In your continued attempt to remain current in your specialty, you strive to read every journal that arrives at your office. You cannot help but notice that many articles are authored by our international colleagues. Several of these investigations involve exhaustive human study protocols that might have been impossible to conduct in the United States because of our rigorous institutional review criteria. You wonder whether there is a need for increased awareness of human rights in research.
Many of the current guidelines for human research evolved after the Second World War. Although Germany had enacted regulations for human experimentation in 1931, the Nazi regime obscured the demarcation between politics and research when thousands of prisoners from varied backgrounds were subjected to brutal, meticulously planned experiments. Over 2 dozen types of experiments were conducted involving the torture and death of people, as investigators observed the effects of intentionally induced injury and disease, supposedly to develop interventions for these maladies.
As a result of the postwar trials, the Nuremburg Code was developed as an ethical standard to safeguard the autonomy of subjects: the freedom of choice to consider participation in an experiment after disclosure of its benefits and harm. Several additional guidelines were subsequently developed, including the Declaration of Helsinki (1964) and later the International Ethical Guidelines for Biomedical Research Involving Human Subjects (1993) by the World Health Organization and the Council for International Organizations of Medical Sciences. The intent of the latter document was to protect members of world cultures from human rights abuses in experimentation.
Yet, as demonstrated in Germany, guidelines can have little influence on human research ethics. Respect for human rights in research appears to increase in the most democratic and politically stable countries, whereas nations governed by highly authoritative, dictatorial governments tend to display the least respect for such rights. Even the impact of institutional review boards here might occasionally be insufficient to deter the abuse of experimental subjects.
What can the scientific community do to encourage human dignity and safety in research? First, journal editors and referees must be highly critical by questioning or rejecting studies that appear to exploit subjects. The study must have a sound scientific design, and the benefits to the subjects must certainly outweigh the risks. Procedures that are not used for therapy should be avoided. For example, exposing a subject to multiple radiographs in a shorter period of time or at higher doses than are typically diagnostic would be of questionable ethical practice.
Ethicists have long debated whether data generated by unethical procedures are “bad science” and are therefore illegitimate. One argument against this contention is that there appears to be no relationship between the validity of scientific findings and the level of ethics from which the data were derived. Yet, the use of results gathered without subject autonomy could encourage the production of additional data from future studies that disrespect human rights.
A second method of encouraging ethical research is to consult and emulate constructive institutions such as the Fogarty International Center of the National Institute of Health. This organization propagates international research of sound scientific design by educating scholars in ethical research tactics. Our specialty can learn from the example of these organizations in developing respect for human subjects.
One of the most objective measures of scholarship is to contribute to knowledge through research, followed by subsequent publication. But we should never sacrifice human safety and respect for ethics for the sake of scientific acclaim. The most universal objective we must remember in conducting human research is one of the most powerful rules of all time: to treat others as you would want them to treat you.