What You
Can Do To Facilitate Efficient IRB Review
Part
II: Informed Consent
Institutional Review Board
722
MSPH 426
(212) 305-5883
1) Tips to
facilitate efficient IRB review: Consent Form Builder
2)
Tips for Increasing
Comprehension of Informed Consent Documents
3) IRB
Terminology Related to Informed Consent
4) Elements
of Informed Consent
5) Criteria
for Waiver of the Elements of Informed Consent
6) Criteria
for Waiver of the Written Documentation of Informed Consent
7) Requirements
for Consent in Pediatric Research
If you have questions about IRB review or procedures,
contact the IRB office at (212) 305-5883.
If you have technical questions, contact the RASCAL help
line
at (212) 870-3480.
Tips to Facilitate Efficient IRB Review
Consent
Form Builder
1.
Create a generic form once; copy and edit as
necessary for each study.
2.
Utilize the three ways to insert text: a) select sample text; b) copy/paste from
another document; c) type.
Typing or copying text: remember that the Consent Form
Builder is a web program and recognizes only basic formatting.
Inserting text from a sample consent: All text related to one element of consent or
topic (e.g., Procedures, Risks, etc.) can be copied into their respective field
in the RASCAL Consent Form Builder.
Bolding of headings:
RASCAL automatically bolds the headings of the elements of
consent (e.g., Purpose and Procedures, Risks, Benefits, etc.), when the consent
is created utilizing the Consent Builder.
Additional headings of a given element of consent or topic
(e.g., Risks of Pregnancy under Risks) should be entered in the sub-heading
field in RASCAL.
Otherwise, inserting an entire consent form into a field in
the RASCAL Consent Form Builder, go to Layout and enter a “0” into all fields
other than the one that contains the consent form. This process will not print the headings in
bold. This process is not recommended by
the IRB as it would decrease comprehension of the consent document.
3.
Be familiar with the required elements of informed
consent, and include the additional elements when appropriate.
4.
Review the “Helpful Consent Form Information”
available from the Consent Form menu.
5.
Read the general instructions in each section of the
consent builder. These will guide you to
submit a consent form to the IRB more successfully.
6.
Ensure that information in the consent form is
consistent with that in the protocol and all other study-related documents.
7.
Maintain a 6th-8th grade
language level throughout the form. See
the IRB’s Tips for Increasing Comprehension of Informed Consent Documents.
8.
Maintain the same voice (second person; e.g., “you”)
throughout the consent form.
9.
Select signature lines cautiously, i.e., include
either “study participant” or “study subject” but not both. Remove any
unnecessary or inappropriate signature lines.
Minimally, a consent document that will be signed should
have the following lines for signature and date: 1) Signature of the Subject or Participant;
2) Signature of the Person Obtaining Informed Consent; and 3) Investigator’s
signature.
The Signature of the Subject or Participant may not be
appropriate for all assent forms.
10.
After attaching the consent form to a protocol and
before submitting it to the IRB, print it out and read it through to evaluate
layout, appearance, flow of text, language level and accuracy. Ensure that all required elements of consent
are included or justify the removal of any element of consent in the Subjects
page of the protocol.
11.
If a consent form includes a chart or table, move the
chart or table into a separate document that will be used as an addendum to the
consent. Attach the addendum in RASCAL
and explain in a cover letter that the attachment should be considered as part
of the consent form.
12.
If an approved consent document needs to be
translated into another language, the investigator can grant access of the
consent document within RASCAL to the individual who will conduct the
translation. For example, if a consent
form needs to be translated into Spanish, the investigator can grant access to
an individual in the Hispanic Research & Recruitment Center (HRRC). Alternatively, one can attach a scanned copy
of the translated form(s) stamped by the HRRC.
13.
Contact the RASCAL help-line if technical assistance
is required (whenever you are unable to perform any function in the Consent
Form Builder or manipulate or edit any text).
Contact the IRB office if questions regarding institutional
policy and/or federal regulations arise during construction of the consent
form.
14.
If similar text is used or required by several
investigators or throughout a department, provide the sample text to the
IRB. The IRB will consider such requests
and revise sample text in the Consent Builder accordingly.
Benefit to using the
Consent Form Builder: As soon as the status
of the protocol changes to “approved”, the consent form will receive the
IRB approval stamp electronically and can immediately be printed by the
researcher.
TIPS FOR INCREASING COMPREHENSION OF
INFORMED CONSENT DOCUMENTS
These guidelines were developed for investigators at
·
Use one or two syllable words whenever possible
·
Write short sentences and paragraphs
·
Define all medical or technical terms in lay language
·
Organize information in sections with clear headings
·
Print all headings in bold
·
Use spacing to emphasize important concepts
·
Avoid contractions such as don’t
IRB
Terminology Related to Informed Consent
Informed Consent A person's
voluntary agreement, based upon adequate knowledge and understanding of
relevant information, to participate in research or to undergo a diagnostic,
therapeutic, or preventive procedure. In giving informed consent, subjects may
not waive or appear to waive any of their legal rights, or release or appear to
release the investigator, the sponsor, the institution or agents thereof from
liability for negligence [Federal Policy §116; 21 CFR 50.20 and 50.25].
