1. The responsibility for compliance with applicable regulations concerning rDNA or infectious agents used in research rests with the Vice President for Research. The Vice President for Research shall be assisted in the discharge of this responsibility by the IBC.
2. When the institution participates in or sponsors rDNA research involving human subjects, the institution must ensure that (a) the IBC has adequate expertise and training (using ad hoc consultants as deemed necessary) and (b) all aspects of applicable sections of the NIH Guidelines regarding experiments involving the deliberate "gene transfer" derived from rDNA into one or more human subjects have been appropriately addressed by the Principal Investigator prior to submission to NIH/ORDA.
1. The IBC is the principal advisory group to the Vice President for Research on the use of rDNA and infectious agents in research. It is the appropriate body to oversee the resolution of concerns involving the use of rDNA and potentially hazardous biological materials brought to the attention of the committee.
2. In accordance with NIH Guidelines and University policy, the Committee shall consist of no fewer than five members, so selected that they collectively have experience and expertise in rDNA technology and the capability to assess the safety of rDNA and infectious agent research and to identify any potential risk to the public health or the environment. At least two members shall not be affiliated with the University and shall represent the interests of the surrounding community with respect to health and protection of the environment. Because Tulane University conducts rDNA research with physical containment at Biosafety Level 3, the IBC shall also include the Biological Safety Officer as a member.
3. No member of the IBC may be involved in the review or approval of a project in which he/she is, has been, or expects to be engaged.
4. The IBC reviews and monitors the use of rDNA and research with infectious agents. Specific responsibilities include the following: a) Assessment of the containment levels required by the NIH Guidelines and University policy. b) Assessment of the facilities, procedures, practices, and training and expertise of personnel involved in research. c) Assurance of compliance with all surveillance data reporting and adverse event reporting required by NIH Guidelines. d) Notification to Principal Investigators of the results of the IBC's review and approval. e) Adoption of emergency plans covering accidental spills and personnel contamination resulting from rDNA or infectious agent research. f) Reporting of any significant problems with or violations of the NIH Guidelines and any significant research related accidents or illnesses to the Vice President for Research and NIH/OBA within 30 days unless the IBC determines that a report has already been filed by the Principal Investigator. g) Review of infectious agents (animal and human viruses, prions, bacteria, parasitic agents and fungi) classified in Risk Groups 2, 3, and 4.
1. Performance of periodic inspections to ensure that laboratory standards are rigorously followed.
2. Consultation with the IBC to plan, develop and conduct training on biological safety practices and procedures relating to rDNA, infectious agents and potentially hazardous biological materials.
3. Report to the IBC any significant problems, violations of the NIH Guidelines, and any significant research related accidents or illnesses of which the BSO becomes aware, unless the BSO determines that report has already been filed by the Principal Investigator.
4, Develop and implement emergency plans for handling spills and personnel contamination, and investigating laboratory accidents involving rDNA, infectious agents and potentially hazardous biological materials.
5. Provide advice on laboratory security.
6. Implement decisions of the IBC.
The Principal Investigator is responsible for full compliance with the policies, practices and procedures set forth under federal guidelines and by the University. This responsibility extends to all aspects of biological safety involving the environment and all individuals who enter or work in the Principal Investigator 's laboratory or collaborate in carrying out the research. Although the Principal Investigator may choose to delegate aspects of the biological safety program to other laboratory personnel or faculty in his/her laboratory, the Principal Investigator retains ultimate responsibility and is accountable for all activities occurring in his/her laboratory.
Office of Biosafety, Tulane University, New Orleans, LA 70112 504-988-0300 firstname.lastname@example.org