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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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ethical history
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

the national research act of 1974
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.

the elements of the belmont report
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
the irb is
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.

slide6

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.

)

what is not human research
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

what does research include
What does research include?
  • Recruitment
  • Consenting process
  • Study intervention(s)/procedures
  • Identifiable data analysis

Participate!

what is informed consent
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.
what are the types of review
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

the review process
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

stay connected
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)