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A Federal Perspective on Compliance

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Title: A Federal Perspective on Compliance


1
A Federal Perspective on Compliance
  • Division of Grants Compliance and Oversight
  • Office of Policy for Extramural Research
    Administration, OERNational Institutes of
    Health, DHHS

2
Division of Grants Compliance and Oversight
Director OPERA
Director, Division of Grants Compliance and
Oversight
Assistant Grants Compliance Officers
  • This Division was established on August 28,
    2001 and has the responsibility for managing both
    internal and external compliance activities.

3
NIH Objective
  • To ensure continued progress on current and
    future NIH-supported research activities while
    minimizing risks to Federal funds

4
Research is a Partnership
  • Collaborative relationship between NIH and
    grantee
  • Mutual need to assure compliance and implement
    proactive compliance measures

5
Who is Responsible?
  • At NIH
  • Grants Management Officer/Specialist
  • Program Official
  • Scientific Review Administrator
  • At the institution
  • Authorized Organizational Official
  • Principal Investigator

6
Compliance is an Institutional Commitment!
7
Compliance Begins at Home
  • You must be in compliance with institutional as
    well as Federal requirements
  • When you have a policy or procedural question,
    start at your institution - institutional
    requirements may be more restrictive
  • Read the Notice of Award

8
A Few Ground Rules
  • Grant awards are made to institutions
  • Recipients of NIH grant funds must comply with
    all applicable Federal statutes, regulations, and
    policies
  • By drawing funds from the HHS Payment Management
    System, grantees agree to the terms and
    conditions of the grant award

9
Common Contributors to Compliance Problems
  • Inadequate resources
  • Lack of understanding of roles and
    responsibilities of institutional staff
  • Inadequate staff training and education
  • Outdated or nonexistent policies and procedures
  • Inadequate management systems (e.g., effort
    reporting, financial management)
  • Perception that internal control systems are not
    necessary

10
Roles and Responsibilities
  • Roles and responsibilities
  • should be clearly defined, communicated, and
    accessible

11
Establish Roles and
Responsibilities
  • Provide a detailed listing of responsibilities,
    including oversight responsibilities, by role
  • Communication is essential. Foster working
    groups or discussion groups for staff involved
    with grant and contract administration at the
    sponsored research and departmental levels
  • Ensure there is a connection between these
    groups, so key information, policy changes, and
    new developments are consistently communicated

12
Establish Roles and
Responsibilities
  • Provide links to related resource information,
    such as institutional requirements, policies and
    procedures, cognizant offices, subject matter
    experts, contact information, and training and
    education opportunities
  • Establish a compliance officer position and/or
    office or committee

13
Training and Education Programs
  • A culture of compliance begins with a culture
    of understanding

14
Develop Effective Training and Education Programs
  • Training and continuing education is critical!
  • Develop formalized education programs and
    consider mandatory training requirements
  • Offer certificate programs
  • Involve respected faculty members to promote
    faculty buy-in

15
Develop Effective Training and Education Programs
  • Utilize individual training plans
  • Roles and responsibilities
  • Internal audit findings are future training
    opportunities
  • Designate a central source of information
  • Education Coordinator/Office that oversees all
    training programs and evaluates them for content
    and effectiveness

16
Develop Effective Training and Education Programs
  • Develop an education program to accommodate new
    and existing staff
  • Orientation for new employees
  • Continuing education programs for staff involved
    with sponsored research
  • Include all personnel with a role in sponsored
    research, including PIs, departmental
    administrators, and sponsored programs staff

17
More on Trainingand Education Training Tips
  • Keep sessions short and provide incentives (e.g.,
    food!)
  • Provide training locations both on and off campus
    (accommodate your busy research staff by bringing
    the training to the labs)
  • Supplement training with web-based information
    and resources, such as online training modules

18
More on Trainingand Education Training Tips
  • Training must be kept current and should be
    consistently provided, otherwise staff may not
    view it as significant
  • Use case studies they are an effective way to
    stimulate rich discussion
  • Include a mechanism for feedback to improve
    course content

19
Policies and Procedures
  • Accessibility of written institutional policies
    and procedures is vital

20
Maintain Current Written Policies and Procedures
  • Accessibility of written institutional policies
    and procedures is vital
  • Maintain centrally
  • Use plain language
  • Update/review regularly to ensure reliability
  • Include roles and responsibilities
  • Make widely available online
  • Provide contact for questions and updates

