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2 Med. L. Int'l 1 (1995-1997)

handle is hein.journals/medclint2 and id is 1 raw text is: Medical Law International, 1995, Vol. 2, pp. 1-21 0968-5332/95 $10 © 1995 A B Academic Publishers-Printed in Great Britain MEDICAL RESEARCH AND TREATMENT: ETHICAL STANDARDS IN THE INTERNATIONAL CONTEXT* MARGARET A. McGREGOR VENNELL** University of Auckland, New Zealand ABSTRACT The paper considers the development of Codes of Health Research Ethics. It also considers the need for codes of ethics governing the provision of health care, and its relationship to research ethics. Is there a need for codes to regulate both research and treatment? Should the norms of the International Ethical Guidelines for Biomedical Research Involving Human Subjects (CIOMS) be incorporated into an International Convention which is binding on signatory states. The paper considers the rights of human subjects and patients to be fully informed about the research and treatment. How can the law or ethics protect this right? It considers whether New Zealand law and ethics measures up to the CIOMS Guidelines. The CIOMS Guidelines provide that any subject who is physically injured as a result of participating in research is entitled to receive financial or other assistance so as to compensate them equitably for any temporary or permanent disability. The paper looks at the effect of New Zealand legislation particularly the Accident Rehabilitation and Compensation Insurance Act 1992, and considers whether New Zealand is providing adequate compensation in compliance with the Guidelines. I THE HISTORY OF EXPERIMENTATION AND CODES OF HEALTH RESEARCH ETHICS Human Experimentation Experiments in health care in general and medicine in particular are as old as medicine itself. Nevertheless it was not until after the Renaissance (1453) that scientific medical research really began. More recently, major advances in the biomedical sciences and in technology have raised ethical issues to which there are no simple answers. There has been widespread concern that abuses could be perpetrated,1 and will be unchecked. The methodology of biomedical experimental research, as with all scientific research, begins with the development of hypotheses. These are generally first tested in laboratories and on animals. But tests on animals do not necessarily produce the same effects and results as tests on human subjects. All research, however carefully designed and

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