Consent
Form
Documentation of informed consent, which may be:
(1) A
written consent document that embodies the elements of informed consent
required by 45CFR46.116. 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; or
(2) A
short form written consent document stating that the elements of informed
consent required by 45CFR46.116 have been presented orally to the subject or
the subject's legally authorized representative. When this method is used,
there shall be a witness to the oral presentation. Also, the IRB shall approve
a written summary of what is to be said to the subject or the representative.
Only the short form itself is to be signed by the subject or the
representative. However, the witness shall sign both the short form and a copy
of the summary, and the person actually obtaining 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.
Assent Agreement
by an individual not competent to give legally valid informed consent (e.g.,
a child or cognitively impaired person) to participate in research.
Parental Permission A
type of surrogate consent in which a parent agrees to enroll their child in
research.
Information Sheet Document
provided to research subject that contains the elements of informed consent but
does not require a signature. Used
either in exempt research, (in which informed consent is not required but may
be desirable) or when written documentation of informed consent has been waived
by the IRB in accordance with 45CFR 46.117(c).
Legally Authorized Representative 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. In
General requirements for informed consent (45 CFR 46.116)
Except as provided
elsewhere in this policy, no investigator may involve a human being as a
subject in research covered by this policy unless the investigator has obtained
the legally effective informed consent of the subject or the subject's legally
authorized representative. An investigator shall seek such consent 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. The information that
is given to the subject or the representative shall be in language
understandable to the subject or the representative. No informed consent,
whether oral or written, may include any exculpatory language through which the
subject or the representative is made to waive or appear to waive any of the
subject's legal rights, or releases or appears to release the investigator, the
sponsor, the institution or its agents from liability for negligence.
(a) Basic elements of
informed consent. Except as provided in paragraph (c) or (d) of this section,
in seeking informed consent the following information shall be provided to each
subject:
(1)
a statement that the study involves research, an explanation of the purposes of
the research and the expected duration of the subject's participation, a
description of the procedures to be followed, and identification of any
procedures which are experimental;
(2)
a description of any reasonably foreseeable risks or discomforts to the
subject;
(3)
a description of any benefits to the subject or to others which may reasonably
be expected from the research;
(4)
a disclosure of appropriate alternative procedures or courses of treatment, if
any, that might be advantageous to the subject;
(5)
a statement describing the extent, if any, to which confidentiality of records
identifying the subject will be maintained;
(6)
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;
(7)
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; and
(8)
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.
(b) additional elements of
informed consent. When appropriate, one or more of the following elements of
information shall also be provided to each subject:
(1)
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;
(2)
anticipated circumstances under which the subject's participation may be
terminated by the investigator without regard to the subject's consent;
(3)
any additional costs to the subject that may result from participation in the
research;
(4)
the consequences of a subject's decision to withdraw from the research and
procedures for orderly termination of participation by the subject;
(5)
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; and
(6)
the approximate number of subjects involved in the study.
Waiver of
Elements of Informed Consent (45 CFR 46.116)
(c)
An 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) 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 or
service programs; (ii) procedures for obtaining benefits or services under
those programs; (iii) possible changes in or alternatives to those programs or
procedures; or (iv) possible changes in methods or levels of payment for
benefits or services under those programs; and
(2) the research could not practicably be carried out
without the waiver or alteration.
(d)
An IRB may approve a consent procedure which does not include, or which alters,
some or all of the elements of informed consent set forth in this section, or
waive the requirements to obtain informed consent provided the IRB finds and
documents that:
(1) the research involves no more than minimal risk
to the subjects;
(2) the waiver or alteration will not adversely
affect the rights and welfare of the subjects;
(3) the research could not practicably be carried out
without the waiver or alteration; and
(4) whenever appropriate, the subjects will be
provided with additional pertinent information after participation.
Waiver of
Written Documentation of Informed Consent (45 CFR 46.117)
(c) An IRB may waive the requirement for the
investigator to obtain a signed consent form for some or all subjects if it
finds either:
(1) 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
(2) 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 documentation requirement is
waived, the IRB may require the investigator to provide subjects with a written
statement regarding the research.
|
Excerpt from Subpart D
(45 CFR 46): Additional DHHS
Protections for Children Involved as Subjects in Research (See Section 408 Below
for Assent and Parental Permission Requirements) |
§46.404
Research not involving greater than minimal risk.
DHHS
will conduct or fund research in which the IRB finds that no greater than
minimal risk to children is presented, only if the IRB finds that adequate
provisions are made for soliciting the assent of the children and the
permission of their parents or guardians, as set forth in §46.408.
