Dual Roles of Physician-Investigator
Physicians involved in research trials sometimes balance opposing roles: they are clinicians practicing medicine, and investigators researching medicine. These roles may overlap and may even be mutually beneficial to a patient on a trial who has the familiarity, trust, convenience, and continuity of their personal oncologist as the investigator. However, these different roles do have boundaries that may be blurred and lead to conflicts within the patient-physician relationship. Patients often depend on their clinician for care, treatment, and subjective medical recommendations (therapeutic orientation). Conversely, an investigator should be totally objective in the collection of data for an experimental drug that may have no therapeutic benefit (research orientation). If the primary oncologist is also the investigator, then the patient’s informed consent should be independent from the influence of the investigator so that no duress is placed on the patient’s decision to participate or comply with the protocol. These dual relationships as practitioner and investigator may harmonize as long as the physician places patient welfare as the paramount interest. The refusal of a patient to participate in a study must never interfere with the patient-physician relationship.
It must also be recognized that the practice of medicine is an imprecise science, whereby physicians apply their medical knowledge to evaluate treatment options. Therefore, even off of a protocol, physicians are every day incorporating therapy, and choices of multiple options to determine which medication or treatment works best for that individual. This practice of choosing between two equal options as educated “trial and error” to determine which medicine works best for the individual is within the scope of medical practice and does not constitute formal research. However, major experimental procedures (even in the context of individualized cases) should be incorporated into a formal research protocol with the patient granting informed consent and Institutional Review Board (IRB) approval. To pioneer innovative or experimental procedures without this formal review would be unethical. Similarly, to collect research data, no matter how simple, safe, or good the intentions, is unethical without a formal research trial approval.
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