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					     NIH Proactive
      Compliance
       Site Visit
Collaborative Training and
    Education Seminar

Medical University of S.C.

      July 26, 2000
 Compliance / Oversight
  NIH’s Compliance Program

        Gary Thompson
Director, Division of Compliance
             OPERA
        301-435-0934
         gt7g@nih.gov
         The Research
          Institution:
          Compliance
It is not apparent that a
 culture of compliance is
 universally present in the
 biomedical research
 enterprise.
Getting to Compliance:

 Our Objective is to…
      Move from
Reactive Noncompliance
          to
Proactive Compliance
               A Look at the NIH
                   Budget...
   FY1999 BUDGET:
       $15.9 Billion
   Extramural Budget:
       $12.8 Billion
            81% of NIH Total
   Grants
       $11.8 Billion
            92% of NIH
             Extramural
   A further look at 1999’s
      total of $12.856B
     Ranking   of ALL Institutions
 Top 5        $1.414B       11.0%
 Top 10       $2.493B       19.4%
 Top 15       $3.397B       26.4%
 Top 20       $4.173B       32.5%
 Top 25       $4.879B       38.0%
 2,430        $12.856B     100%
       Characteristics and
     Principles of Compliance
 Leadership

 InstitutionalCommitment
 Zero Tolerance
 Focus on “high risk” events
Why is Compliance
  important?
          It strengthens the
           relationship of trust
           that exists between
           sponsor and recipient
          It suggests a
           presence of the
           stewardship
           necessary to properly
           safeguard the
           Federal investment in
           biomedical research
       What’s happening at
             NIH...
 Personnel/Organizational     changes in
  OPERA
   Division of Compliance
      Parallel   with OHRP, OLAW, ORI and
       Grantees
 Institutionalassignments
 Incorporating compliance into the grant
  managers stewardship role
 From Not-for-Cause S-V’s to
  Proactive Compliance Site Visits
      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
          NIH Proactive
       Compliance Site Visits
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
   NIH Proactive Compliance
         Site Visits
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
       NIH Proactive Compliance
             Site Visits
THESE SITE VISITS...
   Are NOT audits
   Are NOT investigations
   May or may not result in a formal report
   Will deflect back to the institution any issues of concern
    that need to be addressed with the appropriate NIH
    organization
   Encourage institutional views and perspectives on ways to
    enhance coordination and communication between Federal
    and local oversight programs
   May contribute to the development of “best practices ”
        NIH Proactive Compliance
              Site Visits
WHY THIS, WHY HERE, WHY NOW?
   This proactive effort is consistent with ongoing NIH
    compliance goals and objectives
   Another step in moving from “reactive noncompliance” to
    “proactive compliance”
   The Proactive Compliance site visit helps us to determine
    the congruency of our mutual understanding of certain
    administrative requirements
       Do we both understand the nature of the requirements
        the same way
       NIH Proactive Compliance
             Site Visits
THE FIRST SERIES OF N-F-C SITE VISITS
  ADDRESSED:
   Roles and Responsibilities
   Training and Education
   Financial Conflict of Interest*
   Invention Reporting*
   Policies and Procedures for:
      Clinical Gene Therapy Research*
      Reporting Adverse Events in Clinical Trials*
                             *Regulatory
      Proactive Grants Compliance:
      N-F-C S-V’s - Feedback...
   Constructive and helpful comments
   Open and responsive
   Positive assessment along with constructive
    suggestions for further improvement
   Positive experience
   Worthwhile and helpful to University efforts to
    address various compliance areas
               N-F-C S-V’s:
        Overall General Observations
   Begins process of moving from reactive to proactive
   Confirmed that Compliance is...
      an ongoing and dynamic process
      more likely to be present if it is established as institutional
        expectation
   Value added through...
      discussion of issues in a non-crisis, non-adversarial manner
      educational/outreach effort on 2nd day
   Site Visits build foundation of acquaintance and mutual trust
   Faculty resist notion of being “trained”… they want to be
    “educated”
   Presence of effective institutional oversight was not always
    evident
   NIH Proactive Compliance
         Site Visits
 Thewhole 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
     NIH Proactive Compliance
           Site Visits
A culture of compliance is more likely to
 be present when communicated through
 an institutional commitment to…
  Excellence
  Prevention   rather than treatment
  Quality
  Do   the right thing
  Perform   “Beyond Exceptional”
                    NIH Proactive
                 Compliance Site Visits
   NIH will conduct seven more site visits before 9/30/2000
       Initial contacts have been made with all seven
       All seven are genuinely enthused about participating
   NIH will join with Institution in a collaborative Education
    and Outreach Seminar
       Institution would promote faculty and staff attendance…
       Attendees may receive training credit
   This will help meet NIH goals of:
       Increased Educational Outreach
       Renewed Institutional Commitment to Compliance
            It will also convey an important sense of mutual endeavor and a
             sense that NIH cares...
     Proactive Compliance Site Visits
      Theme: Institutional Oversight
 Roles and Responsibilities
 Training and Education
 Financial Management of Sponsored
  Projects
 Financial Conflict of Interest
 Inventions and Patents
 Data and Safety Monitoring
 Interactive Education/Outreach Seminar
       NIH Proactive
    Compliance Site Visit