§46.405
Research involving greater than minimal risk but presenting the prospect of
direct benefit to the individual subjects.
DHHS
will conduct or fund research in which the IRB finds that more than minimal
risk to children is presented by an intervention or procedure that holds out
the prospect of direct benefit for the individual subject, or by a monitoring
procedure that is likely to contribute to the subject's well-being, only if the
IRB finds that:
(a)
the risk is justified by the anticipated benefit to the subjects;
(b)
the relation of the anticipated benefit to the risk is at least as favorable to
the subjects as that presented by available alternative approaches; and
(c)
adequate provisions are made for soliciting the assent of the children and
permission of their parents or guardians, as set forth in §46.408.
§46.406
Research involving greater than minimal risk and no prospect of direct benefit
to individual subjects, but likely to yield generalizable knowledge about the
subject's disorder or condition.
DHHS
will conduct or fund research in which the IRB finds that more than minimal
risk to children is presented by an intervention or procedure that does not
hold out the prospect of direct benefit for the individual subject, or by a
monitoring procedure which is not likely to contribute to the well-being of the
subject, only if the IRB finds that:
(a)
the risk represents a minor increase over minimal risk;
(b)
the intervention or procedure presents experiences to subjects that are
reasonably commensurate with those inherent in their actual or expected
medical, dental, psychological, social, or educational situations;
(c)
the intervention or procedure is likely to yield generalizable knowledge about
the subjects' disorder or condition which is of vital importance for the
understanding or amelioration of the subjects' disorder or condition; and
(d)
adequate provisions are made for soliciting assent of the children and
permission of their parents or guardians, as set forth in §46.408.
§46.407
Research not otherwise approvable which presents an opportunity to understand,
prevent, or alleviate a serious problem affecting the health or welfare of
children.
DHHS
will conduct or fund research that the IRB does not believe meets the
requirements of §46.404, §46.405,
or §46.406
only if:
(a)
the IRB finds that the research presents a reasonable opportunity to further
the understanding, prevention, or alleviation of a serious problem affecting
the health or welfare of children; and
(b)
the Secretary, after consultation with a panel of experts in pertinent
disciplines (for example: science, medicine, education, ethics, law) and
following opportunity for public review and comment, has determined either:
(1)
that the research in fact satisfies the conditions of §46.404, §46.405,
or §46.406,
as applicable, or (2) the following:
(i)
the research presents a reasonable opportunity to further the understanding,
prevention, or alleviation of a serious problem affecting the health or welfare
of children;
(ii)
the research will be conducted in accordance with sound ethical principles;
(iii)
adequate provisions are made for soliciting the assent of children and the
permission of their parents or guardians, as set forth in §46.408.
§46.408 Requirements for
permission by parents or guardians and for assent by children.
(a) In addition to the determinations
required under other applicable sections of this subpart, the IRB shall
determine that adequate provisions are made for soliciting the assent of the
children, when in the judgment of the IRB the children are capable of providing
assent. In determining whether children are capable of assenting, the IRB shall
take into account the ages, maturity, and psychological state of the children
involved. This judgment may be made for all children to be involved in research
under a particular protocol, or for each child, as the IRB deems appropriate.
If the IRB determines that the capability of some or all of the children is so
limited that they cannot reasonably be consulted or that 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 children and is available only
in the context of the research, the assent of the children is not a necessary
condition for proceeding with the research. Even where the IRB determines that
the subjects are capable of assenting, the IRB may still waive the assent
requirement under circumstances in which consent may be waived in accord with §46.116
of Subpart
A.
(b) In addition to the
determinations required under other applicable sections of this subpart, the
IRB shall determine, in accordance with and to the extent that consent is
required by §46.116
of Subpart
A, that adequate provisions are made for soliciting the permission of each
child's parents or guardian. Where parental permission is to be obtained, the
IRB may find that the permission of one parent is sufficient for research to be
conducted under §46.404
or §46.405.
Where research is covered by §46.406
and §46.407
and permission is to be obtained from parents, 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.
(c) In addition to the provisions
for waiver contained in §46.116
of Subpart
A, if the IRB determines that a research protocol is designed for
conditions or for a subject population for which parental or guardian
permission is not a reasonable requirement to protect the subjects (for example,
neglected or abused children), it may waive the consent requirements in Subpart
A of this part and paragraph (b) of this section, provided an appropriate
mechanism for protecting the children who will participate as subjects in the
research is substituted, and provided further that the waiver is not
inconsistent with Federal, State, or local law. The choice of anappropriate
mechanism would depend upon the nature and purpose of the activities described
in the protocol, the risk and anticipated benefit to the research subjects, and
their age, maturity, status, and condition.
(d) Permission by parents or
guardians shall be documented in accordance with and to the extent required by §46.117
of Subpart
A.
(e) When the IRB determines that
assent is required, it shall also determine whether and how assent must be
documented.