FAQs on Institutional Biosafety Committee (IBC) Administration – April 2024

The NIH Guidelines detail safety practices and containment procedures for basic and clinical research involving recombinant or synthetic nucleic acid molecules, including the creation and use of organisms and viruses containing recombinant or synthetic nucleic acid molecules.

An institution must follow the NIH Guidelines if it receives any funding from the NIH for research involving recombinant or synthetic nucleic acid molecules. Even if only one research project involving recombinant or synthetic nucleic acid molecules at an institution benefits from NIH support, all such projects conducted at or sponsored by that institution must comply with the NIH Guidelines. Also, adherence to the NIH Guidelines may be a condition of support from other federal agencies, or even private funders of research.

Finally, regardless of NIH funding, institutions may be subject to local ordinances, federal or state regulations, or agency guidelines that require compliance with the NIH Guidelines.

Compliance with the NIH Guidelines is important because it promotes the safe conduct of research involving recombinant or synthetic nucleic acid molecules. Also, compliance with the NIH Guidelines is mandatory as a condition of receiving NIH funding for such research. Institutions that fail to comply with the NIH Guidelines risk:

• suspension, limitation, or termination of financial assistance for:
  • non-compliant NIH projects;
  • NIH funding for other research involving recombinant or synthetic nucleic acid molecules at the institution;
  • having to obtain prior NIH approval for any research involving recombinant or synthetic nucleic acid molecules.

Many institutions that do not receive any NIH funding for research involving recombinant or synthetic nucleic acid molecules nonetheless choose voluntarily to comply. These institutions recognize that following the NIH Guidelines promotes the safe and responsible practice of this research and gives the public confidence that the institution is attending to important safety matters.

The NIH Guidelines require physical and biological containment for experiments involving the use of transgenic plants and animals, including insects, and also specifically address research involving gene drive modified organisms (GDMOs). As with other research involving recombinant or synthetic nucleic acid molecules, the appropriate level of containment is graded according to the potential risks of the experiment. Experiments involving GDMOs are required to be conducted at a minimum of Biosafety Level 2 (BL2) containment, though more stringent containment may be necessary depending on the risk assessment findings.  For GDMOs, these considerations include the potential for unintended release and environmental impact.

The NIH Guidelines do not permit experiments involving the deliberate release of transgenic animals and plants (or animals or plants that have had recombinant or synthetic nucleic acid molecules administered to them) into the environment unless, as provided in Section I-A-1, another Federal agency has jurisdiction over the experiment and approves the proposed release. As part of overseeing adherence to the NIH Guidelines, IBCs should ensure that institutional policies and procedures prohibit the release of such animals and plants into the environment when not otherwise federally authorized. Further, institutions should ensure that investigators are educated about proper containment and disposal, as well as other aspects of the NIH Guidelines.

Section III-F of the NIH Guidelines describes experiments that are exempt from the requirements. Details on certain other experiments that may be exempt, as well as exceptions to the exemptions, may be found in Appendix C of the NIH Guidelines.

Institutional Biosafety Committees (IBCs) were established under the NIH Guidelines to provide local review and oversight of nearly all forms of research utilizing recombinant or synthetic nucleic acid molecules. 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.

Each institution is responsible for ensuring that all research involving recombinant or synthetic nucleic acid molecules conducted at or sponsored by that institution is conducted in compliance with the NIH Guidelines. Indeed, the NIH Guidelines place much of the authority, responsibility, and accountability for the safe conduct of the research at the local level. More specifically, each institution conducting or sponsoring research involving recombinant or synthetic nucleic acid molecules 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 (BSO), principal investigators (PI), and laboratory staff;
• Filing an annual report with the NIH OSP that includes (1) a roster of IBC members clearly indicating the chair, contact person and, as applicable, the BSO, plant expert, animal expert, and human gene transfer expert or ad hoc consultant; and (2)biographical sketches 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.

