230 JOURNAL OF COSMETIC SCIENCE For high-throughput routine studies, quality control measures are required to monitor the studies periodically in order to • provide the REC with assurance of compliance with agreed procedures, • identify areas for further improvement, • confirm that the system is not abused, and • check that volunteers are not being "over used." A report of the number of tests conducted and the number of adverse events should be reviewed periodically. Serious adverse events must be reported to the chairman within three working days and followed through to completion. These must be discussed at the next REC meeting to permit members to reconsider the status of their generic approval. Trials should be submitted for ethical review on a case-by-case basis if they involve • "proof of principle studies" • novel or non-routine protocols • products containing novel ingredients • products that have previously caused harm and have since been modified • mrnors Other documents reviewed by the REC should include safety data sheets, panelist information sheets and consent forms, "case-report forms" to record trial data, question­ naires including confidential medical questionnaires, and recruitment advertisements. Issues considered by a committee in preparing its opinion will include those listed in Table IV. The REC/IRB should be cognizant of sponsor deadlines and strive to provide a service that does not delay the start of studies, although clearly the sponsors must also be realistic in their expectations. For regulatory studies, applications for, e.g., clinical trial authorizations can proceed in parallel with application for ethical support, but these trials, if on medicinal products, must be reviewed by a recognized REC. Table IV Examples of Factors Considered by Research Ethics Committees • The relevance of the study, its aims and design. • The benefits versus the risks. • The suitability of the researchers (review of investigator CV) availability of medical support/supervision during the trial and aftercare and the rights to terminate the study scientific responsibilities for preparation, dosage control, and quality assurance of product and analysis of samples. • The safety of the products including purity, and the properties of likely contaminants/additives, and evidence to confirm minimal risk ro subjects. • The suitability of the facilities for the trial (by visiting the test facility if necessary). • The arrangements for recruiting subjects (informed consent, inclusion/exclusion criteria). • The special requirements for recruiting minors, volunteers whose first language is not English, etc. • Medical histories and degree of supervision during, and after, exposure. • The means of identifying, recording, and investigating adverse events. • The amounts of, and the arrangements for, rewards to volunteers and external investigators, and compensation to subjects who are injured (e.g., "No Fault" compensation). • Mechanisms to prevent overuse of individual volunteers. • Documentation (records, reports, security, archiving).

ETHICS OF HUMAN TESTING: IMPLEMENTATION 231 CONCLUSION While proposals for biomedical research programs have been subject to ethical review for many years, regulation of non-medical human studies has tended not to provide an ethics focus. Nevertheless, there are moral and business reasons to seek independent ethics review of all healthy volunteer studies irrespective of the nature of the test protocol and product area. Sufficient codes and guidance exist to enable the basic principles to be identified and applied in a pragmatic manner, thereby assuring the safety and well-being of trial volunteers. By proper planning and professional project management, the process of seeking ethical review need not cause delays in the development program. REFERENCES (1) P.A. Carson and J. Holt, Ethics of studies involving human volunteers: I. Historical background,]. Cosmet. Sci., 57, 215-221 (2006). (2) Guidelines on the Practice of Ethics Committees in Medical Research Involving Human Subjects (Royal College of Physicians, London, 1990). (3) Working Party on Research on Healthy Volunteers,]. Royal Coll. Phys. 20(4), 1 (1986). (4) Professional Brief Guidance for Members Involved with "Healthy Human Volunteer Experiments" (The Royal Society of Chemistry, London, 1994). (5) Code of Conduct, The Market Research Society/Industrial Marketing Research Association. (6) J. H. Steadman, Ethical review of human experimentation in the consumer produces industry, Neth.]. Med., 52, 138-141 (1998). (7) European Commission, The Rules Governing Cosmetic Products in the European Union, Volume 3: Guidelines (Cosmetic Products) (Annex 11 and 12, 1999). (8) The Human Tissue Act, 2004, Chapter 30 (HMSO, London, 2004). (9) P.A.Carson,J. Holt, and M. McGrady, The ethical impact of the UK Human Tissue Act for the foods, cosmetics, toiletries and detergents industries, Res. Ethics Rev., 2(1), 10-14 (2006).