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IRB Review Process at IRB-HSBS

IRB Review Process at IRB-HSBS. IRB Health Sciences & Behavioral Sciences University of Michigan 2009-2010. Goals of this Audiocast. Describe possible IRB review paths Outline the general process of IRB review at IRB-HSBS Implications of timing of IRB submissions

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IRB Review Process at IRB-HSBS

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  1. IRB Review Process at IRB-HSBS IRB Health Sciences & Behavioral Sciences University of Michigan 2009-2010

  2. Goals of this Audiocast • Describe possible IRB review paths • Outline the general process of IRB review at IRB-HSBS • Implications of timing of IRB submissions • Tips to ease the review process 2

  3. Which IRB? • Nine IRBs at UM! • IRB-HSBS if primary appointment is in a unit on central/north campus in Ann Arbor • IRBMED if primary appointment is in the medical school or health system • Five IRBs at IRBMED • IRB Flint if primary appointment is in any unit on that campus • IRB Dearborn if primary appointment is in any unit on that campus 3

  4. Types of IRB Review • Convened (Full) Board • More than minimal risk, vulnerable populations, special circumstances • A small percentage of submissions go to the full board • Expedited • Minimal risk or less • Must meet regulatory criteria • Exempt • Research must fall into one of seven categories in order to be eligible

  5. IRB Review Process Start

  6. How long does it take? • Plan on* • 1-2 weeks for exempt review • 2-4 weeks for expedited review • 4-8 weeks for full board review • Review time variables: • Other applications in process • Sept/Oct and Jan/Feb are peak months • Number of and scope of issues raised in the review of an application • Timing of the submission *these time frames are estimates; frequently, less time is needed

  7. Tips • Consistency, clarity, and completeness • Upload all relevant documents • Issues that can result in delays: • Incomplete/inconsistent application • Informed consent document lacks required elements • Study team members have not completed PEERRS • Documents cannot be opened • Faculty advisor not listed for student PIs • Other issues…..

  8. Post-Approval Activities • Renew the IRB approval when prompted or terminate the study if complete • Submit an amendment if modifications to the study are needed • Get IRB approval before implementing changes • Report any adverse events or protocol deviations to IRB-HSBS

  9. Resources IRB Health Sciences & Behavioral Sciences (IRB-HSBS) • irbhsbs@umich.edu • 936-0933 • www.irb.umich.edu eResearch • www.eresearch.umich.edu • HELP features, tutorial, Sandbox in eResearch Informed consent templates & samples • www.irb.umich.edu/Consent/consent.html Office for Human Research Protections (OHRP) • www.hhs.gov/ohrp Contact IRB-HSBS with your questions!

  10. Research with Human Subjects • Research means a systematic investigation designed to develop or contribute to generalizable knowledge. • Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual, or identifiable private information. 45 CFR 46.102 10

  11. Minimal Risk • Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. 45 CFR 46.102

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