Applicant/Grantee/PI False Certification

Published by the National Science Foundation, Office of Inspector General on 2003-02-13.

Below is a raw (and likely hideous) rendition of the original report. (PDF)

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                                                                                                      NATIONAL SCIENCE FOUNDATION
                                          I                                                                                                              I
                                                                                                       OFFICE OF INSPECTOR GENERAL
                                          II                                                             OFFICE OF INVESTIGATIONS

                                                                                          CLOSEOUT MEMORANDUM                                                I

             Case Number: I01070015                                                                                                                  Page 1 of 1

                                                   li                                                                                                            11

                      The OIG received a &dl fiom NSF7sAnimal Care representative referencing the applicdion for a
                      Single Project ~ s s d m c (SPA)
                                                 e     fiom a university for a pending proposal. The NSF
                      representative noted hat the university had an active award with animal experimentation but that
                      NSF had not approved an SPA.                                                          'I

                                                        II                                                                                                            I1

                      After conducting a site visit, interviewing university officials and the principal investigator for
                      the grant and touring the facility housing the animals being used at the University, OIG &rote its
                      report of investigatioh which did not reach a misconduct in research finding. However, dur
                      report made several r&commendationsto both the University and NSF.                                                                               ll

                                                         r                                                                                                             ,\

                      The University and the agency accepted most of the recommendations from the OIG. On,          24
                      January 2003, NSF s ~a lettert    to the University outlining the remedial actions being taken to
                      ensure that the University is complying with NSF regulations. These remedial actionsdarAin
                      effect for the two d e n t s grants until M e r notice.                                     11
                                                             /I                                                                                                             I1

                      Accordinglyythis case is closed.



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                                                                   II                                                                                                             It






                                                                           I                                                                                                           1
I                                                                           I                                                                                                          I

                                         Agent                                                         Attorney           Supervisor                                                       AIGI

                  Sign 1 date                                                   1
II .     -                                                                                                                                                                             OIG52-2
                  National Science Foundation
                   Office of Inspector General                     11   .

Review of A Violation of Vertebrate Animal Research Requirements
             - A. @cornmendations for Oversight of VertebrateAnimaI Research at I                                           -
                         .University              u

                                                                                                                -- -
            On October 10,1999, L-.---                                  reviewed, approved1and
    subplitted to the Natidd  Science ~okdation( N S q a fds~catification'in oomection wilh

                            [? The certification stated that. l was in compliancewith the 11
    applicable laws far ud of animals in research (Animal Welfare Act (7 U.S.C. 21311and the
    rigulatiohs              @emunder by the US Seaetary of Agriculture [9 C.F.R. 1.1-4.1 I]).


            ~~ecikcall~~ stated that it had a functioning Institutional Animal Care and Uk
    Committee (IACUC) and that the ~ ~ C U ~ r e v i e wande dajwroved the proposed work of Principal
    Investigator (PI) Dr. 1            Associate Professor for -    -  - -,    ,  Based on the "
    evidence gathered during this investigation, we determined that '- IJmowingly falsely " -
    certified to NSF that it was in compliance with the laws applicable to the use of animals in
    research.                 11


    Basis for m a t i o n of False Certifications

            OIG was contacted by Dr. r              ,
                                                    . the NSF r e p d v e to the Interagency :.:
    Research Animal Commi#ee (IRAQ and the NSF Animal Welfare Officer,and informed that
    there was a pending proposal3from         mat would require establishment of a special proj&t
    iismranG between the NSF and            In the process of reviewing this proposal, which had
    been recommetlded for an award, Dr.
                                          :                             '

                                                * found there wa?; a 1999NSF grant4to --- J                                     th.i,
    pmposed animal experimhtation for &ch ' -           apparently did not have the requiredapproyed
    special project assurance. In agreement with OW,the NSF program officer: and Dr.              .11
    NSF's ~ivisionof Grants!andAgreements @CIA) suspendedthe conduct   --      of any animal~esearch
    under the 1999 award andud not approve the new award uhtil '          r complied with the laws ,
    applicableto the use of animals
                                    in dand documented to NSF its compliance!                   .                                           [I

                               a special project assurance7 for research using vertebrate inhals
                      NSF policy req-                                                                                                        .   .
    when the grantee does not have a general assurance6on lile with PHs. A special project       .,
    assurance genedy coversl'one  project and is issued by the agency funding the project.

