Institutional review board training june 2002
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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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Institutional Review Board Training June 2002

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Institutional review board training june 2002

Institutional Review Board TrainingJune 2002


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


Beneficence

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


Justice

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


Protocol review

Protocol Review


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

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

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

    • http://ohsr.od.nih.gov/irb_cbt/#


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