oversight

Human Subject Reg. Violations

Published by the National Science Foundation, Office of Inspector General on 2012-09-12.

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: A11040025                                                                        Page 1 of 1



                  We assessed an allegation that the human subjects research activities of a principal
          investigator 1 (PI) resulted in human subjects violations due to serious and continuing noncompliance
          with the Institutional Review Board (IRB). NSF suspended the awards 2 after the IRB suspended the
          human subjects research studies. NSF also had concerns about the university's oversight ofhuman
          subjects research and management of grant funds. The PI's noncompliance with the IRB included
          poor record keeping, unapproved protocol or consent form modifications and the over-enrollment of
          human subjects in research studies. Following our evaluation of the university's policies and
          procedures, the university instituted a revision of its IRB review processes and post-award approval
          monitoring process for human subjects projects. This included additional oversight and education
          regarding occurrences ofiRB noncompliance. Although the university imposed several corrective
          measures upon the PI, the PI subsequently left the institution for a faculty position at a foreign
          university. 3 Our conclusion is that the human subjects concerns were appropriately remediated by
          the university in conjunction with the IRB. The suspended NSF grants were terminated and the
          remaining obligations cancelled with $310,454 recovered and returned to the Treasury. Accordingly,
                       closed
          this case is -   - with no further action taken.




NSF OIG Form 2 (1 1102)