    ' m & t 1--obsub&by'
'   2&
             -- -     -
                   ."..--            ..~..                                          -             .           7".

     .                       Li,&qa                                                     -.,CO-PrincipaI
    3,,      ...
                                     u/ hv&ator,
                               h'&cipat           ..l.,-&,. Dr.             . ..---..                --~ n- v ~ t o t s .

                     .   .       .       .. .- "5 .                                                   .   -

               .-.           .
    4; -L                        -.--        -'{.hh-. 1             .

      -      ,! .-  -~ria_cipall a ~ ~Dr.r ,
                             ..-.                       ,co-PrincipalInvestigators,        --
                  and'           a   entitle.
                                         . - "j-   - -- -
     Bb10gy." 1t wai funded for or0 1 ; .    a December 5 1999, witfi meffectivedate of July 1,2000.
    $Drr                       ,managing Program Dkector,                               f'   '-

    ~~ttachment2-~of~ionhm'                                    ~Bmti'chCbieC Division of bran& and Apeemeats, NSF.
     Orant Policy Manual, Cbpbr Mf 713c "Beforea grant involving the use of vertebrate animals ia either field or ;
     labomtory activities can be made, NSF must teceive a &&+eat     that the proposdd activity has been &wed and
     approved by the ppropriate hwthtioaal Animal Can.and Use Committee (IACUC) at the grantee orgmhtion, ,
     and that the grantee bas an appovd AnEmal W e W assurance +MI the Public Health Service (PHS)that assures "
                 In addition tq,its failure to secure a special project assurance with the 1999 award and the
.    *   false certification, -- - - did not oversee the conduct of the 1999grant and ensun adhejence to
         the award condition^!^ First,         J permitted Dr.         the principal investigator on the 1999
         grant, to also serve a i the Chair of the Institutional &a1     Care and Use Committee (IACUC)
         that authorized the sibmission of the certification on Dr.           s research proposal. k.":
                                                                               '                                                    a

         position as PI and ch& of the IACUC created an unacceptable conflict of interests when he
         provided oversight and  II
                                    approval for his own research with vertebrate animals.                             I

                  Second, ' -11                for '_ - -       that "[tlhis institution has establish4 and
         will maintain a program for activities involving animals in accordance with the Guide for the
         Can and Use of ~abohtoryAnimals." In fact, there was no IACUC or *mpectedanimal care .
         faility at the time'it submitted the certification.      J completed construction of the Animal
         Care Facility in September 2000, well after it filed the certification for.                on
         October 25,1999. Fuither, at the time of our review (two years afterthe submission of the 1999
         grant),       - rtill did not have a functioning IACUC. - - I violated GC-1, Article 29" by
     1   filing its false certification.                                                                11
                  In consultation with NSF program management, grant officials, and NSF's
          Welfare Officer, NSF decided that the best course of action would be to suspend any vertebrate
          animal research supportedby the 1999grant Our office visited the University to gain an , -
    ... understanclingof how \jest to resolve the issues outlined above. On July 10-11,2001,01d staff
          interviewed key       J -tion          and fsdty members,including the principal investigators
          on the 1999 grant. .-weconfirmed that the certification was false, and that at the time the
        - certification was submitted, there was no inspected f d t y to house animals or approved                         11

