical handicaps may also be compromised in their ability to make decisions in their best
interest.
Confidentiality: The assurance that certain information that may include a subject’s identify,
health, behavior, or lifestyle information or a Sponsor’s proprietary information would not be
disclosed without permission from the subject or the sponsor. Confidentiality is a means of
protecting ones privacy.
Delegated authority to consent of behalf of incapable party: Per Indiana code 16-36-1-6, an
individual authorized to consent to health care for another who for a time will not be
reasonably available to exercise the authority may delegate the authority to consent during
that time to another individual. The delegation; 1) must be in writing; 2) must be signed by
the delegate; 3) must be witnessed by an adult; and 4) may specify conditions on the
authority delegated. Unless the writing expressly provides otherwise, the delegate may not
delegate the authority to another individual.
Good Clinical Practice (GCP): A standard by which clinical trials are designed, performed,
monitored, audited, recorded, analyzed, and reported so that there is public assurance that
the data are credible, and that the rights, integrity, and confidentiality of subjects are
protected.
Impartial Witness: A person, who is independent of the research, who cannot be unfairly
influenced by people involved with the research, who does not have a coercive relationship
with the subject, who attends the informed consent process if the subject or the subject’s
TITLE: Informed Consent General
Requirements and Documentation
REVIEW WITH REVISION: 08/05/2013
POLICY NUMBER: IC 601
PAGE 3 OF 18
legally authorized representative cannot read or comprehend, and who reads any informed
consent form and any other written information supplied to the subject. In cases where a
subject is unable to read or sign the informed consent, an impartial witness attests that the
subject has been completely informed of the nature of the study and has consented to
participate.
Informed Consent: An ongoing process by which a subject or legal representative voluntarily
confirms his or her willingness to participate in a particular research project, after having
been informed of all aspects of the research that are relevant to the subject’s decision to
participate. Informed consent is often, but not always, documented by means of a written,
signed, and dated informed consent form with documentation, which is retained in the
subject’s record.
In Loco Parents: Someone who acts in place of a parent.
Legally Authorized Representative: DHHS and FDA regulations define a legally authorized
representative as an individual or judicial or other body authorized under applicable law to
consent on behalf of a prospective subject to the subject’s participation in the procedure(s)
involved in the research (45 CFR 46.102(c); 21 CFR 50.3(i))
Individual or judicial or other body recognized under Indiana Law, who has legal authority to
consent on behalf of a prospective participant to the individual’s participation in the
procedure(s) involved in the research. Individuals who serve as proxy or surrogate are
recognized in the State of Indiana as the subject’s legally authorized representative, as
defined by DHHS and FDA, and have the ability to consent to participate in human research,
in no particular order of family relationship.
In research conducted in other States or territories, the legal definition of legally authorized
representative will be determined by the reference to the law of that state or territory.
Minimal Risk: The probability and magnitude of harm and discomfort anticipated in the
research are not greater in and of themselves than those ordinarily encountered in daily life
or during the performance of routine physical or psychological examinations or tests (as
defined in 45 CFR 46.102(i)).
Permission: The agreement of parent(s) or guardian(s) to the participation of their child or
ward in research.
Persons authorized to consent for incapable parties: Per Indiana Code 16-36-1-5, if an
individual incapable of consenting has not appointed a health care representative or the
healthcare representative is not reasonably available or declines to act, consent to health
care may be given by:
a. A judicially appointed guardian of the person or a representative appointed; or
b. By a spouse, a parent, an adult child, or an adult sibling if:
1. There is no guardian or other representative; or
TITLE: Informed Consent General
Requirements and Documentation
REVIEW WITH REVISION: 08/05/2013
POLICY NUMBER: IC 601
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2. The guardian or other representative is not reasonably available or declines to
act; or
3. The existence of the guardian or other representative is unknown to the health
care provided; or
c. The individual’s religious superior, if the individual is a member of a religious order.
