Presentation on theme: "The Institutional Review Board"— Presentation transcript:
1 The Institutional Review Board M. Jeffery Mador, M.D.Chair-Buffalo VAMC IRBAssociate Professor of Medicine
2 Outline What is an IRB? How does the IRB impact your research HIPAA Why does it existWhat do we doHow does the IRB impact your researchHIPAAShould it affect research? (no)What you need to know about its impact on your research
3 What is an Institutional Review Board? An administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activitiesIndependent of other committees and independent of the needs of the institutionResearch involving human subjects (or their records) must be reviewed by an IRB
4 Why do IRBs exist? Historical context Nuremburg trials Atrocious trials done in the name of scienceTuskegee syphilis trialstudy designed to look at the natural history of untreated syphilisWillowbrook Hepatitis studyRetarded children were deliberately fed a solution including the feces of children with hepatitis
5 Rules governing IRB activity After the Tuskegee studies were reported in The NY Times and The Washington Post, Congress actedNational Research Act of 1974Established IRBsCode of Federal regulations contains broad outlines of what an IRB should doNew rules are written, generally in response to bad events, such as those occurring in
6 Major research problems occurred between 1999-2001 Death of a research participant in a gene therapy trial at the University of PennsylvaniaFirst suit against a University for clinical researchDeath of a normal volunteer At JHHClosed research activities at the Medical School with the largest federal research budgetInvestigations of ‘research misconduct’ closed research at 10 major research universitiesThe approved informed consent for a study involving subjects with melanoma contained mis-informationFirst suit against members of an IRB
7 Death of a normal subject at Johns Hopkins An investigator was studying the physiology of asthma and reactive airwaysHe asked normal volunteers to inhale a drug formerly used for ↑BP, but taken off the market when better drugs were availableHe made the drug in his lab, and didn’t include that information in the protocolHe was unaware that the drug had been associated with rare pulmonary problemsThe subject, a regular volunteer in research studies, developed respiratory distress about 24 hours post participation and died
8 Problems discovered with IRB activities Insufficient project review by the IRBsCasual review of research projectsLack of attention to regulationsLack of knowledge about research regulations by those doing researchFinancial conflicts of interest by those doing research
9 IRB changes since 2001Requirement for each researcher to complete an educational programAvailable on the webIncreased educational requirements for IRB membersPotential for audits by the Office of Human Research ProtectionHIPAA rules
10 Types of IRB Review Full review Expedited ‘Exempt’ More than minimal riskRequires review and approval (by vote) of a full IRB committeeExpeditedNo more than minimal riskApproved by IRB chair and designated representativesUsually approved relatively rapidly‘Exempt’
11 Continuing reviewAll studies are re-reviewed at least yearly (except for those that are exempt)The IRB sends a reminderInformation desiredNumber enrolledProblems encounteredIs the study still appropriate (literature review)If the investigator does not respond to our reminder, the study will be suspended and may be closed
12 Categories of expedited review Clinical studies on drugs and devices as long as the study does not increase the riskBlood tests, within limitsFrom healthy adults >110 poundsThe amount drawn may not exceed 550 mls over an 8 week period and less than 2Xs/weekDifferent rules for childrenBiologic specimens collected by non-invasive means (scaling of teeth, nail clippings, sputum etc.)
13 Categories of Expedited Review (2) Collection of data through non-invasive procedures routinely employed in clinical practice (excludes x-ray and microwaves)Study of materials collected for non-research purposesMedical record information (confidentiality important)Collection of data by voice recordings, etc.IRB must assure that confidentiality is assured
14 Some studies are exempt from IRB continuing review Exempt studies are reviewed by the IRB chair, designated as exempt and a letter is sent indicating that and the applicable federal RegulationExempt studies do not require continuing reviewSix exempt categoriesSurveys, publicly available tissues or samples, food evaluations, educational testsNote that any study done in minors, prisoners or other special populations cannot be exempt
15 How should this be reviewed? The PI is a physical therapist who wants to investigate the effect of a controlled exercise program on osteoarthritis of the kneeEligible subjects have osteoarthritis and will be randomized to their usual activities or a program which requires supervised exercise 3 Xs/ weekAll subjects have permission from their MD to participate. All will have an x-ray of their knee as part of the study and will answer weekly questionnaires about quality of lifeCan this be expedited?
