ETHICS OF HUMAN TESTING: BACKGROUND 219 In the Tuskegee syphilis experiment 400 poor, black syphilis-positive subjects were studied without treatment even though cheap effective therapy became available. They were not informed about the study but told that they had "bad blood." Their participation was secured by promises of free transport and lunch on "study days" and free medical care and burial after autopsy. This led to guidelines for Institutional Review Boards on the peer review of protocols and the ethical principles which should underpin their decisions (11). Cancer cells were injected into elderly debilitated patients in a New York hospital. The work was funded by the US National Institutes of Health and the case was the subject of an enquiry (10). Parents of premature babies reported that their infants had been included in a research study of a ventilator without their knowledge or consent (12). At one hospital over 2000 organs were removed from 800 children purportedly for research purposes without their parents' knowledge (13). As a result of such events, including the Thalidomide tragedy, a raft of codes appeared,· including the Nuremburg Code (1947), the World Medical Organization's Declaration of Helsinki (1964 and subsequent amendments), the US National Research Act (1974), and the Belmont Report (1979). The Nuremburg Code championed informed consent. It has been argued that this code is based on experiments conducted during wartime and that the experiments were neither ethical nor intended so to be (c.f. with Operation Desert Storm when US military were exempted from the need to gain informed consent when administering a range of therapies to soldiers). The US National Research Act stipulates that all federally funded research must first receive ethical review by Institutional Review Boards (IRBs). The scope and responsi­ bilities of IRBs are given in Title 21 of the Code of Federal Regulations, Parts 50 and 56, and in Title 45 of the Code of Federal Regulations, Part 46. There is a requirement to follow the Declaration of Helsinki or the Belmont report. The Belmont report (14) • differentiated between research and accepted therapy • addressed basic ethical principles (respect for persons, beneficence, and justice) • reviewed application of general ethical principles (informed consent, risk/benefit assessment, and subject selection) The Declaration of Helsinki is also a set of principles, which include the following dicta: • Biomedical research on humans must conform to accepted scientific principles and be based on data from animal experiments and the literature. • The proposals should be in clearly written clinical protocols for review by ethics committees independent of the sponsor and investigator. The protocol should contain a statement of the ethical considerations involved and confirm compliance with the Declaration. • Trials should be conducted and supervised only by suitably scientifically/medically qualified staff: responsibility for the subjects rests with a medically qualified person and not the subjects themselves. • The importance of the objective must be in proportion to the inherent risk to the subject. Assessment of predictable risk should be considered against foreseeable ben­ efits to subjects or to others. The interest of the subject must prevail over the interest of science or society.

220 JOURNAL OF COSMETIC SCIENCE • The subjects' privacy must be assured. The impact of the study on the subjects' physical and mental integrity and on their personality must be minimized. • Hazards must be predictable. • The accuracy of the results of such research must be preserved in publications. • Subjects must be informed about the study and of their right to abstain or withdraw: they must give consent (preferably in writing). • Informed consent must be obtained by a physician independent of the subject. • Informed consent should be obtained from a legal guardian in the case of legal incompetence. Informed consent from the responsible relative is necessary for minors, where physical or mental incapacity make it otherwise impossible for the subject to give informed consent. Minors should also give their own consent where this is possible. Additional principles are listed for medical research combined with professional care, · and the following principles are emphasized for non-therapeutic (non-clinical) biomedi­ cal research on human subjects: • The physician remains the subject's protector. • Subjects should be volunteers who are healthy persons or patients for whom the research is not related to their illness. • The investigator team should cease the work if the study would harm the subject. • The interest of science and society should never take precedence over a subject's well-being. The concept of scientific peer review of research proposals was strengthened by the 197 5 amendment to the Helsinki declaration. In the UK a system of local research ethics committees and multi-center research ethics committees have existed for NHS research since 1966 and 1997, respectively. A re­ quirement for peer review appeared in the 1967 Royal College of Physicians guidelines (15 ). They later issued Guidelines on the Practice of Ethics Committees in Medical Research Involving Human Subjects (16). These are somewhat biased towards the researcher, with an instruction to ethics committees to be ever aware of the need to avoid impeding good medical research. The College also published a report, Research on Healthy Human Vol­ unteers (1 7). Recently, the UK implemented the EC "clinical trials" Directive 2001/20/EC with promulgation of The Medicines for Human Use (Clinical Trials) Regulations 2004. Under these regulations no person shall be permitted to conduct a clinical trial unless there has first been a favorable opinion obtained from an ethics committee. The UK Ethics Committees Authority is responsible for establishing, recognizing and monitoring UK ethics committees, though this relates to those committees reviewing trials on medicinal products only. Good clinical research practices have been produced throughout the developed world, and a major milestone was publication of the guidelines from the International Con­ ference on Harmonization of GCP, which attempt to standardize requirements for Europe, Japan, and the USA. These address ethical considerations for licensed trials (18). CONCLUSION Philosophical theories abound ranging from consequentialism ( the morals of an action should be judged on the basis of the consequences that follow) to deontological theories