Transcript NEOMED TEMPLATE

COMPLIANCE OVERVIEW
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PURPOSE OF THIS PRESENTATION
The purpose of this presentation is to provide a general overview of four
major compliance areas
•Time and Effort Reporting
•IRB compliance
•IACUC compliance
•Financial Conflict of Interest
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This general overview does not replace the requirement for
education and training programs in these and other compliance
areas at NEOMED
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GRANTS ACCOUNTING
TIME AND EFFORT REPORTING
TIME AND EFFORT REPORTING
A BRIEF OVERVIEW
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Completion of time and effort reports is a federal requirement. It is
required for all sources of funding (non federal, federal, industry, etc.)
Time and effort reports are required for all individuals who spend time on
sponsored projects, whether it is charged effort or cost shared effort
Signed time and effort reports are considered legal and auditable
documents
Erroneously certifying time and effort reports is considered fraud
According to OMB Circular A133, those awards that charge salary are at
a higher risk of red flags and audit findings
At NEOMED, over 40% of all expenses on awards in FY12 were spent on
salary and fringes (this does not include the cost shared effort that is also
auditable)
Effort reporting has been the most frequent subject of Federal False
Claims Act enforcement in the university research area in recent years
TIME AND EFFORT REPORTING
HOW EFFORT IS DETERMINED
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Effort is not based off of a 40 hour work week, but based off of the total
hours worked
A reasonable tool for estimating effort is:
Estimate of weekly hours spent on sponsored project
Total hours in an average work week
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= % Effort on
Sponsored project
Total hours worked includes sponsored and non sponsored activities
(total professional effort), for example, one must include the following:
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Administration (including duties as chair, dean, etc.)
Work on all awards, federal or non federal
Attending general departmental faculty meetings
Serving on university committees
Time spent working on projects at other institutions
TIME AND EFFORT REPORTING
EXAMPLES OF QUESTIONS AUDITORS MAY ASK DURING AN AUDIT
In the event of an audit, time and effort reports can be requested. In addition to
reviewing the certified reports, auditors are able to ask those who certified their time
questions regarding their effort. Below are common questions that auditors may ask to
gather information and confirm that the certified reports are accurate.
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What was your general area of study/ research during the audit period?
How many grants did you work on? What are their titles? What is your committed
effort? Who is the sponsor? Can you provide a brief description of each project?
Did you provide assistance on other projects? (if so, how much time was spent
doing this)
How many hours per week do you typically work?
How did you account for your time so you can certify your effort?
Were you on any University committees?
Did you do any teaching?
Do you have any activities outside of the institution? (consulting)
Did you write any proposals? (if so, how much time was spent doing this)
TIME AND EFFORT REPORTING
COMPLIANCE ISSUES, INSTANCES THAT CAN CAUSE FINDINGS
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Failure to include all institutional effort in the effort percentage calculation
Effort reports signed by individuals with insufficient knowledge of the work
performed (the PI must sign for all those who have worked on their award)
Use of a normal 40 hour work week as a basis of effort percentage as opposed to
a reasonable estimate of actual hours worked (if more or less than 40 hours)
Faculty charged 100% to sponsored research
Not counting institutional work performed on an employee’s own time
Effort reports not being returned by the due date
Recertifying or revising already completed and documented time and effort reports
Failure to account for unfunded effort (cost share)
Significant data inconsistency between effort reporting and other documentation
such as:
– Purchasing goods or services on awards that time is not reported on
– Charging 100% of time to an award and supervising those who are not
working on the award
TIME AND EFFORT REPORTING
POTENTIAL OUTCOMES OF AUDIT FINDINGS RELATED TO EFFORT AND
EFFORT REPORTING
If after reviewing the certified reports and gathering additional information, an audit
finding is recorded, the following is a listing of potential outcomes of such audit
findings
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Loss of funding and drawdown privileges for future research activity
Fines and penalties from oversight agencies
Settlement costs and/or damages arising from actions under the Federal and State
False Claims Act
Damage to the institution's reputation
Debarment, suspension, or criminal and/or civil sanctions of the PI
If you have any questions, please contact:
- Marie Baka-Mosko, Grants Accountant II (Ext 6371 or [email protected]) or
- Mike Catlos, Grants Accountant I (Ext 6380 or [email protected])
TIME AND EFFORT REPORTING
SOURCES
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OMB Circulars A21 & A133
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Federal False Claims Act, 31 U.S.C., sections 3729-3733
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http://www.taf.org/federalfca.htm
The National Association of College and University Attorneys
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http://www.whitehouse.gov/omb/circulars_index-education
http://www.higheredcompliance.org/resource/effort-reporting-best-practices-and-recentenforcement-actions/
National Council of University Research Administrators (NCURA)
– http://www.ncuraregion1.org/images/2011_C35-Effortless_Reporting_final.pdf
2 CFR Parts 215 & 220
– http://www.whitehouse.gov/sites/default/files/omb/assets/omb/fedreg/2005/083105_a21.p
df
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INSTITUTIONAL REVIEW BOARD
HUMAN SUBJECTS RESEARCH
HUMAN SUBJECTS RESEARCH
NEOMED Policy
The ethical conduct of biomedical research assumes that the researcher and the
subjects are always fellow human beings, equal in dignity and rights. The researcher’s
quest for knowledge must always be balanced with respect for the person, their rights
and welfare. Thus, NEOMED’s policy is intended to support legitimate scientific inquiry
within the context of human values and ethical principles.