21
Maintain Current Written Policies and Procedures
  • Assign oversight responsibilities
  • Responsibility authority
  • Develop policies with input from involved staff
  • Utilize internal audit findings when developing
    policies and procedures
  • Develop procedures that will set a consistent
    standard

22
Management Systems
  • Grantee organizations are expected to have
    systems, policies, and procedures in place by
    which they manage funds and activities

23
Effective Management Systems
  • Effective management systems include
  • Clear delineation of roles and responsibilities
  • Written policies and procedures
  • Training
  • Internal controls
  • Effective oversight
  • Information sharing
  • Systems must provide reliable and current
    information
  • Management systems should be driven by policy vs.
    process

24
Examples of How toImprove Oversight(Financial
Management)
  • Sponsored programs (pre/post) should be more
    actively involved in financial oversight
  • Perform spot checks of areas in which there are
    repeated findings or repeated questions
  • Perform a random review of selected categories of
    transactions on every grant at closeout
  • Utilize internal audit findings to improve
    systems
  • Review cost transfer policies to ensure
    requirements for making appropriate cost
    transfers are clear and correct. This area is
    often misunderstood by institutional officials,
    PIs, and departmental administrators

25
Examples of How toImprove Oversight(Financial
Management)
  • Provide the PI with a summary of the terms and
    conditions of each grant award
  • Require PIs to certify that they have reviewed
    monthly expenditure reports and agree with
    charges to their projects
  • Send notification to PI ninety days prior to end
    of a project period informing him/her that the
    project is about to end, work must be completed,
    and all transactions processed in order for final
    reports to be prepared and submitted to the
    sponsor in a timely manner
  • Provide FSRs to PIs, either before or after
    submission, to have them verify the accuracy of
    the information submitted to sponsors

26
Strengthen InternalControl Systems
  • Management tools to help achieve results and
    safeguard integrity
  • Provide reasonable assurance
  • Promote efficiency and effectiveness
  • Encourage compliance
  • Ensure that internal controls are functioning as
    intended to achieve objectives
  • Utilize Internal Audit independent evaluation
  • Perform risk assessments focus on high risk
    events

27
Examples of Internal Control Activities
  • Written policies/procedures
  • Segregation of duties
  • Approval and authorization
  • Verification
  • Physical restrictions
  • Documentation
  • Monitoring and reporting

28
What We Have Learned
  • An effective culture of compliance must be
    established from the TOP and be an institutional
    expectation
  • Establish a mechanism for concerns to be heard
  • Personnel need to understand their
    responsibilities

29
What We Have Learned
  • Training and education are critical
  • Good communication throughout the institution is
    essential
  • Adequate systems must be in place to support an
    effective compliance program
  • Dont wait for a catastrophe to start thinking
    about compliance take a proactive stand

30
NIH Proactive Compliance Site Visit Initiative
  • Proactive Compliance Site Visits
  • Division of Grants Compliance and Oversight,
    OPERA, OER, NIH
  • Not an audit or investigation
  • No report
  • Mutual information exchange emphasis on
    partnership

31
NIH Proactive Compliance Site Visit Program has
  • Supported the NIH goal of moving from reactive to
    proactive interactions with our recipient
    community and demonstrated that
  • Compliance is an ongoing and dynamic process that
    is more likely to be present and effective if it
    is established as an institutional expectation
  • Proactive visits confirm and expand the
    foundation of partnership between NIH the
    recipient
  • Proactive visits encourage and support recipient
    efforts to effectively administer and improve
    sponsored program activities

32
Proactive Compliance Site Visit Summary
FY2000-FY2002
  • 26 institutions
  • Top 150 NIH-supported institutions
  • 20 universities/medical schools
  • 4 nonprofits (3 AIRI institutions)
  • 2 hospitals
  • Geographic diversity
  • Expanded education-outreach seminar
  • Proactive Compliance Site Visits A Compendium
  • http//grants.nih.gov/grants/compliance/compl
    iance.htm

33
Dear Grants ComplianceGrantsCompliance_at_nih.gov
  • Q - What does it mean to be designated a High
    Risk
  • grantee by the NIH and what actions are
    taken against
  • the grantee?
  • A The NIH Grants Policy Statement has a section
    on
  • Enforcement Actions
  • http//grants.nih.gov/grants/policy/nihgps_2001
    /part_iia_7.htm
  • There is not a predetermined set of special
    terms and
  • conditions imposed if a grantee is
    designated as high
  • risk. Actions to increase NIH oversight
    such as removal
  • of Expanded Authorities and exclusion from
    the
  • Streamlined Noncompeting Award Process
    have been
  • used in the past, but each case is
    reviewed and actions
  • taken based upon the specific
    circumstances involved.

