# Presentation: 253709

## A Federal Perspective on Compliance

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

## 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.

## NIH Objective

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

## Research is a Partnership

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

## Who is Responsible?

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

## Compliance is an Institutional Commitment!

## 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

## 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

## 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- Outdated or nonexistent policies and procedures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

## Roles and Responsibilities

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

## 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

## 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

## Training and Education Programs

*  **A culture of compliance begins with a culture of understanding*

## 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

## 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

## 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

## More on Trainingand 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

## More on Trainingand 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

## Policies and Procedures

*  **Accessibility of written institutional policies and procedures is vital*

## 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

## 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

## Management Systems

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

## 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

## Examples of How toImprove 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

## Examples of How toImprove 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

## Strengthen InternalControl 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

## Examples of Internal Control Activities

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

## 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

## 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
- Don’t wait for a catastrophe to start thinking about compliance – take a proactive stand

## 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

## 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

## 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/compliance.htm

## Dear Grants Compliance...GrantsCompliance@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](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.

## 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](http://grants1.nih.gov/../WINNT/Temporary%20Internet%20Files/WINNT/Temporary%20Internet%20Files/OLKAC/www.ori.hhs.gov)_).

## 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

## Dear Grants Compliance (cont’d)

- 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)

## 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...

## Dear Grants Compliance (cont’d)

- ...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.

## 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

## 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

## Questions?

**GrantsCompliance@nih.gov**