Institutional Commitment
      to Compliance

Medical University of S.C.
   NIH Proactive
Compliance Site Visit
   NIH
OVERSIGHT

   Gary Thompson
Increased scrutiny of
NIH and what influences
that scrutiny...
              Climate of Expanding
               Resources
              Demand for
               Stewardship
                  Effective Use of the
                   Publics Funds
                  Accountability
                  Integrity
                  Trust
          EXPANDING RE$OURCE$
         plus $4B from FY1998-2000
   More $$ = More      Congressional scrutiny
    scrutiny            Chairman, Senate Budget
                         Committee
                            “closely monitor agency’s
                             handling of increase”
                        Lightning rod for
                         oversight:
                            Better accountability
                            Assure the public and
                             Congress that $$$ are
                             well spent
             COMPLIANCE ISSUES
         Who’s looking and what they are
   Congress         saying:
       Ordered independent audit
            administrative and
             management practices
       Asked IoM                            The highest oversight
            assess NIH’s decision-
             making process
       Challenged NIH Director
            scientific opportunity and
             administrative capacity
   American Association for the
    Advancement of Sciences
            when you spend public
             money you must be held
             accountable
        Sources of Compliance
 News media
               Issues
   Audits and reviews
   Whistleblowers or anonymous complaints
   Grants Management/Program Oversight
   OMA/NIH reviews
   Office of Inspector General oversight
   GAO audits
   DOJ investigations
   Institutional internal audits (A-133)
       100 recent allegations: OIG 24%; NIH 32%; ORI 4%;
        Anonymous 11%; University 6%; Outside 23%
       NIH Proactive
    Compliance Site Visit

  Institutional Oversight

Medical University of S.C.
Administration/Science
Partnership

       Diane Dean
     Kathleen Shino
  The NIH Extramural
   Management Team


         Review




Grants
Management        Program
      Grants Management Officer
The Grants Management Officer (GMO) is the NIH official
  responsible for the business management of the award,
  including but not limited to:
 evaluating grant applications for administrative content
  and compliance with statutes, regulations and guidelines
 negotiating grants
 providing consultation and technical assistance to
  applicants and grantees, including interpretation of grants
  administration policies and provisions
   administering and closing out grants
    Grants Management Officer


The GMO is the only NIH official authorized to
  obligate NIH to the expenditure of funds or to
  change the funding, duration, or other terms and
  conditions of award
Grants Management Specialist
 Analyzes  grant application budgets and
  other grant related information
 Interprets Federal regulations and policies
 Awards grant funds
 Reviews and responds to grantee requests
  or identifies need for other grant changes
 Agent for the Chief Grants Management
  Officer
 Assures compliance with Federal
  regulations, policies and procedures
    Program Official

The Program Official is the NIH official
  knowledgeable of the programmatic,
  scientific, and/or technical aspects of
  assigned applications and grants

