The Institutional Biosafety Committee
|James Bliska, PhD||Chair, Professor, Dept. of Molecular Genetics & Microbiology|
|Jeronimo Cello||Research Scientist, Molecular Genetics & Microbiology|
|Susan Donelan, MD||Director - Healthcare Epidemiology Dept., Assistant Professor, Infectious Diseases|
|Robert Holthausen||Lab Safety Specialist, Biosafety Officer and Hazardous Chemicals Safety Officer|
|Christopher Hubert||Community Member, Cold Spring Harbor Laboratory|
|George Marshall||Community Member, Port Jefferson, NY|
|Tom Zimmerman, DVM||Director, Division of Laboratory Animal Resources|
|Judy Matuk, M.S.||Executive Secretary, non-voting member|
|Mary O'Neill||Assistant Director, Research Compliance|
Relevant Federal Policies and Procedures
ApplicationsIRBNet is SBU's electronic system for the administration and management of IRB records for investigators and CORIHS.
If you have any questions, or would like to schedule in-person training, please contact the Office of Research Compliance, at 631-632-9036.
Office of Biotechnology Activities (OBA), National Institutes of Health
Summary of Section IV-B-7 of the NIH Guidelines for Research Involving Recombinant DNA Molecules
Responsibilities of the Principal Investigator (PI)
On behalf of the institution, the Principal Investigator is responsible for full compliance with the NIH Guidelines in the conduct of recombinant DNA research.
A. As part of this general responsibility, the Principal Investigator shall:
- Initiate or modify no recombinant DNA research which requires Institutional Biosafety Committee approval or notification prior to initiation (see Sections III-A, III-B, III-C, III-D, and III-E, Experiments Covered by the NIH Guidelines) until that research or the proposed modification thereof has been approved by the Institutional Biosafety Committee and has met all other requirements of the NIH Guidelines;
- Investigate and report within 30 days any significant problems pertaining to the operation and implementation of containment practices and procedures, violations of the NIH Guidelines, or any significant research-related accidents and illnesses to:
- Mr. Robert Holthausen (Biological Safety Officer, EH&S),
- Ms. Judy Matuk (on behalf of the Institutional Biosafety Committee),
- NIH/OBA, Office of Biotechnology Activities, National Institutes of Health, 6705 Rockledge Drive, Suite 750, MSC 7985, Bethesda, MD 20892-7985 (20817 for non-USPS mail), 301-496-9838, 301-496-9839 (fax);
- and other appropriate authorities (if applicable, e.g., Dr. Thomas Zimmerman, DLAR Director, when the work involves animal subjects),
- Be adequately trained in good microbiological techniques;
- Adhere to Institutional approved emergency plans for handling accidental spills and personnel contamination (contact Environmental Health and Safety; 2-6410); and
- Comply with shipping requirements for recombinant DNA molecules (see Appendix H, Shipment, for shipping requirements and the Laboratory Safety Monograph for technical recommendations).
B. Prior to Initiating Research, the Principal Investigator shall:
- Make available to all laboratory staff the protocols that describe the potential biohazards and the precautions to be taken;
- Instruct and train laboratory staff in: (i) the practices and techniques required to ensure safety, and (ii) the procedures for dealing with accidents; and
- Inform the laboratory staff of the reasons and provisions for any precautionary medical practices advised or requested (e.g., vaccinations or serum collection).
C. During the Conduct of the Research, the Principal Investigator shall:
- Supervise the safety performance of the laboratory staff to ensure that the required safety practices and techniques are employed;
- Correct work errors and conditions that may result in the release of recombinant DNA materials;
- Ensure the integrity of the physical containment (e.g., biological safety cabinets) and the biological containment (e.g., purity and genotypic and phenotypic characteristics).
- When applicable, comply with reporting requirements for human gene transfer experiments conducted in compliance with the NIH Guidelines (see Appendix M-I-C, Reporting Requirements).
- Remain in communication, as necessary, with the Institutional Biosafety Committee throughout the conduct of the project.
D. Information to Be Submitted by the Principal Investigator to NIH OBA
The Principal Investigator shall:
- Submit information to NIH/OBA for certification of new host-vector systems;
- Petition NIH/OBA, with notice to the Institutional Biosafety Committee, for proposed exemptions to the NIH Guidelines;
- Petition NIH/OBA, with concurrence of the Institutional Biosafety Committee, for approval to conduct experiments specified in Sections III-A-1, Major Actions Under the NIH Guidelines, and III-B, Experiments that Require NIH/OBA and Institutional Biosafety Committee Approval Before Initiation;
- Petition NIH/OBA for determination of containment for experiments requiring case-by-case review; and
- Petition NIH/OBA for determination of containment for experiments not covered by the NIH Guidelines.
- Ensure that all aspects of Appendix M have been appropriately addressed prior to submission of a human gene transfer experiment to NIH OBA, and provide a letter signed by the Principal Investigator(s) on institutional letterhead acknowledging that the documentation being submitted to NIH OBA complies with the requirements set forth in Appendix M. No research participant shall be enrolled (see definition of enrollment in Section I-E-7) in a human gene transfer experiment until the RAC review process has been completed (see Appendix M-I-B, RAC Review Requirements); IBC approval (from the clinical trial site) has been obtained; Institutional Review Board (IRB) approval has been obtained; and all applicable regulatory authorization(s) have been obtained.
For a clinical trial site that is added after the RAC review process, no research participant shall be enrolled (see definition of enrollment in Section I-E-7) at the clinical trial site until the following documentation has been submitted to NIH OBA: (1) IBC approval (from the clinical trial site); (2) IRB approval; (3) IRB-approved informed consent document; (4) curriculum vitae of the principal investigator(s) (no more than two pages in biographical sketch format); and (5) NIH grant number(s) if applicable.
Email Judy Matuk, Assistant Vice President of Research Compliance.