Abstract Title

A PROPOSED MODEL FOR POST-APPROVAL MONITORING (PAM) OF INSTITUTIONAL BIOSAFETY PROTOCOL IN AN ACADEMIC ENVIRONMENT

Presenter Name

Uloma Igara Uche

Abstract

The main goal of this project is to develop inspection program over research work involving biological agents and to ensure compliance with National Institute of Health guidelines.

Presentation Type

Poster

Purpose (a):

Hypothesis: I hypothesize that a well-defined model for post-approval monitoring will enhance the efficiency of biosafety program.

Purpose: To ensure that approved protocols are appropriately executed and any changes are reported for approval.

Methods (b):

Materials: Approved protocols/IBC application

Forms to conduct the post approval monitoring

A program out line or Post approval monitoring

An evaluation process or tool to validate the efficiency of the proposed model

Methods: Prior to PAM, a project protocol has to be approved by the Institutional Biosafety Committee (IBC) and the principal Investigator proceeds with the research. With the current Biosfaty program at UNTHSC, the institutional biosafety officer will conduct an annual inspection of each of these laboratories with containment level BSL2 and BSL2+. We are proposing to develop a model for PAM of Biosafety protocols. The process involve the following steps.

Critically examined the existing biosafety auditing program

Research on existing biosafety auditing program in other academic institutions in Texas.

Development of the proposed model for Post Approval monitoring program

Timeline and major steps involved in the proposed model are:

  • Inspection of the laboratory and laboratory procedures of the on-going research for compliance must be done by the Biosafety officer within 2-3 weeks after the protocol approval. The crucial component of this inspection will be an on the spot education about any deficiencies identified during the inspection.
  • After the first year of approval, a thorough review of the protocol and laboratory procedures should be conducted by an assigned member of the institutional biosafety committee
  • Post-visit communication to the principal investigator about any deficiency or compliance found should be recorded and communicated with the principal investigator. Any training requirement should be communicated effectively.
  • Finally towards the end of the research, another lab procedure evaluation should be conducted.

Results (c):

Results: From the post-approval monitoring, there will be compliance with IBC policies/NIH guidelines and the facility and laboratory workers will be protected from hazardous materials

Conclusions (d):

Conclusion: Institutional Biosafety protocol guides and ensures safety and compliance with policies. An efficient post-approval monitoring would be a tool to assist the IBC with its obligations and facilitate a successful program oversight.

This document is currently not available here.

Share

COinS
 

A PROPOSED MODEL FOR POST-APPROVAL MONITORING (PAM) OF INSTITUTIONAL BIOSAFETY PROTOCOL IN AN ACADEMIC ENVIRONMENT

The main goal of this project is to develop inspection program over research work involving biological agents and to ensure compliance with National Institute of Health guidelines.