inside edition: the scoop on the nih compliance site visits
TRANSCRIPT
INSIDE EDITION:
The Scoop on the NIH Compliance Site Visits
NIHPROACTIVE GRANTS
COMPLIANCE PROGRAM SITE VISITS
Cheryl-Lee Howard, Assistant Provost, Research Projects
AdministrationJohns Hopkins University
410-516-8668/FAX 410-516-7775
Gary Thompson, Director, Division of Grants Compliance
OversightOPERA, NIH
301-435-0934/FAX 301-435-3059
Elizabeth Mora, Director, Sponsored Research
Harvard University
617-405-0716/FAX 617-495-2900
Steven H. Smartt, Director, Division of Sponsored Research
Vanderbilt University
615-322-3825/FAX 615-322-3827
Today’s Presentation:
• Why Did NIH Undertake this Project? (Gary)
• What Happened at Three Sites: – Hopkins was first
(Cheryl)– Harvard was the first of
the “second wave” (Beth)
– Vanderbilt was last (Steve)
• Thoughts from the Site Visit Team: Did it work? What Happens Next? What is the Long Range Impact on Academic Research Community?
NIH COMPLIANCE SITE VISITS
NCURANovember 8, 2000
Gary Thompson, Director Division of Grants Compliance and Oversight,
OPERA, [email protected]
Outline• Why NIH undertook this
project– Organizational
responsibility
– Propelling impetus...
• Institution selection
• S-V subject matter determination
• Selection of S-V Team
• S-V preparation
• At the S-V: Day 1– Opening plenary– Subject matter experts– PI’s/DC’s/DA’s– Closing plenary
• SME feedback
• At the S-V: Day 2 – Education/Outreach
• Evaluation– Did it work?– What happens next?– Long range impact...
Organizational Responsibility
Office of the Director, NIH• Office of Extramural Research (OER)
– Office of Policy for Extramural Research Administration (OPERA)• Division of Grants Compliance and Oversight
– Parallel with OHRP, OLAW, ORI and Grantees
Propelling impetus...• Dramatic budget increases
– Commitment to double budget by 2003
• Issues of noncompliance– University of Minnesota– Thomas Jefferson University
• Loss of human life– University of Pennsylvania
• Increase in noncompliance issues, including a disproportional increase in OMA case workload related to grant issues
Why NIH undertook this project
Moving from
Reactive Noncompliance*to
Proactive Compliance*recognize that we’ll never eliminate reactive
noncompliance
Why NIH undertookthis project
• It is not always apparent that a culture of compliance and oversight is universally present in the biomedical research enterprise.
Expanding Resources = Increased Scrutiny
• FY1999 = +$2M over 1998– 2,430 $12.856B 100%
• Top 25 $4.879B 38.0%
• FY2000 = +$2M over 1999• Projected for FY2001*:
– ??? +2.7M over FY2000• Double between 1998 - 2003
*still on continuing resolution
Dramatic increase in grant related cases in (OMA)
• 37% increase in grant related allegations from FY99 to FY2000
• Grant cases increased from 40% of total cases in FY99 to 53% in FY2000– FY1999 = 30/75 total cases– FY2000 = 41/78 total cases
• Most allegations are institutional and involve Universities
Institution selection
CRITERIA– Level of support– Nature of support– Medical School (seven in Phase II)– Geographic Diversity– OPERA not engaged in active
compliance case
N-F-C-S-V’s and PCSV’s
• JHU[1/1] 1010 $351M$255M• UCSF [4/4] 778 $256M$218M • HARVARD U.[8/19] 625 $217M$109M• VANDERBILT[29/25] 393 $111M$94M• OHSU*[34/29] 365 $103M$81M• UTSWMC/D[35/21] 325 $102M$102M • INDIANA U. [40/38] 345 $92M $71M• U. ARIZONA[49/50] 252 $72M $43M• U. MIAMI[50/42] 207 $72M $59M• MUSC[84/60] 162 $37M $36M
THESE 10 INSTITUTIONS ONLY 4462 $1.413M [11%] $1.068M [16%]
ALL INSTITUTIONS/MED SCHOOLS $12.856M $6.562M
N-F-C Phase I and PCSV Phase IITheme: Institutional Oversight
• Roles and Responsibilities (Dean)
• Training and Education (Dean)
• Financial Management of Sponsored Projects* (Payne)
• Financial Conflict of Interest (McCormack; Mizzell; and Pryor)
• Inventions and Patents (Stone)
• Data and Safety Monitoring (Dixon)
• Clinical Gene Therapy Research (Groesch; Rosenthal; and Jambou)
• Hazardous Waste Disposal* (Demsey)
