Academic journal article The Hastings Center Report

Science in the Service of Healing

Academic journal article The Hastings Center Report

Science in the Service of Healing

Article excerpt

Every major code of ethics concerning research with human subjects, from the Nuremberg Code to the present, has recognized that for clinical research to be ethically justifiable it must satisfy at least the following requirements: value, validity, and protection of the rights and welfare of participants. First, the research question should have value by generating generalizable knowledge that will contribute to "improving diagnostic, therapeutic, and prophylactic procedures and the understanding of the etiology and pathogenesis of disease."[1]

Second, to be scientifically valid the research should be designed in such a manner that the knowledge being sought is likely to be obtained. This requires that the design and methods of the proposed study be reliable and valid. Studies are unethical if they are statistically underpowered, poorly controlled, fail to collect or adequately analyze the appropriate data, or have other design or methodological flaws so that the information obtained is not usable. Such studies exploit human participants and waste limited resources for no benefit.

And third, the rights and welfare of the research participants must be protected. Protection of participants' rights and welfare includes assuring that subjects are not deliberately harmed by participation in research, that the risks of the research are minimized and are justified by the anticipated benefits, and that subjects are selected equitably. Subjects must also be provided adequate information about the study and voluntarily agree to participate (informed consent), confidentiality must be protected, and adequate monitoring of safety must be conducted as appropriate.

It is worth reminding ourselves that clinical research is not health care; the goals and methods of each are distinct. Clinical research aims to identify methods (diagnostic, preventive, or therapeutic) of improving health care and to better understand human health and illness. In contrast, health care is the provision of medical and public health services (often proven to be of value through clinical research) to people who need them. Health care and treatment are not entitlements in much of our world. Even in the United States, no one is entitled to every available service. In every part of the world, hard choices are made regarding the allocation of health care dollars. These choices involve the recognition that because resources are limited, decisions must be made about what services to offer to whom and about the relative priorities among prevention, primary care, and acute and tertiary care, and among different diseases and conditions.

Ideally, health care allocation decisions would not be arbitrary, but rather would be informed by data on outcomes, costs, and the distribution and rates of illness. Clinical research does not guarantee justice in allocation decisions. Through clinical research, however, data are developed that can inform these choices. Thus clinical research is an essential albeit incomplete step toward just allocation of health care resources. As such, there may be a moral imperative to conduct clinical research to find better methods of preventing and treating disease, where "better" implies safe, effective, available, affordable, and acceptable to the people who need it.

The Short Course AZT Trials

Against this backdrop, in May 1997 the Public Citizen's Health Research Group publicly attacked as unethical several clinical trials aimed at investigating ways to reduce perinatal transmission of HIV infection in the developing world, mainly in sub-Saharan Africa and Southeast Asia. A subsequent editorial in the New England Journal of Medicine escalated this controversy, likening the trials to the infamous Tuskegee syphilis study and claiming egregious violations of the rights of trial participants.[2] Although the disagreements were emotional and often harsh,[3] the ethical issues raised by this debate are complex and deserve further attention and dialogue. …

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