Prisoner: According to 45 CFR 46.3.3(c), a prisoner is defined as any individual involuntarily
confined or detained in a penal institution. This term is intended to encompass individuals
sentenced to such an institution under a criminal or civil statute, individuals detained in other
facilities by virtue of states or commitment procedures which provide alternatives to criminal
prosecution or incarceration in a penal institution, and individuals detained pending
arraignment, trial, or sentencing. It is important to note that this category of special
protections also includes situations where a research subject may become a prisoner after
the research has commenced.
Vulnerable subjects: Persons not capable (e.g., mentally, emotionally, or physically
impaired) of appropriately judging the risks/benefits of their participation in a research
study. Also, individuals with incurable disease, persons in nursing homes, unemployed or
impoverished persons, patients in emergency situations, ethnic minority groups, homeless
persons, refugees, minors, persons with developmental disabilities or mental retardation or
mental illness, pregnant women, and those incapable of giving consent or whose capacity for
giving informed consent is limited. Other vulnerable persons may include individuals whose
willingness to volunteer in a research project may be unduly influenced by the expectation,
whether justified or not, of benefits associated with participation, or of a retaliatory response
in case of refusal to participate. Examples include students, subordinate personnel,
members of the armed forces, and persons in detention (prisoners).
Specific Policies
1.1
The Informed Consent Process. Informed consent is more than just a signature on a
form, it is a process of information exchange that may include, in addition to reading
and signing the informed consent document, subject recruitment materials, verbal
instructions, question/answer sessions, and measures of subject understanding. The
responsibility for ensuring that the informed consent process is adequate is shared by
research sponsors, investigators, and the IRB. The following should be considered
when consenting a subject to a research study:
1.1.1
The consent process begins when a potential research subject is initially
contacted. This means that the use of direct advertising is the start of the
informed consent and subject selection process.
1.1.2
Giving the subject adequate information concerning the research in language
that is as non-technical as possible (eighth grade language or lower if more
appropriate for subject population).
1.1.3
Providing ample time and opportunity for the subject or the subject’s legally
authorized representative to inquire about the details of the research project
TITLE: Informed Consent General
Requirements and Documentation
REVIEW WITH REVISION: 08/05/2013
POLICY NUMBER: IC 601
PAGE 5 OF 18
and to decide whether or not to participate in the research, as well as to
consider other available options, if any.
1.2
1.1.4
Responding to subject’s or the subject’s legally authorized representative’s
questions to his/her/their satisfaction.
1.1.5
Ensuring to the degree possible that the subject has comprehended the
information provided about the research.
1.1.6
Obtaining the subject’s or the subject’s legally authorized representative’s
voluntary consent.
1.1.7
Documenting that the process has occurred.
1.1.8
Continuing the informed consent process throughout the subject’s
participation in the study.
The Informed Consent Document
The Consent Form May Be Either of the Following:
1.2.1
A written consent document that embodies the elements of informed
consent described in 21 CFR 50.25 and 45 CFR 46.116(a). This form may be
read to the subject or the subject's legally authorized representative, but, in
any event, the Investigator shall give either the subject or the representative
adequate opportunity to read it before it is signed. The subject must also be
given a copy of the signed form.
1.2.2
A "short form" written consent document stating that the elements of
informed consent as required above have been presented orally to the
subject or the subject's legally authorized representative. When this method
is used, there shall be an impartial witness to the oral presentation. The IRB
must approve a written summary of what is to be said to the subject or
representative. The subject or the representative signs only the short form
itself. However, the witness shall sign both the short form and a copy of
the summary, and the person actually obtaining the consent shall sign a copy
of the summary. A copy of the summary shall be given to the subject or the
representative in addition to a copy of the short form.
TITLE: Informed Consent General
Requirements and Documentation
REVIEW WITH REVISION: 08/05/2013
POLICY NUMBER: IC 601
PAGE 6 OF 18
1.3
Required Elements of Informed Consent
Pursuant to 45 CFR 46.116 and 21 CFR 50.25, certain basic elements must be
included in any informed consent document that is presented to potential research
subjects. Additional elements should be included, when appropriate. Basic elements
include:
A. 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, and identification of any procedures which are
experimental.
B. A description of any reasonably foreseeable risks or discomforts to the subject.
C. A description of any benefits to the subject or to others that may reasonably be
expected from the research.
