Definitions

Allegation of Noncompliance: An unproven assertion of noncompliance.

IBC Noncompliance: Violation of University policy or noncompliance with the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines), the Biosafety in Microbiological and Biomedical Laboratories (BMBL), the Cal/OSHA Bloodborne Pathogen Standard, the CDPH Medical Waste Management Act, and other applicable federal, state and local laws or regulations governing use of biohazardous materials and recombinant or synthetic nucleic acid molecules.

Examples of IBC Noncompliance by Principal Investigators include, but are not limited to, the following:

  • Failure of the Principal Investigator (PI) to adhere to the responsibilities outlined in Section IV-B-7 of the NIH Guidelines
  • Conducting procedures involving biohazardous materials and/or non-exempt recombinant/synthetic nucleic acid molecules without IBC approval
  • Working with an infectious agent, viral vector, or host system that is not documented in an approved IBC protocol
  • Deviating from approved SOPs in a way that could increase the exposure risk of employees or the environment to biohazardous materials and/or non-exempt recombinant/synthetic nucleic acid molecules
  • Conduct of procedures by personnel not adequately trained and/or not listed on an approved IBC protocol
  • Improper disposal of medical waste
  • Conducting procedures involving biohazardous materials and/or recombinant/synthetic nucleic acid molecules in a facility(ies) not approved by EH&S Biosafety for such use
  • Failure to provide appropriate personal protective equipment (PPE) to personnel who are at risk of exposure to biohazardous materials and/or recombinant/synthetic nucleic acid molecules
  • Failure to report an overt exposure to biohazardous materials and/or recombinant/synthetic nucleic acid molecules within the specified reporting timeframe (refer to IBC Policy on Reporting Incidents Involving Biohazard Materials)


Initial Evaluation and Actions

Upon receipt of a reported concern, the IBC Chair, in consultation with the ORA-IBC staff, and Biosafety Officer when applicable, shall take immediate steps to ameliorate the problem and protect employees. Such ameliorative steps may range from confiscation/destruction of biohazardous and/or non-exempt recombinant/synthetic nucleic acids to taking no action other than initiating an investigation into the concern.  In some cases, involvement by the Institutional Official (IO), legal counsel, and other University officials (e.g., Department Chair) may be required at the outset of the investigation.

In every investigation, the person(s) against whom the complaint has been raised shall be given notice of the concern and is provided an opportunity to address the allegations in writing.

Following the initial investigation, the IBC Chair shall elect to either immediately bring the matter before the Committee or appoint a Sub-Committee to investigate the allegation. As much information as is reasonably needed will be collected during the investigation, which may entail reviewing documents, inspecting facilities, and/or holding discussions with pertinent individuals.


IBC Determination

If the allegations prove legitimate, results of the initial evaluation, including all supporting documentation and the PI’s corrective action plan, if developed, will be provided to the Committee for consideration at a convened meeting. Based on the information, the IBC will determine:

  1. the nature of the concern as it relates to the NIH Guidelines, BMBL, University policy and other applicable regulations;
  2. the need for additional actions, such as further investigation or notification of other University officials as appropriate; and
  3. further corrective measures to address the concern and prevent recurrence along with appropriate deadlines for response from the PI.

In all cases, the person(s) against whom the allegations have been directed will be notified of the IBC's decisions in writing.


Institutional Responses

The IBC has the authority to address noncompliance with the NIH Guidelines, the BMBL, University policies and other regulatory requirements. Findings of noncompliance may result in one or more of the following actions:

  • Suspending the use of recombinant/synthetic nucleic acid molecules and/or biohazardous materials pending completion and acceptance by the IBC of a written plan by the PI for the correction and/or prevention of recurrence.
  • Termination of approval for use of recombinant/synthetic nucleic acid molecules and/or biohazardous materials.
  • Confiscation and destruction of the recombinant/synthetic nucleic acid molecules and/or biohazardous materials.
  • Any other action necessary to protect employees, the environment, the public and/or University, including restricting access to the laboratory in order to suspend activities.

If the identity of the complainant is known, he/she will be notified in writing of the completion of the investigation, with an assurance that appropriate remedial action has been taken as applicable.


Reporting to External Agencies

Findings of noncompliance will be reported to the appropriate agency, including, but not limited to, the NIH Office of Biotechnology Activities, Cal/OSHA, California Department of Public Health, and the Centers for Disease Control and Prevention. The Office of Research Administration – IBC is responsible for reporting any significant problems with or violations of the NIH Guidelines and any significant research-related accidents or illnesses to the NIH/OBA within 30 days.  These reports are not intended to be punitive toward the individuals involved, but rather are intended to assist the institution in developing new and better policies and practices to prevent future non-compliances from occurring.


Confidentiality

Details pertaining to an investigation in progress remain confidential to the extent possible to protect all concerned; however, when the IBC releases the final report of its findings to federal regulatory agencies, those reports may become accessible to the public under the Freedom of Information Act.


Approved 7/17/14