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Institutional Review Board Training June 2002

Institutional Review Board Training June 2002. Human Subjects Protection. Arose from: Nazi War Experimentation Tuskeegee Syphilis Experiments Human Subjects Protection governed by: Nuremberg Code Title 45 CFR Part 46 The Belmont Report. Nuremberg Code.

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Institutional Review Board Training June 2002

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  1. Institutional Review Board TrainingJune 2002

  2. Human Subjects Protection • Arose from: • Nazi War Experimentation • Tuskeegee Syphilis Experiments • Human Subjects Protection governed by: • Nuremberg Code • Title 45 CFR Part 46 • The Belmont Report

  3. Nuremberg Code • Voluntary Consent/Option to Leave Study • Scientifically Relevant • Research Avoids Unnecessary Suffering • Degree of Risk Should be Reasonable • Designed to Protect Subjects from Injury • Implemented by Scientifically Qualified Investigators

  4. 45 CFR 46 • Regulation providing details on functions and responsibilities of IRBs that are reviewing federally funded research • Synergy Medical’s IRB will follow these regulations regardless of whether they are funded by a federal entity

  5. Belmont Report • Provides basic ethical principles for research: • Respect for Persons • Beneficence • Justice • Protocols must detail: • Informed Consent • Assessment of Risks/Benefits • Selection of Subjects

  6. Respect for Persons • Individuals should be treated as autonomous agents • Weigh subject’s opinions and choices while refraining from obstructing their actions • Persons with diminished autonomy are entitled to special protection • Infants, children, elderly, prisoners • Extent of protection depends on risk of harm

  7. Beneficence • Implies that efforts are made to secure a subjects well-being through two general rules: • Do Not Harm (Hippocratic Oath) • Maximize possible benefits and minimize possible harms

  8. Justice • The benefits and burdens of research should be equally distributed • No subject in an experiment should have a better or worse chance of potential benefits/risks from the research

  9. Protocol Review

  10. Informed Consent • Related to the ethical principle of Respect for Persons • Consent process must contain the following three elements: • Information • Comprehension • Voluntariness

  11. Assess Risks/Benefits • Related to the ethical principle of Beneficence • Investigators must properly design the research • Reviewers must determine whether any risks are properly justified • Prospective subjects will use this assessment to determine whether or not to participate

  12. Selection of Subjects • Related to the ethical principle of Justice • Provides fair procedures/outcomes in selection of subjects • Potentially beneficial research should not be offered to some favorable patients while selecting undesirable patients for risky research • Randomization

  13. Research covered by IRB • Research involving: • Administration of drugs/other substances • Pregnant women/fetuses • Life-threatening conditions • Physically intrusive procedures • A potential risk to subjects • A potential legal/civil risk

  14. Research Exempt from IRB Review • Risks of reasonably anticipated harms are not greater than those encountered in daily life • Research on the effectiveness of educational, classroom and/or instructional strategies • Research using educational tests (cognitive, diagnostic, aptitude) if subjects’ identities are protected

  15. Research Exempt from IRB Review (continued) • Research using survey or interview procedures where subjects’ identities are thoroughly protected and their answers do not subject them to criminal/civil liability

  16. Research Exempt from IRB Review (continued) • Research using the collection/study of existing data sources, documents, records, specimens or other products if these sources are publicly available or if the information is recorded by the investigator in such a manner that the subjects cannot be identified directly or indirectly

  17. Synergy Medical’s Review Procedure • Applications due 2 wks prior to meeting - NO EXCEPTIONS • Pre-review to check for completeness • IRB Review at monthly meeting • Continuing review

  18. Pre-Review • To be completed by IRB Chair: • Exempt/Expedited/Full Review • Student/residents must have faculty advisor • Informed Consent included • CV of Investigator included • Data Collection sheet included • Detailed protocol included

  19. IRB Review • Scientific Review • Risk Assessment • Subject Selection • Additional Safeguards • Informed Consent • Subject Safety • Subject Privacy/Confidentiality

  20. Scientific Review • Not the primary function of an IRB • Level of Scientific Review • Retrospective chart review - descriptive study • No chance of contact with human subjects • Does not require strict scientific review • Federally funded research • Assumes that funding body reviews for science • Prospective/Experimental Designs • Will require more stringent scientific review

  21. Scientific Review (continued) • Review Evaluates: • Hypothesis(es) • Study design can prove the hypothesis(es) • Contributes to general medical knowledge • Worth exposing subjects to risk

  22. Risk Assessment • Level of Risk • Minimal/More than Minimal • Level of Risk as Identified by Investigator • Prospect of Direct Benefit to Subjects • Requires a subjective decision by the IRB about an acceptable level of risk • Influenced by personal morals and experience

  23. Subject Selection • Requires an evaluation of: • Who the potential subjects are • A clear rationale for inclusion/exclusion of subjects • The subjects are appropriate for the proposed protocol

  24. Additional Safeguards • Must make the determination of whether there are additional safeguards that are necessary for the proposed research to adequately protect human subjects • Must be described in the protocol

  25. Informed Consent • Informed consent is not just a document • Informed consent is a process • Must be obtained from subjects or from a legally authorized representative of the subject • Understandable to subjects in content/language

  26. Informed Consent (continued) • Gives subject ample opportunity to consider whether or not to participate • Must detail who will provide informed consent • Must provide details on where consent will be obtained • Waiver of consent

  27. Subject Safety • Determine if research design minimizes risk to subjects • Project requires use of safety board or other oversight to enhance subject safety

  28. Privacy/Confidentiality • Personally identifiable research data is protected from access or use • Privacy considerations

  29. Continuing Review • Annual review of all approved projects is required • Updates are required if protocols change • All changes must go through this IRB

  30. Documentation of Training for IRB Members • Sign-in Sheet for Training Session • NIH Office of Human Subjects • Internet Based Training Session • Issues Certificate of Completion • One Hour for Completion • Provide Certificate to SCHI IRB • http://ohsr.od.nih.gov/irb_cbt/#

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