                                         1                                                                                 I

           NSF that it will comply with the PHs Policy on Human Care and Use oj'Luboratory Animals. ... Apptiyons
           from organizations not having a general assurance on file with the PHs will be reviewed first for scientificmerit.
           If a decision to support the proposal is reached, NSF will make every effort to arrange for a special assurance to be
          .negotiated."' A special project assurance is given to a university that does not have.a general assurance on file with
           PHs. l'his.specia1project assurance is negotiated with NSF's Animal Welfare Officer and the grantee's
           Authorized Organizational Representative (AOR).
           A general assurance can be provided when an institution is carrying out two or more projects dealing with the same
           kind of research. The/assurancecoven all projects h d e d by the federal government while that assurance is
           Grant General Conditions, Artich 1 states: "The awardee luy full responsibility for the conduct ofthe projed or
           activity supported under this award and for adherence to the award conditions. Although the awardee is          ,I .
           encouraged to seek the advice and opinion of NSF on special problems that may arise, such advice does not
           diminish the awardees respobibility for making sound scientific and administrative judgments and should not
           imply that the responsibility for operating decisions has shifted to NSEn October 1998
         lo The @cation       was sigaed by Dr.              .IACUCChair, Dr.                  IACUC member, and

                              IACUC member.
            Orant General Conditions, h c l e 29 (October 1998) states: "Any awardee performing research on vertebrate
           h a l s shall comply with the Animal Welfare Act [7 U.S.C. 2131et seq.] and the regulations promulgated ,
           thereunder by the b t a r y of ~griculture[9 CFR, 1.1-4.11) perCaining to the humane care, handling, and 1
           lmtment of vertebrate animals held or used for research, teaching or other activities kupported by Federal awards.
           The awardee is expected to h e that the guidelines descn'bed in the National Academy of Science WAS) 1
           Publication, "Guideforthe Care and Use of Laboratory Animas" (1996)are followed and to comply with the,
           Public H d h &mice policy ;md~overnment~rinciplesRegarding the Care and Use ofAnimal (included as Y
           Appendix D to the NAS Guidp)P
                                                                                                             -   /I

protocols for care of the animals. Nevertheless, the PI, Dr.       purchased mice and yas

housing them in the newly constructed facility on campus. He explained that he intended to
develop the neces~'protocolsto take cam of vertebrate animals with these mice. He had
placed himself in the +tenable position of preparing to experiment with animals to develop
protocols that he needed IACUC approval for before he could experiment. Approval of s;cb
protocols is a major pirt of the animal care and use brtifimtions.                      1

         We also met d t h Dr. J                   . -. Executive Vice President and Provost'at
-       who explained ;that in his previous position as Director of the Office of Grants,Contracts
and Sponsored Research at                         he was the Assurance Officer for the
Institutional Animal Care and        ~ornmittee~'~ Before becoming the Executive Vice President
and Provost at :     ', Dr.              WBS-            dean of the College of'
         and Acting p&vost As            s Provost,                    mentioned that he "continues
to consistently encourage faculty to develop proposals to government sponsoring agencies to be
in close wCOntactwith program directors f b m those agencies and to be in full compliance d t h
relevant agency regulations and guideli~es."'~


        If       had b e h in contact with NSF, it could have avail& itself of any of several
avenues to develop the naessary animal &arch prooedures. First,            - could have followed
the guidance in NSF's Grant Policy Manual (GPM Chapter VII 8 713c) and sought NSF's                                   11

assistance in developing an approved Animai Care and Use program. Alternatively, if -         did

not want to establish its own IACUC,it could have sought assistance of a nearby institutioA.
Although         claims it had spoken vciith the m@g      NSF Program ~irector"in 1999
regqding the expected animal use in the research, we can neither bod any evidence of nor have
we been provided any ekidence to support that claim. l5                                                                    I)

        Finally, ; - - - could have submitted a completed special project assurance to the 1
mahaging NSF program; NSF's approval of this special project assurance would have
established a mechanism for handling the h d e d animal research on the campus.           did            "

eventually submit a completed special project assurance to the NSF Animal Welfare Officer for

      Since OIG's visit,        officials have sought to comply with NSF regulations.
Throughout this period, the award remained suspended. The University had difficulty                                             "

