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 i \ 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: I I \ 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 I documentation to us for every proposal submitted to NSF relating to i I 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. i 1 I I I 1 1
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)