On behalf of the institution, IBCs review research involving recombinant or synthetic nucleic acid molecules 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
  • Appendix G – Physical Containment Appendix I – Biological Containment
  • Appendix K – Physical Containment for Large Scale Uses of Organisms Containing Recombinant or Synthetic Nucleic Acid Molecules
  • Appendix L – Physical and Biological Containment for Recombinant or Synthetic Nucleic Acid Molecule Research Involving Plants
  • Appendix M – Physical and Biological Containment for Recombinant or Synthetic Nucleic Acid Molecule Research Involving Animals
• Facilities;
• Institutional procedures and practices; and
• Training and expertise of personnel

IBCs should also:

• Notify the PI 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 research involving recombinant or synthetic nucleic acid molecules; and
• Report to OSP and institutional officials within any substantial problems or violations of the NIH Guidelinesor significant research related accidents or illnesses.

For research subject to Section III-C of the NIH Guidelines (recombinant or synthetic nucleic acid molecule research involving research participants), the IBC must assess biosafety issues related to the research (e.g., administration, shedding).

Research may not be initiated until IBC approval at the clinical trial site, and all other applicable institutional and regulatory authorization(s) and approvals have been obtained.

IBC oversight may conclude after the last participant is administered the final dose of product. However, IBCs may choose to establish other end points for oversight, based on their biosafety assessment of the proposed research.

Additional information on IBC review of human gene transfer research is available in the “Points to Consider for IBCs Reviewing Human Gene Transfer Protocols” FAQ.

Work covered under section III-E of the NIH Guidelines requires a registration document to be submitted to the IBC at the time the research is initiated.

Review and approval prior to initiation of the experiments is not required. Review and approval of the registration by the IBC is still required, but this review and approval does not need to take place before the experiment is initiated. This is in contrast to experiments which are covered under Sections III-A through III-D of the NIH Guidelines, where no work may commence until the IBC approval is given.

Only experiments that are exempt from the NIH Guidelines (Section III-F) can be conducted without the approval of the IBC. All experiments that are not exempt from the NIH Guidelines must be reviewed and approved by the IBC.

An IBC must consist of at least five members. There is no limit on the maximum number of members. Details on committee membership requirements may be found in Section IV-B-2-a of the NIH Guidelines.

Collectively, the membership of an IBC should include:

• Experience and expertise in recombinant or synthetic nucleic acid molecule research and biosafety and physical containment
• Knowledge of:
  • Institutional commitments and policies;
  • Applicable laws;
  • Standards of professional conduct and practice;
  • Community attitudes; and
  • Environmental considerations
• The capability to assess the safety of research involving recombinant and synthetic nucleic acid molecules, and identify potential risks to public health and safety

Every committee is required to have two members not affiliated with the institution who represent the interest of the surrounding community with respect to health and protection of the environment. These may be officials of state or local public health or environmental protection agencies, members of other local governmental bodies, or persons active in medical, occupational health, or environmental concerns in the community. For further guidance on non-affiliated membership, see below.

Depending on the kind of research conducted at your institution, you may also be required to have:

• BSO: If an institution is conducting any high containment research involving recombinant or synthetic nucleic acid molecules (BL 3 or 4), research on a large scale (above 10 liters), or conducts any research involving gene drive modified organisms, there must be a BSO on the IBC.
• Plant Expert: If the institution is conducting research subject to Appendix L there must be a plant expert on the IBC. This person should have expertise in plant, plant pathogen, or pest containment principals. Appendix L describes research involving recombinant or synthetic nucleic acid molecule-containing plants, plant-associated microorganisms, or plant-associated small animals (e.g. arthropods), whose size, quantity, or growth requirements prevent the use of standard laboratory containment conditions as described in Appendix G of the NIH Guidelines
• Animal Expert: If the institution is conducting research subject to Appendix M there must be an animal expert on the IBC. This person should have expertise in animal containment principals. Appendix M describes research involving whole animals in which the animal’s genome has been altered by the stable introduction of recombinant or synthetic nucleic acid molecules or recombinant or synthetic nucleic acid molecules are introduced into the germ-line (transgenic animals), or viable recombinant or synthetic nucleic acid molecule-modified microorganisms are being tested, and research animals’ sizes or growth requirements prevent the use of the physical containment procedures and practices listed in Appendix G of the NIH Guidelines.
• Expertise in human gene transfer: If the institution participates in or sponsors recombinant or synthetic nucleic acid molecule research involving human participants, the institution must ensure that the IBC has adequate expertise and training (using ad hoc consultants as deemed necessary).
• Expertise in gene drive modified organisms: If the institution participates in or sponsors recombinant or synthetic nucleic acid molecule research involving gene drive modified organisms, the institution must ensure that the IBC has adequate expertise and training (using ad hoc consultants as deemed necessary).

