Human Subject Reg. Violations

Published by the National Science Foundation, Office of Inspector General on 2006-04-21.

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

                                                                                11                            11
 Case Number: A05090062                                                                     Page 1 of 1

         This case was generated out of a proactive review effort to assess compliance with NSF's
         requirements for conducting research involving human subjects. In the award selected,' it
         appears that work is being conducting that falls within the definition of research involving human
         subjects. In particular, there is a student evaluation process that appears to go beyond simple
         internal course evaluations. Based on statements in the proposal and the first annual report, the
         awardee2 appears to be tracking students beyond the summer research experience and plans to
         present its generalized knowledge to the research community. The awardee failed to complete
         the NSF cover page section requesting information about research involving human subjects, and
         as a result the NSF Action Processing Form does not code the research as involving human

         In response to our inquiry, the awardee stated that the research did indeed involve human
         subjects and it had not obtained the Institutional Review Board (IRB) approval before initiated
         the funded work. It agreed to halt the research until it obtained a satisfactory review. We
         notified both the NSF Program officer3 and NSF's Human Subjects coordinator4 who both
         concurred that the research must be halted until the IRE3 review was completed.

         Approximately one month later, the awardee informed OIG that the IRE3 review had completed
         an expedited review and approved the research for one year. At our request the awardee
         conducted a proactive review of all its other NSF awards and determined that they are in
         compliance with IRB requirements. Additionally, the awardee under took training for its pre-
         and post award staff as well as faculty and published reminders in its internal electronic
         newsletter regarding human subjects reviews and training dates.

         At our request NSF's databases were updated to contain both the IRB approval letter and the
         Action Processing Form was recoded to indicate this was a nonexempt human subjects project.

         This case is closed.

NSF OIG Form2 (1 1/02)