D. A disclosure of appropriate alternative procedures or courses of treatment, if any,
which might be advantageous to the subject.
E. A statement describing the extent to which, if any, confidentiality of records
identifying the subject will be maintained and that notes the possibility that the
FDA may inspect the records.
F. For research involving more than minimal risk, an explanation as to whether any
compensation is provided 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.
G. 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.
H. A statement that participation is voluntary, that refusal to participate will involve
no penalty or loss of benefits to which the subject is otherwise entitled, and that
the subject may discontinue participation at any time without penalty or loss of
benefits to which the subject is otherwise entitled.
1.4
Additional Elements
When appropriate, and pursuant to 45 CFR 46.116(b) and 21 CFR 50.25(b), one or
more of the following elements of information shall also be provided to each subject:
A. 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. If measures to prevent pregnancy should be taken
while in the study, that should also be explained;
B. Anticipated circumstances under which the subject's participation may be
terminated by the Investigator without regard to the subject's consent. An
unexplained statement that the investigator or sponsor may withdraw subjects at
any time, does not adequately inform the subjects of anticipated circumstances
for such withdrawal. A statement that the investigator may withdraw subjects if
they do not ‘follow study procedures’ is not appropriate. Subject are not in a
position to know all the study procedures. Subjects may be informed; however,
that they may be withdrawn if they do not follow the instructions given to them by
TITLE: Informed Consent General
Requirements and Documentation
REVIEW WITH REVISION: 08/05/2013
C.
D.
E.
F.
G.
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the investigator;
Any additional costs to the subject that may result from participation in the
research;
For studies involving payment for subject participation, a payment statement
explaining details and any conditions of payment;
The consequences of a subject's decision to withdraw from the research and
procedures for orderly termination of participation by the subject. An unexplained
statement that the subject will be asked to submit to tests prior to withdraw, does
not adequately inform the subjects why the test are necessary for the subject’s
welfare.
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.
1.5
The IRB follows applicable Federal, state or local laws, which may require additional
information to be disclosed in order for informed consent to be legally effective.
1.6
Additionally, the IRB may require that information, in addition to that specifically
required by applicable regulation, be given to subjects when in the IRB’s judgment the
information would meaningfully add to the protection of the rights and welfare of
subjects.
1.7
For studies conducted or supported by PHS involving HIV testing, PHS requires that
subjects whose test results are associated with personal identifiers must be informed
of their own test results and provided the opportunity to receive appropriate
counseling unless the situation calls for an exception under special circumstances.
1.8
For studies involving genetic information, the informed consent should include
information regarding the protections provided by the Genetic Information
Nondiscrimination Act (GINA).
1.9
Other Requirements
1.9.1
Second person: The language of the consent document should be in the
second person style so the consent form conveys a dialogue with
information being provided and that there is a choice to be made by the
subject rather than presumption of the subject’s consent with the use of
the first person style.
1.9.2
Language should be simple: The information provided in the informed
consent documents must be in language understandable to the subject.
The informed consent document should not include complex language that
would not be understandable to all subjects. Technical and scientific terms
should be adequately explained using common or lay terminology.
1.9.3
Exculpatory language: Informed consent documents may not contain any
exculpatory language through which the subject is made to waive or appear
TITLE: Informed Consent General
Requirements and Documentation
REVIEW WITH REVISION: 08/05/2013
1.9.4
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to waive legal rights, or releases or appears to release the Investigator, the
Sponsor, or IU Health Bloomington from liability for negligence.
FDA-regulated test articles: For all research involving test articles regulated
by the FDA, informed consent documents must include a statement that the
purpose of the study includes evaluation of both the safety and the
effectiveness of the test article. The consent form must also include a
statement that the FDA has access to the subject's medical records.
1.10 Documentation of Informed Consent
Pursuant to 45 CFR 46.117(a), and except as provided at 45 CFR 46.117(c), Each
subject or his/her LAR must sign and date a copy of the current IRB-approved consent
form prior to enrollment or any participation in any phase of the study, unless the
requirement is waived by the IRB. The form may be read to the subject or the
subject’s LAR, but in any event, the investigator shall give the subject or the LAR
adequate opportunity to read it before it is signed. The subject must also be given a
copy of the signed document.