The Program Official is responsible for the
  scientific monitoring of the research
 Scientific Review Administrator
 Performs  administrative and technical
  review of applications
 Selects reviewers
 Manages study sections and project site
  visits
 Prepares summary statements
 Provides any requested information about
  study section recommendations
 Point of contact for applicants
The Management Team at
Medical University of S.C.
       Authorized Institutional
               Official
This official is the designated representative of the
  grantee organization in matters related to the
  award and administration of its NIH grants,
  including those that require NIH approval or
  changes in award terms and conditions

The signature of the authorized institutional official
  is required for all official correspondence to NIH
Authorized Institutional Official
This individual's signature on the grant application
  further assures that the applicant organization will
  be accountable both for the appropriate use of
  funds awarded and for the performance of the
  grant-supported project or activities resulting from
  the application
The authorized institutional official is accountable
  both for the appropriate use of funds awarded and
  for the performance of the grant-supported project
  or activities resulting from the application
         Principal Investigator
The Principal Investigator (PI) is the member of the
  grantee team responsible for ensuring compliance
  with the financial and administrative aspects of
  the award
NIH encourages the PI to maintain contact with the
  NIH Program Official with respect to the
  scientific aspects of the project
NIH also encourages the PI to maintain appropriate
  contact with the Grants Management Officer
  concerning the business and administrative
  aspects of the award
     Principal Investigator
The PI works closely with designated officials within
  the grantee organization to:
 create and maintain necessary documentation,
  including both technical and administrative reports
 prepare justifications
 ensure that Federal support of research findings
  is appropriately acknowledged in publications,
  announcements, news programs, etc.
 comply with organizational as well as Federal
  requirements
   What if I have a Question?

 Can  my question be answered at my
  institution?
 Can my question be answered by written
  policy or regulations?
 Should my question be answered by an
  office at NIH? Should I call the Grants
  Management Specialist or Program Official
  indicated on the Notice of Grant Award?
   For Policy Questions


 IfI tried the above sources and still have
 a general policy question unanswered, call
 the Division of Grants Policy, Office of
 Policy for Extramural Research
 Administration (OPERA), 301-435-0949
   Information Sources
 MUSC’s  Office of Research and Sponsored
  Programs
 Notice of Grant Award (terms of award)
 NIH Grants Policy Statement
 NIH Guide for Grants and Contracts
 NIH Office of Extramural Research
  Homepage
 Welcome Wagon Letter
 Grants Information at grantsinfo@nih.gov
Administration for
  Faculty/PIs

   Diane Dean
  Kathleen Shino
    Greg Pryor
     Overlap

Scientific Overlap occurs when:
 substantially the same research is proposed in
  more than one application or is submitted to two
  or more different funding sources for review and
  funding consideration, or
 a specific research objective and the research
  design for accomplishing that objective are the
  same or closely related in two or more applications
  or awards, regardless of the funding source
    Overlap

Budgetary overlap occurs when duplicate or
  equivalent budgetary items are requested
  in an application but are already funded or
  provided for by another source

Commitment overlap occurs when any project
  personnel has time commitments exceeding
  100 percent
 Program Income
Program income is gross income that is
  directly generated by the grant-supported
  activity or earned as a result of the award

It can be earned by a grantee, a consortium
  participant, or a contractor under a grant
Program Income
Program Income includes, but is not limited
  to:
 income from fees for services performed
 use or rental of real or personal property
  acquired under the grant
 sale of commodities or items fabricated
  under an award
 license fees and royalties on patents and
  copyrights
 Program Income
The requirements for accountability of
  program income are stated in the terms of
  award
Unless otherwise specified in the terms and
  conditions of the award, NIH grantees are
  not accountable for program income
  accrued after the period of grant support
 Change in Scope
Change in Scope is a change in direction, type
  of training, or other areas that constitute
  a significant change from the aims,
  objectives, or purposes of the originally
  approved project
Change in Scope
Requires Prior Approval
Actions likely to be considered a change in scope include, but are
  not limited to, the following:
 Change in the specific aims approved at the time of award.
 Substitution of one animal model for another.
 Any change from the approved use of animals or human
  subjects.
 Shifting the research emphasis from one disease area to
  another.
 Applying a new technology; i.e., changing assays from those
  approved to a different type of assay.
 Transferring the performance of substantive programmatic
  work to a third party through a consortium agreement, by
  contract, or any other means.
 Change in Scope
 Requires Prior Approval
Actions likely to be considered a change in scope (cont’d):
 Change in key personnel whose expertise is critical to
  the approved project
 Significant rebudgeting whether or not the particular
  expenditure(s) requires prior approval
 Incurrence of patient care costs if not previously
  approved by NIH or if a grantee desires to rebudget
  additional funds into or rebudget funds from the
  patient care category.
    Expanded Authorities
    Provisions
 Extension of project period without additional
  funds
 Carryover of unobligated balances
 Additive cost alternative for use of program
  income
 Waiver of certain cost-related prior approvals
 Preaward costs
Prior Approval
Change in Status, Including Absence of
PI and Other Key Personnel

