How can we promote the best interests of people as a group through research while protecting the rights and welfare of individual research subjects? Examining this central moral concern in biomedical research offers opportunities to teach about how ethics and moral reasoning impact people’s life, health and well being. Without good research there is little information about the safety and efficacy of medical interventions. Consequently, if clinicians use untested interventions they may endanger their patients. But if they use only tested interventions, they may severely limit their treatment options. Children with schizophrenia, for example, are routinely undertreated because many interventions used for adults have not been tested on children. In short, doing human research raises moral problems, but not doing research also raises them.

From its beginning in 1978, teaching research ethics has been an important part of our program in the Department of Medical Humanities at The Brody School of Medicine (BSOM). Our faculty members teach research ethics to medical students, graduate students, medical residents, faculty, and staff. We also participate in research ethics committees and task forces at the medical school, university, and hospital, including the University- Medical Center Institutional Review Board for the Protection of Human Subjects (UMCIRB) and the Institutional Animal Care and Use Committee (IACUC).

Humanities and Medical Education
Our preclinical curriculum has had two full sessions devoted to human research since our program began in 1978. One of these sessions focuses on recent history and important research guidelines including the Nuremberg Code, The Declaration of Helsinki, the Belmont Report, and the US Code of Federal Regulations. In addition, students learn about the Nazi Experiments, the Tuskegee Syphilis Study, the Willowbrook Hepatitis studies, the Human Radiation Experiments, the XYY studies on infants at Boston Lying-In Hospital and other well-known cases. This year we gave special attention to the newly revised Declaration of Helsinki and its possible impact on the moral and political debate about whether or when it was morally permissible for countries to use different standards for inclusion of human subjects at home and abroad. We pick well-known cases to discuss as well as cases that students are likely to encounter in their clinical rotations and as practicing clinicians. While some of our students have had extensive research experience, others have not and need to be introduced to the close and practical connections between research with human subjects and their clinical activities and responsibilities.

Humanities and Basic Medical Sciences
In 1992, our faculty sought and gained approval to introduce a graduate course in research ethics and integrity, offering it for the first time in the spring of 1993. Because we are a small department, we restricted enrollment to students working on their PhDs in the basic medical sciences. Like our courses for the medical students, this course is team-taught. But while the courses for medical students include clinicians as co-instructors, this course for graduate students includes basic science faculty as co-instructors.

Members of the Department of Medical Humanities planned this course in 1992 with faculty from the basic sciences at BSOM. Paul Phibbs, Chair of the Department of Microbiology, was particularly helpful to us. Topics selected at that time included the nature of the scientific enterprise, animal research, human research, authorship, fraud and misconduct, bias, science and politics, patenting, commercialism and conflicts of interest, and the social responsibility of scientists. In recent years the course has also included sessions on publication, peer review, mentoring, data management and analysis, media relations, and genetics research.

The objectives of the course, as stated in 1993, were to
“1) identify the moral, philosophical, and social concerns associated with scientific research and technology;
 2) reflect on the role of the working scientist in helping to develop and implement social policies about scientific and technical issues;
 3) develop critical skills for evaluating the moral, philosophical and social claims, arguments, and goals raised by the work of the professional scientists; and
 4) explore the moral, professional, and social responsibilities of working scientists [1].”

Various members of the department have taught this course, which is offered every other year in the spring. The course satisfies the National Institutes of Health’s (NIH) required research ethics training for graduate students who conduct research on NIH-funded projects.

Programs with Faculty and Staff
To promote education about and adherence to new government regulations, some of which now require training in research ethics, we participate in programs that have been initiated for faculty and staff to reinforce important and accepted professional codes and values. Faculty and staff, especially those who have any duties to human or animal subjects, must know about the rules, regulations and guidelines pertaining to their professional obligations in conducting, evaluating and reporting their research. It is important for investigators to understand current federal and institutional policies as well as the reasons for heightened federal scrutiny. According to Donna Shalala, Former President Clinton’s Secretary of Health and Human Services, “The need to strengthen protections for human subjects is rooted in four recent trends in clinical research. First, researchers may not be doing enough to ensure that subjects fully understand all the potential risks and benefits of a clinical trial…Second, too many researchers are not adhering to standards of good clinical practice … Third, IRBs are under increasing strain …Fourth, the nature of clinical trials themselves is changing [2].”

REFERENCES

1. Kopelman, L.M. “The Medical Humanities Program at East Carolina University” North Carolina Medical Journal 1993; 54, 8: 409-413.

2. Shalala, D. “Protecting Research Subjects: What Must Be Done?,” New England Journal of Medicine 2000; 343, 11: 808-810.