Presentation on IRB History

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Institutional Review Boards (IRBs), Informed
Consent, and Responsibilities
Requirement for IRBs -DHHS 45 CFR Part
46 -FDA 21 CFR 56 Requirement for and Elements
of Informed Consent -DHHS 45 CFR Part 46 -FDA
21 CFR 50
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Requirement for IRB Review
45 CFR 46 In the case of any application
submitted to the Secretary for financial
assistance to conduct research, the Secretary may
not approve or fund any application that is
subject to review by an Institutional Review
Board 21 CFR 56 any clinical investigation
shall not be initiated unless that
investigation has been reviewed and approved by
an IRB
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Purpose of the IRB
A group formally designated by an institution
to review, to approve the initiation of, and to
conduct periodic review of, biomedical and
behavioral research involving human subjects.
The primary purpose of such review is to assure
the protection of the rights and welfare of the
human subjects. The local IRB at the research
site is the cornerstone of the American system of
protection of human subjects.
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IRB Membership
gt 5 members -varying backgrounds -professional
competence to review specific research
activities -diverse membership -one
non-scientific member -one non-institutional
member
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IRBs (cont.)
Review, require modifications to and approve all
human use research -assess risk/benefit
ratio -insure adequate informed
consent Terminate/Suspend research -Risks/adverse
events become excessive or outweigh
benefits -non-compliance of investigator Conduct
continuing review of the research Document all
actions
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Mandated Criteria for IRB Approval of Research
Risks to the subjects are minimized -sound
research design -risks are reasonable in
relation to anticipated benefits -selection of
subjects is equitable -informed consent obtained
-informed consent documented -privacy and
confidentiality protected -additional safeguards
included to protect the rights and welfare of
vulnerable populations
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Special Protections
Fetuses, Pregnant Women, and Human In Vitro
Fertilization - Minimal risks to fetus/mother -
Must meet health needs of fetus/mother Prisoners
- Minimal risk/minor inconvenience - More than
Minimal Risk with potential for
benefit Children - Anticipated benefit -
Solicit assent of the child/Consent of the parents
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Regulatory Categories of Research Related Risk
More than minimal risk - Clinical Trials with
drugs or devices Minimal Risk - What you might
expect to be done at a visit to your physician
for a physical exam Exempt - Educational tests,
surveys, interviews, observation of public
behavior
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IRB Requirements Related to Risk
More than Minimal Risk - IRB Form (Blue Form) -
Protocol - Informed Consent Document - IRB
Review (Full Board) Initial Request Continuing
Review
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IRB Requirements Related to Risk
Minimal Risk - IRB Form (Blue Form) -Protocol -
Informed Consent Document - Expedited IRB
Review - Initial and Continuing Review Exempt -
Not recognized at UTMB - Handled as Expedited
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Other Special Areas of Concern
Genetic Testing/Research on blood or discarded
materials -May be considered in the expedited
category No identifiers No links to
subjects -Referred for Full Board
review Identifiers or links to subjects Risks
of psychological harm or loss of confidentiality
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Informed Consent of Human Research Subjects
General Requirements -Obtained from subject or
subjects legally authorized representative
prior to enrollment. -Provides sufficient
opportunity to consider whether or not to
participate. -Minimizes coercion or undue
influence. --subject reimbursement --finders
fees
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Informed Consent of Human Research Subjects
General Requirements (Cont.) -Written in an
language understandable to the subject or
subjects representative. --written at an 8th
(or lower) grade level --foreign language
consent form -Contains no exculpatory
language --cannot be asked to waive their legal
rights or release the investigator, sponsor,
or institution from liability
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Elements of Informed Consent
Basic Elements -Statement(s) that the study
involves research, purpose of the research,
expected duration of the subjects
participation, description of procedures, and
identification of procedures which are
experimental. -A description of any
reasonably foreseeable risks or discomforts to
the subject. -A description of any benefits to
the subject or to others which may reasonably
be expected from the research.
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Elements of Informed Consent
-A disclosure of appropriate alternative
procedures or courses of treatment, if any,
which might be advantageous to the subject. -A
statement describing the extent, if any, to
which confidentiality of records identifying the
subject will be maintained. -For research
involving more than minimal risk, an explanation
as to whether any compensation and an
explanation as to whether any medical
treatments are available if injury occurs and,
if so, what they consist of, or where further
information may be obtained.
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Elements of Informed Consent
-An explanation of whom to contact for answers
to pertinent questions about the research and
research subjects rights, and whom to contact
in the event of a research related injury to
the subject. -A statement that participation
is voluntary, refusal to participate will
involve no penalty or loss of benefits to which
the subject is otherwise entitled, and that the
subject may discontinue participation at any
time without penalty or loss of benefits to
which the subject is otherwise entitled.
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Elements of Informed Consent
Additional Elements (when appropriate) -A
statement that the particular treatment or
procedure may involve risks to the subject (or
to the embryo or fetus, if the subject is or may
become pregnant) which are currently
unforeseeable. -Anticipated circumstances
under which the subject's participation may be
terminated by the investigator without regard to
the subjects consent. -Additional costs to the
subject that may result from participation in
the research.
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Elements of Informed Consent
-Consequences of the subjects decision to
withdraw from the research and procedures for
orderly termination of participation by the
subject. -A statement that significant new
findings developed during the course of the
research which may relate to the subjects
willingness to continue participation will be
provided to the subject. -The approximate
number of subjects involved in the study.
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Informed Consent
Documentation -Written consent form previously
reviewed and approved by the IRB -Signed by
subject or legally authorized representative
after having the opportunity to read the form
and ask questions -Copy to the person signing
the form (Except for TDCJ subjects) -Separate
consent form for TDCJ subjects
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Informed Consent
IRB Waiver of written informed consent -If it is
the only record linking the subject and the
research principal risk would be potential
breach of confidentiality or -The research
minimal risk and involves no procedures for
which written consent is normally required
outside of the research context. -The IRB may
require the investigator to provide subjects
with a written statement regarding the research
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Informed Consent Special Points
Research requirements are different than clinical
requirements Consent Form must be approved by the
IRB (Prior to use) -Initially and at least
annually during the continuing review
process -Subject or representative must have
research procedures explained to them Research
must be approved by the IRB for non- consenting
subjects No telephone consent
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Waiver of Informed Consent for Emergency Research
Regulations permit waivers -IRB can waive
written consent --Minimal risk --Consent
would provide link/confidentiality
problem Amendment to Regulations in 1996 -IRB
can waive consent requirements for More than
Minimal Risk studies --Special/Stringent
requirements
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Responsibilities
Institutional -Written assurance to NIH Office
for Protection from Research Risks (OPRR)
agreeing to comply with all applicable research
regulations -Appoint an IRB -Provide
sufficient space, facilities, resources and
staff to ensure that the IRB can carry out its
responsibilities
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Responsibilities
IRB -Follow written procedures for initial and
continuing review -Provide oversight -Review
and approve changes to research
activities -Report incidents of non-compliance
involving risks to subjects or any other serious
or continuing non-compliance to OPRR -Suspend
or terminate research activities when necessary
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Responsibilities
Investigator -Perform only IRB approved research
activities -Assume front line position for risk
minimization -Ensure true informed consent
process -Document informed consent -Keep IRB
informed -Keep records and copies of IRB
correspondence
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Results of Non-Compliance
Local Audit Performed -IRB suspension of
research activities -Notify funding agency of
suspension -Probable loss of funding
(temporary or permanent) OPRR/FDA
Audit (Institution or investigator) -Suspension/
restriction of research -Probable loss of
funding -Placed on FDA sanctions list