Continuing Medical Education Formation Médicale Continue Practical Tips for Surgical Research

Although codes of ethics date back millennia to the Hippocratic Oath and the Prayer of Maimonides, modern medical ethics, especially as it relates to research involving humans, began with the Nuremberg Code, a series of principles articulated by jurists at the trial of Nazi physicians responsible for atrocities against prisoners during the Second World War. The core principles of the 10-point Nuremberg Code include voluntary informed consent, lack of coercion, properly formulated experiments and beneficence toward participants. The Nuremberg Code has been largely superseded by the World Medical Association’s Declaration of Helsinki, last revised in 2008. Western biomedical ethics, including research ethics, are guided by 4 overreaching principles: 1. Respect for autonomy: the human capacity and the right to selfdetermination and decision making. 2. Nonmaleficence: avoiding the causation of harm or primum non nocere. 3. Beneficence: acting in a way that benefits the patient after balancing the potential risks and harms. 4. Justice: treating patients in similar positions in a similar manner by distributing risks and costs fairly. The need for surgical research is not in doubt. Well-designed research studies have led to the near disappearance of previously common surgical procedures such as extracranial–intracranial bypass for stroke prevention, internal mammary artery ligation for heart disease and, to some extent, arthroscopy for osteoarthritis of the knee. Conversely, surgical research has led to the continued widespread use of some procedures whose efficacy had been questioned, such as carotid endarterectomy for symptomatic carotid stenosis. There is a perception, however, that surgical procedures, both wellestablished and novel, are held to a less-rigorous standard than are medical treatments, both ethically and methodologically, resulting in procedures being “smuggled” into practice without proper review. As the need for more rigorous evaluation of surgical research is recognized, so too is the need for proper application of ethical principles and oversight to that research. In the following sections, we provide a brief review of some of the more pressing ethical issues encountered in surgical research. Although not meant to be a comprehensive review, this will hopefully act as a starting point for awareness and further discussion of ethical issues in surgical research. By the end of this article, the reader will appreciate the significance of ethics in conducting research involving surgical patients. Patrick J. McDonald, MD, MHSc* Abhaya V. Kulkarni, MD, PhD† Forough Farrokhyar, MPhil, PhD‡§ Mohit Bhandari, MD, MSc‡