Michele Chin-PurcellDavid March

Sarah Waldemar02.17.2009

Hot Topics in Research Compliance

Who is watching?

◦ Office of the Inspector General (OIG) Department of Health and Human Services (DHHS)

◦ National Science Foundation (NSF)◦ Department of Defense (DoD)◦ Department of Justice (DoJ)◦ Office of Research Integrity (ORI)◦ Office of Laboratory Animal Welfare (OLAW)◦ Office for Human Research Protection (OHRP)

The National Scene

The National Scene What are they looking at?

Effort Reporting Cost transfers Direct vs. Indirect Costs Service Centers Human Subject/Research Animals approval

status Final Rule

The National Scene

“The government also alleged

the researchers wrongfully

charged 100 percent of their

summer activity to grants

when the researchers spent

significant time on unrelated

work.”

“Florida International University in

2005 agreed to pay $11.5 million to settle

allegations that it mischarged costs and

overbilled under several contracts and

grants with the Department of Energy,

authorities said.”

“…we estimate that the University

claimed approximately $1.7 million in

unallowable charges as direct costs to

grants, contracts and other

agreements…”

“In response to a written

complaint about this

research, OHRP opened a

compliance oversight

evaluation … regarding

allegations of non-

compliance with HHS

regulations for the

protection of human subjects.”

“The PI has made a significant change from the aims and objectives for purposes of the approved project

and has failed to obtain IACUC approval. This causes a cascade of

events where the grant funds may not be drawn down for the animal work

and the research stops. “

The National Scene

The National Scene What are they looking at?

◦Effort Reporting NSF has severely curtailed cost-sharing requirements, it is no

longer required on proposals nor does it add “weight” to review of proposals

NSF has revised its summer salary policy to allow maximum of two months of senior project personnel regular salary per year(previously limited to 2/9ths of regular academic-year salary)

NIH continues to review PI commitment levels (90% limit recommended for investigators with 5 or more NIH awards)

The National Scene

The National Scene What are they looking at?

◦Cost Transfers

Large fines levied for costs transfers found to be improper Specifically scrutinized are transfers done after award close

out• Costs transferred to other sponsored projects rather than to non-

sponsored funds• Costs transferred between sponsored projects to spend down

remaining balances

• Applies to• Salary transfers• Non-salary transfers

The National Scene

The National SceneWhat are they looking at?

◦Direct vs. Indirect Charges

ensure that costs charged to grants, contracts, and other agreements are allowable under the cost principles established in Office of Management and Budget (OMB) Circular A-21

costs must be reasonable, be allocable, conform to any exclusions or limitations set forth in the cost principles or sponsored agreements, and be given consistent treatment through the application of generally accepted accounting principles

“Major projects” are defined in section F.6.b.2 of the Circular as projects that require an “extensive amount of administrative or clerical support, which is significantly greater than the routine level of such services provided by academic departments.

Applies to: administrative and clerical salaries non salary, general-type supplies and services

The National Scene

The National Scene What are they looking at?

◦Service Centers

assess internal control over compliance with applicable requirements described in the OMB Circulars A-21 andA-133

determine the allowability of direct costs claimed

verify that the correct indirect cost rates were applied to federal awards

The National Scene

The National Scene What are they looking at?

◦Human Subjects/Research Animals Incurring expenses in the absence of a valid IRB or IACUC

approval due to: failure to obtain approval suspension of approval expiration of approval

Institutional processes for notification that spending for these activities must be suspended until approval is obtained

Institutional processed that ensure training for those involved in research using either humans or animals

The National Scene

The National Scene What are they looking at?

◦ Final Rule: FAR Clause 52.203-13 timely disclosure of violations of federal criminal law involving fraud,

conflict of interest, bribery or gratuity violations

violation of Civil False Claims Act

significant overpayments on a contract

disclosure required by “principle” up to three years after project end date

requires written Code of Ethics that require full disclosure

training/education on content of Code of Ethics

applies to domestic and international agreements

The National Scene

What are we doing?

