IRB BASICS: Ethics and Human Subject Protections

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IRB BASICS: Ethics and Human Subject Protections. The Committees on Human Research University of Vermont & Fletcher Allen Health Care. IRB Function. - PowerPoint PPT Presentation

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<ul><li><p>IRB BASICS: Ethics and Human Subject ProtectionsThe Committees on Human Research University of Vermont &amp; Fletcher Allen Health Care09-23-11*</p></li><li><p>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.</p><p>There are two IRBs at the University of Vermont, one designated for the behavioral sciences and one for the medical sciences. These cover activities by both UVM and FAHC researchers.IRB Function09-23-11*</p></li><li><p>Why Do Human Research Subjects Need Protection?</p><p>Trigger EventsEthical Milestones</p><p>The Nazi ExperimentsNuremberg Code 1947Tuskegee Syphilis Study National Commission for the Protection of Human Subjects of Biomedical &amp; Behavioral Research 1974</p><p>* Belmont Report 1978* Common Rule 199109-23-11*</p></li><li><p>The principles of the Belmont Report govern all research supported by the U.S. Government. The ethical principles outlined in the report are the basis for subsequent regulations designed to ensure protection of human subjects in research.The Belmont Report09-23-11*</p></li><li><p> Respect for Persons</p><p> Beneficence</p><p> JusticeThe Basic Principles of the Belmont Report09-23-11*</p></li><li><p>Respect for Persons</p><p>Treat individuals as autonomous agents</p><p>Do not use people as a means to an end</p><p>Allow people to choose for themselves</p><p>Provide extra protections to those with diminished autonomy (i.e., Prisoners, Children, Cognitively Impaired, etc.)09-23-11*</p></li><li><p>Beneficence</p><p>The two general rules formulated from the principle of beneficence are:</p><p>First, do no harm</p><p>Second, maximize possible benefits and minimize risks09-23-11*</p></li><li><p>Justice</p><p>Treat people fairlyFair sharing of burdens and benefits of the research</p><p>An injustice occurs when:benefits to which a person is entitled are denied without good reason, orwhen burdens are imposed unduly.</p><p>09-23-11*</p></li><li><p>Rules Derived RespectInformed Consent ProcessRespect for PrivacyBeneficenceGood research designCompetent investigators/researchersFavorable risk-benefit analysisJusticeEquitable selections of subjects09-23-11*</p></li><li><p>The Common Rule is the set of regulations which were developed to ensure compliance with the principles of the Belmont Report. The regulations fall under the Department of Health and Human Services. These regulations have been adopted by many other federal departments which regulate human research. There are many other regulations with which UVM/FAHC are required to comply, such as the Food and Drug Administration, but these are all in addition to the Common Rule.The Common Rule09-23-11*</p></li><li><p>Institutional assurances of complianceReview of research by an IRBInformed consent of subjectsProtective mechanisms established by The Common Rule09-23-11*</p></li><li><p> UVM and FAHC have negotiated with the Office for Human Research Protections that all of the institutions human subject research activities, regardless of funding, will be guided by the Belmont Report, will comply with the Common Rule, and other regulations as applicable.</p><p>This is referred to as a Federalwide Assurance (FWA).Institutional Assurance09-23-11*</p></li><li><p>IRB Review of Research All research projects are categorized into one of three categories for the IRB review process. Each category is different in the level of scrutiny and submission procedures. The IRB is responsible for making the final decision of which category a research project falls under.</p><p>FullExpeditedExemptResearch Not Involving Human Subjects09-23-11*</p></li><li><p>Full ReviewOne or more Committee member(s) are assigned to review the complete protocol or amendment, consent form, Investigational Drug/Device Brochure and any other protocol materials. These Primary &amp; Secondary Reviewers summarize the protocol or amendment to the Full Committee at a convened meeting and answer questions during the discussion. All other committee members are provided with summary information, for example the Protocol Cover Form and informed consent document. This stresses the importance of the accuracy and details provided in these documents, since the majority of voting members only see these 2 documents!09-23-11*</p></li><li><p>Expedited ReviewProtocols, amendments, or continuing reviews that meet specific federal criteria qualify