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Role of the Non-Affiliated Member in IACUC Protocol Review

The non-affiliated member provides the IACUC with a “reality check” about perspectives on science and animal welfare concerns in the “outside world,” or the community. Because non-affiliated and other lay members can ask the non-technical questions that the public might wish to ask, they provide an independent, fresh perspectives on the issues being discussed, helping to stimulate wider thinking and discussion of issues. In this way, non-affiliated and other lay members not only enhance the IACUC but can also assist scientists in understanding how members of the public view their work. The non-affiliated member in particular is the public conscience of the committee, promoting transparency in the review process and making a positive contribution to animal welfare.

This is a tall order for any individual, particularly when he/she is new to the IACUC mandate and process. A new non-affiliated member will need to invest time in becoming knowledgeable about the regulatory mandate of the IACUC and how the committee functions within the institution he/she is serving. In addition to acquiring background knowledge on laws and regulations impacting animal research and the role and responsibilities that follow from those, some other activities that can help a new non-affiliated member get up to speed include:

• understanding the mandate of the institution and the types of research, teaching or testing being carried out;
• understanding the vision of the Animal Care and Use Program and reviewing institutional policies and procedures relating to the Program;
• reviewing the minutes of IACUC meetings over the past year;
• getting to know current IACUC members; and
• spending time in the animal facility with veterinary and animal care staff, as well as animal users.
Once a non-affiliated member is comfortable with his/her background knowledge, he/she can expect to:
• be present at IACUC meetings and other activities of the committee;
• review animal use protocols and other IACUC documents in between meetings;
• participate actively in protocol deliberations and other discussions during IACUC meetings;
• participate in review and development of the Animal Care and Use Program;
• tour the animal facility/ies during semiannual inspections; and
• be present for assessment visits, such as those conducted by AAALAC International.

During protocol review, non-affiliated members should feel comfortable asking straightforward, honest questions without concern for being less informed, in a scientific sense, than other members at the table. Non-affiliated members should ensure that they are comfortable that the projects being proposed using animals are sufficiently justified. This generally requires questioning the value of the project with respect to its objectives, the potential for pain or distress that the animals may experience, and the competence of the investigators and research staff to conduct the procedures being proposed.

All IACUC members, including the non-affiliated member, must be able to clearly understand each protocol. The onus is on investigators, therefore, to ensure protocols are clear and avoid unnecessary scientific jargon, particularly in the “lay summary” section of the protocol.
A helpful, non-specialist introduction to the principles of experimental design, including some of the following terminology, can be found in:

• Festing, M.F.W., Overend, P., Gaines Das, R., Cortina Borja, M. and Berdoy, M. (2002). The design of animal experiments: reducing animal experiments through better experimental design.
• Laboratory Animal Handbooks, No. 14. Laboratory Animals Ltd/Royal Society of Medicine Press, London. (See especially Chapter 1 – Basic principles of the design of animal experiments).
Some factors that might be considered in evaluating the potential benefit of a study include:

• the clinical or scientific need to investigate the problem or questions described in the protocol, in relation to the range of other potential problems and questions that might be addressed;
• the new and original clinical or scientific insights that are anticipated from the project;
• if the project is part of on-going work, the progress made in previous studies;
• whether, and if so how, the project will develop and/or complement previous studies or other studies in progress;
• if the project involves repetition of previous studies, the strength of the case for replicating and/or extending the previous work;
• the project’s potential links to, and implications for, other areas of research; and
• how the results of the study might be applied in practice.