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> Compliance News |
| Compliance
News is a recurring compliance communication for the University
research community. Established in March 2004, articles are
published through the Research
News Online. Collected and submitted by OAR, Compliance
News aligns with OAR's mission to promote compliance awareness
in sponsored projects management with the University through assistance,
education and communication.
Sources of news items
includes: NCURA Research Compliance Newsletter, Chronicle of Higher
Education, Policy Changes affecting research compliance (Policy
Newsletter), and all University research compliance offices.
Submissions should be
sent to Jennifer Englund at englu061@umn.edu
|
April
2008
Ten Misconduct
Findings Result in 7 Debarments
The following excerpt is from the Office of Research Integrity's
March 2008 newsletter.
Thirty-five percent of the 28 research misconduct cases closed by
the Office of Research Integrity (ORI) in 2007 resulted in research
misconduct findings. Seventy percent of the respondents in those
cases were debarred from receiving government funding for periods
ranging from three years to a lifetime. The ten respondents against
whom misconduct findings were made include an associate professor,
a surgical resident, two postdocs, three graduate students, a research
associate, and two phlebotomists. All ten respondents were prohibited
from serving in any advisory capacity to the Public Health Service.
Administrative actions imposed on the three respondents who were
not debarred include retraction of a published article, data certification,
and the submission of a supervisory plan. From 2002-2006, ORI averaged
11 misconduct findings per year. Misconduct was found in 40% of
the closed cases. Sixty-six percent of the respondents against whom
misconduct findings were made were debarred.
The entire article is available at http://ori.dhhs.gov/publications/documents/Mar08ORINewsletter.pdf.
|
March
2008
NSF OIG '08 Work
Plan Portends More Oversight of Grantees
Excerpted from Federal
Grants News for Colleges and Universities February 2008 newsletter.
Throughout the National Science
Foundation Office of Inspector General (NSF OIG) FY '08 Audit Plan,
the NSF OIG points out the shortcomings in both NSF's oversight
of grantees and of the grantees' grants management systems, particularly
in financial management capabilities. To make its case, the plan
cites a number of completed audits and concludes that:
NSF must have timely
and effective risk assessment; award monitoring and closeout procedures
to ensure that awardees are capable of administering NSF funds
and that the grant expenditures are valid; accurate, allowable,
and consistent with the project's goals and objectives.
To move toward these goals,
the NSF OIG lists a series of planned audits in the preaward; active;
and postaward phases to assess NSF's progress as well as the compliance
level of the NSF grantees. Many of these audits target colleges
and universities, and the NSF OIG says that completed audits continue
to demonstrate that "NSF grantees, including colleges and universities,
vary significantly in their financial management capabilities."
Under the report's preaward
section, the NSF OIG says it will continue audits of the terms and
conditions of NSF's large facility management agreements to determine
their sufficiency and of the foundation's financial and programmatic
oversight of its eight center programs. Universities that have large
facilities agreements or research centers may experience various
forms of increased monitoring from NSF in response to this OIG activity.
Prior Audits Drive
New Audit Targets
As support for its audits
of active awards, the NSF OIG cites a recent audit that found that
over a five-year period approximately 42% of required annual performance
reports had not been submitted. The report also draws attention
to $62 million in unresolved questioned costs in numerous audit
reports, underscoring the need for continued improvement in this
area. Because of these findings, the NSF OIG audits will continue
to focus on the adequacy of awardees' systems for safeguarding and
properly accounting for NSF funds and overall compliance with federal
and NSF award requirements. Audits of contractors also are planned
to assess compliance with disclosed accounting practices, reasonableness
of indirect cost rates, validity of allowable costs, and adequacy
of accounting systems to manage NSF funds.
The NSF OIG will continue
its labor effort audits at colleges and universities. While not
stated in the plan, it is anticipated that approximately 30 grantee
institutions will undergo review.
With regard to the closeout
administrative policies, the NSF OIG will look at NSF's audit resolution
process to determine whether NSF has adequate procedures and has
taken effective corrective actions to resolve grantee audit findings
and recommendations in both A-133 and OIG audits. The plan cites
a 2004 OIG audit that found approximately 61 % of final technical
reports were either submitted late or not at all and notes 74 instances
of investigators who failed to submit final project reports but
still received new NSF funding. The NSF OIG will follow up to see
what corrective action NSF has taken to address these specific audit
findings.
Previous oversight has
come in the form of desk reviews, onsite reviews, audits of new
and continuing grants and contracts, and requests for internal audit
reports, and grantees should expect continuing compliance and system
reviews as well as audits and increased monitoring and enforcement
activities.
Link to the plan:
www.nsf.gov/oig/fy08_audit_plan.pdf.
|
January
11, 2008
Levels and Trends:
FY 2007 Awards and Proposal Data
Levels and Trends is an
annual report of research, training, and public service work performed
by the University of Minnesota and funded by external sponsors.
The Fiscal Year 2007 institutional proposal and award data is available
at http://www.oar.umn.edu/trends/index.cfm.
For more information or questions, contact Mary Bendtsen at mbendtse@umn.edu
or 612.624.0583.
|
November
9, 2007
Mercury Clean-Up
and Compliance in Laboratories
The Resource Conservation and Recovery Act (RCRA) is the source
of most regulations pertaining to mercury use at the University.
Under RCRA, mercury-containing equipment like thermometers, manometers,
barometers, mercury switches, bubblers, and many other commonly
used items in labs are regulated when mercury is spilled or the
item becomes a waste. Careful handling of mercury containing products
is critical due to the extensive environmental damage that results
from mercury releases.