• Interactive Education/Outreach Seminar**not in Phase I NFC’s
S-V: Preparation forand Conduct of…
GOALS:• Increase Educational Outreach• Enhance Administrative Oversight of
Sponsored Research• Renew Institutional Commitment to
Compliance• Receive feedback on obstacles to implementing
Federal rules/NIH policies
S-V: Preparation for and Conduct of…
PURPOSE OF SITE VISIT:
• Assess level of understanding of certain NIH rules by discussing policies, procedures, and practices at recipient institutions to ensure compliance with NIH requirements
S-V: Hoped for outcome
• To increase NIH’s level of confidence in grantee institutions’ ability to effectively manage NIH grant funds
At the SV: Day One• Opening plenary
– Overview• S-V Team• Institutional Officials
• Breakout Sessions– Subject Matter Experts– Principal Investigator’s; Department Chairs;
Departmental Administrators; Sponsored Projects Staff
• Closing Plenary– SME Feedback
• S-V Team• Institutional Officials
At the S-V: Day Two**No Day Two for Phase I
• Education/Outreach– Phase I
• Compliance Seminar at UCSF
– Phase II• All Seven Institutions
– Promoted by Institution
– Faculty and Staff
– Averaged around 150/Institution
– OHSU: More than 300 state wide
NIH Site Visits
END PART I
OF NIH DISCUSSION
Difficulties
• NIH Team using Hopkins visit as a model for developping the process– At the time of our visit, had only scheduled
UCSF and UTDallas(subsequently changed to UT Southwestern Med Ctr Dallas)
• Very general guidelines
• Visit scheduled during Spring Break when many faculty unavailable
THE PLANNING PROCESS
JHU TEAM
• Vice Provost for Research
• Deans for Research from 3 Divisions with NIH Funding
• Controller
• Director of Internal Audit
• Compliance Officer
JHU Team (continued)
• University Counsel
• IRB Chair
• Directors of Offices of Technology Transfer
• With consultation (and lots of effort) from many others
Guidelines from the NIH Team
Key areas:• Roles and Responsibilities• Training and Education• Financial Conflict of Interest• Inventions and Patents• Institutional Review Boards• Institutional Biosafety Committees• Reporting Adverse Events
Guidelines from the Team (continued)
• Provide in advance:– Roles and Responsibilities matrix– Relevant materials on:
• internal audit
• institutional oversight
• internal controls
• training programs (mandatory and optional)
“but please don’t inundate us with paper!”
What we provided:
• List of URL’s for policy and other related materials – 3 pages single spaced
• Research Admin-Roles and Responsibilities– 1-page matrix of who
does what
• Research Compliance Committee membership list
• Research Compliance Organizational Chart
• Detail on the course outlines for training in existence or in design
The Visit
• One day (March 20)--9AM to 4:30 PM• Opening plenary session to present both NIH
overview and JHU overview• Breakout Sessions in four areas:
– Roles & Responsibilities/Education & Training– Financial Conflict of Interest– Inventions and Patents– IRB/Adverse Events
The Visit (continued)
• Group and individual interviews with a dozen faculty and our Biosafety Officer
• Three opportunities for Executive Session conferences for the team
• Exit Conference
The Exit Conference
• Conflict of Interest– NIH has no central file
– NIH requires reporting of all COI unlike NSF
• Adverse Events – interpretation as to
when common rule requires reporting
• Inventions and Patents– Well educated faculty
• Gene Therapy– NIH needs to clarify
guidelines for reporting (when and to whom)
– NIH knows they need to streamline and simplify the reporting process (checklists/clearing house)
The Exit Conference (continued)
• General Comments– Climate, Commitment,Culture to/of excellence– JHU should have a 101 course in Research
Admininstration for Faculty – Decentralization (team approach) works!– Need for consistency in rules and regulations to
reduce confusion– Plans for Web Based Training a plus– Shadow systems:do they indicate poor systems?
