INFORMED CONSENT
701 Consent
Process and Documentation
SOP: 701 Version No: Effective Date:
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Consent Process and
Documentation |
Supercedes
Document Dated: |
1. POLICY
The IRB requires Investigators to obtain the legally effective informed consent.
Informed consent is the process by which the research study is explained to the potential participant and the participant voluntarily agrees to participate in the research. Except as described in Section 1.1.4, informed consent to participate in a research study must be obtained from all participants (or their legally authorized representative) prior to their participation in the research.
The IRB assures that provisions are made to obtain legally effective informed consent prospectively from each research participant or permission from his/her legally authorized representative. However, there are circumstances in which the IRB may grant a waiver of informed consent in accordance with Federal Regulations.
Definition of Legally Effective consent: All of the required elements of the informed consent are contained in the consent form document, the consent of the participant is prospectively obtained, and the person signing the consent form is the participant or the participants’ legally authorized representative.
1.1 Written
Informed consent
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 participant or the
participant's legally authorized representative, the person obtaining consent,
the Principal Investigator, and witness when appropriate.
The informed consent form
will contain all federally required elements of informed consent plus
additional federally required elements as indicated, see A. and B. below.
A. Required
elements of informed consent
1. Consent
will be sought only under circumstances that provide the participant or the
legally authorized representative sufficient opportunity to consider whether or
not to participate and minimize the possibility of coercion or undue influence.
2. Required
core elements of informed consent:
a. A statement that the study involves research,
an explanation of the purposes of the research, the expected duration of the
participant’s participation, a description of the procedures to followed, and
identification of any procedures which are experimental.
b. A
description of any reasonably foreseeable risks or discomforts to the participant.
c. The extent to which, in any confidentiality of
records identifying the participant will be maintained and notes the
possibility that the IRB and (if the study involves a drug or device) the FDA
may inspect the records.
d. 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.
e. An explanation of whom to contact for answers to
pertinent questions about the research and research participants’ rights, and
whom to contact in the event of a research-related injury to the participant.
f.
A statement that
participation is voluntary, that refusal to participate will involve no penalty
or loss of benefits to which the participant is otherwise entitled, and that
the participant may discontinue participation at any time without penalty or
loss of benefits to which the participant is otherwise entitled.
3. Additional Elements of Informed Consent that may
be required:
a. A
statement that the particular treatment or procedure may involve risks to the
participant (or to the embryo or fetus if the participant is or may become
pregnant), which are currently unforeseeable.
b. Anticipated circumstances under which the
participant’s participation may be terminated by the investigator or the
sponsor without regard to the participants consent.
c. Any additional costs to the participant that may
result from participation in the research.
d. The consequences of a participant’s decision to
withdraw from the research and procedures for orderly termination of
participation by the participant.
e. A statement that significant new findings developed
during the course of the research, which may relate to the participant’s
willingness to continue participation, will be provided to the participant.
f.
The approximate
number of participants involved in the study.
B.
Documentation of Informed Consent
1. Except as
described below in Section 1.5, documentation of informed consent (usually
written) is required to participate in research studies involving human
participants. Documentation of informed
consent is required for all studies that involve more than minimal risk.
2. Format of
written informed consent.
a. Unless authorized by the IRB, the consent form
should use the format and template language provided in the sample on the IRB
website.
b. The consent form should be in a question/answer
format.
c. The consent form should be written in the second
person.
d. The consent form should be written in language
understandable to the participant, preferably at a 7th grade
level. All necessary medical or technical
terms should be explained.
e. The consent form may not contain any exculpatory
language through which the participant is made to waive or appears to waive
legal rights, or releases or appears to release the investigator, the sponsor
or the
f. The consent form should be signed and dated by the
participant, the person obtaining consent, and the investigator.
g. Informed Consent forms at the VAMC will include a
witness to the participant’s signature.
h. The participant will be given a copy of the signed
consent form. The original signed
informed consent is to be kept on-file at the Investigator’s site for auditing
purposes.
i. The final approved consent form will be stamped by
the IRB office with the date of approval and date of expiration. The expiration date will be no longer than 1
year after the last review by the full Board or (if expedited review) by the
Chair/Vice-Chair. All participants must
sign the currently approved IRB stamped form prior to participating in any
study related activity.
1.2 Verbal
Consent
A. The Board may approve the use of verbal consent
under the following circumstances:
1.
The participant
is blind.
2.
The participant
is illiterate.
3.
The participant
does not speak English (see 1.3 for more details concerning this group).