Kolthoff Hall renovation activities exposed mercury contamination
in sink traps, sewer pipes, casework, fume hoods, and chemical storage
cabinets. Mercury contaminated dust was detected on surfaces in
most of the labs. The financial cost for mercury clean up and disposal
are in excess of $125,000. Mercury releases can be prevented by
finding alternative mercury free instruments, always handling mercury
with secondary containment, and moving mercury sources away from
sinks.
For further information on mercury use in laboratories go to http://www.epa.gov/glnpo/bnsdocs/hgsbook/labs.pdf.
|
| September
28, 2007
NSF Funding Requires
RCR and Ethics Training
Institutions receiving awards from the National Science Foundation
(NSF) are required to provide training in the responsible conduct
of research (RCR), survival skills, and research ethics under the
America Creating Opportunities to Meaningfully Promote Excellence
in Technology, Education, and Science (COMPETES) Act that was signed
by President Bush on August 9, 2007.
The requirements are in two sections of Title VII which authorizes
NSF funding: Section 7008 - Postdoctoral research fellows, and Section
7009 - Responsible conduct of research. Section 8008 of Title VIII
- Accountability and transparency of activities authorized by this
Act, addresses conflicts of interest in subcontracts. For more information,
go to http://science.house.gov/.
The full article is available at http://ori.dhhs.gov/documents/newsletters/vol15_no4.pdf.
|
| August
24, 2007
Office of Research
Integrity 2006 Annual Report
The Office of Research
Integrity (ORI) produces an annual report on possible research misconduct,
based on information gathered from 111 institutions. The 2006 report
indicates that these institutions were engaged in 73 continuing
cases and 86 new cases related to falsification, fabrication, or
plagiarism. Details are available in the June ORI Newsletter: http://ori.dhhs.gov/publications/documents/ORINewsletter-7-07-Final.pdf.
|
| July
13, 2007
Export Controls
and University Research
Researchers need to be
aware of the possibility that federal export control regulations
can apply to university research. Willful violations of these regulations
can result in prison sentences and large fines.
Normally, university research is excluded from controls under the
"fundamental research" rule. However, if you are working with company
confidential information, or if your ability to publish results
is restricted (other than brief delays to assess patentability),
export controls may apply.
In addition, researchers need to be especially careful about taking
any confidential information overseas. If the information is subject
to controls, it cannot be taken overseas without a license from
the federal government. Any laptops taken out of the country should
be kept in your possession at all times.
For more information, see "Export Controls and University Research:
Basics and Problem Areas," at http://www.research.umn.edu/regulations/export_controls.html,
or call Mark Bohnhorst at 612.624.5298.
|
| May 11,
2007
Small Business
Subcontracting Plans
The University of Minnesota is required to provide a Small Business
Subcontracting Plan (SBP) on federal prime contracts that exceed
$500,000.
The Office of Business Community Economic Development maintains
a Web site with many listings of small business vendors by business
category or by alphabetical order and has a link to the Small Business
Administration site. Please note that the vendor needs to be federally
certified to count on the SBP on the federal prime contract. For
more information, go to http://www.bced.umn.edu/.
For detailed procedures about the entire process, go to http://www.ospa.umn.edu/policiesandprocedures/smallbusinessplans/.
|
February
9, 2007
Reporting Animal
Care Concerns
Animals at the University are counting on all of us to do our jobs
humanely and with concern for their well-being. To report a possible
violation of the rules involving animal care and use:
|
| January
12, 2007
Encryption Guidelines
Encryption has quickly
become a hot topic for University research staff. For researchers
storing private data on laptops or other mobile devices, encryption
is required by the University's Securing Private Data Standard.
Encrypting a hard drive does not need to be complicated, but the
benefits, however, are huge.
The University's Office of Information Technology has developed
a resource page for faculty and staff who need guidance in encrypting
their computers: http://www1.umn.edu/oit/security/Encrypting_Stored_Data.html.
Included in this guide are directions for Macintosh users on how
to turn on the native encryption on their machines. The University's
Securing Private Data Standard is available at http://www1.umn.edu/oit/security/privatedata.html.
|
| December
22, 2006
DHHS Work Plan
Focuses on Cost Transfers
Excerpted from the
Report on Research Compliance, October 2006 newsletter.
Concerned that the "potential effect of unreasonable, unallocable,
or unallowable cost transfers is substantial, considering that the
value of National Institutes of Health grants funds awarded each
year is approaching $20 billion and increasing," the Department
of Health and Human Services Office of Inspector General (OIG) will
zero in on cost transfers during fiscal year 2007, according to
its new work plan. Other issues to be addressed include whether
the Food and Drug Administration properly accounts for the files
of human study subjects; whether salary charges to NIH grants accurately
reflect the portion of researchers' efforts spent on those grants;
and whether colleges and universities have appropriately charged
administrative and clerical salaries to federally sponsored grants
and cooperative agreements. The work plan is available at http://oig.hhs.gov/publications/docs/workplan/2007/Work%20Plan%202007.pdf.
|
| October
27, 2006
Hazardous Waste
Inspection Alert
This message is a reminder to all colleges, departments, and centers
with laboratories concerning proper management of chemical waste.
The University has been informed that regulatory agencies will be
conducting more inspections on the campuses. While we should always
be concerned about compliance with disposal regulations, this is
a good opportunity for researchers to ensure compliance in their
laboratories. Recent inspections have focused on concerns about
labeling and storage of waste, particularly the need to keep waste
containers closed. The Department of Environmental Health and Safety
has summarized what labs need to do to comply. See http://www.dehs.umn.edu/hwd/postcard.pdf.
