Removing `deficiencies' in human research

March 05, 2000|By Ruth Faden and Tom Beauchamp

THE HISTORY of the ethics of research involving human subjects is a history of progress propelled by scandal.

Perhaps it is too soon to tell whether the tragic death of 18-year-old Jesse Gelsinger in September during a gene-therapy experiment at the University of Pennsylvania will join the canon of notorious cases of failure to protect subjects. It is not too soon, however, to use the impetus in public consciousness riveted by this heartbreaking loss to take overdue steps to improve protections for human subjects, especially in innovative areas such as gene therapy.

In October 1995, the Advisory Committee on Human Radiation Experiments, convened to investigate another scandal involving violations of human rights in Cold War-era experiments, reported that it had found evidence of "serious deficiencies in some parts of the current system for the protection of the rights and interests of human subjects."

In January 2000, this same phrase -- "serious deficiencies" -- was used by the Food and Drug Administration to explain why it is halting all research involving human subjects at the institute that conducted the experiment in which Mr. Gelsinger died.

It may not be surprising that serious deficiencies in the system of research review have not been corrected in the past five years, but it is inexcusable.

Despite some significant efforts, oversight of human subject research has been going in the wrong direction. Offices at the FDA and the National Institutes of Health responsible for monitoring the safety of human subjects remain woefully understaffed and undervalued, despite climbing numbers of new research projects. Research ethics committees that operate at the local university level, many of whom labor diligently to protect the interests of human subjects, are similarly overworked, underbudgeted and undervalued. Few institutions have the resources to adequately monitor what happens to human subjects after the paperwork has been reviewed and approved.

In the Pennsylvania case, the facts that have emerged suggest that oversight and monitoring of clinical trials are precisely where the ethical lapses have occurred. Violations that allegedly were not caught in this case include underreporting of adverse effects, underreporting of animal data, and underreporting to government officials, as well as to potential subjects and their families.

It would be wrong to suggest that every research project involving human subjects requires intensive prospective monitoring. Most human research is straightforward and poses few real risks to subjects. But some research projects cry out for heightened scrutiny -- for example, research in uncharted scientific territory, research that carries substantial risk, research in which investigators have financial interests (conflicts of interest, in some cases).

We all have an interest in the advancement of medical science. Most of us know someone whose hopes for the future are dependent on medical progress. Increasingly, this progress is likely to be found in the critical frontiers of genetic medicine.

But a basic truth about medical progress must be faced. Progress entails risk. In the early stages of a new field, these risks can be significant. Many uncertainties and risks remain even after carefully planned laboratory analysis and research with animals. This is precisely why research with human subjects is performed. The highest levels of uncertainty often attend the most inventive and untested work.

Some must bear these risks that science and society ultimately benefit. This is the essence of the moral problem about human-subjects research. It is not confined to gene-therapy trials or even to the more innovative areas of medicine. The practical import is that we owe those who assume risk of harm for our benefit a system of protections free of "serious deficiencies."

Medical ethics and research ethics have long insisted that the safety interests of patient-subjects and human volunteers must take priority over the interests of science and society.

This commitment is not easy to express or to instill in practice, but it deserves more serious consideration than it has received.

Ruth Faden is executive director of the Bioethics Institute at the Johns Hopkins University. Tom Beauchamp is senior research scholar at the Kennedy Institute of Ethics, Georgetown University.

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