Advice on Outcomes
• There will be no written report--no “findings” to be acted upon unless evidence of criminal activity were found
• Best practices will be written and communicated after all 10 visits done
HARVARD
NIH Proactive Site Review:A Perspective from Harvard University
Elizabeth Mora
Director of
Sponsored Research
Harvard University
Agenda
• Background and preparation
• The experience of being the first institution in “Phase Two” of the site visits
• The sentencing
• Afterthoughts
Background
• Here is a picture of the sequence of events timeline (view next three slides):
Background, cont’d
• Johns Hopkins Univ receives letter about visit
• Feb `00
• Harvard’s Office of General Counsel mobilizes task force to prepare (in case!)
• March `00
Background, cont’d
• NIH visits JHU, University of Texas SW, UCSF
• March `00
• Every Friday afternoon for two hours (3-5 pm) OGC convenes task force to prepare, inventory plus research current practices, etc.
• Late March• May-June-July `00
Background, cont’d
HarvardUniversityreceives noticeof NIH visit
NIH on campus
HarvardUniversitysighs in relief
June `00 July 19 + 20 July 21
Preparation Process
• The NIH’s areas of initial focus were:– Roles and Responsibility in Research
Administration– Training and Education– Financial Conflict of Interest– Human Subject - IRB Processes– Animal Care and Use Review Processes– Gene Therapy Review Process
Preparation Process
• The General Counsel hired a paralegal to begin gathering and compiling information, including: written procedures, training materials, website content, matrices of roles and responsibilities, sample reports, etc.
• The notebooks we sent down to NIH were enormous
Preparation Process
• In the meantime, two days before the visit, NIH changed the focus areas by adding two and subtracting one– Animals use was subtracted– Financial Management of Sponsored Projects– Data Safety and Monitoring were added
Preparation Process
• The final week was very stressful– Pulling binders of
information together– Deciding on who would
lead the Harvard sessions, where everything would happen
– Every hotel room in Boston was booked because of the Tall Ships!
Preparation Process
• About a week before the visit, we received detailed instructions from NIH identifying the structure and format of their visit:– Type of position with whom they wanted to
meet– The selection criteria (HU or NIH)– When and format (groups or one-on-one) (see
Appendix A)
Preparation Process• The visit was scheduled to be 1-1/2 days
and occur as follows:– group sessions Wednesday morning in each
focus area– One-on-one sessions Wednesday afternoon
with faculty members and administrators– The Director of Internal Audit and I developed
“mock questions” and distributed them to all involved (see Appendix B)
Preparation Process
• For Thursday morning, NIH requested a joint compliance presentation from Harvard and NIH to Harvard faculty and staff
• PLEASE NOTE: Harvard was the first site visit to move from “NOT FOR CAUSE” to “PROACTIVE”, indicating that the University would be taking a more proactive role in the process through the joint delivery of the Compliance Workshop
Experience Itself
• Okay, what REALLY happened?
• Wednesday morning, Gary Thompson and eight other NIH representatives met for an opening session with Harvard University senior administrators:
Experience Itself
• Mr. Thompson set a very positive tone putting us all at ease, explaining the goals and objectives of the visit– He was even funny!
