ABSTRACT
Clinical research in perioperative cancer medicine can have unique challenges, primarily related to the compromised nature of the research participants. In presurgical settings where patients are more likely to be awake and alert, they are often weak, dependent, distressed, and afraid. These circumstances may make prospective research subjects increasingly suggestible and dependent upon medical advice and influence. The same can be said about many cancer patients who seek pain control-they are vulnerable and their abilities to make decisions may be compromised by significant adjustment disorders, clinical depression, delirium, or desperation for pain relief. Finally, most patients under the care of critical care physicians are in an intensive care unit (ICU), have suffered sudden catastrophic illness or injury, or have acute medical needs postoperatively and are physiologically
compromised with at least single organ failure. Whether their critical care needs result from a severe or terminal illness, these patients usually have diminished or absent decisional capacity for providing informed consent. With these kinds of clinical circumstances in mind, perioperative cancer researchers must design and carry out studies that conform to standard ethical principles and guidelines for research. Becausemuch of this research will take place in hospitals, the researchwill likely undergo ethical review by an independent institutional review board (IRB). To prevent abuse of human subjects, federal regulations mandate IRB review of all research conducted at institutions receiving federal funds. However, investigators’ knowledge about ethical issues and principles in research constitutes an important additional mechanism and safeguard for protecting the welfare of research subjects.
