Biomedical Ethics And Clinical Research

For more than 50 years, scientists, physicians, bioethi-cists, and the media have focused on a variety of issues in research with human subjects, or clinical research. In 1948, in response to the atrocities perpetrated by Nazi experimentation, the Nuremberg Code was developed to set forth guidelines for the acceptable conduct of scientific research. In 1964 the World Medical Association adopted the Declaration of Helsinki, which specifically guides physicians in biomedical research. These documents specify basic moral guidelines ultimately founded on concerns for autonomy, beneficence, and justice. The guidelines require the following:

• Subjects must give voluntary consent before being enrolled in any study after being fully advised of the study's aims, methods, benefits, risks, and discomforts.

• Proposed studies must have sufficient scientific merit to warrant their risks.

• Studies must be designed to avoid all unnecessary physical and mental suffering.

• Potential benefits to subjects must outweigh risks to subjects.

• Researchers must ensure subjects' privacy and confidentiality.

• Subjects must have the right to withdraw from the study at any time.

• Researchers are obligated to stop the study if continuation is likely to result in injury to subjects.

The guidelines further require that research on human subjects be conducted by qualified individuals and that most clinical research be reviewed by an independent committee, which is generally an institutional review board.

In addition to the Nuremberg Code and Declaration of Helsinki, The International Ethical Guidelines for Biomedical Research Involving Human Subjects was issued in 1982 and revised in 1993 by the Council for the International Organization of Medical Sciences (CIOMS). Those guidelines define national policies for biomedical research, apply ethical standards to the circumstances often present in research in economically developing nations, and define mechanisms for ethical review of human subjects research.

In drug studies, specific ethical concerns focus on balancing benefits and burdens to subjects, on the need for investigators to use noninvasive and minimally painful means of determining drug disposition, on minimizing the frequency of bodily fluid sampling, and on choosing study subjects who are representative of the target population whenever possible rather than exposing healthy volunteer subjects. Placebo-controlled studies create special obligations pertaining to the potential deception of subjects and raise difficult questions about subjects' informed consent.

Recently, attention has focused on the issue of international medical research, especially that done with patients in economically developing nations. For example, one controversy focused on a highly publicized placebo-controlled study in Africa examining the prevention of perinatal transmission of HIV using azi-dothymidine (AZT). Since such a study in an economically developed nation would probably not have a placebo arm, critics argue that this reflects a double standard for research. They assert that one standard for ethical research should prevail, regardless of the social and economic conditions of the subjects. Bioethicists and those directly involved in research are reconsidering whether subjects who are already suffering under impoverished conditions might suffer further exploitation at the hands of medical researchers.

Those who designed the study point out that placebo-controlled studies are the most rigorous available and that AZT would not otherwise be available to this population. Enrollment in the study offered a benefit over and above the status quo, they assert, and did not deprive subjects of anything they could otherwise obtain. Yet such "studies in nature" pose complex ethical issues. If the research relies on the continuation of undesirable social conditions, such as the general lack of prenatal care, critics assert that there is a fundamental obligation to improve those background conditions rather than take advantage of access to the perfect "laboratory." While the clinical study has certainly not made the underlying conditions worse, the study has done little to correct the underlying deprivations. Even so, is that the role of pharmaceutical research or a broader social role that goes beyond what researchers should have to provide? While it would be foolhardy to insist that the only ethically acceptable research is done on patients with full access to comprehensive health care, we do not want to make those who are already deprived and in poverty into "lab rats" who participate in research that ultimately benefits primarily those in the developed world.

Clinical research can target the needs of those in economically developing nations and those who are medically underserved in the United States. Yet we must be cautious in the design and implementation of research studies to ensure that those who are the most vulnerable, whether locally or abroad, are offered the most protections and stand to gain proportionately from the studies in which they participate. Research must satisfy the needs of the population in which it is undertaken, and the products developed during the course of the research must subsequently be made reasonably available.

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