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  • Human Subjects Protection Committee

    at Cal Poly Pomona

    The Institutional Review BoardBruce W. Kennedy, MS RLATG CMARCompliance AssociateIRB AdministratorOffice of Research and Graduate StudiesSeptember 21, 2007

  • - AgendaPurpose of the IRBDevelopment of Research EthicsScope of AuthorityRegulations re Human Subjects ReviewElements of Informed ConsentForms and ProceduresHuman Subjects Training and EducationWrap-up Basics of the IRB

  • - PurposeProtect the welfare of human research subjects (or participants).Assure compliance with both federal law and ethical standards for the conduct of human subjects research.Review protocolsEstablish policy for the campusa medical school IRB would be different than a program of behavioral sciencesRespond to non-compliance Basics of the IRB

  • - PurposeThe Cal Poly Pomona IRBThe committeefaculty representing various disciplinesoutside, unaffiliated membersadministratorMeets once per month generallyChair is Dr. David Adams, a professor of philosophy and ethics

    Basics of the IRB

  • Respect for PersonsVoluntary participationInformed consentPrivacy and confidentiality- the IRB PrinciplesBeneficenceJusticeRisks must be justified by benefits to the research subject or to the community.Risks must be minimized.Data gathering must be monitored to ensure safety of subjects.

    Subjects must be selected equitably.Avoid exploitation of vulnerable groups or populations of convenience.Those likely to benefit are not systematically excluded.

    Basics of the IRB

  • - Development of Research EthicsMilestones:1940s - Nuremberg Code 1950s-60s - Controversial studies1964 - Declaration of Helsinki1970s - Common Rule1970s - Belmont Report1990s - 2000s - IRBs and protections

    Basics of the IRB

  • - Research EthicsNuremberg Code At the end of World War II, 23 Nazi doctors and scientists were put on trial for the murder of concentration camp inmates who were used as research subjects. That led to: Informed consent is essential.Risks must be justified by anticipated benefits.Research must be conducted by qualified researchers.Physical and mental suffering must be minimized.

    Basics of the IRB

  • - Research EthicsControversial studies, examples, historical perspectiveMilgram study, 60sThe purpose of this study was to determine response to authority in normal humans. The researchers told recruited volunteers that the purpose was to study learning and memory. Each subject was told to teach a "student" and to punish the students' errors by administering increasing levels of electric shocks. The "student" was a confederate of the researcher who pretended to be a poor learner and mimicked pain and even unconsciousness as the subject increased the levels of electric shock. 63% of the subjects administered lethal shocks; some even after the "student" claimed to have heart disease. Some of the subjects, after being "debriefed" from the study experienced serious emotional crises. Basics of the IRB

  • - Research EthicsControversial studies, examplesTuskegee syphilis study, 1932-1971Initiated by the Public Health Service, this study was designed to document the natural history of syphilis in African-American men.

    Basics of the IRB

    Willowbrook study, 1956In 1956, at an institution for mentally retarded children in Staten Island, New York, a study was initiated to determine the natural history of viral hepatitis and to test the effectiveness of gamma globulin as an agent for inoculating against hepatitis. Children were deliberately infected with a mild form of hepatitis.

  • - Research EthicsDeclaration of Helsinki ...The World Medical Association has developed the Declaration of Helsinki as a statement of ethical principles to provide guidance to physicians and other participants in medical research involving human subjects. Medical research involving human subjects includes research on identifiable human material or identifiable data.Medical progress is based on research which ultimately must rest in part on experimentation involving human subjects. In the field of biomedical research a fundamental distinction must be recognized between medical research in which the aim is essentially diagnostic or therapeutic for a patient, and medical research the essential object of which is purely scientific and without implying direct diagnostic or therapeutic value to the person subjected to the research. Biomedical research involving human subjects must conform to generally accepted scientific principles and should be based on adequately performed laboratory and animal experimentation and on a thorough knowledge of the scientific literature. Basics of the IRB

