2.1 - Requirements of Investigators

Physician-Patient Relationship Section

One area of ethical dilemma of physicians and health care workers can be attributed to the conflicting roles of helping the patient and gaining scientific knowledge, as stated by Schafer (1982)

  In his traditional role of healer, the physician's commitment is exclusively to his patient. By contrast, in his modern role of scientific investigator, the physician engaged in medical research or experimentation has a commitment to promote the acquisition of scientific knowledge.

When properly set, designed, and conducted, a clinical trial is an ethically appropriate way to acquire new knowledge. Clinical decisions for treatment that are based on weak or anecdotal evidence, opinion, or dogma, without the evidence of rigorous scientific support, raise their own ethical questions.

It is not easy to distinguish between clinical research and clinical practice. How often is a physician certain of the outcome from a specific therapy for a particular patient? If the patient’s reaction is predictable, applying the treatment would be described as practice. In the cases when the physician is unsure of the outcome, applying the treatment could be considered research. Many actions by the physician for the benefit of individual patients have the potential of increasing scientific knowledge. Analogously, scientific knowledge gained from research can be of benefit to individual patients. Ethical questions arise when unproven therapies are proposed to replace proven ones and are particularly acute for chronic or fatal illnesses.

Clinical trials are only one of several settings in which the physician’s duty extends beyond his responsibility to the individual patient. For example, vaccinations against communicable disease are promoted by physicians, yet the individual vaccinated incurs a small risk to benefit the population as a whole. Triage is another situation where for the sake of maximizing benefit to the whole, the needs of an individual may not be met.

The American Medical Association has a code of professional ethics that includes the obligation of a physician to conduct medical research: “ A physician shall continue to study, apply and advance scientific knowledge, maintain a commitment to medical education, make relevant information available to patients, colleagues, and the public….” (AMA, 2001). There is also a statement of the physician’s responsibility to the patient as ‘paramount’. Both ethics must be considered when the health professional considers entering a patient in a clinical trial.

Responsible Conduct of Research Training: Section

All clinical investigators should have training in research ethics. The US NIH website has resources for training in the areas of scientific integrity, data, publication, peer review, mentor/trainee relationships, collaboration, human and animal subjects, and conflict of interest. Many funding sources, including the US NIH and NSF, require responsible conduct of research training for all students, trainees, fellows, scholars, and faculty utilizing their funds to conduct research.

Conflict of Interest: Section

A crucial component of ethical medical research is investigator objectivity. Investigators are required by the US Public Health Service, the umbrella organization for the FDA and the NIH, to report any significant financial interest would appear to affect the design, conduct, or reporting of research. (See Guidance from FDA)

Competence: Section

Investigators should be competent technically (evidenced by education, certification, experience) and humanistically (showing compassion and empathy).