XII. Process for Reporting Violations of the NIH Guidelines

  1. Allegations regarding a violation of the NIH Guidelines could be reported through at least two routes:
  • A whistleblower (student, staff, or faculty who in good faith reports real or perceived University-related misconduct).
  • Biosafety staff, during the regular performance of his/her job duties, is informed or made aware of information that a violation of the NIH Guidelines may have occurred.
    • This entails that a staff member is given credible information that is more than mere hearsay. Staff should make reasonable efforts to inquire further about the possibility of a violation.
    • If found to be credible, further investigation will proceed as described below.
  1. Information received through either route requires that the Biosafety Office notify the IBC chair, the Institutional Official (IO) and the EHS Director. If the IBC chair, IO and EHS Director agree to proceed with an investigation, the Biosafety Office will be directed to investigate the allegation. Prior to initiating an investigation, the Biosafety Office shall provide the PI with written notice of the allegation and the plans for an investigation.
  2. Upon completion of the investigation, an investigation report will be prepared and sent to the IBC chair, the IO, and the EHS Director. If after careful review of the investigation report, a majority of these persons opines that the findings reasonably support the allegation of a violation, the investigation report will be sent to the members of the IBC for review.
  1. The investigation report will be considered at a meeting of the IBC convened for that purpose, or at a previously scheduled meeting if one will occur shortly after the report is sent to the IBC members. After consideration of the investigation report, the written materials submitted by the PI if any, and the information presented in person by the PI if any, the members in attendance will determine by majority vote if a violation of the NIH Guidelines has occurred.
  2. If the IBC determines that a violation of the NIH Guidelines has occurred, the IBC chair will prepare a violation report to be sent to NIH/OBA that will outline the review process followed, the findings of the investigation, and any measures that will be taken to reduce the likelihood of the occurrence of such violations in the future.
  3. Alternatively, the IBC chair may ask the PI if he/she wishes to prepare the violation report, as specified in the NIH Guidelines. If the PI chooses to prepare said report, the IBC chair will provide guidance in its preparation. If the IBC chair deems the report prepared by the PI to be unacceptable, the IBC chair will prepare his/her own report.
  4. Independent of who prepares the violation report, the IBC chair will ensure that it is sent to NIH/OBA within 30 days of the Biosafety Office’s becoming aware of the violation. Copies of the violation report will be sent to the IO and to the PI. The BSO will notify NIH/OBA of incidents requiring immediate reporting through an email; a full report will follow after the investigation has been completed.

 

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