 |
|
|
|
 |
 |
 |
|
 |
|
||
|
|||||||||||
Home About SPA Join SPA Education Newsletter Jobs & Fellowships Volunteer Service Abroad Links of Interest
|
SPA Newsletter.
The Ancillary-Care Responsibilities of Medical Researchers: An Ethical Framework for Thinking about the Clinical Care that Researchers owe their Subjects.Richardson, HS, Belsky L The Hastings Report Jan-Feb 2004;25-33Reviewed by: Thomas J. Mancuso, MD, FAAP The title of this thoughtful paper describes the objective of the authors. They posit that researchers owe their subjects "ancillary care", care that goes beyond the requirement of scientific validity, safety, keeping promises and rectifying injuries. The authors stake out a middle ground between the two polar opposite roles researchers might have regarding research subjects: being a personal physician trustee of the patients' well-being or being the disinterested researcher who has only a contractual relationship with a subject. A research subject partially entrusts her health to the researcher. Such entrustment relationships are characterized by both discretion and vulnerability. The research subjects uses discretion in choosing to enroll in a protocol and allow the researcher to exercise judgment in deciding how to act on her behalf in matters of importance to her. Vulnerability refers to the fact the research subject's well being may be affected by how the researcher acts. The limited responsibilities that researchers have toward subjects derive from the permission granted by the subjects (discretion), their resulting vulnerability and the duties resulting from the research h relationship: compassion, engagement and gratitude. Compassion requires that researchers remain responsive to the needs and perspectives of the vulnerable subjects. By engagement, the authors mean that researchers acknowledge the existence of a relationship that extends beyond the narrow confines of the protocol. Gratitude on the part of the researchers toward those who voluntarily enter a protocol that may hold no benefit is self-evident. Finally, the authors address the question of the scope and strength of the entrustment. Here, the detail of the research and of the subjects' is paramount. Consider a hypothetical study of malaria in children in an area where the illness is endemic. If the researchers detect shistosomiasis in 10% of children in the study, provision of care for this illness is clearly within the scope of a partial entrustment relationship. If, in addition to shistosomiasis, approximately 10% of the children suffer from various orthopedic injuries suffered as a result of ill-treated traffic accidents. Treatment of these orthopedic injuries is not within the scope of the research partial entrustment relationship since detection of the injuries is evident and not as a result of research procedures. Consider another study of functional MRI in normal subjects given specific task to do. Researchers in this area have generally agreed that in addition to reviewing the scans for research-related information, radiologists also do diagnostic readings of the MRI's. Commentary This provocative paper should be read by those who themselves are clinical researchers, those who read clinical research papers those who care for patients who also are subjects in clinical research and those who are concerned with the conduct of clinical research especially protection of human subjects. The authors make a good first try at more precisely characterizing the relationship investigators have with their subjects. This difficult relationship has been discussed in the context of the therapeutic misconception seen in oncology patients who enroll in studies but the authors here extend the discussion to all clinical research. Table of Contents
|
|
| © 2008 Society for Pediatric Anesthesia 2209 Dickens Road, Richmond, VA 23230-2005 • Phone: 804-282-9780 • Fax: 804-282-0090 |