Departments and PIs should
reinforce these efforts and motivate their laboratories in implementing
these steps.
|
| September
22, 2006
NSF Audit of Penn
Finds Weaknesses in Effort Reporting
Excerpted from the Report on Research Compliance August 2006
Newsletter.
The National Science Foundation (NSF) Office of Inspector General
(OIG) recently posted the first in a series of audits of effort
reporting, this one at the University of Pennsylvania (Penn). Penn
received $29 million in fiscal year (FY) 2004 from NSF; approximately
$9.4 million went to research activity salaries and wages. The OIG's
objectives were to evaluate the adequacy of Penn's internal controls
to ensure that salary and wages were allowable and determine the
amount of unallowable salary and wages charged to NSF awards in
FY 2002-2004. The OIG randomly selected 46 effort records representing
salary and wages charged to NSF awards in FY 2002-2004. The OIG
found 23 effort reports without after-the-fact confirmation or determination
of whether the reports represented reasonable estimates of actual
effort expended; these reports represented $177,894 or 48 percent
of the value of the statistical sample. For the full article, go
to http://www.oar.umn.edu/RNO_Articles/Report_Rsc_Comp_Penn_Effort.htm.
|
August
25, 2006
Whistleblower
Profile Study
A profile of whistleblowers in Department of Health and Human Services
research misconduct cases was presented in a recent Office of Research
Integrity Newsletter. Most of the 289 whistleblowers in the 259
closed research misconduct investigations from 1994-2003 were faculty
members (57%) rather than administrative or non-faculty members
(19%). Eighteen of the 259 investigations involved more than one
whistleblower. The results of the investigations were also correlated
with the rank of the whistleblower. For the full article, see page
nine of the newsletter: http://ori.dhhs.gov/publications/documents/Mar06ORINewsletter.pdf.
|
| July 14,
2006
Research Compliance
Runs from Application to Closeout
Excerpted from the Report on Research Compliance June 2006 newsletter.
Department administrators are at the front lines of research administration
and are the focus for communication between research and central
administration. Central administration implements regulatory requirements,
but it is often the department administrator who must translate
and impose those requirements on faculty. To read the entire article,
go to http://www.oar.umn.edu/RNO_Articles/ReportonResearchCompliance.cfm.
The University's Guide to Research Compliance is available
in hard copy and online at http://www.research.umn.edu/complianceguide/index.htm.
The Guide assists researchers in the ever-changing world
of research compliance. While the main audience is researchers,
the Guide is a valuable tool for central units as well.
|
June 9,
2006
Human Subjects'
Research Compliance Program in the Office of Regulatory
Affairs (ORA) is responsible for 'for cause' as well as methodically
selected audits and review of research studies for compliance to
regulations.
- To ensure the safety, rights and well-being of research subjects
- To help ensure the quality and integrity of the research
As a proactive
approach we are offering to review studies before research
subjects are enrolled. We will review the standard procedures that
should be observed for the following:
Required training
of research staff
Documentation
of the training of staff authorized to obtain consent from subjects
Use of screening
log, enrollment log, and signature log
Consent process
documentation
Regulatory binder
Study files
Procedures to
follow to ensure research billing compliance, etc.
If you are interested in
having a proactive review of your IRB approved study , please contact
the Office of Regulatory Affairs at 612-624-2431 or email: thoma098@umn.edu
ORA website: http://www.research.umn.edu/regaffairs/human/index.html
|
| May 12,
2006
Beyond the A-133
Audit--Expanding the Focus (Part 3 of 3)
Excerpted from the National Council of University Research Administrators
(NCURA) April/May 2006 newsletter.
In this last in a series of three articles, the authors address
questions auditors are currently asking that expand the audit scope
for nonsalary costs. Topics covered include filing and general audit
observations.
To read the article, go to http://www.oar.umn.edu/RNO_Articles/NCURA_Article_Part_3_of_3.htm.
|
| April
28, 2006
ROHP Reminder
E-mail
notifications will be sent to those enrolled in the Research Occupational
Health Program (ROHP) who have not completed their training or medical
requirements. Federal regulations mandate that all persons having
contact with animals in research be enrolled in an occupational
health program. All persons in contact with animals at the University,
including those working on IACUC approved protocols, are enrolled
in ROHP.
These notifications will specify training and medical requirements
for individuals enrolled in the program. Training requirements can
be completed online and are self-reported into the ROHP database.
Medical requirements are completed in consultation with Boynton
Health Service. A new requirement for those enrolled in the program
includes a medical questionnaire.
For questions regarding ROHP, please call the Office of Regulatory
Affairs at 612.626.3599
|
| March
10, 2006
Grantee Takes
Hit for Unallowable Costs of Subaward
In the first 2006 Department of Health and Human Services (DHHS)
Office of Inspector General (OIG) audit report, the OIG lived up
to its promise to target "subrecipient costs and monitoring." Yale
University received a $1.7 million subaward from the University
of Massachusetts Medical School (UMMS) under an NIH grant. Between
February 2001 and August 2002, the audit found $193,779 in costs
that did not comply with OMB Circular A-21 and subaward terms. In
addition, the principal investigator failed to provide the 25 percent
level of effort proposed in Yale's subaward application.
The OIG recommended Yale, (1) verify that cost transfers are adequately
explained and documented, (2) improve procedures for direct charging
of costs and comply with procedures for confirming effort reports,
and (3) ensure that levels of efforts are satisfied.
