Institutional Biosafety Committee (IBC)

Research Involving recombinant DNA, potentially pathogenic substances/ toxins, and/or human tissue/body fluid

IBC Process in a Nutshell

It is the policy of the University at Albany that any possession of and/or research involving recombinant DNA, genetic manipulation, potentially infectious and/or hazardous agents (this will include human blood and tissues including saliva and may include animal blood and tissues), or importation of biological material must first be reviewed and approved by the Institutional Biosafety Committee (IBC).

The University at Albany has established an IBC that is qualified through the experience and expertise of its members to oversee the institution's biosafety program, facilities, and procedures. The IBC oversees all research and classroom activities conducted at or sponsored by the University that involve recombinant DNA, potentially pathogenic substances/ toxins, and/or human tissue/body fluids. All applicable research and classroom activities must be carried out in accordance with all applicable federal, state and local regulations and policy.

With respect to the Biosafety program, the University accepts the responsibility for compliance with applicable federal, state, and local regulations (see Biosafety Research Regulations links).

Federal and state regulations, as well as university policy, require IBC review prior to conducting research involving recombinant DNA, genetic manipulation, potentially infectious and/or hazardous agents . These regulations pertain to any research conducted by anyone affiliated with the university. This includes not only sponsored research, but also theses, dissertations, and class projects. Research involving recombinant DNA, genetic manipulation, potentially infectious and/or hazardous agents conducted by any faculty, staff, or student under the auspices of the University at Albany must be reviewed by the IBC.

It is the responsibility of the Investigator to submit the proposed research to the IBC for approval before the research has begun. You may not start your research until your protocol has been reviewed and approved by the IBC.

The IACUC requires all individuals listed on an IACUC protocol to complete the required IBC Training before approval will be granted.

Review the Investigator’s Handbook: Biohazardous Materials Research/IBC to learn:

• Personnel Qualifications and Training
• Terms and Concepts
• Program of Biosafety
• Institutional Official
• NIH Guidelines
• The Institutional Biosafety Committee
• IACUC Procedures
• UAlbany Office of Environmental Health and Safety

Use only Current IBC Forms dated 7/6/05.  Applications submitted on the incorrect forms will be returned without review by the IACUC.

Prepare and submit the required number of copies of the completed application to the Office of Research Compliance, MSC 312.

The Investigator will receive notification of receipt and/or review from the ORC 7-14 days after submission. The official IBC letter of approval will follow pending clarification by the Investigator of any issues, as requested by the IBC.

For projects conducted at BL-1 and BL-2, committee approvals are valid for three years from the date of approval. For projects conducted at BL-3 and BL-4, committee approvals are valid for only one (1) year.

If at any time during the approved research period you propose to change the containment level for the research, you must notify the IBC immediately for the committee’s review and approval of the change or modification before it is implemented. Any and all changes to an approved protocol must first be reviewed and approved by the IBC. Use a Modification Request Form - IBC to submit any modifications to the approved protocol.

Before the approval term expires, submit a Continuation Request Form - IBC or Closure Request Form - IBC to the IBC. Approval may be for a term not to exceed the applicable approval term for the protocol.

Investigators shall report any significant problems, violations of the NIH Guidelines, or any significant research-related accidents and illnesses to the Institutional Biosafety Committee, the Office of Research Compliance, and/or the Office of Environmental Health and Safety (where applicable) within 10 calendar days of discovery of the problem, violation or accident, and to NIH/OBA, and other appropriate authorities (if applicable) within 30 days of discovery of the problem, violation or accident. The Investigator is responsible for reporting any serious adverse event immediately to the IBC and the Office for Research Compliance followed by submission of a written report.

Retain IBC records and accompanying documentation for at least 3 years from the date the research was completed.

For more details, see the Investigator’s Handbook: Biohazardous Materials Research/IBC.

Date: 8.22.07