1. + UW-Stout IRB 2014

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) 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.cfmhttp://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 foxwells@uwstout.edu Mai Vang, IRB Secretary, vangmaib@uwstout.edu, 232.2691vangmaib@uwstout.edu Nels Paulson, Chair, paulsonne@uwstout.edu,paulsonne@uwstout.edu Elizabeth Buchanan, Vice-Chair and IRB Leadership Director, buchanane@uwstout.edu, 232.5284 buchanane@uwstout.edu Basic IRB Enquiries: IRB@uwstout.edu

11. + Questions/Discussion