Compliance and the Pre-award Administrator: Addressing Compliance at the Proposal Stage

Amanda Snyder - University of Maryland, BaltimoreDebbie Newton – The University of Tulsa

What do we mean by “Compliance”?

• Definition: the state or act of conforming with or agreeing to do something

• Involves compliance with federal, state, institutional, and sponsor regulations and policies/procedures

Why practice compliance duringthe proposal phase?

• Comply with federal and state regulations• Apply institutional policies consistently– Minimize institutional liability– Educate and protect the investigator(s)– Minimize award negotiations/acceptance issues– Streamline project implementation– Reduce post-award problems– Gain the respect of your faculty– Gain the love and adoration of your post-award colleagues

• AVOID SURPRISES

Major areas of compliance we can address during the proposal phase

• Includes (but is not limited to…)– Human Subjects– Vertebrate Animal Use– Use of Biohazards, Recombinant DNA, Radiation, Select

Agents– Export Control– Financial Concerns – Effort Reporting, Cost Sharing,

Budgeting, OMB Circulars– Subcontracts – Conflict of Interest– Specific sponsor requirements

Human Subjects Involvement• Institutional Review Board (IRB)

– Timeline for protocol approval process– Roles & responsibilities– At what point does sponsor require documentation of

approval• Training Requirements

– Human Subjects Protection– HIPAA

• Are they addressed properly in the proposal?• Budget

– Patient Care Costs– Medicare Billing Analysis

Use of Vertebrate Animals• Institution Animal Care and Use Committee (IACUC)

approvals– Timeline for protocol approval process– Roles & responsibilities– At what point in process does sponsor require the approval

documentation• Training Requirements• Have appropriate sections been included in the

proposal?• Budgeting for animals purchases, animal housing & care

Use of Biohazards, Select Agents, Recombinant DNA, Radiation, etc.

• Institutional Reviews and Approvals– Timeline for approval process– Roles & responsibilities– What sponsor requirements exist

• Training Requirements

Export Controls

• Collect data when working with international sponsors, collaborators, subcontractors, and consultants

• Covers not only physical shipments, but transmission of information

• Can be an issue when bringing collaborators to US campuses as they may receive restricted information

• Approvals and licenses take time to obtain

Financial Concerns

• OMB Circular A-21 (budgets)– Allowable:

• Reasonable• Allocable• Consistent Treatment

– Direct vs. Indirect Costs• Equipment maintenance agreements• Administrative salaries

• OMB Circular A-110– Cost Sharing

• Allowability

Financial Concerns

• Cost Sharing – Required (% of project cost vs. % of request)– Required vs. Allowed – “Voluntary” cost share– Tuition, Indirect costs, Academic year effort, volunteer time

• Committed effort of faculty– Percent time– Course release(s)– Summer compensation– Salary caps

Financial Concerns

• Subcontractors vs. Consultants vs. Vendors/Contractual services

• Tuition charges

• Limits on indirect costs

• Industrial agreements

Subcontracts

• Subcontractor vs. Consultants vs. Vendors/Contractual services

• Flow down compliance requirements• NSF/NIH training requirements• PHS Conflict of Interest requirements• Subcontractor review of solicitation/contract• Indirect cost rate agreement• Debarment and suspension• Required certifications

Conflict of Interest

• Federal Conflict of Interest policy• PHS Conflict of Interest policy– Disclosures must be submitted prior to proposal

submission– Verification of subcontractor compliance

• Industrial agreements• University start-up companies

Sponsor Specific Requirements• Terms and Conditions– Limit effort– Limit IDC recovery– Limited proposal submissions from an institution– Eligibility requirements– Restrictions on foreign nationals– Publication restrictions– Intellectual property rights– Confidential information– Specific payment instructions/limitations (i.e. payment upon

APPROVAL of deliverables)

Institutional Policies

• Faculty workload• Cost of living and merit increases• Tuition policy• Graduate assistantships• Who is allowed to be the PI?• Conflict of interest• Intellectual Property• Travel (reimbursement and foreign travel)• Procurement policy

Tools available to the Pre-award Administrator

• Institutional Routing– Data Collection– If electronic, ability to run reports– If electronic, ability to send – Necessary Approvals

• Training– Understand the basic issues surrounding compliance issues– You don’t need to be the expert, but you need to know where

to go for more info and who in your institution IS the point of contact

• COMMUNICATION!

Tools available to the Pre-award Administrator

• Proposal routing form• Contracted compliance assistance (Visual

Compliance)• NCURA colleagues• List serves (RESADM-L, NCURA Collaborate)• University officials • Post-Award Office

What tools do you use?

Summary

Compliance - Meeting the requirements of a variety of regulations and policies/procedures involving federal, state,

institutional and sponsor requirements.

1. Know what the issues are and who is responsible at your organization for each

2. Learn how to recognize what may become a compliance issue

3. Address them up front4. Document, Document, Document

Questions?

Contact Information

• Debbie Newton, Director of Research and Sponsored Programs, The University of Tulsa– 918-631-2192– deborah-newton@utulsa.edu

• Amanda Snyder, Assistant Director, Sponsored Programs Administration, University of Maryland, Baltimore– 410-706-5590– asnyd007@umaryland.edu