irb review, human subjects research & oral history: legal & ethical responsibilities museology 588

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Discussion with: Sharon Smith Elsayed, Asst. Dir. for Education & Communication. IRB Review, Human Subjects Research & Oral History: Legal & Ethical Responsibilities Museology 588 10-17-08. Session Goals. Clarify the role and authority of the Institutional Review Board (IRB) - PowerPoint PPT Presentation

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  • IRB Review, Human Subjects Research & Oral History: Legal & Ethical Responsibilities

    Museology 58810-17-08Discussion with:Sharon Smith Elsayed, Asst. Dir. for Education & Communication

    Museology 10-17-08

    Session GoalsClarify the role and authority of the Institutional Review Board (IRB)Provide a brief historical context for the current review process, compliance issues, and the context for review of research using oral history interviewing.Explain basic regulatory requirements regarding human subjects research.Explain the IRB application forms, process, and changes underway.Address some of the critical elements of human subjects research and review, (i.e., risks and benefits, consent forms and process, problems that occur, confidentiality of data, etc.)Identify both IRB and researcher responsibilities.

    Museology 10-17-08

    Museology 10-17-08

    Institutional Review Board (IRB)What (and who) is the IRB?IRBs at the UW partner with researchers to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the University of Washington.The IRB has the authority to approve,require modifications in, ordisapprove all research activities that fall within itsjurisdiction as specified by federal regulations,state law, and institutional policy.

    Museology 10-17-08

    Institutional Review Board (IRB)Membership must meet federal (and UW) requirements:FR 5 members (3 = quorum) UW 9 members (5 = quorum)1 Scientist1 Non-affiliated/community member1 Non-scientist (must be present for meeting to occur)Members with sufficient and appropriate expertise to review the research that comes before the Committee.

    Museology 10-17-08

    IRBs at (or affiliated with) the UWUW IRBs (http://www.washington.edu/research/hsd) Biomedical Committees: A, B, DSocial/Behavioral Committees: C, G, JVeterans Administration IRBs: VA & V2 (Biomedical & Social/Behavioral Committees)Subcommittees (Minimal Risk Review): E/A, E/B, E/C, E/J

    Western IRB (WIRB) (http://www.washington.edu/research/hsd/policy_wirb.php) Reviews sponsored clinical trials.

    Cancer Consortium IRB (CC-IRB) (http://www.cancerconsortium.org/irb) Reviews cancer research from consortium members.

    Cooperative Agreements Affiliated Institutions(http://www.washington.edu/research/hsd/coopag.php)

    Museology 10-17-08

    Institutional Review Board (IRB)What do the IRB committees look for?Risk of harm versus potential benefits of study (includes evaluation of study design / scientific merit when risk-benefit evaluation is problematic)Protections of subject privacy and confidentiality (primarily within recruitment and data management)Consent processWhy?

    Museology 10-17-08

    Pre-WWIIEdward Jenner (1789)Smallpox Vaccine

    Claude Bernard (1865)Ethical Maxims

    Louis Pasteur (1885)Rabies Vaccine

    Walter Reed (1900)Yellow Fever

    Museology 10-17-08

    Lessons from Biomedical ResearchNazi War Crimes - WWIIWillowbrook 1950sJewish Chronic Disease Hosp. 1960sTuskegee Syphilis Study 1932-1972Jesse Gelsinger 1999Ellen Roche 2001

    Museology 10-17-08

    Vidich & Bensman (1958)Small Town in Mass Society: Class, Power and Religion in a Rural Community.

    Milgram (1963)Behavioral study of obedience.

    Humphreys (1970)Tearoom Trade:Impersonal Sex in Public Places.

    Zimbardo (1971)Stanford Prison ExperimentFoulks (1979)Alcoholism in Barrow, AlaskaBehavioral Research (just as culpable)

    Museology 10-17-08

    The Belmont ReportEthical Principles and Guidelinesfor theProtection of Human Subjects of Research

    The National Commission for the Protection ofHuman Subjects of Biomedical and Behavioral ResearchApril 18, 1979

    Museology 10-17-08

    The Belmont ReportBasic Ethical Principles:Respect for PersonsIndividual autonomyProtection of individuals with reduced autonomyBeneficenceMaximize benefits and minimize harmsJustice Equitable distribution of research costs and benefits

    Museology 10-17-08

    Application of the DHHS Regulations [45 CFR 46]to Oral History Interviewing (2003)Most oral history interviewing projects are not subject to the requirements of the Department of Health and Human Services (HHS) regulations for the protection of human subjects at 45 CFR part 46, subpart A, and can be excluded from institutional review board (IRB) oversight because they do not involve research as defined by HHS regulations.. . .It is primarily on the grounds that oral history interviews, in general, are not designed to contribute to generalizable knowledge that they are not subject to the requirements of the HHS regulations at 45 CFR part 46 and, therefore, can be excluded from IRB review.

