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 IRBMED IRB-Health Science/Behavioral Science IRB-Flint IRB-Dearborn Main Campus

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

7. Products and Services

8. 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. 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 Products and Services cont’d

10. 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) Products and Services cont’d

12. Staffing Trends

13. Current Tactical Initiatives StrategiesTactics Standardize Regulatory Review practices – 5 Boards Develop best practices Redesign current organization (vertical vs. horizontal – SARA/JARA/ARA) Board Meeting – minutes, contingencies, approval notices FAQs – study teams Informed Consent boilerplate text IRBMED Staff Edit rights – changes to eR app Education and TrainingEnhance offerings for researchers/study teams New brd member training and mentoring program Redesign IRBMED website – toolbox approach Increase indiv./group consultative services Increase office hours (STARs) FAQs – intake specialist/website Improve eR questions and HELP Chairs on-call 24/7 (all Chairs)

14. Current Tactical Initiatives StrategiesTactics ComplianceContinue to assist study teams with FDA inspections Internal QI/QA of board meeting management and decisions – OHRP/FDA Provide Tips-of-the-Week to board members Increase TAT with investigations Encourage informal consultation with IRB ReportsReal-time reports for turnaround time by submission type, board, regulatory team, depts., investigators, etc. Enhanced collaboration with other core and ancillary committee units Test novel/innovative mechanisms for faster sequential or concurrent review models Review current eR application for redundant questions/review processes

15. Opportunities for Collaboration & Synergy 1.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” 2.Regulatory review units – -Assessment of current process - remove review redundancy and duplication of questions (BEU)

16. 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?????

17. Application Review Process

18. Thank You

19. 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

20. 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)

21. 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