   Must notify NIH if the PI or other key personnel
    named in the NGA will:
       withdraw from the project entirely
       be absent 3 months or more
       reduce time devoted to the project by 25% or more
   Must request approval of a substitute PI/key
    person
   Must notify the awarding office GMO in writing if
    grantee wishes to terminate because it cannot
    make suitable alternate arrangements
        Prior Approval
        Change of Grantee Institution
   Required for the transfer of a grant-supported
    project from one institution to another
   Request must include:
       Relinquishing Statement
       Final Invention Statement and Certification
       Grant Application (PHS 398) from the proposed grantee
   All permanent benefits attributable to the original
    grant can be transferred, including equipment
   NIH may request additional information
      Prior Approval
      Restrictions on NGA

   Deviations from special terms or conditions stated
    in the NGA or from the terms and conditions
    included in the NIH Grants Policy Statement
   Activities disapproved or restricted as a condition
    of the award
A Rule of Thumb

Whenever you are contemplating rebudgeting or
  other postaward changes and you are uncertain
  about the need for prior approval, consult, in
  advance, with:
 MUSC Office of Research and Sponsored
  Programs
 Written policies and regulations
 NIH awarding component GMO
    Closeout
    Final Reports

 Failure  to submit timely final reports may
  affect future funding to the organization
    Final Financial Status Report (FSR)
    Final Invention Statement and
     Certification
    Final Progress Report
     Grants Questions?
Diane Dean
Assistant Grants Policy Officer, Office of Policy for
  Extramural Research Administration, OER, NIH
301-435-0930
dd12a@nih.gov


Kathleen Shino
Grants Management Specialist, National Cancer Institute,
   NIH
301-496-8635
shinok@mail.nih.gov
    Contracts, Grants and
    Cooperative Agreements
 Grants and Cooperative Agreements are
  forms of “assistance:”
 With Grants the Government is a PATRON
 With Cooperative Agreements the
  Government is a PARTNER
 Contracts, however, are for “acquisition:”
 And the Government is a PURCHASER
     What about Contracts?

A  legal instrument
 Purpose of the transaction is to acquire
  goods or services for the direct benefit or
  use of the Government
 Government-initiated Statement of Work
 Government identifies evaluation criteria

 Government   requires competition
    Anything else?

 The  Government Project Officer is
  responsible for monitoring the technical
  aspects of the work
 In a cost-reimbursement contracting
  regular financial reporting is critical to
  monitoring progress and performance as
  well as expenditures
    Contracts Questions?
TALK to your cognizant Contract Specialist or
  Contracting Officer

Greg Pryor
Procurement Analyst
Division of Acquisition Policy and Evaluation
Office of Acquisition Management and Policy
OD, NIH
301-496-3432
gp8m@nih.gov
Financial Management
          of
 Sponsored Projects

 Michael D. Payne
   What is Financial
   Management?
 Means   different things to different people

 Responsible accounting, monitoring and
 reporting of sponsored project expenses
   Why Financial Management?
   (continued)
 Accountable   to:
   taxpayers
   congress



 Getthe most research for the funds
 provided
      Why Financial Management?
      (continued)
 Good financial   management ensures that:

    grant/contract funds are expended for their
    intended purpose

 only reasonable,   allowable, allocable and
    consistently applied (direct/indirect)
    expenses are charged to sponsored projects
   Why Financial Management?
   (continued)