B. When verbal consent is obtained, the informed
consent process must be witnessed by someone who is not part of the research
team.
1. When verbal consent is obtained from the participant, an informed consent form will be signed by the witness, the person obtaining consent, and the investigator. The consent form may be the IRB approved informed consent or it may be a short summary that embodies all of the 8 core elements of informed consent (if approved by the IRB). In either case, the original signed consent document will be kept on-file at the investigator’s site for auditing purposes and a copy of the informed consent will be given to the participant.
2. The Board may decide that if verbal consent is obtained that it should be documented by some other method such as audio or videotape.
1.3 Obtaining Informed Consent in Participants Who Do
Not Speak English
A. The
research study needs to be fully explained to the participant in a language
they understand by either a member of the research team who speaks both
languages fluently (English and the participant’s language) or through a
translator.
B.
Documentation of informed consent can be by one of two methods
1.
Written consent:
Translate the IRB approved English version of the informed consent
document. Translated informed consents
must be accompanied by a certified/notarized attestation from the translator
verifying that the translated informed consent accurately reflects the IRB approved
English informed consent. This is the preferred method if it is anticipated
that a significant percentage of the prospective study population is
non-English speaking.
2.
Verbal
consent: Follow option a. or b. from
below:
a.
The translator
fluent in both English and the participants language translates the IRB
approved English consent form orally to the participant in front of a
witness. When the person obtaining
consent is assisted by a translator, the translator may serve as the witness.
The translator should be an impartial person.
The investigator, translator, and the witness must sign the consent
form.
b.
Have an IRB
approved short summary of the study in the participant’s language. The short summary must include the core
elements of informed consent (this is research, participation is voluntary, and
a short summary of the research and its risks/benefits.) The participant and the witness sign the
summary.
C. The IRB must receive all foreign language
versions of the short form document as a condition of approval under the
provisions of §46.117(b)(2).
Expedited review of these versions is acceptable if the protocol, the full
English language informed consent document, and the English version of the short
form document have already been approved by the convened IRB.
1.4 Waiver of Informed Consent:
A. The
requirement for informed consent can be waived partially or entirely by the IRB
(or the chair) if the following conditions are met:
1.
There is no more
than minimal risk (including confidentiality risks) to the participants.
2.
The waiver of
consent will not adversely affect the rights and welfare of the participants
3.
The research
could not practicably be carried out without the waiver.
4.
When
appropriate, the participants will be provided with additional pertinent
information after participation.
B. Examples of
research that might qualify for a waiver of informed consent would be
1.
Retrospective
chart reviews
2.
Observation of
public behavior
3.
Research and
demonstration projects which are conducted by or participant to the approval of
government department or agency heads and which are designed to study,
evaluate, or otherwise examine
4.
Public benefit
or service programs
5.
Procedures for
obtaining benefits or services under those programs
6.
Possible changes
in or alternatives to those programs or procedures
7.
Possible changes
in methods or levels of payment for benefits or services under those programs
C. Emergency exemption from informed consent to
participate in research that would normally require consent (i.e., research
involving more than minimal risk) is not permissible under
1.5 Waiver of Documentation of Informed Consent
A.
Documentation of consent can be waived in part or entirely by the IRB
(or the IRB Chair) if :
1.
There is no more
than minimal risk (including confidentiality risk)
2.
The research
involves no procedure for which written consent is normally required outside
the research context.
3.
The only record
linking the participant and research would be the informed consent document
(and thus the principal risk would be from a breach of confidentiality).
4.
Examples of studies that would qualify for a
waiver of documentation of informed consent include surveys.
5.
The IRB may
require the investigator to provide participants with a written statement
regarding the research that includes some or all of the requirements of
informed consent described in Section 1.1.A.
1.6 Surrogate Consent by a Legally Authorized
Representative
The
IRB will not waive the requirement for informed consent for human research
studies where informed consent is required.
Under special circumstances, it may be appropriate to obtain surrogate
consent to allow patients who are too incapacitated (either physically or
psychologically) to give informed consent for themselves to be enrolled in
research studies. The intent of this provision is to allow research of
incapacitating conditions such as dementia, head trauma, coma, sepsis, and
psychiatric disorders. Generally speaking, it is not intended to allow
enrollment of incapacitated patients into protocols where competent patients
are also to be enrolled (particularly randomized studies) unless the study
involves access to treatments that may be of direct benefit, but are not
available outside of the research context.
