Transcript Document

IRB BASICS
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Ethics and Human
Subject Protections
Viterbo University
IRB
spring 2015
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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.
Appointed by the dean or vice president
for academic affairs.
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 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 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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Full Review
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 Study meets the criteria for full review as listed on
the “submitting to the IRB” tab on the web page.
 The entire committee deliberates on the study
protocol at posted monthly meetings. Meeting
dates posted on the website.
 Full review protocols need to be submitted ONE
WEEK prior to meeting dates.
 The IRB Chair will inform the researcher of the
decision within one working day of the meeting.
 Special populations: prisoners, mental and physical
disability, pregnant women, children (defined
according to state statute).
 High risk of harm to person, others, reputation.
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Expedited Review
 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 the IRB chair and
one 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. Summer research
turnaround is 5 days.
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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.
 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. Summer reviews 3 days.
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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.
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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 is on the IRB Template for Informed Consent
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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 Process
 Informed Consent is
more than just the
IRB-approved
document
 Initial
 Ongoing
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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
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
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Early termination
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Additional costs to subjects
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Consequences of a subject's decision to
withdraw from study participation
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Disclosing new findings which may
impact a subject's willingness to continue
participation
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Number of subjects involved
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Initial Informed Consent
 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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Application Process
 http://www.viterbo.edu/IRB
Application walkthrough
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Information
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See IRB website for current chair and committee members.
http://www.viterbo.edu/irb
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