 Most NIH awards provide for cost
 reimbursement (as opposed to fixed price)
 arrangements
    What does Cost
    Reimbursement Mean?
 Reasonable,  allowable, allocable and
  consistently applied costs will be
  reimbursed based on actual costs incurred

 Includes F&A costs reimbursed based on
  negotiated rate agreement
   Accounting
 Separate   account for each project

 Costs charged in accordance with the cost
 principles (A-21), GPS, A-110, CAS,
 NGA/contract document

 Good source    documentation
    Accounting (continued)
 Program Income    identified

 Cost sharing   accounted for

 NIH salary   rate limitation not exceeded
   Monitoring
 Good oversight   of project expenses

 Compare   actual expenses with budget

 Cash draw   downs consistent with budget
    Monitoring (continued)
 Prior   approvals obtained when necessary

 Minimal    cost transfers

 Good oversight    of subrecipient expenses
   Reporting
 Accuratereporting of project costs to
 appropriate sponsors

 Timely   reporting of project costs

 Timely   close out of expired grants/contracts
    What‟s at Risk?
 Audit Findings/Cost
  Disallowances/Refunds

 Special   Terms and Conditions on NGAs

 Requirement   for Corrective Action Plan
    What‟s at Risk? (cont.)
 Special   Monitoring by NIH

 Temporary    Withholding of Payments

 Withholding of   Future Awards

 Possible criminal/civil/administrative
  penalties in cases of fraud
   Recommendations
 Read and  understand the award‟s financial
  terms and conditions
 Read and understand Federal and University
  policies
 Read and understand cost principles A-21
 Work with University‟s ORSP and NIH‟s
  grant/contract officials
   Conclusion
 Mutual benefit to have in place good
 financial management systems and policies
 and procedures that are consistently
 followed

 We‟re here to work with you on a proactive
 basis to help you achieve/maintain
 outstanding financial management of
 sponsored projects
    Questions?
Michael D. Payne
Director, Division of Financial Advisory Services
Office of Acquisition Management and Policy, OD,
  NIH
301-496-4401
mp16b@nih.gov
Financial Management of
  Sponsored Projects



  The Institutional
    Perspective...
Conflict of Interest

     Greg Pryor
                 The Regulations
 For   Grants: 42 CFR Part 50 Subpart F
 “Responsibility of Applicants for Promoting
  Objectivity in Research”
 For   Contracts: 45 CFR Part 94
 “Responsible Prospective Contractors”
 Involves: PHS $, Research and Investigators
 These Regs. do not apply to Phase I SBIR &
  STTR
           Conflict of Interest
              Regulations
  Regulations which promote Objectivity in
  Research by requiring the establishment of
          Institutional Standards to:

Ensure there is no reasonable expectation that
  design, conduct or reporting of PHS funded
  research is biased by a conflicting financial
           interest of an Investigator.
 Conflict of Interest Regulations
           - Overview -

 What the regulations require.
 Who is affected by the regulations.
 Where the regulations are intended to
  operate.
 How the regulations are supposed to
  operate.
            C.o.I. Overview
                Topics
 The  BIG Picture
 Key Vocabulary: 4 Definitions in the Regs.
 Seven + components/requirements of the
  regulations
 Institutional actions to Manage, Reduce or
  Eliminate C.o.I.
 What PHS can do in cases of
  noncompliance with the regulations
       C.o.I. - The BIG Picture
               since 10/1/95:
Institutions Must:
 Maintain a written, enforced Financial C.o.I.
  Policy for Research Investigators
 Inform Investigators of the Policy, the Reporting
  Responsibilities and the Regulations
 Report to awarding offices (NIH I/Cs) the
  existence of C.o.I.s and how the C.o.I.s are
  M.R.E.ed
        C.o.I. Vocabulary
1. Investigator: P.I. and Anyone Responsible for the
  Design, Conduct or Reporting of PHS Funded
  Research. Includes Investigator’s Spouse &
  Dependent Children for Reporting Financial
  Interests. (PHS includes: NIH, FDA, CDC, etc.)
2. Significant Financial Interest (SFI):
  Anything of Monetary Value. But note Numerous
  Important Exclusions listed in the Regulations!
  (generally any remuneration from the applicant
  organization is excluded from the definition of SFI)
     C.o.I. Vocabulary
     (Continued)
3. Financial Disclosure Statement : A Listing
   of Investigators‟ SF Interests and those of
   her/his spouse and dependent children:
(i) that would be affected by the research; and
(ii) in entities whose financial interests would be
   affected by the research. (e.g., stocks)
 Financial Disclosure Statements: Are to be
   updated annually or as new SFIs occur
         C.o.I. Vocabulary
                  (Continued)
4. Conflict of Interest:
  Exists when the Institutional Designated
  Official reasonably determines that a S.F.I.
  could Directly & Significantly affect the
  design, conduct or reporting of the PHS
  funded research.
         The Seven + Institutional
        Requirements (the Process)
1. Maintain an Enforced, Written C.o.I. Policy
   which complies with the regulations.
2. Designate an Official (D.O.) to solicit &
  review Financial Disclosure Statements
  from Investigators planning to participate in
  the research.
3. By the time of application submission
  assure that the D.O. has received Financial
  Disclosure Statements from Investigators.
               The Seven Institutional
                   Requirements
                   (the Process - continued)