It is also recommended that IBCs include:

• Experts in biosafety and containment,
• Persons knowledgeable in institutional policies and applicable laws,
• Individuals reflecting community attitudes,

At least one representative member from the laboratory staff.

Section IV-B-2-a-(1) of the NIH Guidelines states that at least two members of the IBC shall not be affiliated with the institution. These individuals are supposed to represent the interests of the surrounding community with respect to the environment and public health. The NIH Guidelines suggest several possibilities for non-affiliated members including officials of state or local public health or environmental protection agencies, members of other local governmental bodies, or persons active in medical, occupational health, or environmental concerns in the community. Other possibilities are teachers from local schools, real estate agents, members of local churches, charitable organizations or local support groups. These are people who are often willing to volunteer their time and who generally have a broad perspective on the communities in which they live.

The NIH Guidelines state that unaffiliated members of the IBC should have no relationship with the institution other than their service on the IBC. The determination of whether an individual is unaffiliated is not always a straightforward matter, and good judgment is key.

If the individual under consideration works for an entity that has a business relationship with the institution, he or she would not be a suitable choice to serve on the IBC in an “unaffiliated” capacity. However, affiliation is not created by financial relationships alone. For example, visiting professors have an affiliation with the institution where they teach even if their salary comes from a source outside the institution.

NIH encourages entities wishing to register a new IBC to utilize the Web-based Institutional Biosafety Committee Registration Management System (IBC-RMS).

IBC-RMS can be accessed at: http://ibc-rms.od.nih.gov

The institution must file an annual report that includes:

• An updated committee roster indicating the role of each committee member (e.g., chairperson, contact person, non-institutional members, special experts as relevant, etc.), and
• Biosketches for each new member on the committee

Institutions can file annual reports electronically utilizing IBC-RMS.

In addition to utilizing IBC-RMS to submit an annual report, the system can be used to notify NIH of membership changes that may occur on the IBC throughout the course of the year.

Institutions must report at least annually on their IBC’s membership. The deadline for an annual update is one year after the approval date of the last report submission. If there is a change in the membership of the committee prior to the subsequent annual submission due date, the IBC is required to update the registration at the time of the change. To determine when the next IBC annual report is due, institutions may view their registration information on IBC-RMS or contact NIH OSP directly to obtain this information.

Entities that register their IBC’s via IBC-RMS will be sent email reminders 15 days prior to their IBC registration due date and a subsequent “past due” notification the day it becomes past due (if the entity has not yet filed their report).

There are a number of reasons why entities not subject to the NIH Guidelines choose nonetheless to comply voluntarily. First, it demonstrates the entity adheres to high standards of safety in conducting recombinant or synthetic nucleic acid research. Second, adherence to the NIH Guidelines has been adopted as a requirement by other Federal agencies, so even if an institution does receive NIH funding, it may still be expected to adhere to the NIH Guidelines if it receives funding from certain other agencies. Finally, if the institution adheres to the NIH Guidelines voluntarily, it will be poised to be compliant with this key requirement should it ever seek NIH funding for research subject to the NIH Guidelines.

It is important to note that, under voluntary compliance, NIH expects full adherence to all pertinent requirements. If an institution were to adhere only to certain elements of the NIH Guidelines, the NIH would not be in a position to say that the entity was compliant with the NIH Guidelines.

As part of full compliance, NIH would expect the entity to release its IBC minutes to the public upon request. The entity may redact information that is private or proprietary; however, redaction should be done judiciously and consistently. Some examples of information that may be redacted include trade secret information, the home telephone numbers or home addresses of IBC members, and specific information whose disclosure would directly compromise institutional or national security.