1.10.1 The IRB may approve procedures for documentation of informed consent
that involve (a) a written consent form signed by the subject; (b) a short form
written consent form with oral presentation; or (c) in limited circumstances,
waiver of signed written consent form. Each of these three options is
described in detail below. It is the responsibility of the IRB to determine
which of the procedures described below is appropriate for documenting
informed consent in protocols that it reviews. Generally, only option (a) will
be appropriate.
1.10.1.1
Written consent form signed by subject or legally authorized
representative. In most circumstances, the IRB should require
that informed consent is documented by the use of a written
consent form approved by the IRB and signed by the subject or
the subject's legally authorized representative. The Investigator
should allow the subject or the LAR adequate opportunity to read
the consent document before it is signed. A signed copy of the
document must be given to the person signing the form.
1.10.1.2
The written informed consent document should embody, in
language understandable to the subject, all the elements
necessary for legally effective informed consent (see above).
1.10.1.3
Subjects who do not understand English should be presented
with an informed consent document written in a language
understandable to them.
1.10.2 Pursuant to 45 CFR 46.117(c) and 21 CFR 56.109(c)(1), the IRB may waive
the requirement for the investigator to obtain a signed consent document for
some of all subjects if it finds and documents either:
1..10.2.1 That the only record linking the subject and the research
TITLE: Informed Consent General
Requirements and Documentation
REVIEW WITH REVISION: 08/05/2013
POLICY NUMBER: IC 601
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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. The research is not subject to FDA regulations; or
1.10.2.2
The research involves 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; and
1.10.3 In cases in which the documentation requirement for informed consent is
waived, the investigator shall still provide subjects with a written document
that includes all elements of an informed consent document (unless
otherwise waived by the IRB), which the IRB must review and approve.
1.10.4 The investigator may request these alterations or waivers to the informed
consent process by completing the appropriate section of the summary
safeguard statement. The IRB will use the responses provided within that
section in considering this request.
1.11
Oral Presentation Using Short Form
As an alternative to standard written informed consent documents, oral presentation
of informed consent information may be used.
In such cases, the subject must be provided with both:


A short form written informed consent document stating that the elements
of informed consent have been presented orally to the subject or the
subject’s legally authorized representative; and
A written summary of the information that is presented orally.
1.11.1 A witness to the oral presentation is required. The witness must sign both
the short form written informed consent document and a copy of the written
summary.
1.11.2 The subject or the legally authorized representative must sign the short form
written consent document.
1.11.3 The person obtaining consent (e.g., the Investigator) must sign a copy of the
written summary of the information that is presented orally. The person
obtaining consent may not be the witness to the consent.
1.11.4 Subjects who do not speak English: Where informed consent is documented
using this short form procedure for non-English speaking subjects, the written
informed consent document should embody, in language understandable to
the subject, all the elements necessary for legally effective informed consent.
When this procedure is used with subjects who do not speak English, (i) the
TITLE: Informed Consent General
Requirements and Documentation
REVIEW WITH REVISION: 08/05/2013
POLICY NUMBER: IC 601
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oral presentation and the short form written informed consent document
should be in a language understandable to the subject; (ii) the IRB-approved
English language informed consent document may serve as the summary;
and (iii) the witness should be fluent in both English and the language of the
subject.
1.11.5 The IRB must receive all foreign language versions of the short form
document as a condition of approval.
Expedited review of these versions is acceptable if the convened full IRB has
already approved the protocol, the full English language informed consent
document, and the English version of the short form document.
1.12 PI Responsibilities Regarding the Informed Consent Document
1.12.1 Unless informed consent is waived, the PI must ensure that informed consent
is obtained from each research subject or subject’s legally authorized
representative (LAR) before participation in the research study may begin.
