ETHICS OF HUMAN TESTING: IMPLEMENTATION 227 MEMBERSHIP OF RECS REC membership should be balanced for age, gender, and lay/expert background. The size of the quorum, e.g., 5-7 (to include at least one lay and one expert member), should first be agreed upon, and then the committee size defined to ensure a minimum quorum for any meeting. Typically, the REC may comprise 10 to 18 members maximum. As a guide, at least one third should be lay. OFFICERS A decision must be reached on how the Chair and Vice-chair should be elected. This may be an appointment by the authorizing authority or election by and from within the REC members. A secretary or administrator is required to arrange the meetings, take minutes, maintain REC files/library, and interface with applicants, although written decisions of the committee on specific submissions should be signed by the Chair or Vice Chair. FUNCTIONS The aim of the REC is to provide independent advice to parttctpants, researchers, sponsors, employees, and professionals on the extent to which proposals for studies on healthy human volunteers comply with recognized ethical standards, and to approve, require amendment, or reject studies submitted to it. Its prime responsibility is to protect the dignity, rights, safety, and mental and physical well-being of potential or actual research subjects. Concern over the volunteer must prevail over the interests of science or society. A secondary responsibility is the protection of researchers and insti­ tutions where any matter of an ethical nature might affect them, provided that the interests of the trial volunteers take priority. The scientific robustness of submissions for ethical review should have received prior, separate peer review. While safety and science quality are not the direct responsibility of the REC, it is advisable for the committee to become familiar with the salient ethical components of each type of test that it reviews, including any potential risks to volun­ teers. For example, • Transepidermal water loss measurements are affected by race, gender, site of appli­ cation, and emotional state of the test subject. Experimental design is crucial, and studies should be carried out in a controlled environment at a standard temperature and relative humidity, with time allowed for subjects to reach equilibrium before each assessment is made. • Ethical considerations for compatibility testing of finished cosmetic products in healthy human volunteers are highlighted in Table III (7). • Tests should not cause irreversible damage. Trials on products containing ingredients known to be teratogenic (e.g., in animal studies), depending on safety margins, may need to be restricted to males or post-menopausal women. The committee may require ongoing review and will need to be kept informed of adverse and seriously adverse events and ensure that these are followed through to resolution. Depending upon the type of product being studied and the type of tests undertaken, common potential adverse effects include skin or eye irritation, itching, contact allergy, contact urticaria, pigment changes, hair and nail changes, and subjective symptoms.

228 JOURNAL OF COSMETIC SCIENCE Table III. Recommended Ethical Considerations for Compatibility Testing of Finished Cosmetic Products in Healthy Human Volunteers (after ref. 7) • Not a substitute for animal testing. • Performed only to confirm, in a limited number of subjects, that products do not damage skin and mucous membrane, as already expected from other sources. • Before the trial commences the study supervisor must possess product formulation, pre-clinical safety assessment, its conditions of use, and any warnings. • Protocols should be based on sound science and potential risks. Even if no risks are associated with the work, the studies must not be conducted if they do not comply with scientific criteria. • Tests should not be performed unless the importance of the objective is in proportion to the inherent risks to the subject. • The study muse cease as soon as any risk outweighs the potential benefit of the trial. • Skin compatibility testing should only be carried out by technically qualified persons under medical superv1s10n. • While acceptability tests in consumers do not need review by an REC, compatibility test protocols possibly posing a risk to volunteers should be submitted to an REC for review. • Volunteers are adequately informed of the aims, methods, and potential risks/discomfort, and give their free written consent before being recruited. • Subjects with current dermatitis or who know of past allergic contact dermatitis related to the ingredients should be excluded. • Pregnant or lactating females should be excluded, except in very special listed circumstances. • Children should be excluded, except in very limited identified circumstances when their own free informed consent should be obtained in addition to that of their parent or guardian. • Study reports should include all experimental details to provide a rationale of the trial and to preserve the accuracy of the results. The sourcing of human tissues and other samples from, e.g., hospitals, universities, and commercial establishments for industrial research should also be considered by a REC. These samples are often supplied by patients as part of their medical treatment, e.g., for routine clinical testing or donated through local health services and then sold for research usually without the patient's awareness. Researchers should be able to confirm that their supplier has the necessary consents. From 2006, UK law relating to collection, storage, and use of human samples in research will be tightened by implementation of the Human Tissue Act 2004 (8), which addresses informed-consent and ethical review (9). The Committee should issue an annual report to the "appointing authority," and for internal committees, this should be sent to the most senior manager, e.g., Director of Research or Managing Director. The REC administrator should hold on file CV s for each member and record any relevant training that they receive. Induction training for new members should include back­ ground and history to RECs, their role within the organization, the REC constitution, implementation of REC SOPs, and overview of the types of healthy human volunteer studies routinely submitted. Ongoing training in more specialized elements should be provided as required. MEETINGS Meetings should be arranged to meet demand, and proceedings should be documented. Minutes should not link individual members to comments. They should be copied to