◦Effort Reporting Effort Certification Policy

Effort Certification Reporting Tool (ECRT) Electronic system allows for more timely and accurate

reporting

Oversight through: Risk Assessments – late reporting, uncertified effort PI Reports – unfulfilled commitments Automated follow up of late/missing reports Effort Reporting to be added to faculty education options

The Local Scene

What are we doing?

◦ Cost Transfers Processing Internal Transactions Policy

Worked closely with EFS team to ensure sufficient monitoring is embedded in data fields

Length of time between initial charge and transfer Required approvals in place Query in place for monitoring transactions while reports

are finalized

The Local Scene

What are we doing?

◦ Direct vs. Indirect Charges Removing Uncollectible Costs Policy

justification standards education of grant administrators revised Fiscal Responsibilities module for faculty continued monitoring of questionable expenditures

The Local Scene

What are we doing?

◦ Service Centers Obtaining Approval to Conduct Internal Sales

Policy

assess internal control over compliance with applicable requirements described in the OMB Circulars A-21 and A-133

determine the allowability of direct costs claimed

verify that the correct indirect cost rates were applied to federal awards

The Local Scene

What are we doing?

◦ Human Subjects/Research Animals Research Involving Human Subjects Policy Code of Conduct Policy

confirmation of application/review/renewal congruence

notification of absence/suspension/expiration of protocols – processes being reviewed

UMN training requirements

The Local Scene

What are we doing?

◦ Final Rule: FAR Clause 52.203-13

To be reviewed and monitoring processes and procedures developed in concert with SPA, SFR, UMN Office of Compliance

Education for faculty, grant administrators, central unit staff to be developed and implemented as necessary

Stay tuned for further developments!

What can you do?◦ Educate yourself whenever, however possible – know

what to watch for, what is within the boundaries of compliance, how to resolve issues

◦ Make use of job aids, web sites, your colleagues◦ Stay current on changes in policies and processes◦ Get to know your contacts in the central units◦ Help others whenever possible, teaching is learning◦ Remember to breathe; as Red Green says, “we’re pulling

for you, we’re all in this together.”

Scenes From the Front Line

Selected federal research sites Code of Federal Regulations Federal Acquisition Regulation (FAR) Current NIH Grants Policy Statement (effective for budget periods beginning

on or after December 1, 2003) Notice of publication and list of significant changes for NIH Grants Policy Statement.

Information on Prior Approval NSF Grant Policy Manual Proposal and Award Policies and Procedures Guide (effective for NSF

proposals submitted on or after June 1, 2007) Office of the Inspector General: http://www.oig.hhs.gov/index.asp Office of Research Integrity: http://ori.hhs.gov/ NSF/OIG Audit Reports: http://www.nsf.gov/oig/auditpubs.jsp

OMB Circulars: ◦ A-21 ◦ A-110 ◦ A-133

Resources – The National Scene

Selected University Research PoliciesAnimal Care and Use (Board of Regents)Code of ConductCost Sharing (Offering Cost Sharing, Matching, and In-Kind Contributions on Sponsored Projects) [Procedures]Cost Transfer (Processing Internal Accounting Transactions) [Procedures]Direct/Indirect Costs (Charging of Direct and Facilities and Administrative [Indirect] Costs) [Procedures]Effort Certification [Procedures]Human Subjects (Board of Regents:Research Involving Human Subjects)

Human Subjects (Paying Human Subjects and Maintaining Confidentiality and 1099 Reporting) [Procedures]Misconduct (Academic Misconduct) [Procedures] Misconduct (Reporting and Addressing Concerns of Misconduct) [Procedures]Responsible Conduct of Research

Uncollectible Costs (Removing Uncollectible Costs Charged to Sponsored Projects) [Procedures]

An additional list of policies can be found at: http://www.oar.umn.edu/CA/Rsrch_Policies_EFS.cfm

Resources – The Local Scene

Questions, comments or concerns?

David MarchOARmarch016@umn.edu612-624-1229

Sarah WaldemarOARs-wolg@umn.edu612-624-8349

Michele Chin-PurcellRIOPchin0077@umn.edu612-625-7213

Resources – The Local Scene