1.12.2
Although the PI is ultimately responsible for assuring that an appropriate
informed consent process is approved and carried out, he/she is not required
to personally conduct the consent interview. If permitted by the IRB, the PI
may delegate the responsibility of conducting the consent interview,
including obtaining informed consent, to appropriate members of the
research team. The PI is responsible for assuring that nay such designee is
knowledgeable about the specific research study and the process of
informed consent. Because the IRB needs to be aware of who will be
conducting the consent interview, the PI’s designee, as well as any member
of the research team interacting with subjects as part of the informed
consent process, must be listed on the study summary statement and pass a
human subjects protection tutorial.
1.12.3
A copy of the consent document must be provided to the subject (or LAR) and
the original signed consent document must be retained in the study records.
A copy of the consent document should also be placed in the subject’s
medical record, if appropriate. The copy provided to subjects does not need
to be signed, although a photocopy with signature(s) is preferred.
1.12.4
Although the PI is ultimately responsible for assuring that the content of the
written consent document, if required, is in compliance with IRB
requirements and GCP regulations, if applicable, he/she PI may delegate the
development of the consent document to appropriate members of the
research team.
1.12.5
Upon identification of a potential study subject, the PI or appropriate member
of the research team will be responsible for identifying who is legally
authorized to give consent for the subject, if consent is required. The PI also
needs to explain when informed consent will be obtained, including any
TITLE: Informed Consent General
Requirements and Documentation
REVIEW WITH REVISION: 08/05/2013
POLICY NUMBER: IC 601
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waiting period (between informing the subject and obtaining the consent)
that will be observed. If the subject is physically or mentally unable to
provide consent, then the legally authorized representative may be
approached to give consent for the subject. Careful attention should be given
to any potential impairment to informed consent.
1.12.6
At the time of continuing review, the PI must submit a clean copy of the
currently approved consent document(s), if enrollment is still open. After the
IRB reviews and approves the consent document(s), it(they) will be stamped
with a new approval and continuing review due date. This newly stamped
consent document becomes the “current” consent document for the study
and must be the version signed by all subjects from that date until such time
that a revision to it is approved by the IRB. Previously consented subjects are
not required to sign the newly approved consent document.
1.12.7
Research involving patients. Informed consent must be obtained from each
patient prior to altering his/her care for the purpose of research. Informed
consent must be obtained prior to performing any non-routine procedures, for
examples, testing for eligibility, if being done exclusively for the purpose of
screening for, or participating in, the research study. This could be done
using an abbreviated screening informed consent document and/or the
regular main study consent document.
1.13 Required Informed Consent Document Signatures
1.13.1 The subject (or subject’s LAR) must sign a copy of the stamped, IRB-approved
informed consent document before any study-related procedures are
initiated. In addition to signing the consent document, the subject (or LAR)
must enter the date of signature on the consent document to permit
verification that consent was actually obtained before the subject began
participation in the study. The subject’s medical record/case report form
should document that the consent process occurred prior to participation in
the research.
1.13.2
The person conducting the consent interview must also sign and date the
informed consent document as the “person obtaining consent”. The
signature of the PI is not required on the consent document, unless he/she is
the person conducting the consent interview.
1.13.3
There may be situations when the subject wishes to take the consent
document home in order to review it and/or consider participation in the
research study further before signing the consent document. In fact, all
subjects should be encouraged to do so. In these situations, the person
conducting the consent interview may sign the consent document at that
time, signifying that the consent interview took place. Once the subject has
decided to participate, he/she (or LAR) will sign the consent document at
that time. Thus, it is possible for the signature date of the person obtaining
consent to precede that of the subject.
TITLE: Informed Consent General
Requirements and Documentation
REVIEW WITH REVISION: 08/05/2013
POLICY NUMBER: IC 601
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1.14 Revisions to the Informed Consent Document
1.14.1 Although the PI is ultimately responsible for assuring that the written consent
and any other written information to be provided to subjects is revised
whenever important new information becomes available that may be
relevant to the subject’s willingness to participate, he/she may delegate this
responsibility appropriate members of the research team. Any such revisions
must receive IRB approval prior to use.