• Our Provost responded by welcoming them and giving the group a high level overview of Harvard and our commitment to the research enterprise and related compliance requirements
Experience Itself
• Then, subgroups were divided and the morning working sessions with NIH and HU representatives began
Experience Itself• The morning sessions were interactive and
ended with NIH asking for feedback on how they could make improvements
• As chair of the Roles and Responsibilities Training and Education Subgroup, I raised two items:
1) Modular Grants - while this vehicle has streamlined procedures, the audit ones are still looking for detailed budgets (NIH agreed this was a problem)
Experience Itself
2) Training on compliance - faculty members do not take this seriously unless it comes from NIH
(Boy, did it come the following week!)
Experience Itself
• In the afternoon of the first day, NIH representatives met individually with faculty or in small groups of three: faculty plus department administrator . . .
• NIH requested that we reconvene at 4:30 pm . . .
The Sentencing• Mr. Thompson began the session by
stating that they were very pleased with what they observed and heard, then each NIH focus area leader got up and summarized his/her thoughts
• Wednesday ended with five observations, not to be used in any report but to be possibly incorporated into a set of “best practices” to be issued after all ten site visits:
The Sentencing 1) Confusion in the regulations on the
frequency of financial conflict of interest reporting
2) Cost Transfers - our policy allows cost transfers to occur up to 120 days after original transaction--NIH thought timeframe should not exceed 90 days because of FSR deadlines.
The Sentencing 3) Faculty training - NIH
felt at a minimum, PI’s involved with large program projects should receive training
4) NIH noted some disparity between their interpretation of Gene Therapy regulations and our interpretation
The Sentencing
5) Reliance of shadow systems - NIH noted that in a year after conversion to a new system (Oracle) we may be heavily reliant but stated that over time, they would like to see this reduced . . . (see Appendix C)
• We breathed a small sigh of relief and prepared for Thursday morning (and prayed that faculty members would show up for joint compliance training session)
Experience Itself
• Thursday morning at 8:30, 130 people ~ 60 faculty members packed an amphitheater at HMS
• Gary Thompson led off, then HU presented a version of the topic in response (importance of compliance, roles and responsibilities, financial management, conflict of interest, etc.)
Experience Itself
• 3.5 hours later . . . It was over
• Everyone was happy and relieved and those of us who had participated in the planning and preparation over the past three months, walked around aimlessly for the next several days . . .
Afterthoughts• We established relationships with the NIH
OPERA office and others at NIH
• The visit was helpful to those of us in research administration trying to get the faculty to pay attention
• This was a valuable exercise for us to inventory our own areas of strengths and weakness
• We will leverage the experience in the new term in policy development and training
Questions, Comments
VANDERBILT
Vanderbilt UniversityNIH Compliance Site Visit
NCURA Annual Meeting
November 8, 2000
Vanderbilt UniversityNIH Compliance Visit
• Last of the 10 universities visited in phase 1 and phase 2
• Notified in early June and allowed to suggest possible dates for visit
• Date of visit: September 21-22, 2000
Vanderbilt Organizational Structure
• Single location, but complex structure
• Dual channels for research oversight
• Decentralized support operations
• Key parts under academics, financial, facilities, and treasurer
• Challenges: coordination, communication
Areas reviewed by NIH
• General: – Roles/responsibilities– Training/education
• Specific:– Financial management– Financial conflict of Interest– Invention reporting (technology transfer)– Gene therapy; adverse events monitoring
Planning and Preparation
– Medical center took lead role
– Planning committee (~20 people)• Key administrators in each compliance area
– Task Groups (3-5 members each)• For each area (financial, COI, tech transfer…)
– Integrated presentation of compliance at VU
– Also…preview meetings, edit team
– Web Site:• http://www.vanderbilt.edu/compliance/html/frame_trcp.htm
Outcomes
– Good impression, positive feedback
– Momentum, leverage, planning for comprehensive integrated approach
– Designation of compliance officer(s)
– Monitoring group• Transinstitutional Research Operations Review Group
• Regular, periodic reviews
– Drafted roles and responsibilities statements
– Drafted comprehensive education/training plan
Roles and Responsibilities
• Principal Investigator • Department Chair/Center Director • Department Financial Administrative Officer • Dean's Office or Designee • Compliance Officer • Executive Administration
Roles and Responsibilities (cont)
• Office of Technology Transfer • Institutional Review Board • Division of Animal Care (IACUC) • Institutional Biosafety Committee (IBC)/Biosafety
Officer • Office of Internal Audit • Department of Environmental Health and Safety • Sponsored Research Office• Contract and Grant Accounting
Roles and Responsibilities
• Animal Welfare• Environmental Health & Safety• Financial Administration of Research (Post-Award)• Financial Conflict of Interest• Human Gene Transfer• Human Subjects Protection• Institutional Commitment to Compliance• Patents & Inventions• Sponsored Programs Administration (Pre-Award)
Next Steps
• Further input and buy-in for Roles and Responsibility statements
• Implement training programs in new areas
• Determine how to make training systematic (and more centralized?)
