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UMORStrengthening the Culture of Compliance

While Minimizing Faculty Burden

Lois BrakoAssistant Vice President for Research – Regulatory and Compliance Oversight

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U-M Task Forces and Audits:•2013 – Biologics Oversight Task Force Report•2014 – U-M Internal Audit of General Laboratory Safety•2014 – U-M Internal Audit of Export Controls

External Site Visits:•2012 – CDC Site Visit•2013 – DEA Audits of Controlled Substances•2014 – Office of Laboratory Animal Welfare (OLAW) Site Visit, AAALAC Reaccreditation for Animal Research, USDA Site Visit•Ongoing FDA Audits

These have all identified gaps in U-M oversight that could place university researchers, research funding, and institutional reputation at risk.

Recent Evaluations of Compliance Oversight

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National Academies FDP 2005 and 2012 Faculty Workload Surveys found that: •Researchers spend an average of 42% of their time on administrative requirements•This takes away from time conducting actual research

What does this mean for U-M?•While no increase in administrative burden was observed at the national level, UM faculty complain about increased administrative and compliance requirements.•42% research workload translates into hundreds of millions of dollars every year being spent by PI on administrative tasks instead of actual research.•The Research Policy Committee will conduct a survey study of UM faculty administrative burden.

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U-M’s Research Compliance Commitment

U-M is nationally known as a lead institution supporting the reduction of regulatory burden for researchers while maintaining a high standard of regulatory compliance. UMOR Compliance faculty and staff help direct efforts to reduce burden by participating in leadership roles and activities in national organizations, including:•The Council on Governmental Relations (CoGR)•The Federal Demonstration Partnership (FDP)•The National Research Council (NRC)•The American Association of Medical Schools (AAMC)•Public Responsibility in Medicine and Research (PRIM&R), and •American Association for Laboratory Animal Science (AALAS)

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Regulatory Change – Additional Burden

Over the last few years, significant federally-mandated administrative burdens have been imposed on the research community, including:

•New NIH guidelines for animal research

•Expanded conflict of interest reporting

•New regulations for biological agents and toxins

•Export control regulation reform

Other major regulatory changes include oversight of dual use research of concern, new requirements for registration of clinical trials, and making datasets and publications publicly available

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Research Compliance Oversight - 2013 Structure

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Size of U-M Research Compliance Oversight Programs

Volume of work

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Research Compliance Oversight - Updated Structure

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Research Safety Initiative: Partnership between UMOR and OSEH

New: Research Safety and Compliance Oversight Model

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• Controlled Substances in Research Oversight

• Data Security Initiative

• Export Controls Oversight -– previously part of ORSP, significantly enhanced by

moving it to research compliance

New: Research Compliance Oversight Programs

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Minimizing PI Burden

Major PI challenges:

•Understanding everything that is required of them

•Having the time and tools to fulfill those requirements

UMOR efforts:

•Coordinated communications and messaging

•Improved guidance and training

•Efficient, streamlined business processes

•Robust eResearch system

•Integrated PI workspace to track all requirements

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• Leadership commitment and support

• Education and training

• Leverage IT technologies

Strengthening the Culture of Compliance

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PI Dashboard- Michigan Informational Dashboard for the Administration of Research (MIDAR) -

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Web-based Tools

DRAFT Research Compliance Web Page