Ethical values in the education of biomedical researchers.

Research is a relatively new activity for physicians--scientific medicine and the culture of research that supports it date from only the beginning of this century. Whereas Western physicians have discussed ethical values in patient care for over 2,000 years, a true discourse on the ethics of biomedical research has developed only in the last few decades. Instruction in the ethics of biomedical research has become a part of the professional development of young doctors even more recently. While the history of ethical reflection on biomedical research has been short, scholarly and professional activity in the field has been intense. Unfortunately, contemporary attention to the ethics of research and the integrity of biomedical science has been prompted not by idealism but by public scandals over abuse of human and animal subjects, reports of scientific fraud, and public concern over an apparent lack of general ethical standards among biomedical scientists.[1] Professional discussion of the ethics of biomedical research has resulted largely from the need to identify, punish, and prevent wrongdoing among researchers. In most instances, this discussion has not meant the creation of new ethical norms, but rather the articulation of previously unwritten ethical standards that became evident only as they were violated. Integrity and ethical responsibility in biomedical research have received particularly serious attention in U.S. universities and medical institutions since 1989. That year the National Institutes of Health (NIH) issued a formal requirement that "a program in the principles of scientific integrity be an integral part of the proposed research training effort" of any institution that applies for a National Research Service Award training grant, funds that support graduate students and postdoctoral fellows in biomedical research.[2] In the years since, administrators and faculty in medical universities have spent significant time and effort developing educational programs in research ethics for physicians in training and graduate students in the biomedical sciences. NIH's order was issued amid profound concern among senior medical researchers, science policy experts, and high-ranking members of government that the informal transmission of ethical norms from teacher to student was not enough in today's complex world of biomedical research. The growing emphasis on formal instruction in ethics is intended as a corrective to the past generation's more exclusive concentration on trainees' technical skills and research productivity. By requiring young researchers to study ethics as an essential tool of their work--just as they might study statistics--NIH called for the ethical standards of biomedical science to be formalized, analyzed, and taught deliberately. In seeking to meet NIH's requirement, many schools have struggled to define essential professional values in research and determine what a core curriculum expressing these values should contain. The ethic, al issues facing physician researchers are widely recognized: the humane and respectful use of human and animal subjects in research; the proper maintenance of data and records; conflicts of interest; self-deception and fraud; the definition of intellectual property in authorship, publishing, and patenting; and the scientist's relationship with peers, students, teachers, funders, and society at large. However, there is still work to be done in articulating the ground on which to address specific ethical problems in biomedical research as well as in devising effective methods for ethics instruction. The Source of Ethics in Scientific Research The first intellectual challenge in designing an educational program in the ethics of biomedical research is to define what is meant by ethics. Many courses in medical and research ethics begin with an overview of the fundamental theories and methods of philosophical ethics, which they later apply to the specific problems of the field. …