irb classroom.ppt [read-only] - university of memphis€¦ · irb basics research support services...
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IRB BASICS
Research Support ServicesHuman Subjects Protection Program
University of Memphis
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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.
IRB Function
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The Belmont Report
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1. Respect for Persons
2. Beneficence
3. Justice
The Basic Principles of the Belmont Report
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Respect◦ Informed Consent Process◦ Respect for Privacy
Beneficence◦ Good research design◦ Competent investigators/researchers◦ Favorable risk-benefit analysis
Justice◦ Equitable selections of subjects
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Categories
Full Expedited Exempt Research Not Involving Human Subjects
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Decision Charts:
http://www.hhs.gov/ohrp/policy/checklists/decisioncharts.html
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Initial Review Continuing Review Modifications Adverse Events or Unanticipated Problems Noncompliance Determination
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• Risks are Minimized• Risks are Reasonable in Relation to Benefits• Selection of Subjects is Equitable• Informed Consent will be Sought and Documented• Research Plan Adequately Provides for Monitoring the Data
Collected • 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:
o Approve
o Require modifications prior to approval
o Table
o Disapprove
o Suspend
o Terminate
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• Information • Comprehension• Voluntariness
Informed Consent
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www.memphis.edu/IRBAdministration Building 315
(901) 678-2705
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What happens to my protocol once it is submitted to the IRB?
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IRB Administration
Principle Investigator IRB Reviewers
STARTSubmit
ApplicationApplication Received
Application –Screened for Completion
Receipt of Submission E-mailed
Application –IRB ID# Assigned IRB ID# E-mailed
Application –Review Level Determined
Notification of Review Level E-mailed
Review and Issue Decision
Contingencies
Denied
Approved
Full Board
Expedited
Exempt
Application –Reviewer Decision
Received
Notification of Reviewer Decision E-mailed
Approved or Denied?
ENDIRB Review Complete
Yes
Submit Revisions for Review
No
Application –Revisions Received
Review Revisions and Issue Decision
Contingencies
Denied
Approved
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What kind of timeline should I expect for be able to begin data collection?
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What are the responsibilities of the Lead Investigator?