Because UMMS-not Yale-was the grantee, the OIG is recommending that
UMMS reimburse NIH for the unallowable costs. The complete report
is available at www.oig.hhs.gov/oas/reports/region1/10501501.htm.
|
| February
24, 2006
Beyond the A-133
Audit--Expanding the Focus (Part 2 of 3)
Excerpted from the National Council of University Research Administrators
(NCURA) Sept/Oct newsletter.
When a sponsor conducts an audit of a specific project, the process
can be very different than the usual A-133 audit. Auditors are increasingly
going beyond the normal, general financial system requirements and
are wanting to validate that there is in-depth understanding and
compliance with award terms, on a transaction-by-transaction basis.
In the second of three articles, the authors address some of the
questions auditors are currently asking that expand the audit scope
for non-salary costs. Topics include P-Card use, equipment purchases,
consultant and speaker expenses, and cost sharing. To read the article,
go to www.oar.umn.edu/NURCA_Article_Part_2.cfm.
|
February 10, 2006
NIH Requests
Info on Standards for Care and Use of Lab Animals
The National Institutes of Health (NIH) is soliciting new scientifically
valid information, methods or practices, published data, or other
advances in the humane care and use of laboratory animals. They
are exploring the need to update the laboratory animal welfare
standards of the Guide for the Care and Use of Laboratory
Animals . For additional information, see the Request for
Information at grants.nih.gov/grants/guide/notice-files/NOT-OD-06-011.html.
Submission deadline
is February 28, 2006.
|
| January
13, 2006
Another Reason
to Protect Confidential Research Data
Researchers may be at
risk of unknowingly violating SEC insider-trading laws by sharing
or using nonpublic information about their research in connection
with the buying or selling of securities. U.S. Senate Finance Committee
Chair Chuck Grassley has called for an SEC investigation into whether
doctors participating in clinical trials are sharing nonpublic information
with stock analysts and investors under consulting arrangements
within investment firms in violation of federal insider-trading
laws. A new University procedure, Avoiding
Conflicts of Interest in Special Situations, makes clear
that until the research is completed and the results become publicly
available, researchers must be careful to keep preliminary nonpublic
research results confidential.
|
| December
9, 2005
Cost Transfer
Compliance Audit
The Department of Health and Human Services (DHHS) Inspector General
(IG) has been leading a pilot audit at five institutions. Based
on initial findings, audits of cost transfers will be expanded beyond
the pilot. NIH staff reported, "cost transfer policies tend to be
nonexistent, incorrect, or confusing, and the requirements for making
appropriate cost transfers are often misunderstood by institutional
officials, especially PIs and departmental administrators." Audit
results showed systemic noncompliance including delayed cost transfers,
lack of justification for the transfer, salary and effort transfers
after certification, and reliance on verbal approval from the PI.
The University
cost transfer policy provides comprehensive guidance on issues
concerning this topic.
|
November
11, 2005
University Creates
Guide to Research Compliance
The offices of the Vice
President for Research and Institutional Compliance are excited
to announce the release of the Guide to Research Compliance.
This guide was created to help researchers manage compliance issues
during a research project.
A paper copy of the guide
is being distributed to all researchers as part of an ongoing initiative
to simplify, streamline, and improve compliance support services
at the University. The guide is also available online at http://www.research.umn.edu/complianceguide/index.htm.
Comments and questions
about the guide should be directed through the web site.
|
October
14 , 2005
Beyond the A-133
Audit--Expanding the Focus
Excerpted from the National
Council of University Research Administrators (NCURA) July/Aug newsletter.
Auditors are increasingly reviewing the detail behind the institutional
forms or signature requirements and requesting proof of award-specific
approvals and procedures that show knowledge of and compliance with
the grant terms and condition. Auditors are going beyond the normal,
general financial system requirements and are wanting to validate
in-depth understanding and compliance with award terms, on a transaction-by-transaction
basis.
University research administrators tend to focus on the propriety
of the expense. Is the expense allowable and allocable? Does it
belong to the grant to which it was charged? If the answer to both
of these questions is yes, we assure the principal investigator
and university administration that everything will turn out fine.
However, that reassurance may be premature.
To read the complete article, go to www.oar.umn.edu/NCURA_Article.cfm.
|
| September
23, 2005
Popular Press
Highlights Abuses of Federal Grants
Research programs received
a black eye recently when the Wall Street Journal published
a front-page feature about misuse of National Institutes of Health
(NIH) grant funds. The article highlighted recent settlements of
whistleblower lawsuits paid by universities, and charged that the
misuse of research funds was the "dirty little secret" of the academic
medical research community. The report was republished throughout
the country. To view the article go to www.post-gazette.com/pg/05228/554819.stm.
|
| August
26, 2005
Questionable Research
Practices Examined
When misbehavior in research
is studied, the focus is on falsification, fabrication, and plagiarism
(FFP). These behaviors can produce headline-grabbing examples of
research misconduct. A recent article in Nature presents
the argument that a wider range of questionable behaviors should
be examined to ensure the integrity of scientific research. To identify
these behaviors, they surveyed early- and mid-career scientists,
asking them to self-report how often they had engaged in a list
of questionable practices.
The study provides empirical
evidence that scientists engage in behaviors with as much potential
FFP to damage the integrity of science and scholarship. The authors
also call for an examination of the entire research environment
to identify the institutional and structural systems that foster
these behaviors. The full article can be found at www.nature.com/nature/journal/v435/n7043/full/435737a.html.
|
August
12, 2005
NSF Summer Salary
Rules Must be Followed on CPS Statements
In reports to Congress,
NSF's Inspector General has noted that NSF relies on accurate statements
of Current and Pending Support (CPS) in NSF grant applications and
that misstatements about CPS can lead to Office of Inspector General
(OIG) investigations.
