1. Advancements Towards Compliance Support and Facilitation: Compliance Software Solutions for UT Dr. Robert Nobles Assistant Vice Chancellor for Research March 11, 2014

2. The Age of Enforcement Era of Compliance Process - Previous ≈50 years of research compliance focused on development of compliance infrastructures and education of researchers. Age of Compliance Enforcement - “I like to call this the age of enforcement…There is no longer any question about what the rules are, there is no longer any forgiveness of any significant amount in the system for lax enforcement, for failure to comply.” ( Kathleen Merrigan, Secretary of Agriculture, April 6, 2010)

3. Physical Legal Psychological Social Economic Discomfort Inconvenience Harm Research Risks are Real Issues

4. Importance of an Academic Compliance Program Risk Minimization – Financial Risks & Operational Risks – Health & Safety Risks – Reputational Risks Better Image, Improved Relationships, Greater Trust – Community – Sponsors and Regulators External Pressures – Governmental Expectations (e.g. DHHS OIG, NIH, NSF, etc.) – (Possibly) Reduced Fines and Penalties Greater Efficiency and Improved Outcomes – Elimination of uncertainty and confusion about roles and responsibilities – Better quality research, operations – Identifying and addressing problems early – Reducing likelihood of government audits & investigations – Better trained workforce

5. Rationale for a Software Solution Integration into an online format was intended to ultimately: – Decrease frustration – Enhance the quality of submissions and submission responses – Improve efficiencies – Help researchers maintain compliance

6. “Integrated Research Information Systems” Data Corporation Became a compliance solution in 2005 Features tools for IRB, IBC, RSC, IACUC, COI, etc. Implemented at UTHSC in 2006 Vendor Information

7. iMedRIS Facilitates Communication RESEARCHER INSTITUTIONAL PARTNERS RESEARCH COMPLIANCE OSRSSPONSOR RESEARCH STAFF Researchers have a streamlined mechanism of seeking approval Compliance committees and compliance staff perform reviews and share outcomes Approval documentation maintained and easily retrievable OSP staff will have access Integrated with CITI

8. iMedRIS Projected Timeline Spring 2014 – Coordination with HSC and UT System Summer 2014 – Software integration and Training Fall 2014 – IRB Implementation Spring 2015 – IBC, RSC, & other compliance areas

9. iMedRIS Training and Support Instructions for using the system will be placed on our website: http://www.utk.edu/rese arch/ http://www.utk.edu/rese arch/ This page will include step-by-step screen shots and short videos for creating submissions. Face-to-face trainings will be conducted. A dedicated iMedRIS support “call center” will be created.

10. Top iMedRIS calls/concerns Log in information and student access General Navigation – increased guidance on iMedRIS portal page to assist with starting forms for each program Mechanism for responding to compliance committee requests Occasional glitches that seem to be related to operating systems

11. https://ris02.uthsc.edu Exploring the System