ETHICS OF HUMAN TESTING: BACKGROUND 221 (which judge the morality of an action on the original intentions, motivations, and obligations it seeks to fulfill, i.e., the end does not justify the means). During the past 2000 years fundamental principles have emerged on the ethical standards for medical research on human subjects. The implications of these general ethical rules for non­ medical bio-research are discussed in Part II. REFERENCES (1) J. Katz (Ed.), Experimentation with Human Beings (Russel Sage Foundation, New York, 1972). (2) R. Platt, The ethical basis of medical science, Sci. Basis Med. Ann. Rev., 1-15 (1966). (3a) C. D. Leake (Ed.), Percival's Medical Ethics (Williams and Williams, Baltimore, 1927). (36) G. J. Annas and M.A. Grodin (Eds.), The Nazi Doctors and the Nuremberg Code (Oxford University Press, 1992). (4) H. Beecher, Research and the Individual Subject (Little Brown and Co, Boston, 1970). (5) C. Bernard, An Introduction to the Study of Experimental Medicine translated by H. C. Green (Macmillan, New York, 1927). (6) J. Vollmann and R. Winau, The Prussian regulation of 1900: Early ethical standards for human experimentation in Germany, !RB a Review of Human Subjects Research, 18(4), 9 (1996). (7) Anon, Int. Digest Health Leg., 31, 408-411 (1980). (8) J. Warren, et al., The effect of venescetion and the pooling of blood in the extremeties on atrial pressure and cardiac output in normal subjects with observations on acute circulatory collapse in three in­ stances, Clin. Invest., 24(3), 337-344 (1945). (9) K. Mellanby, Human Guinea Pigs (Blackfriars Press, Leicester, 1945). (10) H.K. Beecher, Ethics and clinical research, N. Eng.]. Med., 274, 1354-1360 (1966). (11) Final Report of the Tuskegee Syphilis Study Ad Hoc Advisory Panel (US Government Printing Office, Washington, DC, 1973). (12) NHS Executive West Midlands Regional Office, Report of a Review of the Research Framework in North Staffordrhire Hospital NHS Trust (Griffiths Report) (Leeds, NHS Executive, 2000). (13) The Royal Liverpool Children's Inquiry, January 2001 (The Stationary Office, 2001). (14) National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (Department of Health, Education anl Welfare, Washington, DC, 1979). (15) C. Bassiouni, T. G. Baffes, and J. T. Evrard, An appraisal of human experimentation in international law and practice: The need for international regulation of human experimentation. J Crim. Law Criminal., 72(4), 1597-1666 (1981). (16) Royal College of Physicians, Guidelines on the Practice of Ethics Committees in Medical Research Involving Human Subjects (Royal College of Physicians, London, 1990). (1 7) Royal College of Physicians, Research on Healthy Human Volunteers (Royal College of Physicians, London, 1986). (18) /CH Guideline for Good Clinical Practice (International Federation of Pharmaceutical Manufacturers Associations, Paris, 1996).

J. Cosmet. Sci., 5 7, 223-231 (May/June 2006) Ethics of studies involving human volunteers. II. Relevance and practical implementation for cosmetic scientists P.A. CARSON and J. HOLT, Capenhurst Independent Research Ethics Committee, "Rowanlea," 2 Green fields 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 importance to the personal products industry of testing novel products in healthy human volunteers and the need to ensure the trials were both safe and ethical were addressed in Part I. The historical development of ethical standards for human testing was also summarized. The present paper highlights the ethical principles to be considered when testing novel non-medicinal products on human volunteers, and it describes how they can be implemented in a pragmatic manner to avoid delay to the sponsor's research program. The structure and function of ethics committees is discussed. INTRODUCTION Part I provided a brief overview of the history of the ethics of medical research on humans (1). The present paper discusses implications and implementation for non­ medical research. The principles that flow from the historical review detailed in Part I may be described as a set of ethical norms that provide a framework for the decision process by which proposals for research with healthy human volunteers may be reviewed. They embrace: (a) Autonomy. The principle of autonomy holds that the individual is free to make choices and is self-governing. This right of individuals to decide their own course of action is a key pillar of modern ethical codes and includes maintaining volunteer confidentiality and obtaining informed consent. • Confidentiality. Autonomy also provides individuals with the right to control access to information about themselves and for it to be shared only on a "need to know basis" for professional purposes. The control over disclosure is an important responsibility for the researcher. • Informed consent. Volunteers must give their consent to the research process after being given a full explanation of the experiment, its risk, and potential benefits (if any). It is also incumbent upon the investigator to ensure the volunteer is capable of making an informed decision, i.e., be able to receive the relevant information, retain it, process it, and formulate a decision. Consideration should be given to the vulner- 223