IBC Policy 510 - Investigation of Noncompliance | Office of Research Compliance

Adopted May 21, 2026

I. Policy Purpose

This policy establishes procedures for the identification, evaluation, and resolution of alleged and confirmed noncompliance related to activities involving recombinant or synthetic nucleic acids and biohazardous materials. It ensures compliance with applicable regulations and promotes the safety of personnel, the public, and the environment.

II. Policy Definitions

Allegation of Noncompliance means an unproven assertion of noncompliance.

IBC Noncompliance means a 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), and other applicable federal, state, and local laws or regulations governing the use of biohazardous materials and recombinant or synthetic nucleic acid molecules.

Regulated Activities include any research, teaching, and/or contracted service activity with r/sNAs or biological hazards conducted by SIUC faculty, staff, volunteers, and students.

r/sNA refers to recombinant or synthetic nucleic acid molecules. These molecules are subject to the federal NIH Guidelines cited above.

III. Policy Statement

All activities involving recombinant or synthetic nucleic acids, biohazardous materials, or other IBC regulated activities must be conducted in compliance with applicable University policies and regulatory requirements. Allegations of noncompliance will be reviewed promptly, and confirmed instances will be addressed through appropriate corrective actions to ensure the protection of personnel, the public, and the environment.

IV. General Procedures

Reporting Allegations of Noncompliance

Concerns may be reported in writing to ibc@siu.edu, verbally to the IBC Chair or IBC Biosafety Officer, or anonymously to the Office of Research Compliance at 618-453-4530 or through the anonymous web reporting tool. SIUC will not tolerate retaliation against individuals who report violations.

Initial Evaluation and Actions

Upon receipt of a reported concern, the IBC Chair, in consultation with the Office of Research Compliance, and IBC Biosafety Officer will immediately conduct an initial appraisal to determine if circumstances merit a full evaluation.

The initial appraisal will consider the nature and extent of the concern, whether the issue presents a potential immediate risk and if the concern involves noncompliance with University policy or federal regulations.

When necessary, the IBC Chair, in consultation with the Office of Research Compliance, the Biosafety Officer, and when appropriate, staff from the Center for Environmental Health and Safety, shall take immediate steps to ameliorate the problem and protect employees.

Such 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.

The initial appraisal will consider if the allegation or report is determined to be credible or meets the definition of noncompliance. Otherwise, a summary of the allegation or report is documented with no further action being required.

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.

In some cases, involvement by the Institutional Official (IO), legal counsel, and other University officials (e.g., Unit Director) 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 provided an opportunity to address the allegations in writing.

No individual with a conflict of interest shall participate in an investigation of alleged noncompliance.

IBC Determination

If the allegations prove legitimate, results of the initial evaluation, including all supporting documentation and any recommended corrective action(s) will be provided to the Committee for consideration at a convened meeting. The IBC will determine:

the nature of the concern as it relates to the NIH Guidelines, BMBL, University policy and other applicable regulations;
the need for additional actions, such as further investigation or notification of other University officials as appropriate; and
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 PI’s use of any IBC regulated 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 any IBC regulated materials.

Confiscation and destruction of any IBC regulated materials.

Any other action the IBC deems necessary to protect employees, students, the environment, the public and/or University.

If the identity of the complainant is known, they will be notified in writing of the completion of the investigation.

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, the Centers for Disease Control and Prevention, or sponsoring agencies as required. The 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 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-compliance 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, those reports may become accessible to the public under the Freedom of Information Act.

Examples of IBC Noncompliance

Examples 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 regulated biological waste.
Conducting procedures involving biohazardous materials and/or recombinant/synthetic nucleic acid molecules in a facility(ies) not approved 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 to the IBC (refer to IBC Policy on Reporting Incidents Involving Biohazard Materials).

IBC Policy 510 - Investigation of Noncompliance