2. A Federal Perspective on Compliance Division of Grants Compliance and Oversight Office of Policy for Extramural Research Administration, OER National Institutes of Health, DHHS

3. 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.

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

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

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

8. 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

9. 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

10. 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Lack of understanding of roles and responsibilities of institutional staff Inadequate staff training and education Outdated or nonexistent policies and procedures Inadequate management systems (e.g., effort reporting, financial management) Perception that internal control systems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

11. Roles and Responsibilities Roles and responsibilities should be clearly defined, communicated, and accessible

12. 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

13. 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

14. Training and Education Programs A culture of compliance begins with a culture of understanding

15. 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

16. 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

17. 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

18. 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

19. 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

20. Policies and Procedures Accessibility of written institutional policies and procedures is vital

21. 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

22. 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

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

24. 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

25. 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

26. 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

27. 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

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

29. 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

30. 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

31. 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

32. 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

33. 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

34. 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 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.

35. 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 ). www.ori.hhs.gov

36. 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

37. 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)

38. 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…

39. 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: 1) an application for an independent Scientist Award (K02) proposing essentially identical research in an application for an individual research project; and 2) 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.

40. 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

41. 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

42. Questions? GrantsCompliance@nih.gov