Ruth Macklin

Revising the Declaration of Helsinki: a work in progress

Global disparities in health among rich and poor nations have been well documented. Health disparities are even worse for women in resource-poor countries than for men. Obstacles to women's health and access to health services include deeply rooted customs or cultural norms, including religious teachings and practices; ideological and political factors; poor health infrastructure; and discriminatory laws or failure to enforce laws designed to protect the rights of women. The most striking inequalities exist in the area of reproductive and sexual health. The situation is worse in those parts of the world in which women are systematically oppressed, have few civil rights, or are in such dire poverty that they are unable to afford preventive and therapeutic services that are otherwise available to women of greater means even in their own countries. These gender inequalities can be remedied, in part, by economic development that would improve women's access to prenatal care and skilled maternity services. In large measure, however, significant improvement in women's health, especially reproductive and sexual health, will only come about with a change in cultural attitudes and practices, in addition to legal reforms and better enforcement of existing human rights provisions.

Some people might argue that there are already too many different documents, guidelines, and regulations in bioethics. Some overlap with one another, some are advisory and lack legal force, others are legally binding in countries, and still others are directed at narrow topics within bioethics, such as HIV/AIDS and human genetics. As the latest document to enter the fray, the UNESCO Declaration has the widest scope of any previous document. It embraces not only research involving human beings, but addresses broader concerns in medicine and healthcare. The UNESCO draft declaration has some minor weaknesses, but on the whole, the strengths outweigh the weaknesses. One weakness is that some items in the draft are stated in a way that is too restrictive, thereby appearing to rule out legitimate activities. A strength of the Declaration is that it is relatively brief, yet at the same time contains sufficient detail to make it something more than a rehearsal of mere pieties. As the most recent of the numerous bioethics and human rights documents, the UNESCO draft draws on many of the earlier documents and also includes some of the most recent thinking about ethical norms and obligations. Perhaps its greatest strength lies not in details of the principles or their implementation, but rather in its stature as an international declaration issued by a United Nations organization.

It means no more than respect for persons or their autonomy Appeals to human dignity populate the landscape of medical ethics. Claims that some feature of medical research or practice violates or threatens human dignity abound, often in connection with developments in genetics or reproductive technology. But are such charges coherent? Is dignity a useful concept for an ethical analysis of medical activities? A close inspection of leading examples shows that appeals to dignity are either vague restatements of other, more precise, notions or mere slogans that add nothing to an understanding of the topic. Possibly the most prominent references to dignity appear in the many international human rights instruments, such as the United Nations' universal declaration of human rights.1 With few exceptions, these conventions do not address medical treatment or research. A leading exception is the Council of Europe's convention for the protection of human rights and dignity of the human being with regard to the application of biology and medicine.2 In this and other documents “dignity” seems to have no meaning beyond what is implied by the principle of medical ethics, respect for persons: the need to obtain voluntary, informed consent; the requirement to protect confidentiality; …

What makes individuals, groups, or even entire countries vulnerable? And why is vulnerability a concern in bioethics? A simple answer to both questions is that vulnerable individuals and groups are subject to exploitation, and exploitation is morally wrong. This analysis is limited to two areas. First is the context of multinational research, in which vulnerable people can be exploited even if they are not harmed, and harmed even if they are not exploited. The type of multinational research likely to raise the most ethical concerns is that in which the investigators or sponsors are from a powerful industrialised country or a giant pharmaceutical company and the research is conducted in a developing country. Second is the situation of women, who are made vulnerable in cultural settings or in entire countries in which they are oppressed and powerless. In the face of cultural values and practices, or governmental policies, these women suffer serious consequences for their health and even lives. Examples are provided, and it is suggested that in some cases vulnerable individuals can be harmed but not exploited. On the positive side, recent developments reveal a new awareness of exploitation and efforts to enhance the ability of developing countries to protect themselves and their citizens from exploitation at the hands of powerful sponsors of research. In addition, human rights principles are increasingly being used to monitor the actions (or inaction) of governments regarding women's reproductive rights and vulnerability with respect to HIV/AIDS, and to take remedial actions.

Gillon is correct that the four principles provide a sound and useful way of analysing moral dilemmas. As he observes, the approach using these principles does not provide a unique solution to dilemmas. This can be illustrated by alternatives to Gillon’s own analysis of the four case scenarios. In the first scenario, a different set of factual assumptions could yield a different conclusion about what is required by the principle of beneficence. In the second scenario, although Gillon’s conclusion is correct, what is open to question is his claim that what society regards as the child’s best interest determines what really is in the child’s best interest. The third scenario shows how it may be reasonable for the principle of beneficence to take precedence over autonomy in certain circumstances, yet like the first scenario, the ethical conclusion relies on a set of empirical assumptions and predictions of what is likely to occur. The fourth scenario illustrates how one can draw different conclusions based on the importance given to the precautionary principle.