NEOMED shares with most research institutions the philosophy that human subjects
are a valuable resource and that this resource should not be expended on meaningless
investigations, even if participation carries no apparent risk.
NEOMED’s Institutional Review Board (IRB) encourages and supports quality research.
Research involving human subjects conducted by faculty, staff, or students on its
premises or under its sponsorship, whether supported by outside funds or not, must be
reviewed and approved by the NEOMED Institutional Review Board (IRB) for human
subjects research. The NEOMED IRB retains final judgment, to the extent allowed by
Federal regulations, as to whether a particular activity is covered by this policy.
NEOMED is in full compliance with State and Federal regulations for the protection of
human subjects and further extends such policies to include all human research projects,
whether sponsored by Federal agencies or not.
NEOMED’s IRB is guided by the ethical principles regarding all research involving humans as
subjects as set forth in:
1. The “Declaration of Helsinki” of the World Medical Association which sets international
ethical guidelines for human subject research; and
2. The “Belmont Report” which identifies basic ethical principles for the conduct of
research involving human subjects. The three basic principles outlined by the Belmont
Report are:
a. RESPECT FOR PERSONS - acknowledge autonomy; protect those with diminished
autonomy
b. BENEFICENCE - do no harm; maximize possible benefits and minimize possible
harm.
c. JUSTICE - in selecting subjects, distribute the burdens and benefits of research
equally among the various classes of society.
IMPORTANT DEFINITIONS
For the purpose of applying policies about human subject protection,
RESEARCH is defined as a systematic investigation designed to develop or
contribute to generalizable knowledge.
HUMAN SUBJECT is defined as a living individual about whom an
investigator conducting research obtains:
– Data through intervention or interaction with the individual, or
– Identifiable private information, or
– Pathological specimens of any type from humans
IRB approval must be obtained PRIOR to any activity. This includes
advertising, recruiting subjects, gathering pilot data, conducting research,
analyzing, presenting and publishing data
RESPONSIBILITIES OF A PRINCIPAL INVESTIGATOR (PI)
The PI of the protocol is responsible for:
• Supervising the research process to ensure not only safety and
protection of subjects, but that all investigators are properly trained
• Having the appropriate resources to conduct the study
• Not deviating from the protocol
• Conducting research in an ethical manner
• Knowing and adhering to all local and state laws, and federal regulations
regarding the safety and protection of human subjects
HUMAN SUBJECTS TRAINING
Investigators engaged in human subjects research must have completed human
subject research protections training before the protocol will be approved. Training
may be obtained through the Collaborative Institutional Training Initiative (CITI)
course in The Protection of Human Research Subjects at
https://www.citiprogram.org/default.asp, or through the National Institutes of
Health, Office of Extramural Research, Protecting Human Research Participants
course at http://phrp.nihtraining.com/users/login.php.
IRB Chair: Julie Aultman, Ph.D., Ext. 6113
Human Protections Administrator: Beth Cline, M.S., M.L.S. Ext. 6498
Committee Coordinator: Trish Wilson, CRA, Ext. 6364
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Please submit all materials for IRB review to Trish Wilson, CRA, Research
Administrator, Room G-235, Blacklow Primary Care Building.
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OFFICE OF RESEARCH AND SPONSORED PROGRAMS
COST SHARE
Cost Share
Overview
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Cost sharing is the portion of total project or program costs that is
not borne by the sponsor. Cost sharing occurs when the sponsor
requires, or the University commits, funds beyond those awarded
by the sponsoring agency.
The cost share pledge may be either a fixed amount of money or a
percentage of the project costs.
It is the University’s objective to obtain full cost reimbursement from
its sponsors, therefore, it is the policy of the University that, unless
mandated by the sponsor, voluntary cost sharing is strongly
discouraged.