A. The use of surrogate consent in incompetent
participants in a study must be approved by the full IRB (either a general
permission or specific permission for a individual participant). In deciding whether it is appropriate to
allow the use of surrogate consent the Board will consider:
1. Will
participating in the study directly benefit the potential participant?
2. Are there alternative standard/approved
treatments available for this participant?
3. Could this study be done in a less
vulnerable; i.e., competent, population?
4. If there
is no hope of a direct benefit to the individual participant, would the
information gained result in a potential benefit for other patients with the
same incapacitating condition?
5. If there
is no hope of a direct benefit to the individual participant, is there more
than a minimal risk to participation?
B. The participant must be treated by a
physician (MD or DO) who is on the faculty of the medical or osteopathic
school. If the treating M.D. or D.O and the investigator are not the same
person then the investigator must get the approval of the treating
physician.
C. The participant must be incapable of
giving informed consent for a local institutional-review board approved
experimental treatment, test, or drug.
The Board will address who will be making the determination that the
participant is incompetent.
D. Informed consent may be obtained from a legal
guardian, attorney-in-fact with health care decision authority or a family member
(in the following order: spouse, adult child, either parent, adult sibling, or
a relative by blood or marriage). When the legal
guardian or attorney-in-fact with health care decision authority provides
consent, the investigator should obtain a copy of the guardianship papers.
E.
If the patient previously refused to participate in the research (at a
time when he/she was competent to make that decision), his wishes cannot be
subsequently overridden by the legal guardian or family member after the
participant become incompetent.
F. Patients who are incompetent to give informed consent
may still be able to assent to participation.
(The Board may require or waive participant assent, depending on the
level of incapacity).
G. If it is a long-term study and the participant
regains competency, the informed consent process should be repeated with the
participant.
H. Non-therapeutic research
may be allowed if it entails no more than minimal risk to the participant.
I.
Surrogate
consent cannot be used for participants who (in addition to being
incapacitated) are pregnant or prisoners.
J.
For surrogate
consent involving VA patients, the approval of the VA Chief of Staff is also
required.
1.7 Informed Consent in Vulnerable Populations
A. Informed Consent in Children
Definitions:
A. "Assent" means a child's
affirmative agreement to participate in research. Mere failure to object should
not, absent affirmative agreement, be construed as assent. "Permission" means the agreement of
parent(s) or guardian to the participation of their child or ward in research.
B. Child
Informed consent must adhere to the following:
1.
Children are
defined as being less than 18 years old.
2.
In children, informed
consent will be obtained from the parent (s) or legal guardian.
3.
Research
involving more than minimal risk requires both parents’ signatures when both
are available. Both parents must give their
permission unless one parent is deceased, unknown, incompetent, or not
reasonably available, or when only one parent has legal responsibility for the
care and custody of the child.
4.
For some kinds
of research, where documentation of informed consent would normally be waived
(such as surveys), it may be required in children.
5.
Assent from the
child will usually be required unless:
a.
The minor
participant is too immature/incapacitated to be consulted.
b.
The
intervention/procedure involved in the research holds out prospect of direct
benefit that is important to health or wellbeing of the child and is available
only in the context of the research.
c.
The assent
document would be the only link between the participant and the research and
would pose a confidentiality risk.
d.
How assent will
be documented depends on the age, maturity, and psychological state of the
child
i.
Age < 7 years old
(waived or verbal assent, as determined by the Board).
ii.
Age 7-12 years old
(simple 1 page assent statement).
iii.
Age 13-17 (use the
regular consent form, which is supposed to be written at a 7th grade
level). A statement of assent is added
to this form for the participant to sign.
B. Informed Consent in Pregnant Women.
For
research involving pregnant women and/or their fetuses, consent must be
obtained from both the pregnant woman and father unless:
C.
Informed Consent in Native Americans
1. Informed consent from the individual participant
alone is sufficient if the study is not directed at or about Native Americans
as a group.
2. For studies about Native Americans as a group,
informed consent is required from the individual participant and the
appropriate tribal authority.
D.
Informed Consent in Prisoner Populations
1. The consent must be written, or adapted, to the
educational level of this population.
2. The ability of the Investigator to maintain
confidentiality of the prisoner-participant prior to, during and after the
research project concludes.
Other vulnerable groups may include mentally impaired
persons, participants in AIDS research, employees of the Sponsor or
Investigator, terminally ill patients, and the elderly. The IRB defines the elderly as 65 years of
age and older. The IRB will determine special protections for these groups on a
case-by-case basis, taking into account the risks and benefits and other
protections afforded by institutional policies and state and federal law.
2. Scope
These policies and procedures apply to all research
submitted to the IRB.
