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A
regulatory criterion for IRB approval is that informed
consent will be sought from each prospective participant
or the participant’s legally authorized representative,
in accordance with and to the extent required by the
regulations. This cannot be accomplished solely by
evaluation of a written consent document, since the
consent process is a discussion that should be culturally
and linguistically appropriate to the research population,
and not simply a consent form. Instead, the IRB should
know the nature and circumstances of the consent process,
and judge whether the consent process meets the required
attributes described in the regulatory criteria for
approval. The investigator may not involve a human
being as a participant in research unless the investigator
has obtained the legally effective informed consent
of the participant or the
Participant’s legally authorized representative. Under
the regulatory requirements the consent process should
fulfill these attributes:
•
The consent process provides sufficient opportunity
to consider whether to participate.
• The consent process minimizes the possibility of
coercion or undue influence.
• The consent discussion is in language understandable
to the participant or the representative.
• The consent discussion is free of exculpatory language.
Evaluation
of the circumstances of consent may require the IRB
to know who will conduct the consent interview, the
timing of obtaining informed consent, and any waiting
period between informing the participant and obtaining
the consent.
When
some or all of the participants are likely to be vulnerable
to coercion or undue influence, the IRB should consider
additional safeguards to provide for appropriate informed
consent. If the IRB reviews research that involves
children, pregnant women, fetuses, neonates, prisoners,
or adults who lack the ability to consent, non-English
speakers, the IRB consider the regulations as well
as any local policies and procedures for these vulnerable
individuals.
Assent
From Adults Who Cannot Give Consent
The Partners IRBs have developed policies and procedures
for considering studies in which adult subjects will
not be able to give consent due to their diseases
or disorders. In some circumstances surrogate consent,
based upon the substituted judgment provided by a
close family member of health care proxy may be acceptable.
The IRB will carefully consider the risks and benefits
of studies where surrogate consent is proposed. Guidance
for these vulnerable subjects is found here: http://intranet.massgeneral.org/phrc/surrogate_consent_memo.pdf
Assent
From Children
The IRB must 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 providing
assent, the IRB must 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.
The
assent of the children is not a necessary condition
for proceeding with the research if the IRB determines
that either of the following is true:
•
That the capability of some or all of the children
is so limited that they cannot reasonably be consulted.
• 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.
Even
where the IRB determines that the participants are
capable of giving assent, the IRB may still waive
the assent requirement if it finds and documents that:
•
The research involves no more than minimal risk to
the participants;
• The waiver will not adversely affect the rights
and welfare of the participants;
• The research could not practicably be carried out
without the waiver; and
• Whenever appropriate, the participants will be provided
with additional pertinent information after participation.
In
addition the IRB must determine, in accordance with
and to the extent that consent is required by the
regulations, 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,
{FDA: if consistent with State law,} for research
that is found to be of minimal risk to the children,
or research that involves greater than minimal risk
but presents the prospect of direct benefit to the
individual subjects. Either way, the IRB needs to
determine whether both parents are a necessary part
of the permissions process or, when the research meets
one of the two categories above, it is sufficient
to include only one parent.
Where
research involves 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; or research found
to be not otherwise approvable which presents an opportunity
to understand, prevent, or alleviate a serious problem
affecting the health or welfare of children; both
parents must give their permission for their child
to participate in the research 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 {FDA: if consistent
with State law}.
Permission
by parents or guardians shall be documented in accordance
with and to the extent required by the regulations.
When
the IRB determines that assent is required, it shall
also determine whether and how assent must be documented.
Observing
the Consent Process
According to the federal regulations, IRBs have the
authority to observe or have a third party observe
the consent process. The IRB should have policies
and procedures that describe how the IRB considers
and implements such monitoring. Specifically, IRBs
should consider monitoring of the informed consent
a method that can be used to provide for an appropriate
consent process in special situations, and have a
mechanism by which observation of the consent process
might be implemented. For example, observation of
the consent process might provide additional protections
when research involves adults with potentially limited
decision-making capacity. Observation of the consent
process might be performed by the IRB, research review
unit staff, other individuals in the organization,
or by a third party hired by the organization, investigator,
or sponsor.
References:
AHRPP Evaluation form
OHRP Guidebook |
