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Research at URI

Biosafety

Overview

The University of Rhode Island Institutional Biosafety Committee (IBC) reviews and approves Biological Research protocols.  Biological Research is defined as any laboratory research activity involving:

  • Recombinant DNA (rDNA),
  • Biological agents (i.e., viable infectious microorganisms (including prions) regardless of their pathogenicity to humans)
  • Human or nonhuman primate materials, or
  • Biological toxins subject to the National Select Agents Registry Program managed by the U.S. Departments of Health and Human Services (HHS) and Agriculture (USDA). The current list of toxins is identified at: http://www.selectagents.gov/index.html

Prior to commencing Biological Research, investigators must submit a protocol for review by the IBC. The IBC is established to ensure that Biological Research is conducted safely and that compliance is maintained with the following guidelines and regulations:

The IBC works in conjunction with the URI Institutional Animal Care and Use Committee (IACUC) and the URI Office of Safety and Risk Management.

Committee Information

If any members of the University of Rhode Island community or the general public wish to forward comments or questions to the Institutional Biosafety Committee (IBC) or attend a meeting, please contact the IBC.

The IBC encourages all Principal Investigators with pending applications to attend IBC meetings where their research will be discussed.  Please contact the IBC administrator who will place the PI name on the agenda for attendance.  

Proposals to conduct Biological Research may be submitted at any time to the IBC through IRBNet. For more information about IRBNet see the IRBNet Directions page 

Policies

The URI IBC Governance and Operating Policies details the roles and responsibilities of the committee, the PI and others involved in the oversight of Biological Research. Additionally, it contains policies, procedures, and guidelines to guide researchers conducting Biological Research. 

Guidelines and Regulations

  • The National Institutes of Health (NIH) NIH Guideline for Research Involving Recombinant DNA Molecules (NIH Guidelines) mandates the establishment of an Institutional Biosafety Committee (IBC) for the review and oversight of Biological Research involving recombinant deoxyribonucleic acid (rDNA) and synthetic DNA molecules and specify practices for constructing and handling: (i) recombinant deoxyribonucleic acid (rDNA) molecules, and (ii) organisms and viruses containing rDNA molecules. Adherence to the NIH Guidelines is a requirement for all institutions receiving funding from the NIH.
  • Biosafety in Microbiological and Biomedical Laboratories (BMBL) published by the Centers for Disease Control and Prevention is the guidance document for the practice for biosafety -- the discipline addressing the safe handling and containment of infectious microorganisms and hazardous biological materials.
  • The NIH Office of Biotechnology Activities (OBA) promotes science, safety, and ethics in biotechnology through advancement of knowledge, enhancement of public understanding, and development of sound public policies. OBA accomplishes its mission through analysis, deliberation, and communication of scientific, medical, ethical, legal, and social issues.
  • The Occupational Safety and Health Administration (OSHA) has established OSHA Bloodborne Pathogen Standard 1910.1030 for work with human blood and body fluids and tissue, primary cell lines and established cell lines that have not been proven to be free of bloodborne pathogens.
  • Select agents and toxins are biological agents and toxins that could pose a severe threat to public health and plant health, or to animal or plant products. The U.S. lists of Select Agents and Toxins are maintained by the Departments of Health and Human Service and Agriculture, and are found in the Select Agent Regulations (42 CFR Part 73, 9 CFR Part 121, and 7 CFR Part 331). Possession of select agents (or toxins above identified thresholds) requires compliance with these Select Agent Regulations.

Additional References

Forms and Submission Process

All Biological Research (as defined in the URI IBC Governance and Operating Policies) must be reviewed and approved by the IBC. All submissions to the IBC must be submitted through IRBNet.

The following steps will allow you to complete and submit the forms.  Should you have any issues or questions, please contact compliance@ds.uri.edu for assistance in the process.

  • Check that you have installed the latest version of Adobe Acrobat or Reader.  The link to install Adobe Reader is: http://get.adobe.com/reader
  • Download the IBC Registration Document (see below).
  • Mac and iOS Users, open the file using Adobe Reader rather than the Preview function built into your Mac OS.
  • Windows users, open the file using Adobe Acrobat or Reader rather than using a web browser.
  • Save the form once you have entered your information.
  • To submit the form for IBC review, upload the file in IRBNet.
  • For questions in completing or submitting the forms, contact compliance@ds.uri.edu.

Forms

Forms are also available on the IRBNet library

Training
The URI Office of Safety and Risk Management provides comprehensive training for personnel conducting Biological Research. Training is required for all personnel working at Biosafety Level 2 or higher on approved IBC protocols. This training covers biosafety guidelines followed at URI, the U.S. Occupational Safety & Health (OSHA)'s Bloodborne Pathogen Program, disinfection and waste disposal procedures, and the use of biological safety cabinets. More information is available about these and other training courses at University of Rhode Island Safety and Risk Management.

Reporting
Research-related Accidents and Illnesses and Violations of the NIH Guidelines

The URI Institutional Biosafety Governance and Operating Policies and the NIH (National Institutes of Health) Guidelines for Research Involving Recombinant DNA Molecules require submission of a report to the NIH of “any significant problems, violations of the Guidelines, or any significant research-related accidents and illnesses.”

PIs are required to notify the URI EHS and the Office of Research Integrity as soon as possible in the event of a potential or overt exposure to rDNA , a biological agent, human or human primate material or biological toxin, suspected laboratory acquired infection, or violation of the NIH Guidelines. This is required even if the staff was not seen by Occupational Health or the Emergency Department. Of behalf of the PI, the IBC will report to the appropriate agency as required. Additional information regarding reporting is provided below.

Contact Information:

Ted Myatt, Sc.D.
Director of Research Integrity
Phone: (401) 874-2636
E-mail: tedmyatt@mail.uri.edu

Reports can also be made anonymously through the URI Ethics Hotline, an independently administered, toll-free hot line at 1-855-236-1845 or www.uriethicsline.com. Please note that there may be a time lag in reporting using this service.