Human Subject Reg. Violations

Published by the National Science Foundation, Office of Inspector General on 2003-12-31.

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


                                                         OFFICE OF INSPECTOR GENERAL
                                                           OFFICE OF INVESTIGATIONS

                                                 CLOSEOUT MEMORANDUM

                While reviewing an awardee7s1annual report, we identified discrepancies with other
         documents in the award jacket.' Specifically, the Human Subjects box on the cover page was
         unchecked while the independent evaluator's report stated that program was updating its Institutional
         Review Board (IRB) materials. Additional inconsistencies were found, including an unchecked
         Human Subjects box on NSF's Action Processing ~ o m (APF).     i ~    Further investigation of the
         awardee revealed that identifying information about minors participating in the project was publicly
         available on the organization's web site. We recommended that the awardee remove the identifjing
         information from public view pending completion of our investigation, and it did so. We                            ,
         recommended that NSF suspend the award pending IRB review of the entire project. NSF suspended

                 We worked with the awardee, its IRB,and NSF to achieve compliance. We ensured that
         relevant information was provided to the IRB. This information included, among other things, a
         copy of the original proposal, which the IRE3 had not seen previously. After reviewing all the
         materials, the IRB issued a letter stating that the project was non-exempt, involving not greater than
         minimal risk. NSF then lifted the suspension.
                 Because of the awardee's inexperience in award management, we also recommended that
         NSF require the awardee: to submit the results'of each subsequent IRB review over the life of the
         awad; to certifjr its attendance at professional grants management training; and to treat the award as
         an at-risk award. NSF has accepted these recommendations with the exception that grants
         management training was recommended to, rather than required of, the awardee.
                 While the awardee was resolving the IRE3 issues, we learned that the web pages that revealed                   I
         identifying information about minors are part of the awardee's non-NSF-supported activities.
         However, the awardee had erroneously used NSF funds in these activities, thereby establishing a
         connection between NSF support and these activities. We agreed with the awardee that crediting the
         NSF grant account for the erroneous payment would sever the connection between NSF and these
         non-NSF-supported a~tivities.~    The awardee provided documentation that the NSF account had been
         credited a reasonable amount; then the awardee reactivated the web pages.
                 We also reviewed the 17 other awards in the NSF program5 that funded the awardee and
         identified several internal NSF program issues. We found a lack of compliance with and
         understanding of the Human Subjects (HS) regulations6 within the program office. All of the

          :                nonprofit organization with no previous experience administering a federal grant

           NSF Form 1036
           Otherwise, the awardee would have needed to request a change of scope for the NSF award and receive additional

           45 C.F.R. part 690 Protection of Human Subjects

NSF OIG Form 2 (1 1102)

                                 t                                      1

                                               NATIONAL SCIENCE FOUNDATION
                                                OFFICE OF INSPECTOR GENERAL
                                                 OFFICE OF INVESTIGATIONS

                                        CLOSEOUT MEMORANDUM

Case Number: A03060032                                                                   Page 2 of 2

    programs awards involved HS issues. The program officer7had not coded the relevant APF section
    for any of the 17 awards. Only 7 proposal cover pages indicated HS-related research. Of those, NSF
    had received only 3 IRB certificationswhen the awards were approved while 4 were pending. When
    discussing this with NSF, we were informed that the relevant sections of the Grant Proposal Guide
    (GPG) and Proposal and Award Manual (PAM) could be read as inconsistent with each other,
    possibly resulting in confusion as to the program officer's responsibilities.
            We recommended that NSF: ensure that all the award jackets in the program were corrected
    to reflect the exemptlnonexempt status of the projects including appropriate documentation; ensure
    that all grants and program officers in the affected directorate receive refresher training in HS
    compliance; provide information on the web-based training effort; ensure that relevant program
    announcements contain advisory language about HS requirements; ensure that the GPG and PAM
    instructions are consistent with each other; amend the Prospective New Awardee Guide (PNAG) to
    contain a review of compliance issues such as HS requirements; and ensure that its outreach efforts
    contain sessions on HS compliance.
            The affected directorate"nformed us that they: have corrected the award jackets, including
    documentation; have begun annual awareness training for division directors and staff; and are
    working to identify programs most likely to have HS implications, to add a hard edit in proposal
    processing for those programs, and to perform semi-annual analyses to check the process.
            At the agency level, NSF reported that the web-based training effort is operational, is being
    edited, and will be publicized to program staff. NSF stated its belief that: the GPG is the
    appropriate vehicle for informing prospective awardees about HS requirements but it will revise the
    PAM to clarifyprogram officers' responsibilities; and the purpose of the PNAG is the assessment of
    financial viability, thus inclusion of HS compliance information would be inappropriate. NSF
    agreed to research additional outreach methods and to make an informal assessment of program areas
    involving large-scale HS research, which may require refresher training for NSF personnel.

           Accordingly, this case is closed.