Types of Cost Share
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Mandatory – cost sharing that the sponsor requires as a condition of
receiving the award.
Voluntary Committed – cost sharing committed by the PI in the proposal
that is not required by the sponsor. If the proposal is accepted by the
sponsor, the proposed cost sharing is then considered mandatory, becomes a
required term or condition of the award, and must be provided and
documented.
Voluntary Uncommitted – cost sharing that is not committed or budgeted in
the proposal but is committed internally, e.g., unfunded salary that is not
mentioned in the proposal. It does not need to be tracked for cost accounting
purposes or reported to the sponsor.
In-Kind – cost sharing through the provision of goods and/or services whose
value can be established in the open marketplace. In-kind cost share is
usually provided outside of the University, thus it is not reflected in the
University’s financial system.
Salary Cap – cost sharing that results from the difference between an
investigator’s actual salary/benefits and a salary cap mandated by the
sponsor.
Allowable Cost Share Expenditures
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Costs must be necessary and reasonable for proper and efficient accomplishment
of the project or program. The allowability of specific costs as cost sharing is
usually determined by the sponsor’s specific award terms and conditions. Cost
shared expenses must meet the same standards that apply to the costs that are
directly charged to a project (see 2 CFR 220, OMB Circular A-21). Note that for
federal awards, cost share sources must be nonfederal, unless specifically
allowed.
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Examples of Allowable Cost Share: Salaries and benefits, equipment, supplies,
travel, indirect costs (only if specifically allowed by sponsor)
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Cost share must be approved by the individual, department, or entity that has
authority over the source of the funds, e.g., Supervisor/Chair must approve
salary/benefits cost share. Cost share is approved through internal proposal
routing forms.
Disallowed Cost Share Expenditures
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Expenditures generally not allowed: costs that are included as part of the F&A
cost rate, such as building and equipment depreciation, department administration,
space; administrative salaries; general office supplies; salary dollars in excess of
regulatory salary caps; and unallowable F&A. (Note: indirect cost recovery
voluntarily waived or reduced is considered University voluntary, uncommitted cost
share).
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Double counting – cost share can only be committed and reported as cost share
once.
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Costs Incurred Outside the Project Period – Costs that have already been incurred
prior to the award date are generally unallowable as cost share; costs incurred
after the project end date are likewise unallowable.
Post-Award Cost Sharing Processes
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All committed cost sharing is subject to audit and the University must substantiate the cost
sharing expenditures.
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Investigators should work with Grants Accounting to verify cost sharing information. Grants
Accounting has the responsibility of providing confirmation and certification to sponsors that
the University has fulfilled its cost sharing commitments under a specific award.
Other
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Please NOTE that some sponsors, e.g., National Science Foundation, do not allow cost share;
therefore, it must not be committed in the application.
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COMPARATIVE MEDICINE UNIT
ANIMAL CARE AND USE
IACUC
– The NEOMED Institutional Animal Care and Use Committee
(IACUC) is responsible for overseeing all aspects of animal
care and use on the NEOMED campus. The Institutional
Official (IO), in cooperation with the IACUC, is charged with
assuring to federal agencies that the animal care program
adheres to applicable regulations and policies.
– The IACUC is committed to working with the investigative
community in a collegial manner to assure animal welfare and
the conduct of high quality animal-based research.
– Federal agencies have requirements for reporting
noncompliance and related events with which the IACUC and
the IO must comply.
– Please contact the IACUC Chairperson, the Regulatory Affairs
Coordinator, or the Attending Veterinarian for advice or
assistance regarding any matters pertaining to the IACUC.
IACUC AND PROTOCOLS
– Compliance with all aspects of an IACUC approved protocol is an
essential requirement of the Office of Laboratory Animal Welfare
(OLAW), the United States Department of Agriculture (USDA),
and AAALAC. For example:
• All procedures (surgical, nonsurgical, anesthetic, pre- & post-procedural
care) must be carried out as they are described in the protocol.
• The use of all compounds, analgesics, and anesthetics associated with
animal experimentation and care, including routes of administration and
dosing schedules, must comply with the approved protocol.
• Annual reviews and triennial renewals must be completed on time for ongoing protocols. The IACUC is obligated to suspend animal work on
protocols that have not been renewed and approved by the expiration
date.
– Deviations from the aforementioned are potentially reportable to
OLAW, USDA, AAALAC, and the funding agency.
– Protocols can be modified to address proposed changes,
however, changes must be approved by the IACUC before they
are implemented. Some proposed changes may require a new
protocol.
IACUC AND PERSONNEL
– Personnel who work on animals must be listed as a
Participant on the protocol under which they work.