'"ttachment     -
              3 Dr.                 'I   i   also served as Director of the OfEce of Research and Academic Development at
                      , 'Inthat position, he was responsible for the management of research and oversight and
 compliance review pmgrams.    --- systemic
                           - The    -        failures of this oversight are d e s m i in OIG's previous          h
 investigation involving (              - ,OIG Case P                    As a result of that investigation, NSF '
 imposed remedial actions od the University to ensure that it receives proposals that had received appropriate ,
   Attachment 4 Page 1 of ~ u g u s3,2001,
                                     t        afiidavit from Dr.                    , Bxecutive Vice President a,nd
   Dr.              ,former mahaging Program Dimetor, (              PWYam.
" We note that.in connection with the -                poppaal, LSSU did contact ~ ~ ~ l banimal
                                                                                              o u tcare issues but it
  failed to alert NSF to the 1999 grant that did not have approved animal care &d use protocols.
l6 Attachment 5 Assurance ofiCompliancewi?h NSF Reauirements on Humane h e and Use of Vertebrate
  Animals, approved October 1'5,2001,by Dr. - - .
                          1                                                                               I
 identifjhg a veterinarian that met the guidelines for IACUC membrship." It also had problkns
 ~ettingup an IACUC meeting to approve the proposed work and get the full assurance completed                                        '

 to meet NSF requirements. Nevertheless, the university has now succeeded in creating a
 functioning IACUC,had a facilities inspection, and submitted a special project assurand for
 approval by the NSF.Animal Welfhre Officer. NSF reinstated the 1999 award on October  'I

        In the process vf reviewing and resolving this matter, we worked closely with the
 Division of Grants and Agreements, the NSF Animal Welfm Officer, and NSF                 I'

 management. With their concurrence, we recommend the folloy@g requirements be             ,
 implemented in addition to those already in effect. We believe these additional requirements
 should be incorporated into relevant awards made to r      for a period of 3 years.     11

 1.        In conjunction8with each propok involving research with vertebrate animal$ l                                         .-
           should provide a statement that it has:                                                                 I

                   a a f o h mechanism for assuring compliance with relevant federal regulati?ns,
                 . b. trained faculty and staff that are responsible for the - a
                                                                                 . . . onI
                      conduct of federal grants.                                           11

2;         During the life &the two awards,                should provide annual follow-up reports to NSF
          . as part of the annual project report required by Section VILA. of the Animal WeIfhre
                                       I1                                                                              1
                  a detailing actions it has taken in connection with NSF supported vertkbrate
                     animh research,                                                          11
                  b. describing its.efforts to ensure that the requirements of Grant Policy Manual 5
                     713 ahd Grant General Conditions 5 28 (April 200 1) have been fulfilled, and
      ,           c. descriyg the &ts of any state or federal agency inspection of its facilities
                     and ip responses to any recommendations made in connection with hose
                     inspections.                                                                I

In reSponse to our report'lfor comments, the University agreed to abide by our recommendations,

 "9 CFR 5 2.3 1@)    IACUC ~Ambecship"(1) The members of each Committee shall be appointed by the Chief #I
  &dve                of the research facilitr; (2) The C o m m b shall be composed of a Chahman and at least two
  additional members; (3) ofthe members of the Mw:              (i) At least one shall be a Doctor of Veterinary i
  Medicine, with training or eiperienoe in laboratory animal science and medicine, who has direct or delegated
  programresponsibility for activities involving animals at the research facility; At least one shall not be 11
  affiliated in any way with the Wility other tfian as a member of the Committee,and shall not be a member of the
  immediate family of a person'who is W a t e d with the facility. The S e m W y intends that such person will I
, provide representation for general community interests in the proper care and treatmeht of animals; (4) if the
  Committee consists of more than three members,not more &an three members shall be h m the same
  admmMWive unit of the facility."                                                                ,

                                            11                                                                             I1

       but did not agree with ihe report findings.'8 we contacted the Executive Vice President
       and ~rovodwho provided no fivther information about the University's position. We are
       therefore forwarding this report and recommendations for NSF review without kwivision.
                     /I                                                            W

