A Federal Perspective on Compliance

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A Federal Perspective on Compliance

• Division of Grants Compliance and Oversight
• Office of Policy for Extramural Research
  Administration, OERNational Institutes of
  Health, DHHS

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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.

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NIH Objective

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

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Research is a Partnership

• Collaborative relationship between NIH and
  grantee
• Mutual need to assure compliance and implement
  proactive compliance measures

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Who is Responsible?

• At NIH
• Grants Management Officer/Specialist
• Program Official
• Scientific Review Administrator
• At the institution
• Authorized Organizational Official
• Principal Investigator

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Compliance is an Institutional Commitment!
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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

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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

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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• Outdated or nonexistent policies and procedures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

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Roles and Responsibilities

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

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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

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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

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Training and Education Programs

• A culture of compliance begins with a culture
  of understanding

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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

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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

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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

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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

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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

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Policies and Procedures

• Accessibility of written institutional policies
  and procedures is vital

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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

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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

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Management Systems

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

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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

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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

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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

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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

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Examples of Internal Control Activities

• Written policies/procedures
• Segregation of duties
• Approval and authorization
• Verification
• Physical restrictions
• Documentation
• Monitoring and reporting

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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

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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

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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

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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

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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

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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.

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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).
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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
  

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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 [phone]
• Fax [phone]
• 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)

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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

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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.

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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

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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

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Questions?

• GrantsCompliance_at_nih.gov