NEOMED TEMPLATECOMPLIANCE OVERVIEW

NEOMED TEMPLATE

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

This general overview does not replace the requirement for education and training programs in these and other compliance areas at NEOMED

NEOMED TEMPLATEGRANTS ACCOUNTING

TIME AND EFFORT REPORTING

TIME AND EFFORT REPORTINGA BRIEF OVERVIEW

• 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 REPORTINGHOW EFFORT IS DETERMINED

• 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:

• Total hours worked includes sponsored and non sponsored activities (total professional effort), for example, one must include the following:

– 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

= % Effort on Sponsored projectTotal hours in an average work week

Estimate of weekly hours spent on sponsored project

TIME AND EFFORT REPORTINGEXAMPLES 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.

• 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 REPORTINGCOMPLIANCE ISSUES, INSTANCES THAT CAN CAUSE FINDINGS

• 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 REPORTINGPOTENTIAL 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

• 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 mbaka@neomed.edu) or

- Mike Catlos, Grants Accountant I (Ext 6380 or mcatlos@neomed.edu)

TIME AND EFFORT REPORTINGSOURCES

• OMB Circulars A21 & A133– http://www.whitehouse.gov/omb/circulars_index-education

• Federal False Claims Act, 31 U.S.C., sections 3729-3733– http://www.taf.org/federalfca.htm

• The National Association of College and University Attorneys– http://www.higheredcompliance.org/resource/effort-reporting-best-practices-and-recent-e

nforcement-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.

pdf

NEOMED TEMPLATEINSTITUTIONAL REVIEW BOARD

HUMAN SUBJECTS RESEARCH

HUMAN SUBJECTS RESEARCHNEOMED 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. 6113Human Protections Administrator: Beth Cline, M.S., M.L.S. Ext. 6498Committee Coordinator: Trish Wilson, CRA, Ext. 6364

• Please submit all materials for IRB review to Trish Wilson, CRA, Research Administrator, Room G-235, Blacklow Primary Care Building.

NEOMED TEMPLATEOFFICE OF RESEARCH AND SPONSORED PROGRAMS

COST SHARE

Cost Share

Overview

• 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

• 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

• 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.

• Examples of Allowable Cost Share: Salaries and benefits, equipment, supplies, travel, indirect costs (only if specifically allowed by sponsor)

• 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

• 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).

• Double counting – cost share can only be committed and reported as cost share once.

• 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

• All committed cost sharing is subject to audit and the University must substantiate the cost sharing expenditures.

• 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

• Please NOTE that some sponsors, e.g., National Science Foundation, do not allow cost share; therefore, it must not be committed in the application.

NEOMED TEMPLATECOMPARATIVE 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 on-going 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

• 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.

• 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

• Potential Outcomes to NEOMED– 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.

NEOMED TEMPLATEOFFICE OF THE GENERAL COUNSEL

FINANCIAL CONFLICT OF INTEREST IN RESEARCH

FINANCIAL CONFLICT OF INTEREST IN RESEARCHKey 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 DISCLOSURESInvestigators 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

• Prior to engaging in research related to any PHS-funded grant or contract and at least every four years

• 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

• 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

• Institutions must make their COI policy publicly available on the Institutional website

• 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