NIH Site Visits
START PART II
OF NIH
DISCUSSION
Evaluation: Did it work?• The whole is greater than the sum of its
parts...– Observations from an individual site visit offer
a limited view; however, there is significant value added with each subsequent site visit, especially when viewed cumulatively
– In this context...• three offers more than one• ten will offer more than three
Evaluation: Did it work?Institutional feedback…
• Proactive approach universally praised– Build a foundation of acquaintance and mutual trust– Constructive and helpful– Significant value added and provided substantial education– Open and responsive
• Humanized the NIH presence• Appreciated S-V team personality and sense of humor• Characterized the NIH approach to this initiative as “refreshing”• Collegial, interactive, fair, and instructive• Value added through discussion of issues in a non-crisis, non-adversarial manner• Raised awareness and culture of compliance• Contacts made will be useful in future• Recognized growth in NIH budget, but questioned how much of increases were
going to support “infrastructure”
Evaluation: Did it work?Comments by Dr. Ruth Kirschstein, Acting
Director, NIH: The PCSV’s...• Focus on the most important issues• Give us knowledge of how institutions
implement our policies• Help identify difficulties institutions face in
fulfilling Federal requirements• Help us to be both a partner and a steward• Will continue to be conducted...
Evaluation: What did we learn?
• Some institutions have developed a culture of compliance - compliance is a habit of mind and a habit of work
• Site visit preparation helped promote a greater awareness and appreciation of compliance
• Sharing lessons learned from PCSVs will be both essential and valuable - everyone has a place at the table
• Faculty resist “training”… they’re much more receptive to “education” … they need to understand the value added
Evaluation: Did it work?More from the S-V Team
• Concern over lack of NIH & IC resources (staff & $$) to provide follow-up where appropriate
• Liked structure of subject matter interviews - valuable and provided good exchange of information
• Receipt of institutional materials in advance was helpful for preparation … less was more
• Comfortable and positive approach• Continue emphasis on proactive mode• Fixed site visit team provided better continuity• CERT participation was valuable• OMB observer:
– Appreciated emphasis on responsibilities and accountability– Impressed by ability of S-V Team to provide expert feedback at end
of Day 1
Evaluation: More lessons learned...
• Value in preparing for Site Visit– “…NIH presence has a galvanizing impact on increasing
compliance and strengthening cultures of compliance.”
• Value in “hearing it from NIH”• Undercurrent of distrust
– Conflict of Interest– Closely related research
• Concerns about the “cost of compliance”– At the Institutions– At the NIH
Evaluation:“Roles & Responsibilities”
• Value in formal comprehensive roles and responsibilities matrix
• Routing sheet used as a control mechanism to help assure compliance
• Need (and desire) for more “work/discussion” groups… problem solving
• Applied Practice: Comprehensive R&R matrix organized by position and responsibility that includes both vertical and horizontal relationships. Ideally, this information should be posted on the web with links to related policies and procedures as well as to training and education opportunities and requirements.
Evaluation: “Training and Education”
• Many training courses available from various sources, but few have a consolidated source of training information for faculty and staff
• Strong reliance on Departmental Administrators to be the “experts” but rarely did we observe institutional support for these staff with an individual training plan reflective of a formalized education program
• Need for new PI training/education was identified in most institutions
• Applied Practice: Web-based training programs are designed to augment rather than supplant traditional classroom setting.
