3. Reduced Liability
Given the current system of malpractice and liability regulations governing healthcare practice, physicians need to fully understand the ethical aspects of surgical innovation and/or clinical research with human subjects. By ensuring a rigorous ethical review of their work and by fully informing patients of the experimental nature of the procedure, surgical investigators are better protected against unintentional breeches of federal guidelines pertaining to human subjects' research. Also, in case of unanticipated adverse events resulting from the studied therapy, rightfully choosing the formal research route provides better legal protection.
Surgical innovation, a practice that has yet to be precisely demarcated and defined, may fall outside of mainstream regulatory guidelines. This means that legal mechanisms may be unable to sufficiently protect patients from becoming involved in projects that should be properly organized as formal human subjects research. The policy gap places the burden on surgical innovators to act in the best interests of their patients, an assessment that requires ethical analysis. If they fail to recognize potential ethical concerns raised by their work, surgeons may be subject to retrospective "regulation", in the form of malpractice litigation. Questionable cases are often logical topics for review in morbidity and mortality conferences. Additional professional repercussions can include formal reprimands by state licensing boards, as in the case of two surgeons from New York (link). These are serious concerns that should motivate all surgical investigators to study research ethics.
Next - Research Ethics in Surgical Clinical Research
Return to Index