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

216 JOURNAL OF COSMETIC SCIENCE HISTORY OF RESEARCH ETHICS Ethics are the moral principles governing the conduct of a particular activity. As morals are accepted behavioral patterns dictated by the society, they change as societies vary temporally and geographically. Most of the very early experimentation on man was done with medical disciplines in mind (anatomy, physiology, pathology, etc), and it is only in more recent times that research has become focused on consumer benefits. While these are key to the progress of the consumer goods industry, special consideration should be given to the risk benefit analyses of such work. The impetus for human testing originates from the advancement of medical knowledge, with examples dating back to Hippocrates, who observed movements in the contralateral side of a child's body as he scratched the surface of the cortex from which he was removing bone splinters (1). Early reports of concern for the ethics of such work date back ca 2000-2500 years. A Persian prince in the second century AD advised a medical student to "experiment freely, but not on people of high rank or political importance" (2). The Hippocratic oath, written between 470 and 360 BC, states I will follow that system of regime which, according to my ability and judgment, I consider for the benefit of my patients and abstain from whatever is deleterious and mischievous. I will give no deadly medicine to anyone if asked, nor suggest any such counsel. Its scope does not include "experimentation," which was only first addressed in the 18th century in Medical Ethics by the English physician Percival (3a). He acknowledged the need for medical research with judgment of the ethical validity of experimental procedure based on test design, its basis in established or analogous theory, and on peer review and expert advice: Whenever cases occur, attended with circumstances not heretofore observed, or in which ordinary modes of practice have been attempted without success, it is for the public good, and in especial degree advantageous to the poor (who, being the most numerous class of our society, are the greatest beneficiaries of the healing art) that new remedies and new methods of chirugical treatment should be devised but, in the accomplishment of the salutary purpose, the gentlemen of the faculty should be scrupulously and conscientiously governed by sound reason, just analogy, or well-authenticated facts. And no such trials should be instituted without a previous consultation of the physicians or surgeons according to the nature of the case. Given the paternalistic culture prevailing within the medical profession at the time, it is not surprising that even these principles ignore important ethical considerations such as protection of the subjects and their consent to procedures to which they may be subjected. Reference to the benefits for the poorest members of society is surprising since at the time medical care would have been beyond their grasp, unless this amounts to tacit direction to use the poor for experimentation. Beaumont in 1833 performed numerous non-therapeutic human studies into gastric physiology. Like Percival, he required that the investigator be conscientious and re­ sponsible and that the experiment be well planned, methodical and designed to provide the maximum amount of information possible. He extended Percival's code by incor­ poration of the need for voluntary (if not informed) consent and showed concern for the subject's well-being (4): "The experiment is to be discontinued when it causes distress to the subject." He also addressed risk-benefit analysis.