Responsibilities of Principal Investigators

A. The Principal Investigator (PI), on behalf of the Institution, is responsible for fully complying with the NIH Guidelines in conducting any recombinant DNA research.

As part of that responsibility, the PI shall:

Be aware of recombinant DNA biosafety requirements and assure that requirements and procedures of Texas A&M University are followed; 

assure that all work involving recombinant DNA is registered with the IBC; assure that necessary safeguards and procedures are maintained in the work place; follow the NIH Guidelines for Research Involving Recombinant DNA Molecules. It is essential for PIs working with recombinant DNA to be thoroughly familiar with the NIH Guidelines and follow appropriate CDC/NIH Biosafety Guidelines;

a. Make the initial determination of the required levels of physical or biological containment in accordance with the NIH Guidelines;

b. Select appropriate microbiological practices and laboratory techniques to be used in the research; 

(See NIH Guidelines for Research Involving Recombinant DNA Molecules (referenced in Footnote 1 below) for information on containment requirements.)

Appendix G specifies physical containment requirements for standard laboratory experiments and defines Biosafety Level 1 through Biosafety Level 4. For large scale (>10 liters) research or production, Appendix K (Physical Containment for Large Scale Uses of Organisms Containing Recombinant Molecules) supersedes Appendix G. Appendix K defines Good Large Scale Practice BL1-LS through- BL3-LS. For certain work with plants, Appendix P (Physical and Biological Containment for Recombinant DNA Research Involving Plants) supersedes Appendix G. Appendix P defines Biosafety Levels BL1-P through BL4-P. For certain work with certain animals, Appendix Q (Physical and Biological Containment for Recombinant DNA Research Involving Animals) supersedes Appendix G. Appendix Q defines Biosafety Levels BL1-N through BL4-N.)

• Assure that all review and approval requirements are fulfilled prior to initiating any new or modified research procedures;
• Comply with shipping requirements for recombinant DNA molecules;
• Submit the initial research protocol if required by NIH Guidelines or institutional requirements;
• Notify the Biological Safety Officer (BSO) when required safety inspections and certification of containment facilities and biological safety cabinets are needed;
• Notify the IBC of any significant changes in experimental protocol or location of research;
• Provide information to the IBC and BSO, as necessary.
• Remain in communication with the IBC throughout the conduct of the project.

B. Responsibilities of the Principal Investigator prior to initiating research

The PI shall:

• Assure that labs and work places are identified with appropriate warning signs; and that personnel are properly trained and are informed regarding biohazards;
• Make available to the laboratory staff, copies of the protocols that describe the potential biohazards and the precautions to be taken;
• Assure that staff are trained in the safe work practices and techniques and in the procedures for dealing with accidental spills and personnel exposure;
• Inform staff of the reasons and provisions for any precautionary medical practices advised or requested, such as vaccinations or serum collection;
• Prepare a written contingency plan for handling emergency conditions such as spills, personnel exposure, loss of containment, power failure, etc.

C. Responsibilities of the Principal Investigator during the research

The PI shall:

• Supervise the staff to assure that the required safety practices and techniques are employed, and that appropriate containment procedures are followed;
• Investigate and provide written reports to the BSO, the IBC and the NIH Office of Recombinant DNA Activities (ORDA) regarding any significant problems pertaining to the operation and implementation of biohazard-containment practices and procedures, violations of the NIH Guidelines and all significant research-related accidents and illnesses;
• Correct work errors and conditions that may result in the release of recombinant DNA materials;
• Ensure the integrity of physical containment (e.g., biological safety cabinets) and the biological containment (e.g., purity and genotypic and phenotypic characteristics);
• Adhere to IBC-approved emergency plans for handling accidental spills and personnel contamination;
• Assure proper handling and disposal of biohazardous waste.

Footnotes

1. NIH Guidlines for Research Involving Recombinant DNA Molecules, Federal Register, 60(20726), April 27, 1995 and updates. 
2. Biosafety in Microbiological and Biomedical Laboratories, U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control and National Institutes of Health, 3rd Edition, May, 1993. HHS Publication No. (CDC) 93-8395. 
3. USDA Guidelines for Research with Genetically Modified Organisms Outside Contained Facilities, Office of Agricultural Biotechnology, USDA, Washington, D.C., May, 1989 and updates.
4. Certain restrictions and regulations may apply to shipment an d transport of genetically altered material.