"Attachment 6   -I        I1
                                      ,response to report.
--                               --          z-            -                   --   -   -

             .   d

                                         .    /I
             B.      RI
                     Research Proiect Assurances

                            NSF's expectations regarding the review and approval of vertebrate animal reseakch are
                     found in the Grant Policy Manual,the terms and conditions accompanying each award, the Grant
                     Proposal Guide, and ihe Proposal and Award Manual. Although these documents generally
                     speak to different audiences, they reflect the same policy. NSF's policy relies on the Animal
                     Welfare Act, the Public Health Service Policy on Humane Care and Use of Laboratory Animals,
                     and the National Academy of Sciences' Guidefor the Care and Use of Laboratory Animuls.
                     Specifically, institutions are expected to review the applicable rules and obtain approval for
                     vertebrate animal resehch through the institution's htitutional Animal Care and Use
                     Committee (IACUC).                                                                     , 11

                             Institutions that conduct projects involving vertebrate animal research funded by the NM
                     are expected to have a general assurance on file with OLAW. Those that do not have a ge'neral
                     assurance but wish to conduct such research are expected to work with the fimding agency to
                     execute a special proj&t as,-         or to work with another institution to take responsibility for
                     approval AND monitoring. The general or special project assurance must be approved and in
                     place BEFORE any research using vertebrate animals can be conducted.
                            If an organization notifies an NSF program officer that they need a special project
         .           assurance,that program officer then:
                                    For those awardee organizations that have no general assurance on file with the     I
                            Office of Laboratory Animd Welfare (OLAW) (small colleges or small businesses, for
                            example), the ~iogramOfficer must initiate procedures for the preparatian of a speyial
                            assurance acceptable to NSF before an award can be made. This should be initiated only
                            after review for yientific merit has been performed and an award recommendation is
                            likely. The arrangements for a special assurance should be undertaken in consultation
                            with the NSF representative to the Intera ency Research Animal Committee (IRAC) and
                            will be handled on a case-by-case basis. IF

                      The NSF Proposial and Award Manual and the Grant Policy Manual do not provide @cie!nt
                     information to program officers, grants officials, and the NSF's Animal Welfare Officer
                     (AWO)~'to provide guidance on assessing special project assurances or the need for them. NSF
                     policy does not require the AWO to consult with legal, policy or ethics officials within the
                     agency nor does it identify those individuals. We are aware that NSF officials are available to
                     c o d t with the AWO, if the AWO detenpines it's necessary. However informally consultations
                     may lead to misunderstanding as stafhg for these positions changes occur.
                            NSF currently has such a structure and guidance for the review and approval of hum&
                     subject research assurances. Wben a grantee organization proposes to conduct nonexempt
                     ''PAM Chapter W.B.2.b(3).  .

                        The AWO b the NSF mprientative to IRAC. currently h                 ,Pmgram Officer, Division of
                     -- - - --                                            ..
human subject research, NSF expects that it will have an Institutional Review Board (IRB) in
conformance with the Common Rule for the protection of human subjects. Generally,
institutions that conduct human subject research will have a Multiple Pmject Assurance &PA)
on file with DHHS' Office of Human Reseamh Protections. If an institution does not haye an
MPA, NSF recommends that it contact a nearby organization with a valid MPA and arrange for
that organization's IRB to review and approve proposals that contain human subject resych, If
an organization cannot make such arrangements, NSF explains that NSF:
                      I                                                                    I

         may constitute,,anad hoc panel to review the proposal and give a Single Pmject       '

     .   Assurance (SPA) for that project. This panel will be convened and chaired by t h e l ~ ~ ~
         Human Subjects Coordinator and will include the relevant Program Officer and at '1least
         three additional persons chosen fiom the following groups:
                        I                                                                 I1
                        o       A representative of the Office of the General Counsel (OGC);
                        o       A representative of DGA;                                   11

                                A representative of the Policy Office (BFA); or
                      - o       the NSF Program Officer for Ethics and Value studies?' fi

