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University of Michigan Medical School Institutional Review Board (IRBMED)

University of Michigan Medical School Institutional Review Board (IRBMED). Jan Hewett, JD November 1, 2011. Purpose. Mission Protect rights and welfare of human research subjects Protect ability of institution to conduct human subjects research Achieve in effective and efficient manner.

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University of Michigan Medical School Institutional Review Board (IRBMED)

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  1. University of Michigan Medical School Institutional Review Board (IRBMED) Jan Hewett, JD November 1, 2011

  2. Purpose Mission • Protect rights and welfare of human research subjects • Protect ability of institution to conduct human subjects research • Achieve in effective and efficient manner

  3. U of M Institutional Review Boards • IRB-Health Science/Behavioral Science • IRBMED • Main Campus • IRB-Flint • IRB-Dearborn

  4. Customers – Internal & External Stakeholders • Research subjects • Institution and its faculty and staff • Sponsors • Oversight agencies (OHRP, FDA, OCR) • Internal Committees (CCC-PRC, IDS, CRAO, MCRU, CTO, RDRC-SHUR) • Society • Provides $$$ to conduct research • Beneficiaries of knowledge produced by research

  5. Organizational Structure

  6. Organizational Structure

  7. Products and Services

  8. Products and Services 1. Provide high quality regulatory review of UMMS faculty research projects • Regulated (45 CFR 46 (Common Rule)/21 CFR 50, 56, 164 (FDA/HIPAA) • Not-Regulated (OHRP/FDA) projects (QI/QA, HIPAA Waivers, Cert. Prep to Research, Case Studies) • 1-on-1 consultative services for research study teams (>300 since 2008) • Speak to A Regulatory Analyst (STARs) (2009)

  9. Products and Services cont’d 2. Board Member Management – OHRP/OVPR • Federal reporting responsibilities (Rosters) • Strategic assessment of need, recruitment, member performance evaluation and COI 3. Education • Workshops (Apps 101, Consent, Adverse Events, etc.) • Staff and Board Member training • Regulatory Guidance and Website

  10. Products and Services cont’d 4. Compliance • Complaints – subjects, study teams, Compliance Hotline, etc. • Not-for-Cause/For-Cause investigations – Serious and/or Continuing Noncompliance • UM Compliance reporting (UMMS/OVPR/FDA/OHRP) • Study team education – FDA 483 Audit Corrective & Preventative Action (CAPA)

  11. Staffing Trends

  12. Current Tactical Initiatives

  13. Current Tactical Initiatives

  14. Opportunities for Collaboration & Synergy • Researcher/Study Teams – • Early consultation on research projects • Best application template examples • 24/7 Education opportunities (podcasts, audio) • Increased IRBMED workshops • Expedited Reviewer – improved TAT and model applications for no more than minimal risk (NMTMR) projects • Symposium/Lecture Series – “Research Privacy & HIPAA -10-18-11” • Regulatory review units – • Assessment of current process - remove review redundancy and duplication of questions (BEU)

  15. Opportunities for Collaboration & Synergy 3. Announced Notice Proposed Rule Making (ANPRM) - Organized discussion/response to changes proposed for Common Rule 4. Joint Institute Initiative – UMHS/Peking University – - Innovative IRB model for projects conducted at both sites Question to you –what can we do for you beyond the items listed?????

  16. Application Review Process

  17. Thank You

  18. Key Performance Indicators • Submission review to first subject enrolled turnaround time (TAT) • All core and ancillary committees/IRBMED only • IRBMED only - staff review versus board member review • Study team • First time quality of submissions • Based on the no. of contingencies/Board Action Deferrals (BADs) • Assess by investigator, department, disease/condition, support personnel • Board Member expertise and performance • Impact on review TAT and education for investigators

  19. Key Performance Indicators • Elimination of waste in the review process • Standardization - contingency notification, development of minutes, unassigned projects, more board members, edit rights by the IRB staff • IRBMED staff review versus board member review versus study team • Federal Demonstration Projects (FDPs) • Challenge current regulations • 2-yr scheduled continuation review • “Exemption 7” (Identifiable data)

  20. Benchmarked Data and Performance • Multiple groups look at IRB data • Not always to - more like a • Electronic (commercial product/home grown), paper • Offices have different mechanisms for regulatory review • paid expedited reviewers, staff expedited reviewers, limited submissions (only regulated projects, HIPPA review done by Privacy Office) • Internal efforts – UM • Quarterly review by IRB (full board, expedited, exempt) • Posted OVPR/HRPP website • External efforts – Nationally • NCCN, CTSA Regulatory Support, Big-Ten CIC, private orgs

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