  • - Research EthicsCommon Rule ...The National Research Act was passed in 1974 which established:a national commission for the Protection of Human Subjects of Biomedical and Behavioral Research.the requirement for establishment of IRBs at institutions receiving federal monies.the various regulatory standards known collectively as the Common Rule.effective since 1991adopted by 19 federal agenciesbased upon subpart A 45 CFR 46this, a set of basic regulatory standards Basics of the IRB

  • - Research EthicsBelmont Report ...published in 1979included the Belmont Principlesrespect for personsbeneficence andjustice

    Basics of the IRB

  • - Research EthicsRisks ...Evaluated according to the probability and magnitude of any harm that might occur Will the risk occur in almost all subjects or in only one of 10,000 subjects? Quantify risk according to the magnitude of harmminor itchinesscould some subjects die? social, legal, economic, or psychological risksrisks may apply to the individual subject or may apply to a broader segment of the society.

    Basics of the IRB

  • - Scope of AuthorityAny research undertaken at Cal Poly Pomona, or involving Cal Poly faculty, staff, or students either as investigators or subjects. Basics of the IRB

  • - RegulationsCode of Federal Regulations Title 21, CFR Part 50 and CFR Part 56Food and Drug Administration (FDA)Focused on clinical, medical, therapeutic studiesTitle 45, Public welfare, CFR Part 46 (45 CFR 46)Department of Health and Human Services (DHHS)Protection of human subjects in generalMiscellaneous others at the federal, state, and institutional levels Basics of the IRB

    DHHShas these componentsFDANIHOHRPand the research is overseen by theIRB

  • - RegulationsDefinition of subject A human subject is a living individual about whom an investigator (whether professional or student) conducting research obtains: (a) data through intervention or interaction with the individual or (b) identifiable private information.Vulnerable subjectsprisoners, children, pregnant women, fetus, medically-afflicted, plus others Basics of the IRB

  • - RegulationsDefinition of research ...Covered research is any systematic investigation including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Basics of the IRB

  • - RegulationsIs it research? ...Collecting data for the purpose of publication, professional presentation at a conference or seminar, dissemination to colleagues on the Internet, or inclusion in a dissertation does count as research.For teachers, gathering data from students to: (a) improve your teaching, (b) assess your course or program, or (c) collect student input for employment actions does not constitute research. Basics of the IRB

  • - RegulationsAre you doing research? Assess your role ...Conducting typical research as a principal investigator, abbreviated as PI.student, graduate student, clinician, investigatorActing in the capacity of a teacher with the intention of assisting your students to learn.Acting in the capacity of a researcher with the intention of studying the process of teaching and learning. Publication of results is not a necessary condition. Basics of the IRB

  • - RegulationsWhat are data?ExamplesSurvey sheets and questionnaires, biological samples, audio and video tapes, transcripts of verbal communication, photographs, paper and electronic records, and moreExisting (archived) data or samplesObservation of public behaviorCollection of new data though human interventionPrivacy and de-identificationStorage and retentionProtectedMedical records and HIPAAConfidential vs. anonymous collectionDefinitionsCan the collected data be traced back?Can the data identify one or more persons? Basics of the IRB

  • - RegulationsMeans of protocol review ...ExemptResearch using existing data or samples.Observation of public behavior.Research involving surveys or questionnaires where no personally identifying information is gathered or retained.Eligibility for exemption must be determined by the IRB, not the investigator.ExpeditedPoses no more than minimal risk to the subject, i.e., no more than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests." Approvable by review of two members of the Board.Doesnt necessarily mean quick or fast review.Full boardResearch that is neither exempt nor expeditable must receive review by the full committee.Means a convened meeting of the IRB for face-to-face discussion. Basics of the IRB

  • - Informed consentElements of informed consent include Explanation of the purpose(s) of the research.Description of the procedure(s) to be followed.Summary of the data to be collected.Description of any foreseeable risks or discomforts to the subject.Description of the benefits to the subject or to others, including compensation. Explanation of how the investigator (PI) will maintain confidentiality of records. Contact information of all PIs.A