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IRB BASICS
Ethics and Human
Subject Protections
Summer 2016
Viterbo University
IRB
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IRB Function
The purpose of an IRB is to review
human subjects research and ensure the
rights and welfare of those involved in
research are protected.
IRB is a federal mandate.
The Viterbo University IRB website is
found at http://viterb.edu/IRB
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Rules Derived from
Belmont Report
http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html
 Respect
 Informed Consent Process/ Autonomous
decision making
 Respect for Privacy
 Beneficence
 Do no harm
 Competent investigators/researchers
 Provide resources for participants
 Justice
 Equitable selections of subjects
 Fair distribution of risks and benefits
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IRB Review
Responsibilities
 Initial Reviews and Approvals
 Continuing Review for ongoing studies
 Amendments/ Changes to studies
 Safety Information or Unanticipated Problems to
Subjects or Others
 Study Closure
 Compliance (most institutions have designated
compliance officers)
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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.
Research that does NOT involve human subjects
is not reviewed by the IRB.
Full
Expedited
Exempt
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Exempt Review
 Committee review is not required for
certain categories of research activities
that involve no risk to human subjects.
 Exempt does not mean the study needs
no submission to the IRB. It means it can be
exempt from multiple reviewers review.
 Exempt reviews are reviewed by one
member of the IRB committee
 Exempt reviews turned around in one
week.
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Expedited Review
 The complete application, consent
form, and any other materials receive
review and approval by the IRB chair
and one other committee member.
 Expedited does not mean “fast” it is a
federal term used for research that
must meet specific criteria (DHHS 45
CFR 46.110)
 Expedited reviews are turned around in
a 2 week timeframe.
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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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IRB Review and Determination of
“Research Not Involving Human
Subjects”
 Certain forms of research do not involve
human subjects or do not meet the definition
of research according to the federal
guidelines.
 Oral histories
 Case studies (certain conditions)
 Quality improvement
 Historical, anonymous data sets
 See details on oral history, case study, and
class projects posted on the IRB website.
Criteria for IRB Approval
(Checklist on the Website)
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•
Risks are Minimized (Consistent with a sound research design and does
not unnecessarily expose subjects to risk)
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Risks are Reasonable in Relation to Benefits
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Selection of Subjects is Equitable
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Informed Consent will be Sought for Each Prospective Subject
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Informed Consent will Be Documented
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Agency permission provided for off campus studies
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IRB Application identifies data collection, study procedures, data
storage, and informed consent processes.
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Informed Consent Templates are on the website.
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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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Researcher submits NIH Training obtained within last 3 years.
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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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Application Process
 http://www.viterbo.edu/IRB
Apply through the Virbatim
software program. User
guide on the website.
Information
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Chair: Dr. David Bauer , djbauer@viterbo.edu, 796-3712
http://www.viterbo.edu/irb