4. Provide the D.O. with guidelines to identify C.o.I.s &
   take appropriate action to Manage, Reduce or Eliminate
   them
5. Maintain records of all Financial Disclosure Statements
   & Institutional actions regarding each C.o.I.
6. Establish enforcement mechanisms & provide sanctions
   where appropriate.
7. Certify to 1.- 6. Above in each application.
         The Seven+Institutional
      Requirements (the Process-continued)
7. A. Report to the awarding component
  (NIH I/Cs) C.o.I.s prior to spending funds
  under an award and M.R. or E. the C.o.I.
  (No details sent to NIH at this point)
7. B. Upon request from awarding
  component, must make information
  available re. all C.o.I.s & how C.o.I.s have
  been M.R. or E.ed.
7. C. Otherwise comply with the regulations.
          Managing, Reducing or
              Eliminating
        Financial Conflicts of Interests
               at the Institution
     (These are examples offered in the Regs.)
Institutions may:
 Publicly Disclose the S.F.I. (most common)
 Monitor research by independent reviewers
 Modify research plan
 Divest the S.F.I.
 Sever relationship(s) that create conflict(s)
       When Failure to Comply has Biased
        Design, Conduct or Reporting of
                   Research
 Institution must promptly notify awarding
  component of corrective action taken or to be
  taken.
 Awarding component may take action or refer
  back to the Institution for further action perhaps
  with directions about what to do.
 Awarding component may review all records
  pertinent to compliance & may determine to
  suspend funding until the matter is resolved.
   In the Case of Biased Clinical Research to
   Evaluate the Safety, or Effectiveness of a
        Drug, Medical Device or Treatment


 TheInstitution must require the investigator(s)
 involved to disclose the conflicting interest in
 each public presentation of the results of the
 research.

        (This is a legislative requirement)
                Summary
 42 CFR    Part 50 Subpart F - Grant
 45 CFR Part 94 - Contracts
 Since 10/1/95 Institutions must maintain a
  written, enforced C.o.I. policy for Research
  Investigators
 Investigators, S.F.I.s, F.D.S.s, C.o.I.
 7+ Institutional requirements
 Institutional Activities to M.R. or E. C.o.I.
         Future $CoI Developments
 On 8/15-16/00 HHS     will hold public discussions in
  at the NIH to determine new ways to manage CoIs
  so that research subjects are appropriately
  informed and to further ensure that research results
  are analyzed and presented objectively
 How $CoI is dealt with as it affects researchers,
  IRB members and Institutions will be discussed
 Expecting 600 attendees
 See http://aspe.hhs.gov/sp/coi/index.htm
       Where to get More Information
 Frequently  asked questions re. C.o.I.+ the
  regulations appear in 7/3/96 Federal Register
 http://www.nih.gov/grants/policy/coifaq.htm


                     Greg Pryor
    Phone (301) 496-3432; Fax (301) 402-1199
                    gp8m@nih.gov
   Division of Acquisition Policy and Evaluations,
    Office Acquisition Management and Policy,
             Office of the Director, NIH
Conflict of Interest




