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J. Cosmet. Sci. ! 57, 215-221 (May/June 2006) Ethics of studies involving human volunteers. I. Historical background P.A. CARSON and J. HOLT, Capenhurst Independent Research Ethics Committee, "Rowan/ea," 2 Greenfields Avenue, Bromborough, Wirral CH62 6DD (P.A.C.), and 4-Front Research, Unit 6, Capenhurst Technology Park, Capenhurst, Chester CHI 6ER U.H.), U.K. Accepted for publication January 19, 2006. Synopsis The evaluation of personal products using panels of human volunteers is crucial to the continued develop­ ment of the industry. Nowadays, however, it is increasingly important to ensure that such studies are both safe for the participants and are ethical. As a means of defining general rules for judging and justifying the ethics of human testing, historical milestones in the development of human experimentation are given. While most experience originates from biomedical research, findings help establish standards of ethical review of non-therapeutic human testing used in the cosmetics industry. INTRODUCTION In order to meet ever-demanding consumer expectations and to survive in a competitive business environment, the cosmetics and toiletries industry constantly strives to create novel or improved formulations to delight their customers. No matter how superior innovative personal products can be shown by laboratory investigations, such scientific support will, however, fail to translate into sales unless consumers perceive the benefits firsthand during use, and without experiencing gross negatives. This, together with legislation and moral obligations to prevent product testing on animals, results in the development program progressing rapidly from bench experiments to efficacy and sen­ sory trials in healthy human volunteers. With the increasing technical complexity of personal care products and the claims made for them, the boundaries of testing carried out on volunteers are constantly expanded. The industry has a good reputation in conducting such studies safely! but it is also important for the experimenter to consider the ethical aspects of research on human volunteers and to demonstrate high ethical standards for these investigations. The present paper provides a brief review of the history of ethics associated with experiments on humans to further aid appreciation of the requirements for the personal products industry to be discussed in Part II (this issue). 215