Information in the CPS
section of grant proposals should reflect all current and pending
support for all sponsors (including NSF) for both ongoing and proposed
projects. Long-standing NSF instructions direct that all effort
to be "devoted" to the project must be listed. For currently-funded
projects, that means the full amount of funded summer salary must
be listed on the CPS. For proposed projects, the effort proposed
must be listed. In addition, all committed effort must be shown,
regardless of whether funding is received for that effort.
If an individual has multiple
NSF grants with summer salary support, the total support of person-months
for awards and pending proposals may not exceed two-ninths of his
or her regular academic-year salary. If a PI with two months of
NSF summer salary support wishes to submit a proposal for additional
summer support, the PI must list the currently funded support on
the CPS and should identify in the proposal the reductions in the
currently funded support that will be requested in the event the
new proposal is awarded.
The NSF CPS instructions
are consistent with the NSF budget instructions, which are quite
clear that NSF will not provide funding for more than two months
of summer salary for a given year.
|
| July
8, 2005
NSF Audit Shows
Importance of Cost-Share Documentation
An audit published by
the NSF Office of the Inspector General (OIG) (excerpted here from
Report on Research Compliance , March 2005) highlighted
the challenges of documenting cost sharing applied to NSF awards.
The principal investigator on the audited award did not have adequate
documentation to track institutional cost share or to monitor the
sub-recipient cost share. Initially, $526,000 of cost sharing was
questioned by the NSF. Ultimately, $302,483 in cost share charges
were denied by NSF resulting in an award reduction of $195,133.
Summary findings included:
- Two sub-recipients did not meet committed cost share obligations;
- Third party cost share was inadequately documented;
- One employee charged 100% of his salary as cost share on the
grant when he was only authorized to work 75% on the grant;
- Documentation of consultant fees of $35,000 did not substantiate
how the work benefited the award.
To read the OIG audit
report, go to www.nsf.gov/oig/STCC_05-01-002_final.pdf.
For information on cost
share "Best Practices," go to process.umn.edu/groups/controller/documents/information/sponsored_reporting_proc.cfm
or contact SFR at 612.624.4313.
|
| June
24, 2005
Research Compliance
Program
The Research Compliance
Program in the Office of Regulatory Affairs (ORA) is responsible
for audits of research studies involving human subjects under the
purview of the University of Minnesota Institutional Review Board
(IRB). The overall purpose of the Research Compliance Program is
to:
- Ensure the safety, rights, and well-being of research subjects;
- Help ensure the quality and integrity of research.
Research studies are
audited based on requests from the IRB, for cause requests,
or the risk category, and the audits ensure compliance with federal,
state, local, and institutional regulations and guidelines.
The Research Compliance
Program is also responsible for the registration and oversight of
studies involving human embryos or embryonic stem cell lines ineligible
for federal or state funding. These research studies can begin only
after registering with ORA. Prior to registration such studies must
have IRB approval, follow necessary accounting standards, and use
only private funding as per Academic/Administrative Policy 2.1.11.
For more information on the Research Compliance Program, go to www.research.umn.edu/regaffairs/human/index.html.
Questions about the Research Compliance Program may be sent to ORA
at ora@umn.edu.
|
| June
10, 2005
Mayo Pays $6.5
Million to Settle Allegations of Grant Fraud
The Mayo Foundation, parent
organization of the Mayo Clinic, has paid $6.5 million to the Federal
Government to resolve allegations that it misspent millions of dollars
in federal research grants.
The Justice Department
said Mayo had routinely transferred money from one grant to another
to pay for unauthorized expenses and tried to hide the transactions
from the agencies that paid the bills. The investigation showed
not only improperly transferred expenses, but also that Mayo had
an accounting system unable to monitor and manage charges made to
federal grants in a manner required by federal law.
"All recipients of federal
grant money must comply with the restrictions placed on the use
of that grant money,' said Peter Keisler, the Assistant Attorney
General for the Civil Division of the Department of Justice. "[The]
settlement demonstrates our commitment to vigorously pursue allegations
of fraud and abuse in federal grant programs."
The Department of Justice
press release: http://www.usdoj.gov/opa/pr/2005/May/05_civ_292.htm
|
| May
27, 2005
Former GWU Professor
Pleads Guilty to Embezzling
In April 2005, a former
tenured professor of engineering at George Washington University
(GWU) pled guilty to embezzling nearly $1 million in federal grant
funds. Nabih E. Bedewi admitted to directing much of the money to
his own private companies.
Mr. Bedewi, principal
investigator on cooperative agreements with the U.S. Department
of Transportation, admitted that he caused to be submitted and approved
for payment fraudulently-inflated invoices and used an alias to
help him direct hundreds of thousands of dollars into companies
he owned or in which he had substantial interest.
To read the press release on this
case from the U.S. Department of Justice, go to www.usdoj.gov/usao/dc/Press_Releases/2005_Archives/Apr_2005/05120.htm.
|
| May
13, 2005
Compliance issues
noted by the Department of Audits
Recent compliance issues
involving sponsored projects include:
- Monitoring committed effort levels for compliance with the terms
of the grant/contract.
- Establishing a process to ensure all researchers certify effort
on each project.
- Ensuring all required employees file REPA and ROC forms.
