University of Michigan Medical School Institutional Review Board

(IRBMED)

Jan Hewett, JDNovember 1, 2011

Purpose

Mission 1. Protect rights and welfare of human research

subjects2. Protect ability of institution to conduct human

subjects research– Achieve in effective and efficient manner

U of M Institutional Review Boards

•IRBMED •IRB-Health Science/Behavioral Science

•IRB-Flint •IRB-Dearborn

•Main Campus

Customers – Internal & External

Stakeholders1. Research subjects2. Institution and its faculty and staff3. Sponsors4. Oversight agencies (OHRP, FDA, OCR)5. Internal Committees (CCC-PRC, IDS, CRAO,

MCRU, CTO, RDRC-SHUR)6. Society

Provides $$$ to conduct research Beneficiaries of knowledge produced by

research

Organizational Structure

Organizational Structure

•Products and Services

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)

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

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

Staffing Trends

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2008 2009 2010

# of

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# of

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ons

Total IRBMED Submissions Total # of full time staff Total # of IRB voting members

Current Tactical InitiativesStrategies Tactics

Standardize Regulatory Review practices – 5 BoardsDevelop 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 Training • Enhance 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)

Current Tactical InitiativesStrategies Tactics

Compliance • Continue 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

Reports • Real-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

Opportunities for Collaboration & Synergy1. 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)

Opportunities for Collaboration & Synergy3. 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?????

Application Review Process

Thank You

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

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)

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