michele chin-purcell david march sarah waldemar 02.17.2009
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Hot Topics in Research Compliance. Michele Chin-Purcell David March Sarah Waldemar 02.17.2009. The National Scene. Who is watching? Office of the Inspector General (OIG) Department of Health and Human Services (DHHS) National Science Foundation (NSF) Department of Defense (DoD) - PowerPoint PPT PresentationTRANSCRIPT
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 [email protected]
Sarah [email protected]
Michele [email protected]
Resources – The Local Scene