oversight

Human Subject Reg. Violations

Published by the National Science Foundation, Office of Inspector General on 2012-08-30.

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: A12020005                                                                        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 award2 after the IRB suspended the
          human subjects research studies. The IRB directed an on-site audit which found several IRB
          protocol deviations. The PI implemented several corrective measures which included the
          modification of recruitment procedures, enrollment log documentation, permission forms and the
          destruction of collected information that was deemed unapproved. Although the PI was advised that
          all modifications to an IRB protocol should be submitted and approved through an amendment, the
          PI instead submitted a new IRB protocol which was subsequently reviewed and approved. The IRB
          lifted the suspension of the PI's research activities and imposed a requirement that the PI and
          research staff attend IRB educational sessions. Furthermore, the institution's Office of Research
          Support scheduled quarterly audits of the PI's compliance with the IRB protocol. NSF rescinded the
          suspension of the PI's NSF award. Our conclusion is that the human subjects concerns were
          appropriately remediated. Accordingly, this case is closed with no further action taken.




NSF OIG Form 2 (11102)