- Reviewing expenditures for allowability, allocability, appropriateness,
authorization, and proper justification.
- Establishing procedures to ensure all extensions, re-budgeting,
and changes in principal investigators, key personnel, committed
effort level, and workscope are approved by the sponsor when required.
- Documenting all committed cost sharing and matching funds expenditures.
- Monitoring of technical report deadlines to ensure timely submissions.
- Monitoring fixed price contracts to ensure expenses are charged
appropriately, deficits addressed, and accounts are closed on
a timely basis.
Additional compliance
issues and other recent Department of Audits findings are found
at http://www.umn.edu/audit/MostCommonFindings.htm
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| April
22, 2005
Research Occupational
Health Program
The Office of Regulatory
Affairs has launched a new Web-based reporting system for tracking
medical and training requirements for the Research Occupational
Health Program (ROHP).
Federal Regulations mandate
that all persons having contact with animals in research be enrolled
in an occupational health program. The University of Minnesota 's
ROHP consists of two major components - a training component and
a medical component.
The training component
involves web-based self education on various hazards that may be
associated with animal use in research. The content is based on
the particular species of animal or other risk factors involved
in individual research projects. Once the material is reviewed,
the training is self reported through the ROHP system. As IACUC
protocols are submitted, individuals will be notified by email regarding
which parts of the training they need to complete. The medical component
of ROHP is conducted by Boynton Health Service. Individuals, again,
will be notified regarding which medical requirements need to be
completed and will consult with a health care provider at Boynton.
Contact the Office of
Regulatory Affairs with questions about ROHP, 612-626-3599.
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| April
8, 2005
NIH Issues New
Animal Welfare Guidance
The National Institutes
of Health's Office of Laboratory Animal Welfare and the Office of
Extramural Research issued new guidance on prompt reporting requirements
for its public health service policy on humane care and use of laboratory
animals. The new guidance is intended to assist with determining
what, when, and how situations should be reported and to promote
greater uniformity in reporting.
To review the NIH Notice, visit: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-034.html
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| March
25, 2005
How to Protect
Against Research Misconduct in Labs
The following guidance
is excerpted from a presentation by Alan Price, Ph.D., Associate
Director for Investigative Oversight, Office of Research Integrity,
given at the March 9 conference, "Promoting an Ethical Research
Culture:"
- Look carefully at raw data from coworkers (postdocs, students
and technicians)
- Take seriously the concerns about data, or actual allegations,
from staff
- Be careful how you resolve disputes or breakup with former collaborators
- If you find evidence of misconduct in your lab, report it and
remove yourself
- If you suspect misconduct, inform officials. Do not try to entrap
the person you suspect
- Do good science, be a good mentor, and show direct interest
in your students' work
- Take responsibility for your lab's research
For questions about the
conference or ethical research at the U of M, contact Carol Foth
at rcr@umn.edu.
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| March
11, 2005
NSF Audit Reveals
PIs do not Submit Timely Annual & Final Reports
In a recent audit, the
NSF Inspector General (OIG) found that 47 percent of all final and
annual reports required over the past five years were submitted
late or not at all. The audit also revealed a number of principal
investigators (PIs) received new awards before NSF had received
or approved reports on previous grants.
The OIG urged NSF to develop
an automated reminder for PIs when reports are due and overdue,
and to clarify the responsibilities of NSF and recipient institutions
to ensure timely reports. The audit also recommended developing
policies governing when a PI can receive a new grant without submitting
a final report on a previous one.
In response, NSF asserted that development
of a comprehensive report tracking system is underway. The response
letter said NSF is considering a system that would prevent any awards
from being made to PIs who have overdue annual or final project
reports. The OIG audit report and NSF response are available
at www.nsf.gov/oig/05-2-006Final.pdf.
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| February
25, 2005
Biosafety Compliance
Information
Environmental Health and
Safety uses a monthly electronic mailing, BioBasics On-Line
, to keep researchers informed about biosafety compliance issues
and biosafety updates to the Institutional Biosafety Committee (IBC)
web site. To subscribe to BioBasics On-Line , e-mail charb002@umn.edu.
The IBC web site is the University
of Minnesota's primary source of information for biosafety compliance,
http://www.ibc.umn.edu/ .
All safety guidelines outlined in the CDC/NIH publication Biosafety
in Microbiological and Biomedical Laboratories (BMBL) 4th Edition
and the NIH Guidelines
for Research Involving Recombinant DNA Molecules must be
followed. In addition, University specific
procedures are found in the Biosafety Principles and
Practices section of the IBC web site. Fact sheets designed
for use as training tools are added to the web site on a regular
basis. Fact sheets can be accessed at, http://www.ibc.umn.edu/factsheets.html
. Questions about this article should be directed to Darlene
Charboneau, Environmental Health & Safety, charb002@umn.edu.
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| February
11, 2005
Animal Use Protocol
Transfers
All vertebrate animal use
must be pre-approved by the Institutional Animal Care and Use Committee,
IACUC. Each Animal
Usage Form submitted receives a unique protocol number. Whenever
an animal needs to be transferred (change PI, move from a breeding
to a research/teaching protocol, renew an expiring protocol, etc.)
a transfer form
must be completed and submitted to RAR to officially track the animals
and their approved use.
Frequently when a protocol is renewed,
it is assumed that animals housed under the old or expired protocol
will be automatically transferred to the renewal protocol-- that
is not the case. Investigators must submit a protocol transfer
to have animals placed onto new protocols. In addition, the renewal
protocol must have animal numbers listed in the Transferred
column on the Animal Request Table. Otherwise, the animals
transferred from the expiring protocol will be deducted from the
number of animals approved for purchase. Contact Cynthia Gillett
at gille002@umn.edu with
questions about this article.
