Transcript UW-Stout IRB 2014

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UW-Stout IRB
2014
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News from the IRB
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New protocol form
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New online training
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New certification
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New staff
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The Mission of the IRB
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To protect the welfare, safety, and well-being of research
participants
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Codified in federal regulations at 45CFR46
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Upheld through UW-Stout through the FWA
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Snapshot: Background of IRBs
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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
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Regulations protecting human subjects became effective May 30, 1974
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Creation of IRBs
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1974 – establishment of National Commission for the protection of Human Subjects of
Biomedical and Behavioral Research
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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
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In response to the Belmont Report, the DHHS and FDA codified
human subjects protection in Title 45, Part 46 CFR
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“all research involving human subjects conducted, supported or
otherwise subject to regulation by any federal department or
agency…”
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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
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Get certified!! All UW-Stout researchers need to complete the
new training!
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New materials, updated examples, available in qualtrics:
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https://uwstout.qualtrics.com/SE/?SID=SV_9miEKZTmUCMJSPb
Review the RS materials:
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http://www.uwstout.edu/rs/humansubjects.cfm
Start with OHRP decision making charts: Is it research? Is it
human subjects research?
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http://www.hhs.gov/ohrp/policy/checklists/decisioncharts.html
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The New Protocol and Updated
Training
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Walks investigators through a series of steps and facilitates
learning along the way.
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Available at http://www.uwstout.edu/rs/humansubjects.cfm
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Caution: Do not submit old forms or they will be returned.
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Caution: New certificates of completion are required.
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Reminders
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10 working days required; may be longer if protocol requires
full board review.
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Advisors must sign advisees protocols.
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E-signatures are acceptable.
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Proof read.
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Updated IRB Contacts
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Sue Foxwell, Human Subjects Administrator,
[email protected], 232.2477
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Mai Vang, IRB Secretary, [email protected], 232.2691
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Nels Paulson, Chair, [email protected],
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Elizabeth Buchanan, Vice-Chair and IRB Leadership Director,
[email protected], 232.5284
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Basic IRB Enquiries: [email protected]
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Questions/Discussion