34
Dear Grants Compliance
Q How do I report scientific misconduct
related to NIH grants? A You should
notify the Office of Research Integrity
(ORI), Department of Health and Human Services,
of scientific misconduct involving (1)
research supported by Public Health
Service (PHS) funds or (2) an application
for PHS funds. The National Institutes of
Health (NIH) as well as several other
agencies are a part of the PHS. The following
ORI website provides further information
about reporting scientific misconduct
(www.ori.hhs.gov).
35
Dear Grants Compliance
  • Q - I suspect grant funds are being
    inappropriately spent
  • and would like to speak to someone to
    report misuse
  • of NIH grant funds. Who should I contact?
  • A - You have several options for reporting
    financial
  • mismanagement. If you would like to gain
    further
  • insight into the situation or discuss
    institutional
  • policies, you may want to begin by
    contacting the
  • grantee institution (Sponsored Research
    Office) or the
  • NIH grants management office that funded the
    grant
  • http//grants.nih.gov/grants/stafflist_gmos.htm

36
Dear Grants Compliance (contd)
  • If you would like to make a formal allegation of
    misuse
  • of grant funds, you should contact either of the
  • following two organizations with your complaint.
    You
  • may submit an anonymous complaint if you so
    choose.
  • NIH Office of Management Assessment
  • Division of Program Integrity
  • http//oma.od.nih.gov/pi/
  • Phone (301) 496-5586
  • Fax (301) 402-0548
  • DHHS Office of Inspector General
  • http//oig.hhs.gov/oei/hotline/hhshot.html
  • Phone 1-800-HHS-TIPS (1-800-447-8477) (this is a
  • Hotline number which offers a confidential means
    of
  • reporting allegations)

37
Dear Grants Compliance
  • Q Can I submit an application to different
    institutes
  • within the NIH, or to AHRQ, at the same
    time?
  • A - Submission of more than one application
    within the
  • same review cycle is permissible for some,
    but not all,
  • award mechanisms For a NRSA Fellowship (F
    series), only
  • one application may be submitted in the same
    review cycle.
  • For an investigator-initiated grant (R01),
    small grant (R03),
  • career development award (K-Series,
    excepting K08), small
  • business innovation research grant (SBIR),
    small business
  • technology transfer grant (STTR), or a
    conference grant (R13),
  • more than one application in the same review
    cycle may be
  • submitted, if each application describes a
    different research
  • topic

38
Dear Grants Compliance (contd)
  • Submissions of identical applications to
    different
  • agencies within the PHS or to different
    Institutes
  • within an agency are not allowed. Essentially
  • identical applications will not be reviewed
    except for
  • an application for an independent Scientist Award
    (K02) proposing essentially identical research
    in an application for an individual research
    project and
  • an individual research project identical to a
    subproject that is part of a program project
    (P01) or other
  • P-series grants, such as P30 or P50.

39
Useful Websites
  • NIH Guide for Grants and Contracts
  • http//grants.nih.gov/grants/
  • Grants Policy and Guidance
  • http//grants.nih.gov/grants/policy/policy.htm
  • Proactive Compliance Site Visits FY2000-FY2002
  • A Compendium of Findings Observations
  • http//grants.nih.gov/grants/compliance/
  • compendium_2002.htm
  • NIH Conflict of Interest Information
  • http//grants.nih.gov/grants/policy/coi/index.htm

40
Useful Websites
  • Office of Management Assessment
  • http//oma.od.nih.gov
  • Office of the Inspector General
  • http//oig.hhs.gov
  • Office of Research Integrity
  • http//ori.dhhs.gov
  • Office for Human Research Protections
  • http//ohrp.osophs.dhhs.gov/index.htm
  • Office of Laboratory Animal Welfare
  • http//grants.nih.gov/grants/olaw/olaw.htm

41
Questions?
  • GrantsCompliance_at_nih.gov
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