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| January
28, 2005
Patent Office
Publishes CREATE Act Regulations
On January 11 th , the
U.S. Patent and Trademark Office published an interim rule implementing
the Cooperative Research and Technology Enhancement Act of 2004
(CREATE Act). The act was passed by Congress to encourage collaboration
among researchers.
A recent lawsuit had a
chilling effect on collaboration by establishing that patent rights
were lost when two scientists shared their work in the process of
research. The new act will establish procedures for creating joint
research agreements that will allow collaboration to continue while
individuals retain patent rights to the inventions that flow from
that collaboration. To review the regulations, visit: http://www.regulations.gov/freddocs/05-00461.htm
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| January
14, 2005
Yale Forces Out
Tenured Professor Accused of Financial Misconduct
Excerpted from The
Chronicle of Higher Education, Jan 11, 2005.
A tenured professor at
Yale University 's School of Management has lost his job because
of alleged indiscretions with university funds. Florencio López-de-Silanes,
director of the Yale's International Institute for Corporate Governance,
had allegedly padded his business-travel expenses by about $150,000
since he was recruited to Yale in 2001.
Mr. López-de-Silanes
has made full restitution to the university and, in a written statement
admitted his error without going into detail. "I made a mistake,
and I deeply regret any unintended harm," he wrote in a message
issued by his lawyer. "I am leaving Yale because it is the
right thing to do for the institute and all concerned." López-de-Silanes
did not take any steps to retain tenure. In his research and writing,
López-de-Silanes advocated for mandatory disclosure rules
and civil lawsuits as a means of keeping corporate executives honest.
A university spokesman confirmed the general reasons behind
Mr. López-de-Silanes's departure saying "He has resigned
from Yale as a result of financial misconduct and irregularities.
Appropriate actions have been taken." The spokesman reported
further that Yale is undertaking an audit of its expense procedures.
He said the audit would not be limited in focus to any one of the
university's schools and he declined to comment on whether the audit
was a response to this case.
December 10, 2004
UC Berkeley Computer
System Hacked, Records Accessed
In October, someone improperly
accessed a database of names and Social Security numbers of about
1.4 million California residents that was stored in a computer system
at the University of California, Berkeley. Reuters reports
that school officials and the FBI are trying to determine whether
the hacker obtained personal information for illegal uses.
The names accessed by the hacker were being used by a UC Berkeley
researcher who had collected data on elderly people and individuals
who provide in-home care to seniors to study the impact of wages
on in-home care. Read more about this story at http://www.informationweek.com/story/showArticle.jhtml?articleID=50900249
Questions
about this article should be directed to Susan McKinney, CRM, director,
Records & Information Management at mckin018@umn.edu.
November 12, 2004
Recent HHS OIG
Audits show vulnerable areas in Federal Award Management
The Department of Health
and Human Services' (HHS) OIG recently released two audit reports
of universities that reveal troublesome vulnerabilities regarding
fundamental award administration practices. Two vulnerabilities
emerged as the chief reasons why federal auditors issued findings:
1) Improper design and
implementation of institutional policies related to employee time-
and effort-reporting that comply with OMB Circular A-21, Cost Principles
for Educational Institutions, and
2) Failure to create clear
lines of authority and responsibility when collaborative arrangements
(such as subgrants and subcontracts) are involved.
Additionally, a considerable amount
of the questioned costs involved the fact that, at the time of the
audit, documentation was inadequate to allow a determination
as to allowability. These findings surfaced
because the institution had either a poorly designed policy or procedure,
or experienced significant failure of the persons working
on the projects to adhere to a policy or procedure that would have
prevented violations of federal rules. Both OIG audit
reports are posed on the OIG Web site, www.oig.hhs.gov/w-new.html
.
Questions about the content
of this article should be directed to Sue Paulson at spaul@umn.edu
October 22, 2004
Program Income Article
Win Ann Schumi, Assistant
Vice President for Research, recently authored another article for
the National Council of University Research Administrators (NCURA)
Newsletter. The article, titled "Program Income - An Interesting
Topic in Grants Management," may be found on pages 9 and 10 of the
newsletter, available at www.ncura.edu/data/newsroom/newsletters/pdf/septoct04.pdf
October 8, 2004
OIG Disallows $500,000
in Costs, Challenges Additional $1.7 Million
The Department Health and
Human Service's Office of Inspector General (OIG) recommended in
an audit report that East Carolina University repay $565,820 to
the National Library of Medicine (NLM) for unallowable costs it
charged to a $4.5 million contract received from NLM. Another $1.7
million of charges to the contract were not sufficiently documented
and must be examined to determine disallowances. Over 57 percent
of the costs claimed for this project were recommended for financial
adjustment.
The audit report states
that the NLM contract was regularly charged for unallowable costs.
For example:
- The contract was charged for the salaries and fringe benefits
of employees who had been instructed to falsely certify effort
even though they were not actually working on the project.
- The contract was charged for equipment that was not and would
not ever be used for the project.
- The contract was charged for payments to firms with business
relationships with the former Co-PI, even though the services
were either not rendered or not related to the contract.
- The contract was charged for the salaries and fringe benefits
of administrative personnel whose duties did not apply directly
to the project.
The report is available at http://oig.hhs.gov/oas/reports/region4/40401001.pdf.