The Institutional
  Perspective...
Extramural Intellectual
      Property:
  Invention Reporting
 Policy and Procedures



   George Stone, Ph.D.
 Stewardship of Federal Funds
 How   funds will be expended
   Fiscalmanagement
   Programmatic assessment

 How   research will be conducted
   Research  integrity
   Conflict of interests

 How research outcomes will benefit the public
 (both directly and indirectly)
   Encourage  application of intellectual property
   Share outcomes to spawn new research ideas
Government-Supported Intellectual
Property…pre-1980

 Any  intellectual property derived through
  Federal funding agreements could be claimed
  by the Government
   F.A.R.   52.227-13
 Not uniformly exercised across the
  Government
 Result = no commercialization/application
  incentive
 Bayh-Dole Act Of 1980

 Gave  Grantee Organizations/Contractors Title
  to Inventions Arising From Federal Funding
  Agreements
   Required   pursuit of tech. transfer opportunities
 Government     retains license to practice the
  invention
 Result = Commercialization/application of
  Federally funded inventions
    Implementation of Bayh-Dole:
    37 Code of Federal Regulations, Section 401.14
   Defines Terms, Parties
   Prescribes Order of Disposition of Rights
       Grantee org.
         Gov‟t.

         Inventor(s)

   Prescribes Chronology of Reporting
    Requirements for Grantee/Contractor
    Organization
       http:/iedison.gov/timeline.html
   Prescribes Basis for & Extent of
    Government Action to Retain Rights
       Grantee/Contractor Organization
     Responsibilities in Invention Reporting
          NIH Grants Policy Statement - Section II:
       Administrative Requirements (per 37CFR, 401.14)
   Organization to Implement Employee Agreements
     Investigator to relinquish rights
     Investigator to report “subject” invention(s) in timely
      way
           as needed (review annually)
   Organization to disclose each invention
         within 60   days of reporting by investigator
   Organization to Resolve Title
         within 2   years
   Organization to File Patent
           within 1 yr. of election
             NIH Grantees/Contractors
              Responsibilities…cont.
   Organization to Provide License to the Govt.
       upon title election
   Organization to indicate Govt. Support on Patent
       with patent appl.
   Organization to share royalties with inventor(s)
       when available
   Organization to ensure Small Businesses given
    preference in licensing
       where feasible
   Organization to ensure Product Manufacturing in U.S.
       required unless by waiver
       NIH Responsibilities in
        Invention Reporting
            37 CFR, Section 401.14
 Maintain Confidentiality  for Benefit of
  Grantee/Contractor/Inventor
 Ensure Government License to Invention
 Include Patent Rights Clause (by reference) in
  All Funding Agreements
 Require Periodic Reporting On Utilization
 Facilitate Transfer of Technology
   GrantPermission For Assignment of Rights
   Waive Requirement For U.S. Manufacture
    NIH Responsibilities…cont.

 Ensure   Equal Access to Intellectual Property
   “March   In” to Provide License to Responsible
     Applicant
   Restrict Title In Exceptional Circumstances
   Encourage wide distribution of Research Tools
 Ensure   Compliance of 37CFR;401.14
   Oversight of Grantee Organization Reporting
   Education of Grantee Organization Community
 Didactic Content to inform investigators &
  grantee/contractor organizations
    37CFR 401
    Invention Policy Issues
    Invention Reporting Procedures/forms

