UW-Stout IRB 2014
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Transcript UW-Stout IRB 2014
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UW-Stout IRB
2014
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News from the IRB
New protocol form
New online training
New certification
New staff
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The Mission of the IRB
To protect the welfare, safety, and well-being of research
participants
Codified in federal regulations at 45CFR46
Upheld through UW-Stout through the FWA
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Snapshot: Background of IRBs
Grew out of responses to Tuskegee and Nuremburg Trials which violated:
Voluntary consent of human subjects
Capacity to consent
Freedom from coercion
Comprehension of risks and benefits
Minimization of risk/harm
Favorable risk/benefit ratio
Qualified investigators
Appropriate methods
Freedom to withdraw
Regulations protecting human subjects became effective May 30, 1974
Creation of IRBs
1974 – establishment of National Commission for the protection of Human Subjects of
Biomedical and Behavioral Research
The Belmont Report released 1979; a policy statement – the single most
important document to use as a base for subject research (Available:
http://ohsr.od.nih.gov/guidelines/belmont.html)
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The Belmont Report
Basic
principles for ethical treatment of human
subjects and research:
Respect for persons – involves a recognition of the
personal dignity and autonomy of individuals, and
special protection of those with diminished autonomy;
must obtain informed consent
Beneficence – entails an obligation to protect persons
from harm by maximizing anticipated benefits and
minimizing possible risks from research; must engage
in risk benefit analysis and minimize risks
Justice – requires that risks and benefits are distributed
equally; requires that subjects be fairly selected
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CFR
In response to the Belmont Report, the DHHS and FDA codified
human subjects protection in Title 45, Part 46 CFR
“all research involving human subjects conducted, supported or
otherwise subject to regulation by any federal department or
agency…”
Stout commitment to ethical research
Provides guidelines—there is subjectivity in the interpretations
of research ethics to some degree: Every IRB is different! UWStout board strives for consistency.
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The Basics
Get certified!! All UW-Stout researchers need to complete the
new training!
New materials, updated examples, available in qualtrics:
https://uwstout.qualtrics.com/SE/?SID=SV_9miEKZTmUCMJSPb
Review the RS materials:
http://www.uwstout.edu/rs/humansubjects.cfm
Start with OHRP decision making charts: Is it research? Is it
human subjects research?
http://www.hhs.gov/ohrp/policy/checklists/decisioncharts.html
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The New Protocol and Updated
Training
Walks investigators through a series of steps and facilitates
learning along the way.
Available at http://www.uwstout.edu/rs/humansubjects.cfm
Caution: Do not submit old forms or they will be returned.
Caution: New certificates of completion are required.
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Reminders
10 working days required; may be longer if protocol requires
full board review.
Advisors must sign advisees protocols.
E-signatures are acceptable.
Proof read.
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Updated IRB Contacts
Sue Foxwell, Human Subjects Administrator,
[email protected], 232.2477
Mai Vang, IRB Secretary, [email protected], 232.2691
Nels Paulson, Chair, [email protected],
Elizabeth Buchanan, Vice-Chair and IRB Leadership Director,
[email protected], 232.5284
Basic IRB Enquiries: [email protected]
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Questions/Discussion