Transcript IRB BASICS: Ethics and Human Subject Protections The Committees on Human Research University of Vermont & Fletcher Allen Health Care 09-23-11

IRB BASICS:
Ethics and Human
Subject Protections
The Committees on Human Research
University of Vermont & Fletcher Allen Health Care
09-23-11
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IRB Function
The purpose of an IRB is to review
research and to ensure the rights and
welfare of human subjects involved in
research are adequately protected.
There are two IRBs at the University of
Vermont, one designated for the
behavioral sciences and one for the
medical sciences. These cover activities
by both UVM and FAHC researchers.
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Why Do Human Research
Subjects Need Protection?
Trigger Events
Ethical Milestones
The Nazi Experiments
Nuremberg Code 1947
Tuskegee Syphilis Study
National Commission for
the Protection of Human
Subjects of Biomedical &
Behavioral Research 1974
* Belmont Report
* Common Rule
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1978
1991
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The Belmont Report
The principles of the Belmont Report
govern all research supported by the
U.S. Government. The ethical
principles outlined in the report are
the basis for subsequent regulations
designed to ensure protection of
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human subjects in research.
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The Basic Principles of the
Belmont Report
1. Respect for Persons
2. Beneficence
3. Justice
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Respect for Persons
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Treat individuals as autonomous agents
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Do not use people as a means to an end
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Allow people to choose for themselves
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Provide extra protections to those with
diminished autonomy (i.e., Prisoners,
Children, Cognitively Impaired, etc.)
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Beneficence
The two general rules formulated from
the principle of beneficence are:
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First, do no harm
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Second, maximize possible
benefits and minimize risks
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Justice
o Treat people fairly
o Fair sharing of burdens and
benefits of the research
An injustice occurs when:
1. benefits to which a person is
entitled are denied without good
reason, or
2. when burdens are imposed
unduly.
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Rules Derived
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Respect
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Beneficence
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Good research design
Competent investigators/researchers
Favorable risk-benefit analysis
Justice
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Informed Consent Process
Respect for Privacy
Equitable selections of subjects
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The Common Rule
The “Common Rule” is the set of regulations
which were developed to ensure compliance with
the principles of the Belmont Report. The
regulations fall under the Department of Health
and Human Services. These regulations have
been adopted by many other federal
departments which regulate human research.
There are many other regulations with which
UVM/FAHC are required to comply, such as the
Food and Drug Administration, but these are all
in addition to the “Common Rule”.
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Protective mechanisms
established by The Common Rule
o Institutional assurances of compliance
o Review of research by an IRB
o Informed consent of subjects
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Institutional Assurance
UVM and FAHC have negotiated with the Office
for Human Research Protections that all of the
institution’s human subject research activities,
regardless of funding, will be guided by the
Belmont Report, will comply with the Common
Rule, and other regulations as applicable.
This is referred to as a
Federalwide Assurance (FWA).
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IRB Review of Research
All research projects are categorized into one of
three categories for the IRB review process.
Each category is different in the level of scrutiny
and submission procedures. The IRB is
responsible for making the final decision of which
category a research project falls under.
Full
 Expedited
 Exempt
 Research Not Involving Human
Subjects
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Full Review
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One or more Committee member(s) are assigned
to review the complete protocol or amendment,
consent form, Investigational Drug/Device
Brochure and any other protocol materials.
These Primary & Secondary Reviewers summarize
the protocol or amendment to the Full Committee
at a convened meeting and answer questions
during the discussion.
All other committee members are provided with
summary information, for example the Protocol
Cover Form and informed consent
document. This stresses the importance of the
accuracy and details provided in these
documents, since the majority of voting members
only see these 2 documents!
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Expedited Review
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Protocols, amendments, or continuing
reviews that meet specific federal criteria
qualify for an expedited review.
The complete protocol, consent form, and
any other protocol materials receive
review and approval by a Committee
Chair.
Expedited does not mean “fast” it is a
federal term used for research that must
meet specific criteria (DHHS 45 CFR
46.110)
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Exempt from IRB Review
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Committee review is not required for
certain categories of research activities
that involve little or no risk to human
subjects.
To determine if your research qualifies for
exemption from formal committee review,
complete the “Protocol Exemption Review
and Determination Checklist.”
Only the IRB can make the
determination of Exempt, this cannot
be determined by researchers!
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IRB Review and Determination of
“Research Not Involving Human
Subjects”
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There is some research that involves coded
private information or specimens that do not
involve human subjects.
When conducting research using data or
specimens, the level of review by the IRB
depends primarily on one factor: whether the
data or specimens are identifiable to the principal
investigator or key personnel.
Determinations of whether research
involving coded private information or
biological specimens is considered to be
“human subjects research” must be made by
the IRB, not the investigator.
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Types of Review
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Initial
Continuing Review
Amendments
Safety Information or
Unanticipated Problems to
Subjects or Others
Noncompliance
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Criteria for IRB Approval
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Risks are Minimized (Consistent with a sound research design
and does not unnecessarily expose subjects to risk)
Risks are Reasonable in Relation to Benefits
Selection of Subjects is Equitable
Informed Consent will be Sought for Each Prospective Subject
Informed Consent will Be Documented
Research Plan Adequately Provides for Monitoring the Data
Collected to Ensure Safety of the Subjects
Research Plan Adequately Protects the Privacy of Subjects
and Maintains Confidentiality
When some or all of the subjects are likely to be vulnerable to
coercion or undue influence, additional safeguards need to be
included in the protocol to protect the rights and welfare of these
subjects.
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The IRB has the authority to:
oApprove
oRequire modifications prior to
approval
oTable
oDisapprove all research activities
including proposed changes in
previously approved human
subject research.
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Informed Consent
• Information – includes research
procedure, purpose, risks, benefits,
alternatives, etc.
• Comprehension – function of
intelligence, rationality, maturity and
language, presentation of information
must be adapted to the subject’s
capacity
• Voluntariness –requires conditions
free of coercion and undue influence
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Consent Form Required
Elements
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Statement that the study involves research
Research is described
Description of Risks
Description of Benefits
Disclosure of Alternatives
Confidentiality
If more than minimal risk, compensation
and/or medical treatment
Participation is voluntary
Whom to Contact
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Additional Elements of
Informed Consent
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Unforeseeable risks
Early termination
Additional costs to subjects
Consequences of a subject's decision to
withdraw from study participation
Disclosing new findings which may
impact a subject's willingness to
continue participation
Number of subjects involved
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Informed Consent Process
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Informed Consent
is more than just
the IRB-approved
document
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Initial
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Ongoing
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Initial Informed Consent
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Take the time at the initial discussion with
subjects so that they have a thorough
understanding of what they are making a
commitment towards
Test subject comprehension
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Research versus standard of care procedures
Time commitment
Randomization
Alternatives
Potential costs
Risks and Benefits
Taking time upfront with potential subjects most
likely will improve subject understanding and
improve retention
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Ongoing Consent
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Every time you have an encounter with a
subject gives researchers an opportunity
to continue the informed consent process
Discuss new information that may impact
a subject’s willingness to continue study
participation (i.e., new known risks,
benefits, alternatives, changes in study
design, etc.)
Remind subject of study goals and
objectives this will improve subject
compliance with the protocol and improve
retention of subjects
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Information
IRB Review Process
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University of Vermont
Research Protections office
213 Waterman Building
85 South Prospect Street
Burlington, Vermont 05405
(802)656-5040
www.uvm.edu/irb
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