Presentation on theme: "IRB BASICS: Ethics and Human Subject Protections"— Presentation transcript:
1 IRB BASICS: Ethics and Human Subject Protections __________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________The Committees on Human ResearchUniversity of Vermont & Fletcher Allen Health Care
2 IRB FunctionThe purpose of an IRB is to review research and to ensure the rights and welfare of human subjects involved in research are adequately protected.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.__________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________
3 Why Do Human Research Subjects Need Protection? Trigger Events Ethical MilestonesThe Nazi Experiments Nuremberg Code 1947Tuskegee Syphilis Study National Commission for the Protection of Human Subjects of Biomedical & Behavioral Research 1974* Belmont Report* Common RuleMostly Nazi Experiments
4 The Belmont ReportThe 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.__________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________
5 The Basic Principles of the Belmont Report Respect for PersonsBeneficenceJustice__________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________
6 Respect for Persons Treat individuals as autonomous agents Do not use people as a means to an endAllow people to choose for themselvesProvide extra protections to those with diminished autonomy (i.e., Prisoners, Children, Cognitively Impaired, etc.)
7 Beneficence First, do no harm The two general rules formulated from the principle of beneficence are:First, do no harmSecond, maximize possible benefits and minimize risks
8 Justice Treat people fairly Fair sharing of burdens and benefits of the researchAn injustice occurs when:benefits to which a person is entitled are denied without good reason, orwhen burdens are imposed unduly.
9 Rules Derived Respect Beneficence Justice Informed Consent Process Respect for PrivacyBeneficenceGood research designCompetent investigators/researchersFavorable risk-benefit analysisJusticeEquitable selections of subjects
10 The Common RuleThe “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”.__________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________
11 Protective mechanisms established by The Common Rule Institutional assurances of complianceReview of research by an IRBInformed consent of subjects__________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________
12 Federalwide Assurance (FWA). Institutional AssuranceUVM and FAHC have negotiated with the Office for Human Research Protections that all of the institution’s 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.This is referred to as aFederalwide Assurance (FWA).__________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________
13 IRB Review of Research Full Expedited Exempt 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.FullExpeditedExemptResearch Not Involving Human Subjects
14 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 & 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!
15 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 )
16 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!
17 IRB Review and Determination of “Research Not Involving Human Subjects” There 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.
18 Types of Review Initial Continuing Review Amendments Safety Information or Unanticipated Problems to Subjects or OthersNoncompliance
19 Criteria for IRB Approval 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.
20 The IRB has the authority to: ApproveRequire modifications prior to approvalTable__________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________Disapprove all research activities including proposed changes in previously approved human subject research.
21 Informed ConsentInformation – includes research procedure, purpose, risks, benefits, alternatives, etc.Comprehension – function of intelligence, rationality, maturity and language, presentation of information must be adapted to the subject’s capacityVoluntariness –requires conditions free of coercion and undue influence__________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________
22 Consent Form Required Elements Statement that the study involves researchResearch is describedDescription of RisksDescription of BenefitsDisclosure of AlternativesConfidentialityIf more than minimal risk, compensation and/or medical treatmentParticipation is voluntaryWhom to Contact
23 Additional Elements of Informed Consent Unforeseeable risksEarly terminationAdditional costs to subjectsConsequences of a subject's decision to withdraw from study participationDisclosing new findings which may impact a subject's willingness to continue participationNumber of subjects involved
24 Informed Consent Process Informed Consent is more than just the IRB-approved documentInitialOngoing
25 Initial Informed Consent Take 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 retention
26 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 subject’s 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
27 Research Protections office Information__________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________IRB Review ProcessUniversity of VermontResearch Protections office213 Waterman Building85 South Prospect StreetBurlington, Vermont 05405(802)