 Submission  of Invention Report Records via Secure,
  Interactive Web-Based System
    Production Deployment     - Oct. „97
    Single interface to report inventions sponsored by 13 Federal
     agencies
 IEdison    url = http://www.iedison.gov
 Examples of Research Tools
 Useful In Commercial
 Applications
 D2 dopamine   receptor     screening
 Immortalized liver cells   disease model
 ERKO mice                  screening
 basement membrane          reagent sales
 G protein antibodies       reagent sales
 HIV protease               screening
NIH Director‟s Working Group
Recommendations For NIH
 Promote  free dissemination of research
  tools without legal entanglements
 Further use of UBMTA
 Develop guidelines for extramural MTAs
  and licensing
 Review and strengthen current policies
 Establish “research tools forum”
 New Guidelines For Recipients
 Of NIH Grants & Contracts
 Guidelines    published in Federal Register
   Vol.   64, #100, pp. 28205-28209 (May 25, 1999)
 Principles   for:
   ensuring academic freedom and publication
   minimizing administrative impediments
   implementing Bayh-Dole Act
   disseminating research resources
   Sources Of Information On NIH
   Research Tools And Policy
 NIH Director‟s   Forum -
 www.nih.gov/welcome/forum/
 Working Group    Report -
 www.nih.gov/news/researchtools/index.htm
 Research   Tool Guidelines -
 www.nih.gov/od/ott/RTguide.htm
 NIH Office   of Technology Transfer -
 www.nih.gov/od/ott
   Questions?
George Stone, Ph.D.
Chief, Extramural Inventions and
  Technology Resources Branch, Office of Policy
  for Extramural Research Administration, NIH
301-435-0679
george.stone@nih.gov
Data and Safety Monitoring
     of Clinical Trials

 Dennis O. Dixon, Ph.D.
Data and Safety Monitoring of
Clinical Trials -- Background

 Stop any trial as soon as objectives have
 been met
 Avoid exposure of volunteers to excessive
 risk
 Data and Safety Monitoring of
 Clinical Trials – Recent Changes
 All NIH-supported trials require monitoring (6/98)
 IRBs must be notified of the outcomes of data
  and safety monitoring board reviews (6/99)
 All trials need to follow monitoring plans (6/00)
Data and Safety Monitoring of
Clinical Trials – Some
Approaches
   Independent Board, explicit guidelines
   Internal committee
   Designated medical monitor
Data and Safety Monitoring of
Clinical Trials – Scope of Reports
  Recent and cumulative enrollment and
  retention
  Data collection and quality control
  Summary of toxicity and interpretation
  Summary of treatment responses and
  interpretation
Data and Safety Monitoring of
Clinical Trials – IRB Role
 Determine which research activities require
 continuing review more frequently than every
 12 months
 Review progress reports submitted by
 investigators
    Questions?
Dennis O. Dixon, Ph.D.
Chief, Biostatistics Research Branch
Division of Acquired Immunodeficiency Syndrome
National Institute of Allergy and Infectious Diseases,
  NIH
301-496-0694
dd23a@nih.gov
Intellectual Property:
Invention Reporting Policy and
          Procedures


   The Institutional
     Perspective...
NIH Proactive Compliance
       Site Visit
  Risks Associated
        with
   Noncompliance
The NIH Perspective...
False Claims Act / Qui Tam
   False Claims Act (FCA)
       Allows an individual, known as the “relator” to file suit
        on behalf of the US alleging that false or fraudulent
        claims have been submitted to the government.
       The government has a period of time to investigate
        the allegations to determine whether to take over the
        suit or to allow the relator to pursue it alone.
   Qui Tam (a provision of FCA)
       Persons who file qui tam suits may recover from 15 to
        25% of the settlement or judgment if the US litigates
        the case, or up to 30% if they pursue it on their own.
            Since the FCA was amended in 1986, the number of qui
             tam suits have risen from 33 (1987) to 534 (1997)
            Whistleblowers have received about $300M with
             additional awards pending.
 RISKS ASSOCIATED WITH
     NONCOMPLIANCE:
   What can grantees lose?
 Administrative     economies and privilege
 Confidence
 Credibility
 Monetary      considerations
 Respect
 Self-determination
 Trust
COMPLIANCE ISSUES
  Risky Business...
        From the Chronicle of
          Higher Education:
        for falsifying information on
        a Federal grant application
        (listing of corporate sponsors)
         Professor      at UW-
          Madison
         3-months jail
          sentence
         $10,000 fine
    Possible Implications of
        Noncompliance:
 Corrective Actions
 Special Terms and Conditions of
  Award
 Loss of Expanded Authorities
 Cost Disallowance
 Suspension/Termination of Award
 Improved   Systems and Policies
     NIH Proactive
  Compliance Site Visit
Risks Associated with
    Noncompliance:
  The Institutional
     Perspective
       NIH Proactive
    Compliance Site Visit
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 attending this seminar
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