1. What is an Institutional Biosafety Committee?

Institutional Biosafety Committees (IBCs) were established under the NIH Guidelines for Research Involving Recombinant DNA Molecules to provide local review and oversight of nearly all forms of research utilizing recombinant DNA.  Over time, many institutions have chosen to assign their IBCs the responsibility of reviewing a variety of experimentation that involves biological materials (e.g., infectious agents) and other potentially hazardous agents (e.g., carcinogens). This additional responsibility is assigned entirely at the discretion of the institution.

2. What are the responsibilities of institutions with regard to IBCs?

Each institution is responsible for ensuring that all recombinant DNA research conducted at or sponsored by that institution is conducted in compliance with the NIH Guidelines.  Institutional authority and responsibility place accountability for the safe conduct of the research at the local level. More specifically, each institution conducting or sponsoring recombinant DNA research that is covered by the NIH Guidelines is responsible for:
• Establishing an IBC;
• Ensuring that the IBC has adequate expertise and training (using ad hoc consultants as necessary);
• Providing appropriate training for the IBC chair and members, Biological Safety Officer, principal investigators, and laboratory staff;
• Filing an annual report with the NIH Office of Biotechnology Activities that includes (1) a roster of IBC members clearly indicating the chair, contact person and, as applicable, the biological safety officer, plant expert, animal expert, and human gene transfer expert or ad hoc consultant;  and (2) biographical sketches (e.g., curricula vitae or résumé) of all IBC members, including community members;
• Establishing procedures that the IBC shall follow in its initial and continuing review and approval of applications, proposals, and activities; and making available to the public, upon request, all IBC meeting minutes and any documents submitted to or received from funding agencies that those agencies must make available to the public.
  
  
3. What are the general responsibilities of IBCs and what matters do they consider in their review of research involving recombinant DNA?

On behalf of the institution, IBCs review recombinant DNA research projects for compliance with the NIH Guidelines.  This entails examination of a number of matters, including: 


• Containment levels; some useful resources to refer to when assessing containment levels are:
  
  Appendices of the NIH Guidelines:

• Appendix B  - Table 1: Basis for the Classification of Biohazardous Agents by Risk Group (RG)  
• Appendix G – Physical Containment
• Appendix I – Biological Containment
• Appendix K – Physical Containment for Large Scale Uses of Organisms Containing Recombinant DNA Molecules 
• Appendix P – Physical and Biological Containment for Recombinant DNA Research Involving Plants 
• Appendix Q – Physical and Biological Containment for Recombinant DNA Research Involving Animals
  
  

CDC and NIH Biosafety in Microbiological and Biomedical Laboratories (BMBL)  

American Biological Safety Association’s Risk Group Classification for Infectious Agents.

• Facilities;
• Institutional procedures and practices; and 
• Training and expertise of personnel

For human gene transfer experiments, IBCs also are responsible for ensuring that:

• All aspects of Appendix M of the NIH Guidelines have been addressed by the principal investigator; 
• Final IBC approval is granted after the RAC review process is complete; and
• Research projects are in compliance with the institution’s health surveillance requirements and data and adverse event reporting requirements.

IBCs should also: 

• Notify the principal investigator of IBC review and approval.
• Set containment levels and modify containment levels for ongoing experiments as warranted;
• Implement contingency plans for handling accidental spills and personnel contamination resulting from recombinant DNA research; and
• Report to OBA and institutional officials within 30 days any: 

•  Substantial problems or violations of the NIH Guidelines; and
•  Significant research related accidents or illnesses.

4. What is the role of the IBC in human gene transfer research?

The IBC must review and approve all experiments involving the deliberate transfer of recombinant DNA, or DNA or RNA derived from recombinant DNA, into any human research participants.  The investigator proposing this activity must submit to the IBC information on the source of the DNA, the nature of the inserted DNA sequences, the vectors to be used, information on whether an attempt will be made to obtain expression of a foreign gene (and if so, the protein that will be produced), and the containment conditions that will be implemented.  The IBC must ensure that all aspects of Appendix M of the NIH Guidelines (requirements for human gene transfer experiments) have been addressed.  The committee must also consider the issues raised and recommendations made during the course of RAC review, as applicable, along with any responses that the principal investigator may have prepared.   No research participants may be enrolled in the study until the RAC review process has been completed and the investigator has obtained IBC approval from the clinical trial site,  IRB approval, and all applicable regulatory authorizations.

5. What are acceptable modes of convening IBCs? May IBCs conduct official business by email?

The NIH Guidelines do not prescribe how IBCs should be convened, but they do speak to the preparation of meeting minutes (Section IV-B-2-a-(7)), and they encourage institutions to accommodate public attendance at meetings (Section IV-B-2-a-(6)). Thus, IBCs should be convened in a manner that allows for fulfillment of these two expectations. In general, email exchanges cannot fulfill these expectations of the NIH Guidelines, and thus it is not acceptable for IBCs to “meet” by email.

One approach acceptable for satisfying the NIH Guidelines is the traditional face-to-face meeting. Another is for institutions to use technology, such as teleconferencing, which is often more convenient for participants. Techniques such as teleconferencing still allow the institution to create a written record of the meeting and to provide access through dial-in services, thereby fulfilling the expectations of the NIH Guidelines. Email can nonetheless be an important tool to aid the IBC in conducting certain activities. For example, it is acceptable for institutions to use email for distribution of protocol materials, to conduct pre-meeting reviews, to poll members about particular matters, and other similar tasks. However, when IBC members are voting on protocol approvals or otherwise conducting official business, they are expected to meet together in a manner whereby minutes are taken to record the committee's actions and to document its fulfillment of IBC duties as articulated in the NIH Guidelines.

6. How often should IBCs meet?  

The frequency of IBCs meetings should be commensurate with the volume of protocols needing review, the nature and risks of the research, and the need for continuing oversight. Although the NIH Guidelines do not set a minimum threshold for meeting frequency, IBCs are expected to meet as often as necessary to carry out the functions prescribed in Section IV-B-2-b, including periodically reviewing recombinant DNA research conducted at the institution to ensure compliance with the NIH Guidelines (Section IV-B-2-b-(5)).


7. How have the roles and responsibilities of IBCs changed with the announcement of new Federal biosecurity initiatives, including the establishment of a National Science Advisory Board on Biosecurity (NSABB) and a proposed role for IBCs in the review of "dual-use" research?  
   The roles and responsibilities of IBCs have not changed.  For the time being, IBCs should continue to carry out the duties outlined in the NIH Guidelines for Research Involving Recombinant DNA Molecules.  The Federal government has proposed a future role for IBCs in the review of "dual use" research, or legitimate research that nonetheless has the potential to be misused in ways that could threaten public health. 
   
   The NSABB will be proposing guidelines for consideration by the Federal government that will eventually define a role for IBCs in the oversight of this arena of research.  IBCs and other stakeholders will have a voice in the development of these guidelines.  The IBC community will be notified directly of any future changes in their responsibilities.  In addition, any relevant developments will be posted on this Web site.