1.14.2
When revised informed consent documents have been approved by the IRB,
they will be appropriately stamped with the new approval date, however, the
continuing review due date will remain the same (unless the informed
consent is approved at the time of continuing review). Newly enrolled
subjects must sign this now approved version of the consent document.
1.14.3
While some changes to the informed consent document do not require
currently enrolled subjects to reconsent, for example minor changes that do
not affect the risk/benefit ratio, there are some situations that do require
currently enrolled subject to reconsent, for example, the discovery of a
previously unknown serious side effect. When an already enrolled subject
reconsents using a new informed consent document, a note should be made
in the subject’s record. Additionally, the original signed new consent
document must be retained in the study records and a copy provided to the
subject (or LAR). Any previously signed consent documents should be
retained and not discarded.
1.14.4
In cases where subjects have completed active study or follow-up procedures
and new safety information is discovered that may affect a subject’s
participation or long-term risks from the treatment, the subject must be
informed of this new information. This may be accomplished through
reconsenting subjects with a revised consent document which explains this
new information or by other methods of notification approved by the IRB. The
timelines of informing subjects and/or reconsenting them will depend on the
seriousness of the new information.
1.15 Informed Consent Procedures for Non-English Speaking Subjects
1.15.1 Pursuant to 45 CFR 46.116 and 21 CFR 50.20, information that is given to a
subject or a subject’s representative shall be in language understandable to
the subject or the representative. Thus, when speaking to a potential subject
who speaks English, the consent interview shall be conducted in English and
the consent document shall be written in English. Likewise, when speaking
to a potential subject who does not speak English, the consent interview shall
be conduct in a language understandable to the individual and the consent
document shall be written in a language understandable to the individual. If
the investigator anticipates that non-English speaking individuals will likely
TITLE: Informed Consent General
Requirements and Documentation
REVIEW WITH REVISION: 08/05/2013
POLICY NUMBER: IC 601
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be enrolled in the study, plans for language-appropriate consent procedures
should be considered and describe in the IRB submission.
1.15.1.1 In some circumstances, a non-English consent document may be
required. The IRB must approve all consents, including nonEnglish versions. In these circumstances, the IRB will require
certification that the translated documents are correct or
documentation that the non-English version has been reviewed by
an expert in the required language.
1.15.2 If a non-English speaking subject is unexpectedly encountered and plans do
not exist for conducting the consent interview, including providing the
potential subject with a language-appropriate consent document,
investigators should carefully consider the ethical and legal implications of
enrolling a subject when a language barrier exists. If, after careful
consideration, the investigator believes it would be in the best interest of the
potential subject to enroll in the study and there is not time to develop and
submit a language-appropriate consent document to the IRB for review, the
subject may still be enrolled as long as the consent interview is conducted in
a language understandable to the subject, for example, with the use of a
translator or anther appropriate individual.
1.15.2.1 The informed consent process must be documented using the IRBapproved short form written consent document and following the
procedures below:
1.15.2.1.1
A written summary embodying the basic and
required additional elements of disclosure must be
available for use during the oral presentation.
1.15.2.1.2
There shall be a witness to the oral presentation. The
translator may serve as the witness.
1.15.2.1.3
The subject or the subject’s LAR will sign the short
form consent document.
1.15.2.1.4
The witness will sign both the short form consent
document and a copy of the summary.
1.15.2.1.5
The person actually obtaining consent will sign a
copy of the summary.
1.15.2.1.6
A copy of the signed short form consent document
and summary will be given to the subject or the LAR.
1.15.3 The informed consent process shall be documented in the subject’s records.
The translator or other appropriate individual should be part of the ongoing
communication throughout the research study and should be conversant in
both English and the language of the subject.
TITLE: Informed Consent General
Requirements and Documentation
REVIEW WITH REVISION: 08/05/2013
POLICY NUMBER: IC 601
PAGE 14 OF 18
1.15.4 If such a situation occurs, it shall be reported to the IRB at the time of
continuing review. The IRB will consider the circumstances of the subject’s
enrollment and determine the appropriateness of requiring the investigator
to develop a language-appropriate consent document for future purposes.
