View
217
Download
0
Category
Tags:
Preview:
Citation preview
Institutional Review BoardHistory and Ethics
2
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
3
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
4
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.
6
What is NOT Human Research?
7
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?
8
Recruitment
Consenting process
Study intervention(s)/procedures
Identifiable data analysis
Participate!
What is Informed Consent?
9
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?
10
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
12
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)
Recommended