16 How should this study be reviewed? A dentist is interested in why students chose to have oral piercingsHe develops a survey in which high school students will be asked a variety of questions incl.Do you have any oral piercings?Have you ever considered having one?Did you have any hesitation about a piercing. If so, what were your concerns?The survey is anonymous, without an ICWhat kind of review should this be?
17 What happens to full review projects? The full protocol is reviewed by two IRB membersThe primary reviewer generally has knowledge of the subject (if not available on the committee, an outside reviewer is used)These reviewers must not have a personal interest in the studyThe abstract and informed consent are sent to all other membersEach reviewer completes an evaluation form which the IRB keeps as part of the file
18 What do we review? Research design The informed consent Are the objectives clear with sufficient background information to justify the study?Is there a reasonable statistical plan?Does it require more subjects than can reasonably be enrolledAre risks minimized and reasonable in relationship to any potential benefitThe informed consentHIPAA requirements
19 What should be in the IC? Clear indication that this is research Description of what will be doneDescription of risks and benefitsIndicate that participation is ‘voluntary’alternatives to participation and what these are?A statement about compensation for potential injury is needed.Usually the statement says that there is no compensation (UB policy)
20 When is an informed consent needed? Any direct interventionAny study requiring a review by the Full IRB committeeAny project in which the risk is greater than that occurring in an ‘ordinary’ dayWhat about chart reviews?That becomes a HIPAA issueAUTHORIZATION VS. WAIVER
21 IRB decisions Full approval Approval pending minor changes Tabled Most commonTabledMajor questions have been raised about the study design, but the study is believed to be worthwhileDisapproved (rare)
22 Other IRB communication Once approved, the study must be done as describedChanges to the study or to the informed consent need to be approved by the IRBAds must be approvedDeviations from the proposal need to be sent to the IRB
23 Interventions in “normal” subjects What does the IRB think about?What is the risk?Is the risk reasonable, since there is no benefit to the subject?The benefit is to the researcher who plans to publish the studySince there is risk and no benefit, many studies offer compensation.But what distinguishes re-imbursement from inducement?
24 Is this study likely to be approved? The investigator is interested in the breathing mechanics of ‘deep sea’ diversSubjects who dive without breathing apparatus can go to great depths and apparently survive low oxygen tensionSubjects, competitive deep sea divers, will be asked to wear monitors of oxygen tension, cardiac monitors and do their usual diveThere is no benefit to the diver, only to science, and the dive is associated with some riskThere are deaths associated with this competitive diving
25 HIPAA – Health Insurance Portability and Accountability The law was written to protect individuals from losing insurance with a job changeCongress was supposed to define and establish guidelines for medical privacy but didn’t get around to itThus the law was written by the Department of Health and Human ServicesClearly it has far reaching effects, particularly in research
26 HIPAA authorizationResearchers can create PHI, access and receive PHI by reviewing recordsIf this is being done prospectively, the patient must authorize the release of informationThe authorization may be included in the whole informed consent or be a separate document
27 Waivers Retrospective medical record review If possible, signatures from the involved individuals are neededThis is impossible in many casesSubject has died or has movedA waiver allows you to access that information, providing thatThere is a plan to protect the informationIt is coded or somehow securedStatement that the research cannot be done without it
28 De-identified dataData that is de-identified, according to 18 identifiers, is not subject to HIPAA rulesBut the investigator must get the data when it has been de-identifiedRemoving identifiers and storing data under a secure code doesn’t fulfill the letter of the law
29 ConclusionInstitutional Review Boards exist to protect participants in researchIRBs also protect researchersSecond opinion about research qualityIs the question worth asking?Is the study being done in the safest way?Can the question be answered?Can it be statistically justified?HIPAA concerns are so far manageable, although an added burden for many
30 Questions Health sciences IRB 150 Parker Hall Phone 829-2752 Contact: Darlene CampanellaWebsite:Buffalo VAMC_Phone:
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