Institutional Review BoardHistory and Ethics

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Ethical History

1939

-194

5: H

oloca

ust

1945

-194

9: N

urem

burg

Tria

ls

1964: Declaration of Helsinki

1932-1972: PHS Syphilis Study

1946

-194

8: P

HS Gua

tem

ala In

ocula

tion

Study

1961

-196

3: M

ilgra

m S

tudy

1971

: Sta

nfor

d Pris

on E

xper

imen

t

1970

: Tea

room

Sex

Stu

dy

1963

-196

6: W

illowbr

ook C

hildr

en’s

Study 1989-2010: Havasupai

1966: Beecher Paper

1947: Nuremburg Code

1974: National Research Act;

First regulations published

1978: Belmont Report

1981: HHS regulations revised

1991: 15 federal agencies

adopt the “Comm

on Rule”

1980: FDA regulations issued

1999

: Jes

se G

elsing

er d

ies

at U

niv. P

enns

ylvan

ia

1951

: Hen

rietta

Lac

ks

The National Research Act of 1974

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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

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Respect for PersonsProtecting 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

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

JusticeMaximizing 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

The IRB is…5

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.

What is Human Research?

Human SubjectResearch

Human subject means 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.

)

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.

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What is NOT Human Research?

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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?

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Recruitment

Consenting process

Study intervention(s)/procedures

Identifiable data analysis

Participate!

What is Informed Consent?

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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?

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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 Process11

Application Submission:

Include Current Project

Approval Form,

Protocol, All Recruitment

Materials, Consent

Form(s), and questions or

surveys

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

Stay Connected13

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, CIPAssistant Director, HSPPmarshm@email.arizona.edu

520-626-7575 (Direct) or 520-626-6721 (Main)