UW-Stout IRB 2014

1. UW-Stout IRB2014

2. News from the IRB • New protocol form • New online training • New certification • New staff

3. 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

4. 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)

5. 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

6. 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! UW-Stout board strives for consistency.

7. 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

8. 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.

9. 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.

10. Updated IRB Contacts • Sue Foxwell, Human Subjects Administrator, foxwells@uwstout.edu, 232.2477 • Mai Vang, IRB Secretary, vangmaib@uwstout.edu, 232.2691 • Nels Paulson, Chair, paulsonne@uwstout.edu, • Elizabeth Buchanan, Vice-Chair and IRB Leadership Director, buchanane@uwstout.edu, 232.5284 • Basic IRB Enquiries: IRB@uwstout.edu

11. Questions/Discussion