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IRB BASICS

IRB BASICS. Research Support Services Human Subjects Protection Program University of Memphis. 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. The Belmont Report.

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IRB BASICS

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  1. IRB BASICS Research Support ServicesHuman Subjects Protection Program University of Memphis

  2. 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.

  3. The Belmont Report

  4. The Basic Principles of the Belmont Report Respect for Persons Beneficence Justice

  5. Rules Applied • Respect • Informed Consent Process • Respect for Privacy • Beneficence • Good research design • Competent investigators/researchers • Favorable risk-benefit analysis • Justice • Equitable selections of subjects

  6. IRB Review of Research Categories • Full • Expedited • Exempt • Research Not Involving Human Subjects

  7. Decision Charts: http://www.hhs.gov/ohrp/policy/checklists/decisioncharts.html

  8. Types of Review • Initial Review • Continuing Review • Modifications • Adverse Events or Unanticipated Problems • Noncompliance • Determination

  9. Criteria for IRB Approval • 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.

  10. The IRB has the authority to: • Approve • Require modifications prior to approval • Table • Disapprove • Suspend • Terminate

  11. Informed Consent • Information • Comprehension • Voluntariness

  12. www.memphis.edu/IRB Administration Building 315 (901) 678-2705

  13. Social & Behavioral Research Course

  14. Biomedical Research

  15. What happens to my protocol once it is submitted to the IRB?

  16. IRB Administration Principle Investigator IRB Reviewers START Submit Application Application Received Review and Issue Decision Application – Screened for Completion Receipt of Submission E-mailed Approved Contingencies Denied Application – IRB ID# Assigned IRB ID# E-mailed Review Revisions and Issue Decision Application – Review Level Determined Notification of Review Level E-mailed Approved Contingencies Notification of Reviewer Decision E-mailed Exempt Full Board Denied Approved or Denied? Expedited END IRB Review Complete Yes No Application – Reviewer Decision Received Submit Revisions for Review Application – Revisions Received

  17. What kind of timeline should I expect for be able to begin data collection?

  18. What are the responsibilities of the Lead Investigator?

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