Research Compliance: Models for Managing - Panel Carol Blum, Council on Governmental Relations (COGR) Peter Dunn, Purdue University Ara Tahmassian, Boston University

In Perspective Increase in: – Number – Type – Complexity Changes in Operation Breadth of Impact

Risks of Shifting Landscape High-Profile Events High Profile Attention Changes in Prosecutorial Approach and Settlement Outcomes

Organizational Impact In the past: – Add-on to sponsored programs – Committees self-managing – Special needs addressed case-by-case Currently: – Alter reporting structures – Staff support for various functions – Breadth of issues mitigated by uniform approaches

What is compliance? It is the proverbial Hydra the multi-headed monster! You need to start by clearly defining the scope Is limited to certain areas (e.g. non-financial, financial) or all encompassing? Is it centralized in one office with responsibility to develop and implement? Is it a coordinating office that acts as a quality assurance or auditing office?

Structure Where does it report? – Depends on the institutional organization What is the authority? – Depends on the scope – Should have clear definition and limits – Generally is shared and matrix Who reports to the Office – Depends on the authority and scope

Boston University and Boston Medical Center BU has: – Two campuses, 16 Schools, 2 Graduate Divisions and an Honors College – Charles River Campus (CRC) with 13 Schools, Honors College and 1 Graduate Division – Medical Campus with 3 Schools and Graduate Medical Sciences – Number of centers and Institutes – A University Provost and Chief Academic Officer and Medical Campus Provost BMC is the affiliated Hospital which is a separate legal entity and has its own research program

Office of Research Compliance Was created in October of 2006 to unify the research compliance and support for both BU and BUMC Prior to that each campus and BMC had its own separate structure (e.g. most of the assurances, permits, licenses, policies, procedures, etc.) For all practical purposes in many instances they were separate entities Difficult for faculty to collaborate from one side with the other

Office of Research Compliance, (Cont’d) Office of responsible for all non-financial research compliance issues Operational units (e.g. fCOI, Animal Care and Use, Committees, RCRC, Research Integrity, EHS, Research Occupational Health, etc.) with the exception of BMC Sponsored Program were put under the ORC as “shared services” Unified all permits, assurances, policies, procedures, etc.

Office of Research Compliance Reporting Associate VP Research Compliance has a matrix reporting to – CEO of BMC – VP Research and Associate Provost for Research at CRC – Provost of Medical Campus (has its own Associate Provost for Research) Advantage is direct contact with those in position to make decision Some challenges with building consensus for three needs

Does it Work? The program and structure was based on what was best for meeting the needs of the entities and making collaborative research easier while ensuring compliance Overall it has worked well Eliminated many duplicative programs and streamlined processes Faculty have easier time collaborating under single set of requirements Funding methodology had to be developed to allocate costs in fair way Program has to make sure it is seen as unbiased and cater to specific needs of each entity (e.g. clinical, research, undergraduate)

Challenges Providing support personnel at two locations Human Subject is still two separate programs due to different needs at Medical Campus vs. Charles River Campus which is mainly social behavioral and student research programs Two different grant administration offices due to legal requirements requires sub-awards Contract was simplified by BU Office doing all contract and cost transfers for expenses

Factors You Should Consider The BU structure and reporting was based on the unique organization of the BU and BMC. The questions that you should consider in designing your program include: Do you have multiple campuses? Is all research administered through one entity? Is there a single individual responsible for all research at your institution? Will a centralized support structure work for you?

Purdue University Indiana’s Land Grant University A university system consisting of four campuses: – West Lafayette – Indiana University Purdue University Fort Wayne (IPFW) – Calumet – North Central No (human) Medical School College of Pharmacy, School of Nursing, School of Veterinary Medicine

Purdue University, (cont’d) Purdue West Lafayette manages research compliance (OVPR, REM/Physical Facilities) and sponsored projects (Sponsored Program Services) for the Purdue University System. Centrally managed research compliance functions for all campuses of the University System. – Reporting to the Vice President for Research Responsible for protection of research subjects, conflict of interest, biosafety, research security (export control and classified research) – Reporting to the Vice President for Physical Facilities Radiological and Environmental Management (REM) responsible for oversight of general lab safety, chemical safety, use of radiation and radiation-producing devices (including laser safety), research use of controlled substances.

OVPR Research Compliance – Components – Regulatory oversight committees which review, approve, oversee execution of protocols; staff who evaluate financial interest disclosures and manage COIs and oversee Select Agent Program. Human Research Protection Program Purdue Animal Care and Use Committee/Laboratory Animal Program Institutional Biosafety Committee Conflict of Interest Select Agent Program – Research Regulatory Compliance Identifies regulatory issues associated with proposals after submission Ensures that active, congruent protocols and/or Technology Control Plans exist before release of funds and throughout life of project Monitors required RCR Training Assists in project closeout (delinquent technical/invention reports) – Research Quality Assurance Reviews process to ensure is working and produces desired impact Post approval monitoring for regulatory oversight committees Support external audits [Good Laboratory Practice Quality Assurance]

How is it Working? Advantages: Separation in OVPR of oversight, compliance, and quality assurance functions ensures that – Oversight faculty/staff not overworked, – Different individuals responsible for protocol development/review (good cop) and post- approval monitoring (bad cop) – Dedicated staff available for monitoring sponsored program compliance – Separate staff without other line responsibilities focus on quality assurance. Challenges: Split responsibilities between OVPR and OVPF requires continuing communication and managing relationships. Regional campus faculty question central management by WL for system; need to be reminded of costs and risks of campus specific distributed system

Thank you Carol Blum, Peter Dunn, Ara Tahmassian,