1.16 Informed Consent for Illiterate English-Speaking Subjects
1.16.1 A person who can understand and comprehend spoken English, but does not
read or write, can be enrolled in a study. However, special care must be taken
to ensure that they are able to understand the concepts of the study and
evaluate the risks and benefits of being in the study when it is explained
verbally.
1.16.2 The informed consent document should document the method used for
communication with the prospective subject and the specific means by which
the prospective subject communicated agreement to participate in the study,
such as signing the consent document, or “making their mark”, if
appropriate.
1.16.3
An impartial witness should witness the entire consent process and sign the
consent document.
1.17 Informed Consent Procedures Via Telephone
1.17.1 There may be situations when obtaining informed consent from subjects over
the telephone is appropriate. In these situations, the person obtaining
consent must document that the informed consent process took place by
making appropriate notation regarding the process in the proper files.
1.17.2
Informed consent may only be obtained via telephone when written
documentation of informed consent has been waived by the IRB. If a waiver
of documentation of informed consent has not been approved by the IRB, ,
the person discussing the research study with the potential subject should
sign and date the consent document prior to mailing or faxing it to the
potential subject. Appropriate notation should be made in the subject’s
records indicating that the process took place. Once the subject receives,
signs, and returns the informed consent document to the study site, the
document should again be signed and dated by the appropriate member of
the research team who receives the document. Research-related
intervention may not begin until the signed informed consent document is
received by the study team.
1.18 Informed Consent Procedures Via Fax
1.18.1 There may also be situations when obtaining informed consent from subjects
via fax is appropriate. This is acceptable in situations where the informed
consent process has already been appropriately conducted in person. For
example, it is acceptable for the informed consent process to take place in
TITLE: Informed Consent General
Requirements and Documentation
REVIEW WITH REVISION: 08/05/2013
POLICY NUMBER: IC 601
PAGE 15 OF 18
person, to allow the potentials subject time to take the consent document
home in order to consider participation, and then have the subject sign and
fax the informed consent document back to the research site. In this case,
the consenter should sign the informed consent document and make
appropriate notes to the subject’s records upon completion of the informed
consent discussion. The subject may then fax a signed copy of the informed
consent document to the research site. Upon receipt, the PI or appropriate
designee should again sign and date the document as acknowledgement of
receipt and make appropriate notations to the subject’s record. The subject
should still return the signed original informed consent document either at
the next visit or via mail to the research site at his/her earliest opportunity.
The appropriate recipient of the signed original informed consent document
should sign and date it, file it with faxed copy, and make appropriate notes to
the subject’s record. The notes to file coinciding with the dates and
signatures on the informed consent documents provide the source
documentation that confirm and explain how the process occurred.
1.19 Informed Consent Procedures With Special Populations. Because of the special
vulnerability of certain populations of subjects, including children, prisoners, pregnant
women, and cognitively impaired individuals, federal regulations, state and local laws,
and institutional policies require additional protections regarding their consent to
participate in a research study. Please see the IUHB SOP on Vulnerable Populations
for guidance on the additional consent requirements when involving these vulnerable
populations in research.
1.20 Alteration of Informed Consent
1.20.1 Pursuant to 45 CFR 46.116(c), the IRB may approve a consent procedure
which does not include, or which alters some or all of the elements of
informed consent set forth above, or waive the requirement to obtain
informed consent provided the IRB finds and documents that:
1.20.1.1 The research or demonstration project is to be conducted by or
subject to the approval of state or local government officials, and
is designed to study, evaluate, or otherwise examine: (i) public
benefit of service programs; (ii) procedures for obtaining benefits
or services under those programs; (iii) possible changes in or
alternative to those programs or procedures, or (iv) possible
changes in methods or levels of payment for benefits or services
under those programs.