September 10, 2004
NCURA Article
on Compliance at the U
Win Ann Schumi, Assistant
Vice President for Research, and Tom Schumacher, Director of Institutional
Compliance, recently authored an article for the National Council
of University Research Administrators (NCURA) Newsletter.
The article, titled "Growing a Culture of Compliance at the University
of Minnesota," may be found on pages 6 through 8 at this link:
http://www.ncura.edu/data/newsroom/newsletters/pdf/julyaugust04.pdf.
July 9, 2004
New Policy on Clinical
Trials and Other Fixed Price Contracts
Effective July 1st, the
University of Minnesota has implemented a new policy titled "Handling
Clinical Trials and Other Fixed Price Contracts." The policy was
developed because these types of performance-based awards
are often financed differently from other kinds of research agreements.
As a result, Sponsored Projects Administration and Sponsored Financial
Reporting have developed new processes and oversight mechanisms
to meet the unique compliance needs of these types of projects.
The policy and the procedure,
titled "Handling Industry-Sponsored Clinical Trial Research Agreements,"
are focused on industry-sponsored clinical trials. Procedures for
handling other types of fixed-price agreements may be added at a
later date. The new policy is found in the UWide Policy Library
at http://www.fpd.finop.umn.edu/groups/ppd/documents/policy/clinical_trials_pol.cfm
June 25, 2004
Revised Cost Transfer
Procedure
Sponsored Projects Administration
(SPA) and Accounting Services have revised the cost transfer procedure.
The most significant change relates to processing an IX that debits
multiple sponsored accounts. Effective immediately, the certified
approver from each department debited on the document must approve
it. SPA and Accounting Services made this change so that project
staff will be informed when their accounts are being debited.
The procedure, Adjusting or Correcting Internal Accounting Transactions
for Sponsored Accounts (3.2.4.3), can be found at http://www.fpd.finop.umn.edu/groups/ppd/documents/procedure/adjusting_or_correcting_spon.cfm
June 11, 2004
HHS Audit Faults
Effort Reporting Documentation
The Department of Health
and Human Services Office of Inspector General (OIG) published an
audit in April that highlights the importance of making sure we
follow our own University of Minnesota policies and procedures with
regard to effort reporting. The OIG visited Northeastern University
to assess expenditures charged to a NIH grant totaling $525,188
over a seven-year period. At the end of the review, the OIG audit
declared that $61,215 in salaries, fringe benefits, and related
indirect costs were not adequately documented and recommended the
institution return the funds.
While the OIG audit did not contend
that money was inappropriately spent, it found that the university
had not maintained adequate documentation required by its own policies
and procedures, and therefore could not support the salaries charged
to the grant. The OIG audit may be found at http://oig.hhs.gov/oas/reports/region1/10301502.htm.
May 14, 2004
Records Retention
Policy Updated
University of Minnesota
Policy 3.9.1, Managing University Records Retention, was recently
updated by bringing the U-Wide Records Retention Schedule up-to-date
and by adding an appendix titled "General Retention Guidelines for
Financial Documents." The updated policy is available at http://www.fpd.finop.umn.edu/groups/ppd/documents/policy/record_retention.cfm.
The retention schedule
applies to all University departments, units, and agencies. In addition,
this retention schedule applies to all formats of information, including
but not limited to, hard copy paper records, electronic media, and
microforms. Departments and units are encouraged to use electronic
formats to manage and store their information. Electronic records
must be maintained and accessible according to the retention schedule
and destroyed when the retention period for that format has been
met. Electronic records, such as word processing documents, may
be destroyed if a paper copy has been made and filed in the unit's
record keeping system.
For more information, contact
Susan McKinney, CRM, at 612.625.3497 or susanmckinney@mail.ogc.umn.edu
April 23, 2004
Compliance Advice
for Cost Sharing the NSF Way
During a recent satellite
conference, the head of NSF's Policy Office of the Division of Grants
and Agreements, Jean Feldman, addressed head-on the controversial
question of cost sharing. The National Council of University Research
Administrators (NCURA) sponsored the event, titled "Cost Sharing
Management". "If a program solicitation does not specify that we
include cost sharing, then eliminate it from the budget," Feldman
said. "If a percentage is established, we mean no more or less."
Cost sharing represents a compliance challenge and financial burden
to the institution. According to Feldman, it is a misconception
that cost sharing improves the likelihood of being funded by the
NSF. Reviewers will know about cost sharing requirements but will
not see the amounts specified in proposal budgets.
March 26, 2004
Nonfederal Sponsors
Impose New Restrictions on Funding
This article is excerpted
from the Federal Grants News for Colleges and Universities, March
2004 issue. Two large sponsors of university research and
other sponsored activities recently announced changes in their grants
policies that could affect whether institutions or individual investigators
will be eligible to receive funding from these organizations. These
funding restrictions raise the concern that other sponsors may limit
their research support of investigators over certain issues.
- The Ford Foundation
has informed its grantees about the changes in a memo dated
January 8, 2004. To monitor it's grantees, the Foundation is expanding
its oversight and monitoring and has added this audit language
to the grant agreement letter: "The Foundation is authorized to
conduct audits, including on-site audits, at any time during the
term of the grant, and within four years after the completion
of the grant." To read the entire memo, go to http://www.fordfound.org/about/docs/ff_grantee_memo.pdf.
- The American Cancer Society
(ACS) has issued a new policy
prohibiting any individual investigator who receives funds from
tobacco companies from receiving ACS funding as well. The ACS
Research Program Web site is located at http://www.cancer.org/docroot/RES/RES_0.asp.
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