Evaluation: “Financial Management”
• At most institutions, pre-award and post-award functions were organizationally and sometimes geographically separate. The separateness of the two offices contributed to some problems related to communication and interaction between employees in the two groups.
• Lack of timely and accurate financial information was identified as problematic with regard to the financial management of projects and resulted in formal or informal “shadow” accounting systems being maintained by departments
• Applied Practice: A Sponsored Projects Expenditure Compliance Office (post-award) is extremely effective at monitoring charges to sponsored projects, identifying questionable or inappropriate charges and formally notifying appropriate institution officials.
Evaluation:“Financial Conflict of Interest”
• Generally, institutions do not have adequate outreach and education to their faculty regarding the PHS Financial CoI regulations.
• Faculty perceive that identifying CoIs is a “blemish” on their research or professional standing (e.g., CoI is not inherently wrong as long as once disclosed and identified it is managed, reduced, or eliminated).
• There seems to be some element of distrust between faculty and their own institution, as well as between faculty and the NIH. Some faculty expressed fear that full disclosure might result in a reduction in their institutional salary or adversely affect NIH funding.
• Applied Practice: A regularly scheduled forum where faculty is free to discuss potential conflicts with the CoI Committee and designated officials may go a long way to “de-mystify” and “decriminalize” the reporting process.
Evaluation:“Patents and Inventions”
• Most investigators interviewed were not familiar with the major provisions of Bayh-Dole-related regulations.
• In no case did any grantee organization have adequate human resources to regularly visit labs to “search out” subject inventions; rather, they rely on PI’s to inform them of inventions.
• Faculty members are more likely to report inventions to their technology licensing staff when they recognize benefits of technology transfer to their research program and their institution.
• Applied Practice: The strongest tech transfer programs have discretionary funds specifically earmarked for use by faculty who are in pursuit of specific licensing opportunities. When such funds had been made available, processes were in place to recoup funds out of the revenue generated once successful licensing has been accomplished.
Evaluation:“Clinical Trial Data and Safety
Monitoring”• Institutions generally support the need for greater attention to
data and safety monitoring of clinical trials, in the interest of both human subject protections and credibility of trial results.
• The value of trial monitoring arises from the intellectual activity of summarizing the trial results to date by the investigator and discussing them with colleagues.
• In some institutions a GCRC is involved in much of the trial research and is well positioned to monitor through its existing committee structure.
• Applied Practice: For determining the adequacy of monitoring plans, IRBs should require monitoring plans as part of their initial protocol review. At least one institution went even further, requiring that all clinical trials have a named medical monitor to check the assessment of all adverse events.
Evaluation:“Clinical Gene Transfer
Research”• Multi-site trials and industry-sponsored trials appear to
present additional challenges in terms of understanding who is responsible for reporting required information, when reports are to be made, and to what entities.
• Concerns were expressed that the already, and likely increasing, administrative burden associated with gene therapy research: – 1) may dissuade new investigators from pursuing this important line of
research;– 2) could increase the likelihood of inadvertent noncompliance; and– 3) necessitates additional administrative/oversight functions that are costly
and often not covered by traditional research grants.
What happens next?• There will be more site visits!• We‘ll try to maintain a “proactive” approach…• Yet to be determined:
– Purpose– Nature– Scope– Selection Criteria
• Same or Different?• Do we stay focused on Top 100?• Do we use our “radar” screen? • Can institutions “volunteer” for a site visit?• How many site visits?
• Who conducts the site visit?– NIH Staff only?
• What about institutional peers? – One team? More than one team?
Long range impact...• Establish NIH presence• Proactive – Partners and Stewards together • Strengthen relationships of trust
– Within the Institution– Between Institutions and NIH – Maintain public trust
• Identify potential trouble spots and focus on prevention• Preserve biomedical research enterprise by reducing
associated risks of noncompliance• Build alliance of compliance
– We’re in this together … it’s not “us” against “you”– Accreditation??? – Certification???