Regulations and Guidelines

THE NIH GUIDELINES FOR RESEARCH INVOLVING RECOMBINANT AND SYNTHETIC NUCLEIC ACID MOLECULES

The NIH Guidelines outline procedures involving use of recombinant and synthetic nucleic acid molecules and describe the roles, responsibilities, and relationships among the principal investigator (PI), the Institutional Biosafety Committee (rDNA review committee), and the National Institutes of Health (NIH). The NIH Guidelines also cover the use of transgenic animals in research.

The NIH Guidelines also contain helpful information regarding physical and biological containment guidelines and risk assessment (categorized into Risk Group 1, 2, 3, or 4).

Compliance with the NIH Guidelines is a necessity due to federal NIH funding received by UT Arlington.  All projects involving recombinant DNA techniques conducted at or sponsored by an institution that receives NIH funds for projects involving such techniques must comply with the NIH Guidelines.  Noncompliance may result in:  (i) suspension, limitation, or termination of NIH funds for all recombinant DNA research at the institution, or (ii) a requirement for prior NIH approval of any or all recombinant DNA projects at the institution.

 

BIOSAFETY IN MICROBIOLOGICAL AND BIOMEDICAL LABORATORIES, 5TH EDITION

The Centers for Disease Control (CDC’s) Biosafety in Microbiological and Biomedical Laboratories, (the “BMBL”) establishes a code of practice for biosafety in laboratories - one that all members of the research and laboratory community can utilize to safeguard themselves and their colleagues, and to protect the public health and environment.

The BMBL contains helpful information regarding risk assessment, laboratory safety standards, containment guidelines, and categorization of biological agents/material into containment levels (referred to as Biosafety Level 1, 2, 3, or 4).  These classifications are based on infectivity, severity of disease, transmissibility, and the nature of the work being conducted.

In November 2020, the CDC announced the release of the 6th Edition of the BMBL.  A summary of the changes can be found here: BMBL 6th Edition - Summary of Changes.

UTA Recombinant/Synthetic Nucleic Acid Molecules Policy

Policy RA-PO8

UTA IBC Standard Operating Procedures (SOPs)

IBC Review Procedures and Training

IBC Roles and Responsibilities

IBC Review of Concerns, Incidents, and Potential Non-Compliance