This stafEng structure l!rovides legal, technical, and policy support for the review and apPr?oval
of SPAS. Unlike the SPA process for research on human subjects, where NSF serves as the IRB
for a specific human subjects project, the process for establishing an SPA for vertebrate animal
research does not reuire review and approval of the research by NSF's AWO. The AWO !,
ensures only that a properly convened IACUC committee is in place at an institution. Although
the institutional LACUC'decides whether to approve the project, NSF's AWO should have the
sthe legal, technical, and policy support in approving specific project assurances as does NSF's
Human Subjects ~oor&tor.                                                                      11
                          n                                                                    11
We recommend that NSP:
                              I)                                                                    I

    1. Revise its procedures and staftlng structure for reviewing special assurances for
       vertebrate animal'kesearch to ensure that the special assurances comply with technical,
       legal, and policy requirements.
                               I                                                                    'I

   2. Pmvide more extensive vertebrate animal research-training program for new program
      officers as well as provide regular updates or protocol ref'reshers for permanent.staff.
   3. Easure that NSF programs have instituted mechanisms to protect the interests of N S F ' ( ~ ~
      aote in this context that the first award to     was awarded without the necessary

      SPA). For example, every six months management should review programs that support
      vertebrate animal research to ensure that each award is accompanied by the appropriate


*'PAM Chapter W.A.4.c.(3)
                                NATIONAL SCIENCE FOUNDATION
                                        4201 WILSON BOULEVARD
                 li                    ARLINGTON, VIRGINIA 22230

January 24,2003

Dr. -              i
E x ~ i t Vice
          h ~kesidintand Provost

                                -- -
Re: NSF GrantsiI.;                     mi- - - ,
Dear Dr          - -
While the NSF Office of the Inspector General's Report dated April 1,2002, does not
contain a finding of misconduct in science against the University, NSF has decided to ,
take the following remedial actions concerning the University (Part I) and the two currbnt
grants referenced above that involve vertebrate animals research (Part Q.
                          I!                                                                   I,

   I.     In conjunction with each proposal involving research with vertebrate animals,
                 is required to provide a statement that it has:
          a. A fdmal mechanism for assuring compliance with relevant federal             ,
              regulations, and
          b. ~ r a a e dfaculty and staffthat are responsible for the administration and
              conduct of federal grants. '

   II.    During d e life of the two awards referenced above,          is required to
          provide annual follow-up reports to NSF based on the annual report required''
          by Section VILA of the Animal Welfare Assurance:
          a. ~ e t a i k actions
                          n~      it has taken in connection with NSF supported vertebrat~
             animals research,
          b. Describing its efforts to ensue that the requirements of Grant Policy
             ~ a n u k lSection
                        ,        7 13, and Grant General Conditions, Article 29 (July               II

             2002),' have been filfilled, and
          c. Describing the results of any state or federal agency inspection of its
             facilities and its responses to any recommendations made in connection C
             with those inspections.
-   In additioq - 1 , - must be in compliance with the NSP Grants Policy Manual, section

    713 "Animal Welfare Requirements". In accordance with Section 713, the grantee is
    responsible for daving a project, involving the use of vertebrate animals, approved by an
    IACUC establis6e-d through a multi-project assurance with the Office of Laboratory "
    Animal Welfan of the MH,or through a single-project assurance approved by the NSF.
    Any future awards to -- - J will require new assurances, and the approvals must be h
    place before the issuance of the awards.

    All of the documthts described
                                          that need to be submitted to the NSF, should be
    sent to the attention of Dr.             the NSF Animal Welfare Officer.

    The remedial actidns in Part I will be in effmt until M e r notice. The actions requird in
    Part I1 would be inneffect as long as the grants have not expired. Please advise the    ,,
    appropriate Univerbity departments and officials affected by this action. Thank you for
    your continued cooberation.


    Sincerely,              [I




    Grants officer       li           '             /
    Division of Grants and Agreements

    Cc:        -
                       .,NSF Animal Welfare Officer