– Protocol Participants must know and comply with all
aspects of the approved protocol. Responsibility for
protocol compliance rests with all participants, not just
the Principal Investigator.
– In order to be listed on a protocol as a Protocol
Participant, applicants must complete online training,
occupational health and safety training, a facility
tour/orientation, and a Protocol Participation or Addition
of Personnel form.
– Approval of the Addition of Personnel form is rapid once
requirements are met – administrative approval is all that
is required.
IACUC PROCESS AND POTENTIAL OUTCOMES
ASSOCIATED WITH NONCOMPLIANCE
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Process - Upon notification of a potential noncompliant event, representatives of the
IACUC review the matter with the involved persons and report their findings to the
IACUC. The IACUC determines if a noncompliance occurred and, if so, recommends a
course of action to the IO. The IACUC communicates required actions to the Principal
Investigator, and the IO notifies external agencies as necessary.
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Potential Outcomes to Investigator
– Official reprimand
– Investigator and staff undergo retraining; retraining may include service on the
IACUC
– Loss of impacted animals, access to them (placed on a holding protocol until issue
is resolved) and/or loss of data collected from them
– Reimburse funding award account for funds used to support impacted activity &/or
loss of funding
– Suspension or termination of protocol
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Potential Outcomes to NEOMED
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Research program audit
Loss of funding
Monetary fines
Other penalties
ANIMAL CARE AND USE REMINDERS
• All importation of animals from unapproved suppliers must
have approval of the Comparative Medicine Unit (CMU)
Director, whether housing will occur or not.
• All animal exports must have approval of the CMU Director.
• Standard mouse and rat cages in the CMU are limited to
one dam with one litter ; sires, other females, and additional
litters cannot be housed with them.
• Confirmation of death after euthanasia is essential
regardless of the method of euthanasia.
• Chemicals and other substances administered to animals
must be pharmaceutical-grade unless the IACUC has
granted approval for the use of non-pharmaceutical grade
preparations.
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OFFICE OF THE GENERAL COUNSEL
FINANCIAL CONFLICT OF INTEREST IN RESEARCH
FINANCIAL CONFLICT OF
INTEREST IN RESEARCH
Key changes to the Public Health Services (PHS) regulations effective August 24, 2012:
• Lower financial disclosure thresholds
– 1995 regulation imposed $10,000 threshold  now $5,000 with expanded
definitions of what constitutes a “significant financial interest”
• Broader spectrum of financial interests required for disclosure
– 1995 regulation required disclosure of financial interests related to PHS-research
 now require disclosure related to “institutional responsibilities”
• Increased reporting to PHS about conflicts
– 1995 regulation required limited reporting  now require more detailed reporting
stating the amount of financial interest and must be updated annually
• Institutional conflict of interest information is made publicly available
– 1995 regulation had no such requirement  need make COI policy available to
the public, in addition to certain COI information about investigators
• Investigator training
– 1995 regulation had no such requirement  now required prior to engaging in
PHS research
INVESTIGATOR DISCLOSURES
Investigators must disclose any “significant financial interests” related to their “institutional
responsibilities”
Significant Financial Interests (SFI)
• Minimum threshold of $5,000 generally applies to payments and equity
interests
• Includes any equity interest in non-publicly traded entities
• Excludes income from seminars, lectures, or teaching, and service on
advisory or review panels for government agencies, institutions of higher
education, academic teaching hospitals, medical centers, or research
institutes affiliated with an institution of higher education
• Excludes income from investment vehicles, such as mutual funds and
retirement accounts, as long as the investigator does not directly control the
investment decisions made in these vehicles
Institutional Responsibilities
• Refer to an investigator's professional responsibilities on behalf of the
institution, which may include activities such as research, research
consultation, teaching, professional practice, institutional committee
memberships, and service on panels such as Institutional Review Boards or
Data and Safety Monitoring Boards
INVESTIGATOR TRAINING
Each Investigator must complete training
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Prior to engaging in research related to any PHS-funded grant or contract and at
least every four years
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Immediately, if:
– the Institution’s COI policies change in a manner that affects Investigator
requirements
– an Investigator is new to an Institution
– an Institution finds an Investigator noncompliant with Institution’s COI policy or
management plan
INSTITUTIONAL DUTIES
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Institutions must determine if the SFI disclosed by the Investigator constitute a
financial conflict of interest
– If so, the Institution must develop a management plans around that interest
containing certain pieces of required information
– COI management plans must be reported to PHS and updated annually
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Institutions must make their COI policy publicly available on the Institutional
website
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Institutions must make certain information about COIs held by senior/key
personnel must be made publicly available via website or in a written response to
any requests for COI information