Frequently Asked Questions

The National Institutes of Health (NIH) has specific guidelines, developed by its Office of Biotechnology Activities, for safe conduct of research that involves recombinant or synthetic nucleic acid molecules. Any institution that receives research funding from the NIH must follow these guidelines. Compliance is mandatory as a condition of receiving NIH funding and may also affect grant support from other federal agencies and potentially even from private sponsors. Institutions that fail to comply with the NIH guidelines risk losing existing grants and becoming ineligible to apply for other support.

The IBC provides local review and oversight of research with recombinant or synthetic nucleic acid molecules. 

The NIH guidelines require that IBC members have expertise that enables them to evaluate the possibility that research could pose a risk to public health and safety. Given the types of research currently performed at Middlebury, the core standing committee must consist of at least five members, including the following:

• A person with experience and expertise in research with recombinant or synthetic nucleic acid molecules.
• A person with experience and expertise in animal containment principles.
• A radiation safety expert.
• Two members of the local community, not affiliated in any way with the College, who represent community interests related to health and environmental protection.

In addition, the IBC may recruit additional members ad hoc to inform deliberations when committee members do not have the expertise required to review a specific protocol.

The IBC meets annually or as needed throughout the academic year if there are proposals to review.

Incident Reporting

The IBC must report any significant problems, violations of the NIH Guidelines, or any significant research-related accidents and illnesses to NIH OBA in writing within 30 days. Any spill or accident during recombinant DNA research that leads to personal injury or illness or to a breach of containment must be reported. Such events might include, for example, skin punctures with needles containing recombinant DNA, the escape or improper disposition of a transgenic animal, or spills of high-risk recombinant materials that occur outside of a biosafety cabinet. Failure to adhere to the NIH Guidelines also must be reported.

Annual Report

The IBC maintains a registration with NIH OBA and must file an annual report that includes the following:

• A current committee roster.
• The role of each committee member (e.g.,chairperson, contact person, noninstitutional members, special experts as relevant, etc.).
• A biosketch (curricula vitae, résumé) for each new member on the committee.

Disclosure

The IBC must keep detailed minutes of meetings and must make them available to NIH OBA on request. It must also make meeting minutes, rosters, and biographical sketches that have been submitted to NIH available to the public upon request.