Advancements Towards Compliance Support and Facilitation:

Compliance Software Solutions for UT

Dr. Robert NoblesAssistant Vice Chancellor for

ResearchMarch 11, 2014

The Age of EnforcementEra 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)

Physical

Lega

l

Psycho

logica

l

Social

Econ

omic

Discomfort

Inconvenience

Harm

Research Risks are Real Issues

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

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

• “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

iMedRIS Facilitates Communication

RESEARCHER

INSTITUTIONAL PARTNERS

RESEARCH COMPLIANCE

OSRS

SPONSOR

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

iMedRIS Projected Timeline

Spring 2014 –

Coordination with HSC

and UT System

Summer 2014 – Software

integration and Training

Fall 2014 – IRB Implementatio

n

Spring 2015 – IBC, RSC, &

other compliance

areas

iMedRIS Training and Support

• Instructions for using the system will be placed on our website: http://www.utk.edu/research/

• 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.

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

• https://ris02.uthsc.edu

Exploring the System