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Human Subject Protection Program

Human Subject Protection Program. IRB Update Fall 2011 Mariette Marsh, MPA, CIP Assistant Director, HSPP marshm@email.arizona.edu 520-626-7575 (Direct) or 520-626-6721 (Main). New Information. Revised Investigator Manual and policies released electronically August 1, 2011

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Human Subject Protection Program

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  1. Human Subject Protection Program IRB Update Fall 2011 Mariette Marsh, MPA, CIP Assistant Director, HSPP marshm@email.arizona.edu 520-626-7575 (Direct) or 520-626-6721 (Main)

  2. New Information • Revised Investigator Manual and policies released electronically August 1, 2011 • Only the forms posted on the HSPP website will be accepted (version 8/1/11) after September 1, 2011. All other forms will be sent back to PI without review. 2

  3. Summary of Changes • Clarified the UA interpretation of generalizable knowledge (found in definition of research) • Added the federal definitions for engaged in human research and minimal risk • Simplified the scope of the UA Human Subject Protection Program (HSPP) and Institutional Review Boards (IRB) oversight • Revised from Q&A Format to Statements

  4. Changes cont. • Changed CITI expiration from three (3) to four (4) years • Clarified engagement of collaborators in research who are not from the UA • Included information regarding deferral of IRB oversight • Updated CIRB submission requirements • Clarified fees for human research

  5. Changes cont. • Clarified requirements for obtaining waiver of PHI/consent when doing records reviews • Clarified information regarding the documentation of informed consent (written, short form, unwritten oral, and electronic) • Added information regarding access to educational records • Clarified definition regarding Unanticipated Problems • Added information about how to proceed when a subject withdraws from a DHHS-funded study

  6. Appendices • Appendix A – Common Rule agencies – Removed VA information into own VA Supplement (to be released at a later date) • Appendix A-2 – Department of Navy. • Appendix B - Projects that involve humans but are not research have been condensed for clarity and added a section clarifying student class assignments and independent research projects case reports, oral histories

  7. Appendices cont. • Appendix C – Updated the organizational chart • Appendix D - Replaced consent form guidance with links to recommended websites and templates • Appendix E – New, vulnerable population guidance

  8. New Forms • F109: VOTF modification form • F206: This is a new application for CIRB projects.  • F207: This is a new application for our College of Medicine-Phoenix scholarly projects only. • F215: This is a new minor modification form. • F299: This form is for external researchers (e.g. ASU, Purdue University, University of Phoenix) who want to come and do research on the UA campus, but have no affiliation and the UA is not engaged in research.   

  9. Stay Connected Visit our website www.orcr.vpr.arizona.edu/irbto get the newest forms and updates Sign up for the HSPP Listserv to get the latest information and updates- it’s easy: http://orcr.vpr.arizona.edu/irb/UA_Research Mariette Marsh, MPA, CIP Assistant Director, HSPP marshm@email.arizona.edu 520-626-7575 (Direct) or 520-626-6721 (Main) 9

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