for an expedited review. The complete protocol, consent form, and any other protocol materials receive review and approval by a Committee Chair.Expedited does not mean fast it is a federal term used for research that must meet specific criteria (DHHS 45 CFR 46.110)09-23-11*</p></li><li><p>Exempt from IRB ReviewCommittee review is not required for certain categories of research activities that involve little or no risk to human subjects. To determine if your research qualifies for exemption from formal committee review, complete the Protocol Exemption Review and Determination Checklist. Only the IRB can make the determination of Exempt, this cannot be determined by researchers!09-23-11*</p></li><li><p> IRB Review and Determination of Research Not Involving Human SubjectsThere is some research that involves coded private information or specimens that do not involve human subjects.When conducting research using data or specimens, the level of review by the IRB depends primarily on one factor: whether the data or specimens are identifiable to the principal investigator or key personnel.Determinations of whether research involving coded private information or biological specimens is considered to be human subjects research must be made by the IRB, not the investigator.09-23-11*</p></li><li><p>Types of ReviewInitialContinuing ReviewAmendmentsSafety Information or Unanticipated Problems to Subjects or OthersNoncompliance09-23-11*</p></li><li><p>Criteria for IRB Approval</p><p>Risks are Minimized (Consistent with a sound research design and does not unnecessarily expose subjects to risk)Risks are Reasonable in Relation to BenefitsSelection of Subjects is EquitableInformed Consent will be Sought for Each Prospective SubjectInformed Consent will Be DocumentedResearch Plan Adequately Provides for Monitoring the Data Collected to Ensure Safety of the SubjectsResearch Plan Adequately Protects the Privacy of Subjects and Maintains ConfidentialityWhen 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.09-23-11*</p></li><li><p>The IRB has the authority to:ApproveRequire modifications prior to approvalTableDisapprove all research activities including proposed changes in previously approved human subject research.</p><p>09-23-11*</p></li><li><p>Information includes research procedure, purpose, risks, benefits, alternatives, etc.Comprehension function of intelligence, rationality, maturity and language, presentation of information must be adapted to the subjects capacityVoluntariness requires conditions free of coercion and undue influenceInformed Consent09-23-11*</p></li><li><p>Consent Form Required ElementsStatement that the study involves researchResearch is describedDescription of RisksDescription of BenefitsDisclosure of Alternatives ConfidentialityIf more than minimal risk, compensation and/or medical treatmentParticipation is voluntaryWhom to Contact 09-23-11*</p></li><li><p>Additional Elements of Informed ConsentUnforeseeable risksEarly termination Additional costs to subjectsConsequences of a subject's decision to withdraw from study participationDisclosing new findings which may impact a subject's willingness to continue participation Number of subjects involved09-23-11*</p></li><li><p>Informed Consent ProcessInformed Consent is more than just the IRB-approved document</p><p>Initial </p><p>Ongoing09-23-11*</p></li><li><p>Initial Informed ConsentTake the time at the initial discussion with subjects so that they have a thorough understanding of what they are making a commitment towardsTest subject comprehensionResearch versus standard of care proceduresTime commitmentRandomizationAlternativesPotential costsRisks and BenefitsTaking time upfront with potential subjects most likely will improve subject understanding and improve retention09-23-11*</p></li><li><p>Ongoing ConsentEvery time you have an encounter with a subject gives researchers an opportunity to continue the informed consent processDiscuss new information that may impact a subjects willingness to continue study participation (i.e., new known risks, benefits, alternatives, changes in study design, etc.)Remind subject of study goals and objectives this will improve subject compliance with the protocol and improve retention of subjects</p><p>09-23-11*</p></li><li><p>InformationUniversity of Vermont Research Protections office213 Waterman Building 85 South Prospect StreetBurlington, Vermont 05405(802)656-5040www.uvm.edu/irbIRB Review Process09-23-11*</p><p>*__________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________*__________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________*Mostly Nazi 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