oversight

Biohazard Reg. Violations

Published by the National Science Foundation, Office of Inspector General on 2004-02-06.

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

                                                    NATIONAL SCIENCE FOUNDATION
                                                     OFFICE OF INSPECTOR GENERAL
                                                       OFFICE OF INVESTIGATIONS

                                              CLOSEOUT MEMORANDUM

Case Number: A03040021                                                                  Page 1 of 2



           In August 1999, following an extensive investigation, we reported to NSF
      management about the oversight of biosafety by a n institution,' concluding that

                the evidence demonstrates the Uniiersity's failure, despite its professed
                concern, to establish either clear, well-defined, and appropriate oversight
                guidelines, and to disseminate those guidelines to the appropriate parties, or a
                functional, comprehensive oversight structure. These failures created a
                systemic, long-term atmosphere of inattention regarding biosafety issues.'

      After evaluating our report as well as submissions by the institution, NSF concluded that
      "questions remain concerning the effectiveness of the oversight structure of biohazardous
      research" at the institution, "particularly . . . concerning the viability and operations of the
      biosafety committee . . . ." Accordingly, for a period of three years beginning on 10 July 2000,
      NSF required the institution

                to submit supporting documentation with any proposal sent to NSF relating to
                biohazardous research. That documentation must include (a) a statement of
                whether the research was required to be reviewed by                  biosafety
                committee, (b) documents evidencing the biosafety committee's approval of
                the proposed research agenda, and (c) documents evidencing the biosafety
                committee's rationale for its approval for the particular proposal.3

              The three-year period expired on 10 July 2003. In that period, the institution
      submitted 16 proposals to NSF related to biohazardous research, and submitted the required
      letters with only half of those. On the occasions when we contacted the institution about
      proposals submitted without the required letters, they were belatedly provided.




        .-
          Investigation Report for OIG Case. -
          Letter dated 10 July 2000 from NSF Assistant General Counsel.


                            Agent                     Attorney            Supervisor               AIGI

  Sign 1 date
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                                          NATIONAL SCIENCE FOUNDATION
                                           OFFICE OF INSPECTOR GENERAL
                                             OFFICE OF INVESTIGATIONS

                                     CLOSEOUT MEMORANDUM

Case Number:                                                                      Page 2 of 2
                                                                                                   -
            We contacted the institution to express our concern about its approach to compliance
     with the requirements imposed by NSF, which appeared to reflect continued indifference to
     biosafety and a need for the imposition of additional administrative requirements. In
     response, the institution insisted that it takes biosafety very seriously, stated that the
     instances of apparent noncompliance were aberrational, and offered to comply with two
     additional administrative compliance requirements:
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            1.    The institution would audit all biohazardous related research proposals
                  submitted to NSF from 10 July 2000 to 9 July 2003, and submit for each such
                  proposal evidence of IBC review including the IBC letter approving the
                  proposed research; and

            2.    Until 31 July 2004, the institution will continue to submit supporting
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                  documentation to us for every proposal submitted to NSF relating to
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                  biohazardous research.

     We accepted the institution's proffer. We subsequently received and reviewed the audit,               I
     which appeared to reflect compliance with applicable requirements. Based on the audit and
     the institution's commitment to comply with biosafety requirements-and to provide us with
     documentation of such compliance until 3 1 July 2004-this case is closed.



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