Creating a Culture of Compliance at a Primarily Undergraduate

Institution: A work in progressMegan Williams

Associate Director & IRB AdministratorSponsored Programs & Research Admin

Salem State Universitymwilliams@salemstate.edu

• Bringing Compliance to a PUIEvolution of changes that brought compliance to a

headUrgency created by ARRA awardDevelop a planOvercome resistance & implementEvaluate, re-evaluate & make it stick

• Evolution:Grants Office becomes Sponsored Programs and

Research Administration through University restructure• Formerly pre-award assistance, restructured to include

post award and IRB• .5 FTE added, eventually 1 FTE• Research compliance added as needs progressed

Salem State College becomes University• Maintains mission as teaching institution• State university with strong union & governance structure

• Evolution:IRB moved from Graduate School to Sponsored

Programs and Research Administration• First compliance program adopted under Research

Administration• In need of major overhaul

– Paper intensive process– No university supported policy or procedure– Approximately 300 applications per year

» Mostly student

• Evolution: IRB Overhaul (2008-2012)

• Wrote & enacted first ever IRB policy• Revised procedures to decrease review timetable, “expedite”

process and cut out red tape• Researched OHRP regulations, other state and university

applications, websites, and forms to reinvent SSU’s application and processes

• Re-created paper application & associated forms as well as sample consent/disclosures

• Created IRB website with process, procedures, online pdf forms, sample consent forms and disclosure statements, and FAQ’s

• Evolution:IRB Overhaul, cont:• Transitioned paper application, modification and

renewal process to university developed online application, faculty “approval” and review systems– Imbedded as part of the Salem State web portal

» Allows faculty, student, administration/staff or external researcher applications

• Changes to IRB - Outcomes:Transition to online application, faculty approval and

review systems has decreased review timeframe to 2 weeks, most reviewed within days

Increase in applications from approximately 300 to upwards of 400 per year• Davis Educational Foundation grant award also responsible for

major increase in faculty research in classrooms and learning assessments (Faculty Learning Communities)

Ongoing effort to improve and modify systemsProof in the pudding - change is good

• Urgency Created:University awarded its first large scale NSF award

with ARRA funding• NSF & FFATA compliance issues take center stage and

necessitate policy reviews

• Multiple subrecipients which presented cultural and language differences

Timeliness & reporting issues

• Urgency Created:Compliance Issues faced:• FFATA reporting• MMARS (state) reporting• Time & Effort reporting • Suspension & debarment• IRB review and documented training

– NSF, ARRA, and FFATA all new to university– No policies or procedures in place– Delays in funding/spending

• Urgency Created:Lesson learned:• Need to evaluate current & established university

policies, determine our needs, and be better prepared for other large federal awards in the future

• Develop the PlanGraduate Assistant ProjectInventory university policies (not just research)Determine policies in place, policies needed, and

gapsCreated matrix of agencies, awards, and policies

required to maintain compliance

• Develop the Plan:Compliance Assessment Project• Large gaps in communication, organization and

structure• Research administration new to university• Federal awards, increased transparency and reporting

requirements also new– Major cultural change in how we think and do business– RCR, FCOI, Export Controls, IACUC, FFATA, FOIA, Time & Effort

• Implement the Plan & Overcome Resistance to Change: Where do we begin & how?

• Focus on what’s immediately necessary:– FFATA, FCOI, IACUC, RCR, Time & Effort

• Reinforce that lack of compliance results in potential lack of funding and debarment– Risk is too great– NSF ARRA audit supported need

University governance structure prevents ad hoc policy making• Multi level review and approval creates challenge in establishing policies

in timely manner• Time & Effort – faculty who teach day + evening + course release(s) +

administrative release + advising + research = +100%– No university policy or cap (120%? 140%?)

• Overcome Resistance to Change Culture shock requires educating ourselves, administration and

faculty• Immediate answer is usually No:

– No funding, not needed, teaching not research institution, etc.• Need to be creative in convincing change:

– IACUC - bring it on-campus to promote faculty research and eliminate out sourcing» No policy or committee (Policy approved & Committee appointed Fall 2012)

• 2 rats + Cat Cove = outsourced reviews & site visits• Faculty lacked incentive & sense of university support to be principal

researchers which results in many subawards • Rather than be the sub recipient, let’s be the prime

– Time & Effort – Open checkbook! » Commonwealth of MA publishes all state salaries» Prior to Open Checkbook, activities reported separately, not cumulative

• Overcome Resistance to Change:SPRA team communicates internally and externally

within university» Joined forces with Faculty Research Group» Added question to IRB application “Is this project

funded?”» Visited classes & departments with presentation,

discussions» Moved office space to be next to Financial Services &

grant accountants» Joined Internal Control and Risk Assessment Group and

communicated risks

• Implementing ChangeeRA Software needed• New required policies, increased transparency and

greater accountability requires increased university support, policies and a way to monitor and track research and sponsored projectso Monitor, track, and report communications, time and effort,

compliance issues and documented training, proposal development, interface with post award budgets and spending

• Project currently awaiting on state funding allocation for FY14

• Implementing Change:Capitalize on Opportunities

• NSF ARRA audit:– Time & Effort and debarment issues with subrecipients

• Open Checkbook – salaries open to all• NIH FCOI policy – MGH subaward• ARRA FFATA • IACUC – faculty initiated

– Plus additional NSF applications and awards• Faculty Research in Liberia, Iceland• University collaborations in China• CEDS – Service Center policy• NSF Geology awards - RCR

• Overcome Resistance & Implement Change: Demonstrate willingness to make change, take on new projects, and

create positive outcomes• New IRB systems• IACUC• eRA proposal

Create a positive culture where faculty and staff want to work with you and share info

Support the mission and strategic plan• eRA IT proposal supports university vision:

– The Salem State University Strategic Plan will be directly supported with the implementation of such a system though the Foundational Objectives and Goals: All areas of the university must support the transformational objectives if we are to be successful. Achieving the foundational objectives will strengthen our ability to offer an exceptional experience for our students and create a dynamic and rewarding workplace for our faculty and staff

• Overcome Resistance & Implement Change:Support the mission and strategic plan, cont:• A University which supports research and professional

development• Be competitive in competitive field (higher education)

– Demonstrate competitiveness brings higher visibility & faculty research to the institution

• Evaluate, re-evaluate and make it stick– Where are we now?

• New policies developed and procedures in place to track and monitor funding, training

• eRA system proposal awaiting state funding• SPRA access to grant budgets for post award monitoring• SPRA staff added to institutional risk management

committee• SPRA joined with Faculty Research committee to join

internal and external faculty research projects and funding– Facilitated communication & exposure to faculty

• Evaluate, re-evaluate and make it stickMoving Forward

• Constant re-evaluation– Federal regulations, institutional needs, and faculty interests

constantly changing which necessitates consistent re-evaluation» Maintain professional development through regional and

national conferences, webinars, training to stay current, gain expertise, and grow knowledgebase

• Still in need of some policies & procedures• Need more staff in tight fiscal times, particularly if/when

eRA software funded & implemented

• Questions, Comments, Ideas?