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.
1932-1972: PHS Syphilis Study
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
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
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.
Ensuring reasonable, non-exploitative and carefully considered benefits among persons and groups
Maximizing good outcomes for science, humanity, and the individual research participants while avoiding or minimizing unnecessary risk, harm, or wrong
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)
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.
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
Work that is not Generalizable
See Investigator Manual appendix B:
Projects are classified into three categories
Approval Letter Issued
Classification of project
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
Research Continues or Concludes
Investigator makes revisions
Click on ‘Quick Guide to Getting Started’
Mariette Marsh, MPA, CIP
Assistant Director, HSPP
520-626-7575 (Direct) or 520-626-6721 (Main)