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Frequently Asked Questions (FAQs) of Interest to IBCs
- How many members are required on my 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.
- When selecting members for my IBC, what qualifications or experience should I look for in potential candidates?
Collectively, the membership of your committee should include:
Experience and expertise in:
- Recombinant DNA technology; and
- Biosafety and physical containment
Knowledge of:
- Institutional commitments and policies;
- Applicable laws;
- Standards of professional conduct and practice;
- Community attitudes; and
- The environment
The capability to:
- Assess the safety of recombinant DNA research; and
- Identify potential risks to public health and safety
- What special expertise or perspectives are either required or recommended for the IBC?
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 Question 4 below.
Depending on the kind of research conducted at your institution, you may also be required to have:
- Biosafety Officer (BSO): If your institution is conducting any recombinant DNA research above biosafety level 2 or on a large scale (above 10 liters), you must have a Biosafety Officer on your committee.
- Plant Expert: If your institution is conducting research involving recombinant DNA-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 you must have a Plant Expert on your committee. This person should have expertise in plant, plant pathogen or pest containment principals.
- Animal Expert: If your institution is conducting research involving whole animals in which the animal’s genome has been altered by stable introduction of recombinant DNA or recombinant DNA is introduced into the germ-line (transgenic animals), and viable recombinant DNA-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 you must have a Animal Expert on your committee. This person should have expertise in animal containment principals.
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.
- What kinds of individuals are appropriate as “non-affiliated members” of the IBC?
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 often key.
If the individual under consideration works for an entity that has a business relationship with your institution, he or she would not be a suitable choice to serve on your IBC in an “unaffiliated” capacity. However, affiliation is not created by financial relationships alone. For example, an adjunct professor whose salary comes from a source outside the institution nonetheless has an affiliation with the institution at which he or she teaches.
Whoever is selected to serve in this important capacity, the institution should be in a position to justify its selection of non-affiliated IBC members should the independence of those individuals ever be called into question.
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