Developing the Harvard Catalyst IRB Reliance Agreement

Barbara E. Bierer, MDDirector, Harvard Catalyst Regulatory Knowledge and Support Program

Senior Vice President, Research, Brigham and Women’s Hospitaland

Sabune J. Winkler, JDDirector, Harvard Catalyst Regulatory Affairs Operations

CTSA Champions of ChangeJune 22, 2009

Overview

• Whirlwind overview of Harvard Catalyst– Connections– Enabling research At the cutting edge of discovery

– Nurturing C/T investigators

• Development of IRB Reliance Agreement– Initial Business Challenges– Establishing Common Principles– Elements of Reliance– Ongoing work

Children’s Hospital

Dana Farber Cancer Institute

Massachusetts General Hospital

Joslin

Harvard University

Harvard Business School

Harvard Divinity School

Harvard Graduate School of Design

Harvard Graduate School of Education

Harvard Law School

Harvard School of Engineering and Applied Sciences

Harvard University Health Services

Kennedy School of Government

Radcliff Institute for Advanced Study

Harvard Medical School

Harvard School of Public Health Beth Israel

Deaconess Medical Center

Harvard School of Dental Medicine

Cambridge Health Alliance

Forsyth Institute

Immune Disease Institute

Massachusetts Eye and Ear Infirmary

Judge Baker Children’s Center

Brigham and Women’s Hospital

McLean Hospital

Broad Institute of MIT and Harvard MIT

Boston College Connell School of Nursing Veteran Affairs

Boston Healthcare

System

Spaulding

Rehabilitation Hospital

Schepens Eye Research Institute

Mount Auburn Hospital

Harvard Catalyst Programs

• Bioinformatics• Biostatistics and Research Design • Community Engagement• Ethics in Clinical and Translational Research• Faculty Diversity and Development• Health Disparities Research• Novel Clinical and Translational Methodologies• Participant and Clinical Interactions Resource• Pediatrics• Pilot and Collaborative Translational and Clinical Studies• Regulatory Knowledge and Support• Research Education, Training, and Career Development• Translational Technologies and Resources

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18 Harvard Medical School Affiliated Entities• Beth Israel Deaconess Medical Center• Brigham and Women’s Hospital/Faulkner• Cambridge Health Alliance• Children’s Hospital Boston• Dana-Farber Cancer Institute• Forsyth Institute• Harvard Pilgrim Health Care• Hebrew SeniorLife• Immune Disease Institute• Joslin Diabetes Center• Judge Baker Children’s Center• Massachusetts Eye & Ear Infirmary• Massachusetts General Hospital• McLean Hospital• Mount Auburn Hospital• Schepens Eye Research Institute• Spaulding Rehabilitation Hospital• Veterans Affairs Boston Healthcare System

Participating Institutions

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Harvard University• Harvard University• Harvard Business School• Harvard Divinity School• Harvard Graduate School of Design• Harvard Graduate School of Education• Harvard Law School• Harvard School of Engineering and Applied

Sciences• Harvard University Health Services• Kennedy School of Government• Radcliffe Institute for Advanced StudyHarvard Medical School• Harvard School of Dental MedicineHarvard School of Public Health

Harvard Catalyst Participating Institutions• Boston College Connell School of Nursing• Massachusetts Institute of Technology• Broad Institute of MIT and Harvard

Color indicates signatories of the Harvard Common Reciprocal Reliance Agreement

Participating Institutions – Initial Business Challenges

Challenge: Creation of a centralized process in a decentralized environment, while respecting that each Harvard signatory is a separate legal entity with separate (and mostly accredited) human research protections programs

Early Decisions:

• Definition of participation (all? Former GCRC entities?)• Nature of authorization (one IRB? cede review? Joint

review by each IRB?)• Scope of review (exemptions? Clinical trials?)• Definition of institutional stakeholders? (Institute

Officials, FWA signatories, IRB Directors, HRPP offices, attorneys)

• Alignment with Harvard’s NCI-designated cancer center

Development of the Common Reliance Agreement: Early steps

After identification of initial participating institutions, common agreement on:

1. Scope of agreement - Reliance agreement: common reciprocal reliance authorization (“relying institution” & “reviewing institution”)Eliminate duplicative IRB review, promote collaborative researchEach has FWA

2. Agreement of ‘Jurisdiction of PI”Institution that employs overall PI has responsibility unless ceded

3. Process for request of reliance and selction process Overall PI and site PI(s) initiate requests via on line Cede Review form (in development)Determination of appropriate IRB to review (e.g. IRB expertise, patient number or complexity of Rx, liability)Notification to overall PIAuthority once ceded (may withdraw for cause) and limits of authority (e.g. medical staff privileges)

4. Duties and Responsibilities to investigators, of reviewing and relying IRB CoordinationReports of amendments, adverse or unantiicpated events, protocol violations, etcConflict of Interest reviewHIPAANotification of IRB decisions, of deadlines for renewals and lapsesPolicy compliance responsibilitySponsored research agreements and contracting

Development of the Common Reliance Agreement: Early steps

5. Integrate contracting offices by defining IRB Approval and Activation

Agreed that IRB approval is not alone the basis for activation of the Study. Each institution could request delay of the activation of a study for any reason including the need for an executed clinical trial agreement.

6. Procedures for Managing Serious or Continuing Non-ComplianceAgreed to notifications based on the timeline of discovery (ie. Discovery, Investigation, Suspension, Disapproval or Termination, Findings, etc.) Who would investigate what, and expectation of cooperation Findings and reportingAccess to records and corrective actionsAuditsRecord keepingConfidentiality

7. Subject injury and unanticipating problemsReviewing and relying IRBs obligation to reportManagement of injuries

8. Term and termination

Development of the Common Reliance Agreement: Early steps

Further agreement upon:

1. “Uncheck the box” - Aligned federalwide assurances to ensure consistent OHRP reporting requirements

2. Align human research protection to three year renewals Aligned requirements for human research protection (ie. CITI) continuing education for re-credentialing of researchers to every three years instead of the disparate approaches ranging from annual renewal to none.

3. Agree Upon Conflict of Interest Disclosure – Zero dollar Agreed to harmonize IRB conflict of interest disclosure policies to “zero dollar” instead of the disparate conflict of interest approaches ranging from “zero dollar” to the Harvard Medical School rules and/or the federal rules.

4. Address various HIPAA statusHarvard institutions are covered, hybrid and not covered. Agreed to review requirements to harmonize regulatory processes among institutions when research involves the use of Protected Health Informatio

Development of the Common Reliance Agreement – Ongoing Work

Common Reliance Agreement was fully executed on March 31, 2009 and the work continues:

1. Expand the common IRB Reliance Agreement to additional Harvard teaching affiliates and entities

2. Harmonize Informed Consents - Subject Injury Language

3. Harmonize Informed Consents – HIPAA Authorizations

4. Draft Conflict of Interest Policy

5. Create electronic “cede review” form

6. Create of database to share “cede review” requests and info

7. Harmonize regulatory processes among institutions regarding regulatory interpretations by creating uniform definitions and reviews for various categories of study (discarded tissue, exempt, expedited, full board, medical record review).

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http://catalyst.harvard.edu