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UTEP IBC Handbook

Introduction
Statement of Purpose
UTEP IBC Composition
Roles and Responsibilities
IBC Policies and Procedures
Submission Types
Review Types, Processes, and Timeline
Protocol Termination
Protocol Deviations and Allegations of Non-Compliance

Protocol Deviations and Allegations of Non-Compliance

 
Definitions

Protocol Deviation:

A protocol deviation occurs when there is an inconsistency in a research study between the protocol that has been reviewed and approved by the IBC and the actual activities being done. As defined below, protocol deviations may be minor, moderate, or major. Protocol deviations involving a human gene transfer study will be subject to IRB and IBC policies.

Minor Protocol Deviation:

The deviation has no substantive effect on the biosafety risks and does not meet any criteria listed for Moderate or Major Protocol Deviations.

Major Protocol Deviation:
  • The deviation has harmed or posed a risk of substantive harm to the safety of personnel or human subjects.
  • The deviation has posed a risk of minimal harm to the safety of personnel or human subjects.
  • The deviation resulted in a regulatory violation that can be acceptably resolved or; There is a history of repeated minor protocol deviations from the same laboratory, site, or research team.
  • There has been a failure to follow up on actions and recommendations ordered by the IBC to correct minor or moderate protocol deviations.
  • The deviation resulted from willful or knowing misconduct on the part of the investigator(s).
  • The deviation involves severe or continuing noncompliance with federal, state, or local research regulations.
  • The deviation resulted in a violation of the select agent regulations.
  • There have been repeated minor or moderate protocol deviations from the same investigator.
  • There has been a failure to follow action ordered by the IBC to correct minor or major protocol deviations

Reporting Requirements

Minor Protocol Deviations. Minor protocol deviations do not need to be reported to the IBC. However, the IBC analyst will review any minor protocol deviations that come to the IBC's attention and may require corrective action.

Major Protocol Deviations. All major protocol deviations must be reported to the IBC as described below.

Direct substantive harm or risk of substantive harm is a significant protocol deviation. It must be reported to the UTEP IBC (and IRB if human subjects are involved) within 72 hours of discovery of the deviation

Procedure for Reporting Allegations of Non-compliance

The concerned individual may report allegations to any of the following:
  • Associate Vice President, RCRA
  • IBC Chair
  • Any IBC member
  • Biological Safety Officer
  • Vice President for Research & Innovation
The IBC chair is responsible for the receipt and disposition of all complaints. All allegations will remain confidential to the extent possible. When the complainant wishes to be openly identified, the IBC Chair will acknowledge receipt of the allegations to the complainant in writing. The UTEP: Whistleblower Policy should be consulted for specific information on individual protection.

The IBC Chair will appoint a subcommittee to determine if the complaint has sufficient grounds to warrant a full investigation. All individuals involved in the investigation will be informed about the purpose of the investigation and how it will be conducted. In its investigation, the subcommittee will examine all pertinent documents and procedures, interview involved personnel and report its findings to the entire IBC. The IBC will then vote either in a convened meeting or electronically for the following options:
  • Accept the recommendations of the investigating subcommittee
  • Offer further suggestions or comments
  • Request a convened meeting to discuss the concern and/or the report. A single member’s request for a convened meeting to consider a concern will result in a convened meeting
Based on the investigation report, the IBC will determine the required actions. IBC determinations may include, but are not limited to:
  • Investigation did not reveal an issue of non-compliance
  • Investigation revealed non-compliance
  • Related aspects of the program require further review
  • Other related institutional programs may require review
For any noncompliance with IBC policy, the IBC must prescribe corrective actions, appropriate deadlines, and reporting requirements. The IBC must determine whether the noncompliance meets the criteria for actionable as determined by the IBC.

Examples of corrective actions include:
  • Terminate approval of the respective research protocol
  • Suspend approval of the respective research protocol pending completion and acceptance by the IBC of an independent audit of the study and/or the submission, by the PI, of a written plan for the correction and/or prevention of the problem
  • Institute an IBC-mandated corrective action plan and independent audit of the study
  • Other actions as the IBC deems appropriate, including recommendations to the Vice President for Research for confiscating and destroying rDNA and/or biohazardous materials
In writing, the IBC Chair will communicate the results of the IBC evaluation of a reported concern to the person responsible for reporting the concern, the PI, the Vice President for Research, the PI’s Department Chair, and the Associate Vice President of RCRA. The communication will include a summary of the concern, the findings of the investigation, determinations of the IBC, and the recommended corrective actions/sanctions. The letter will also inform the person(s) who initiated the report of their option to appeal the decision within ten days of receipt of this letter by writing the IBC Chair detailing the basis of the appeal and requesting a meeting with the IBC. The IBC is obligated to report within  thirty days , through the Vice President for Research & Innovation, any significant problems, violations of the NIH Guidelines, or any significant research-related accidents and illnesses to NIH’s Office of Biotechnology Activities unless the institution determines that the PI or Biological Safety Officer has already filed a report.

Failure to comply

PIs must comply with the IBC standards outlined in this Handbook. Noncompliance includes, but is not necessarily limited to:

Failure to register biohazardous agents, including non-exempt rDNA or SNAMs

Poor biological safety/containment practices documented through routine lab inspections

Failure to correct a documented (confirmed) biological safety complaint or concern

Any infractions will be reported to the IBC, potentially leading to suspending or canceling all authorized registrations. The PI's Department Chair, Dean, and other relevant administrators will be informed of the violation(s).