3. Responsibility
The
IRB Chairperson or IRB Vice-Chairperson is responsible for determining whether
informed consent exemptions or waivers of documentation of informed consent are
applicable and appropriate.
It is the responsibility of the IRB to
determine which of the procedures at §46.117(b)
is appropriate for documenting informed consent in protocols that it reviews.
4. Applicable Regulations and Guidelines
21
CFR 50.23, 50.24
21
CFR 56. 109 (c), 56.109 (d)
45
CFR 46.116
45
CFR 46 Subpart A.
45
CFR 46 Subpart B.
45
CFR 46 Subpart D
OHRP
Guidance:
5. References to other applicable SOPS
This
SOP affects all other SOPs.
6. Attachments
701-A Informed Consent Template
701-A-1 Informed Consent to Participate in a
Research Study
701-A-2 Non-Tape Recorded Interview Consent
Script
701-A-3 Tape Recorded Interview Consent Script
701-A-4 Anonymous/Confidential Survey Consent
Script
701-B Child Assent Template
701-C Tissue Consent Template
701-D Patient Information Sheet – Tissue
Banking
502G-A Emergency Use Consent Template
7. Process Overview
7.1 The IRB
Coordinator is responsible for reviewing the consent form to assure all eight
required elements and the five additional elements of the consent form are
present. The IRB Coordinator will
communicate to the Investigator any needed changes prior to the meeting, if
time allows. The IRB members will review
the consent for content, the required elements and request changes at the
convened IRB meeting. In the case of
Expedited review, the IRB Chairperson will review the consent and recommend
changes. The IRB Coordinator will print
the Pre-review letter or appropriate IRB letter to request changes. When changes are returned, the IRB
Coordinator confirms all the changes have been made and then presents them to
the IRB Chairperson for review and approval.
7.2 The IRB
Coordinator will review the proposed verbal consent process and may ask for
changes or clarification prior to the IRB meeting. The IRB Coordinator will describe the
approved process to conduct and document the verbal consent process in the
minutes and in the appropriate IRB correspondence to the Investigator.
7.3 The IRB Coordinator will confirm that any consent
form in a language other than English received in the IRB office, also includes
a notorized statement from the translator.
The IRB Coordinator will document in the minutes and in the appropriate
correspondence to the Investigator a clear description of the approved method
of obtaining consent for non-English speaking participants.
7.4 The IRB Coordinator confirms the request of a waiver
of Informed Consent on the IRB application.
This information is considered by the IRB Chairperson or the IRB members
at the time of review of the study.
Waiver is granted by the IRB Chairperson or convened IRB and documented
in the correspondence to the Investigator and/or in the meeting minutes.
7.5 Waiver of documentation of the informed
consent is considered at the time of review of the study. The IRB Coordinator
will document in the letter to the Investigator the approved method for waiver
of documentation of informed consent.
The letter may include a requirement that the participants receive a
written statement regarding the research that includes some or all of the requirements
of informed consent.
7.6 The IRB Coordinator will document clearly in
the minutes and the appropriate correspondence to the Investigator the approved
method for obtaining surrogate consent by a legally authorized
representative. This process may include
the assent (and therefore an assent form) for the participant to sign. If the study involves surrogate consenting
involving VA participant, the IRB Coordinator will confirm there is a letter
from the VA Chief of Staff to allow this procedure.
7.7 For those project that involve pregnant
women, the IRB Coordinator and IRB members will review the consent form for the
inclusion of a signature line for the father, when appropriate. The consideration of a line for the father to
consent will be documented in the minutes and letter to the Investigator.
7.8 The IRB Coordinator will evaluate the
submission for a letter from the appropriate tribal authority in studies about
Native Americans. If this letter is not
included in the first submission, the IRB Coordinator may request it prior to
IRB review if time allows. Tribal
approval should be documented in the minutes and letter to the
Investigator. Final IRB approval will
not be granted until the tribal authority gives approval.
8
Procedures
Employed to Implement this Policy.
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Ensure consent forms conform to templates and ensure all consent forms are submitted. Relay information between the investigator and the IRB, IRB Chairperson, IRB Vice-Chairperson. |
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Determine eligibility for
exemption from or waiver of documentation of informed consent Review of informed consent
forms that qualify for expedited review. Review of consent forms initially reviewed by the IRB that have been revised per the IRB’s instructions. |
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Review of Informed Consent
Forms. The IRB will ensure the consent form allows for the signature of both parents where research meets the regulation of §46.406 and §46.407 |