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Institutional Review Board History and Ethics

Institutional Review Board History and Ethics. Ethical History. 1932-1972: PHS Syphilis Study. 1989-2010: Havasupai. 1946-1948: PHS Guatemala Inoculation Study. 1963-1966: Willowbrook Children ’ s Study. 1971: Stanford Prison Experiment. 1945-1949: Nuremburg Trials.

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Institutional Review Board History and Ethics

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  1. Institutional Review BoardHistory and Ethics

  2. Ethical History 1932-1972: PHS Syphilis Study 1989-2010: Havasupai 1946-1948: PHS Guatemala Inoculation Study 1963-1966: Willowbrook Children’s Study 1971: Stanford Prison Experiment 1945-1949: Nuremburg Trials 1999: Jesse Gelsinger diesat Univ. Pennsylvania 1970: Tearoom Sex Study 1961-1963: Milgram Study 1939-1945: Holocaust 1951: Henrietta Lacks 1966: Beecher Paper 1991: 15 federal agenciesadopt the “Common Rule” 1978: Belmont Report 1947: Nuremburg Code 1974: National Research Act; First regulations published 1964: Declaration of Helsinki 1980: FDA regulations issued 1981: HHS regulations revised

  3. The National Research Act of 1974 Established the National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research. Established the concept of the IRB In 1978, identified ethical principles that should govern human research.

  4. The Elements of the Belmont Report Beneficence Ensuring reasonable, non-exploitative and carefully considered benefits among persons and groups • Equitable selection of subjects • Includes all groups that may benefit but does not single out one group Justice Maximizing good outcomes for science, humanity, and the individual research participants while avoiding or minimizing unnecessary risk, harm, or wrong • Provide benefit, protect from harm, limit risk • Risk-benefit assessment, standard procedures used Respect for Persons Protecting autonomy, having courtesy and respect for individuals as persons, including those who are not autonomous (e.g., infants, the mentally retarded, senile persons) • Each person has individual rights • Obtain informed consent, protect privacy, maintain confidentiality

  5. The IRB is… A group of people established to protect the rights and welfare of persons who participate in research. Part of this responsibility includes examining the ethical nature of the research and whether the proposed work follows Federal, state, and local laws.

  6. What is Human Research? Research Human Subject Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. *The University of Arizona interprets generalizable to mean that results can be applied to the population at large. Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains • Data through intervention or interaction with the individual, or • Identifiable private information. )

  7. What is NOT Human Research? Work that is not Generalizable • Program Evaluations • Quality Improvement • Case Reports • Oral History See Investigator Manual appendix B: http://orcr.arizona.edu/sites/orcr.arizona.edu/files/HRP-103%20v2013-01.pdf

  8. What does research include? • Recruitment • Consenting process • Study intervention(s)/procedures • Identifiable data analysis Participate!

  9. What is Informed Consent? • Consent is a process, not just obtaining a signature. • Consent should take into account the age, maturity, cognitive status, and language level of a potential subject. • Consent may involve the use of visual aids, information sheets, and/or videos. • Consent does not end with the signing of the consent form. As the study progresses, subjects should be updated with relevant information about the study and asked if they would like to continue (re-consent). • In some cases, it may not be appropriate or possible to consent subjects. The Federal regulations have provisions for when this can be done.

  10. What are the types of review? Projects are classified into three categories • Exempt low risk • Expedited minimal risk (no more risk than everyday life) • Full Committee greater than minimal risk

  11. The Review Process Approval Letter Issued Classification of project Research Begins Application Submission: Include Current Project Approval Form, Protocol, All Recruitment Materials, Consent Form(s), and questions or surveys Continuing Review Required (if not exempt) Exempt, Expedited or Full Review Review and Approval Revisions Requested Revisions Accepted Research Continues or Concludes Investigator makes revisions

  12. Research may not begin until the IRB has granted approval!

  13. Stay Connected • Visit our website at: www.orcr.arizona.edu/hspp • Sign up for the IRB listserv to get the latest information: Click on ‘Quick Guide to Getting Started’ • Contact us at: VPR-IRB@email.arizona.edu Mariette Marsh, MPA, CIP Assistant Director, HSPP marshm@email.arizona.edu 520-626-7575 (Direct) or 520-626-6721 (Main)

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