1.20.1.2 The research could not practicably be carried out without the
waiver or alteration;
1.20.1.3 The research is not subject to FDA regulations.
1.20.2 Pursuant to 45 CFR 46.116(d), the IRB may approve a consent procedure
which does not include, or which alters some or all of the elements of
TITLE: Informed Consent General
Requirements and Documentation
REVIEW WITH REVISION: 08/05/2013
POLICY NUMBER: IC 601
PAGE 16 OF 18
informed consent set forth above, or waive the requirements to obtain
informed consent provided the IRB finds and documents that:
1.20.3
The research procedure involves no more than minimal risk to the
subjects;
1.20.4 The waiver or alteration will not adversely affect the rights and welfare of the
subjects;
1.20.5
The research could not practicably be carried out without he waiver
or alternation (Note: The IRB typically considers face-to-fact interaction
between the PI, or other member of the research team, and the subject to
practicably enable the informed consent process to take place, and thus
would likely not grant a waiver of the informed consent process).
1.20.6
Whenever appropriate, the subjects will be provided with additional pertinent
information after participation; and
1.20.7 The research is not subject to FDA regulations.
1.20.8 The informed consent requirements in this policy are not intended to
preempt any applicable federal, state, or local laws which require additional
information to be disclosed in order for information consent to be legally
effective.
1.20.9 Nothing in this policy is intended to limit the authority of a physician to
provide emergency medical care, to the extent the physician is permitted to
do so under applicable federal, state, or local law.
1.21
Additional Policies & Procedures
1.21.1 Exception from Informed Consent Requirements for Planned Emergency
Research. Pursuant to 21 CFR 50.24, the IRB may approve a clinical
investigation without requiring that informed consent of all research subjects
be obtained. See IUHB SOP regarding the Authorization for Emergency Use
of and Planned Emergency Research with Investigational Agents/Devices.
TITLE: Informed Consent General
Requirements and Documentation
REVIEW WITH REVISION: 08/05/2013
POLICY NUMBER: IC 601
PAGE 17 OF 18
1.21.2 Exception from Informed Consent Requirements for Clinical Investigations.
Pursuant to 21 CFR 50.23(a), there are certain allowable circumstances
when an exception to the informed consent requirements may be
appropriate. See IUHB SOP regarding the Authorization for Emergency Use of
and Planned Emergency Research with Investigational Agents/Devises.
1.22 Research Subject to Department of Defense (DOD) Regulations
1.22.1
The IRB must determine that the disclosure includes that provisions for
research-related injury follow the requirement of the DOD component.
1.22.2
If the research participant meets the definition of ‘experimental subject’, a
waiver of the consent process is prohibited unless a waiver is obtained from
the Secretary of Defense. If the research participant does not meet the
definition of ‘experimental subject’, the IRB may waive the consent process.
2. SCOPE
These policies and procedures apply to all research submitted to the IRB.
3. RESPONSIBILITY
IRB Administrator, or designee, is responsible for reviewing all incoming informed consent
documents and for communicating with Investigators to bring documents into compliance.
4. APPLICABLE REGULATIONS AND GUIDELINES
21 CFR 50
45 CFR 46.116, 46.117
45 CFR 46.404, 46.405, 46.406, 46.407
OHRP Guidance/Special Protections for Children as Research Subjects
FDA Information Sheets, 1998
5. REFERENCES TO OTHER APPLICABLE SOPs
This SOP affects all other SOPs.
6. ATTACHMENTS
IC 601-A Informed Consent Template
IC 601-B Informed Consent Document Template: Informed Consent: Collection & Storage
of Human Biological Materials for Research Purposes
IC 601-C Informed Consent Document Template: Venipuncture
IC 601-D Statement on the Risks of Radiation
IC 601-E Glossary of Medical to Lay Terms
IC 601-F Certificate of Translation
TITLE: Informed Consent General
Requirements and Documentation
REVIEW WITH REVISION: 08/05/2013
POLICY NUMBER: IC 601
PAGE 18 OF 18
7. PROCESS OVERVIEW
Describe the requirements for obtaining informed consent and documentation of informed
consent.
8. PROCEDURES EMPLOYED TO IMPLEMENT THIS POLICY
Who
Task
IRB Administrator
Review proposed ICFs upon receipt of study and
confirm that all required elements are present.
If elements are missing, return consent
document to Investigator with request for
revision and suggested language (where
appropriate).
Tool
Informed Consent
Document Template