    Museology 10-17-08

    Guidance on Oral History Interviews"Oral History" is a general name for projects intending to elicit personal information from individuals. Similar to interviews, questionnaires or surveys, the oral history method may, or may not require IRB review.. . .

    IRBs are charged with reviewing research with human subjects. Since both research and human subjects have a technical meaning in the context of the Federal regulations (specifically 45 CFR 46) that mandate IRB review, it is not always clear whether specific activities are covered by the regulations.

    Museology 10-17-08

    So defining what is research is pretty straightforward, isnt it?Are you doing research?A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

    Are you doing research with humans?A living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or 2) identifiable private information.

    . . . and what difference does this make in what we do?

    Museology 10-17-08

    Are we clear on what oral history interviewingwould need IRB review and what would not?Give me some examplesorAsk questions about some ideas.

    Museology 10-17-08

    When are oral history interviews defined as research?When they are systematic meaning that the project is structured to generate consistent and reliable information. Obtaining information collected in an unsystematic way is not designed to yield information that is representative. Rather, the results are most likely idiosyncratic, so that the results do not differentiate between the general and particular.When the intent of the activity is to generate generalizable knowledge:Generalizable knowledge is knowledge that abstracts away from the particular individual event. In order to be generalizable, the results of the investigation can be applied to other circumstances. Research involving human subjects would employ eliciting members of a population who are important only as representatives of that population, not because of their individuality. If the activities are designed to generate information that can validly be generalized, IRB review is required.

    Museology 10-17-08

    When are oral history interviews defined as research?If the oral history interview data are collected, at the onset, with the intent to compare, contrast, or establish commonalities between different segments or among members of the same segment (e.g., content analysis, discourse analysis, or coding for themes or other qualitative analysis methods) the data are likely being used to create generalizable knowledge. If the data are being collected with the intent of being used to create generalizable knowledge, the project is considered research under 45 CFR 46.102 and would require IRB review.When they involve human subjects:Is the information individually identifiable?Is the information private?What is the intent of the researcher?

    Museology 10-17-08

    Three types of research and levels of review:Exempt/Departmental Approval with Administrative IRB Review Research that involves human subjects but meets regulations to be exempt from IRB review (six categories), as there is no risk to subjects. Minimal Risk (Expedited)/IRB Subcommittee Review Research that poses no more risk to subjects than would be encountered by the average person in his/her daily activities (nine categories).More than Minimal Risk/IRB Full Committee Review Research that poses more risk to subjects than would be encountered by the average person in his/her daily activities.Not Human Subjects Research/??? Activities that do not fit the regulatory definition for human or research.

    Museology 10-17-08

    One difference is in which form is used:Exempt Research Certificate of Exemption Minimal Risk () & More than Minimal Risk Human Subjects Review Application (UW 13-11)Medical Records Medical Records Review FormRepositories Repository Application FormUse of Biological Specimens Review Determination http://www.washington.edu/research/hsd/forms_paper.php

    Museology 10-17-08

    Whats in the works on forms:Exempt Research IRB Application: Exemption Certificate of ExemptionMinimal Risk () & More than Minimal Risk IRB Application: Core Modules & Supplemental Sections Certificate of ApprovalNon-Human Subjects (BioS, PE, QA/QI, etc.) Review Determination Form Notice of DeterminationWhen Conditional Approval is granted Conditional Approval Response Form + ModificationAnnually (or more often if required by the IRB) Continuing Review FormAny time something changes Modification FormWhen something goes wrong Problem ReportWhen the study is done Closeout Report http://www.washington.edu/research/hsd/forms_paper.php

    Museology 10-17-08

    Criteria for IRB Approval of ResearchRisks to Subjects are MinimizedProcedures are consistent with sound research design and do not unnecessarily ex