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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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human subjects protection
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
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
45 cfr 46
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
belmont report
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
respect for persons
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
  • 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
  • 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
informed consent
Informed Consent
  • Related to the ethical principle of Respect for Persons
  • Consent process must contain the following three elements:
    • Information
    • Comprehension
    • Voluntariness
assess risks benefits
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
selection of subjects
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
research covered by irb
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
research exempt from irb review
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
research exempt from irb review continued
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
research exempt from irb review continued1
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
synergy medical s review procedure
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
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
irb review
IRB Review
  • Scientific Review
  • Risk Assessment
  • Subject Selection
  • Additional Safeguards
  • Informed Consent
  • Subject Safety
  • Subject Privacy/Confidentiality
scientific review
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
scientific review continued
Scientific Review (continued)
  • Review Evaluates:
    • Hypothesis(es)
    • Study design can prove the hypothesis(es)
    • Contributes to general medical knowledge
    • Worth exposing subjects to risk
risk assessment
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
subject selection
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
additional safeguards
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
informed consent1
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
informed consent continued
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
subject safety
Subject Safety
  • Determine if research design minimizes risk to subjects
  • Project requires use of safety board or other oversight to enhance subject safety
privacy confidentiality
  • Personally identifiable research data is protected from access or use
  • Privacy considerations
continuing review
Continuing Review
  • Annual review of all approved projects is required
  • Updates are required if protocols change
  • All changes must go through this IRB
documentation of training for irb members
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