Introduction
A satisfactory informed consent process for clinical research can be elusive under the best of circumstances. Prospective enrollees may be limited in their understanding of the process by poor education or serious illness. Conflicts of interest may bias investigators' presentations of information. Time constraints and a host of other factors can likewise intrude. In view of such challenges, some observers have proposed that, at least for some kinds of research, prospective enrollees should have someone - a "patient advocate" or "research subject advocate" - to enhance the process.
Indeed, one commentator has insisted that such advocates already have a well-established role. In a recent lawsuit the plaintiff's attorney claimed that in the research context, patient advocate constitutes a profession for which there is a clear standard of care to which all members should be held.[1] According to that putative standard, a patient advocate is responsible for assuring that prospective clinical trial enrollees understand the risks and benefits of the research study, and must tell prospective research subjects whether it is in their best interest to enroll. Additionally, advocates are supposed to advise patients and families on whatever issues arise during the course of the entire research project. In the lawsuit mentioned above, this purported standard would have required the patient advocate to ensure that the research institution does not erroneously send bills to subjects or their families, and to set up communications among subjects' spouses.
Closer inspection, however, will reveal that concepts such as patient advocate or research subject advocate actually have so many different uses that they lack any generally recognized meaning, let alone a uniform standard of care binding upon all. Drawing on published literature, an Internet search, and personal conversations, this article explores that diversity of meaning. The objective is not to create an exhaustive catalogue, but simply to show that "patient advocate" has no single meaning and thus cannot carry any clear set of one-size-fits-all duties. Rather than establishing one umbrella term, it is better to specify which particular services an advocate will provide in a given research project. Given the variability among research trials and subjects' needs, preserving a diversity of services arguably is the best approach.
As a matter of semantic housekeeping, this article will not dwell on the choice between "patient," "subject," "volunteer," "participant" or other terms referring to people who enroll in clinical research. Assuredly the choice can be important. Some commentators find "subject" impersonal[2] or confusing.[3] "Volunteer" does not apply to everyone, since others can enroll people lacking decisionmaking capacity in research. "Participant" can characterize investigators as well as non-researchers. "Patient" can invite a therapeutic misconception in which research interventions are mistakenly seen as treatment. At the same time, "patient" can seem more applicable than "subject" for people who are seriously ill and receiving a mix of standard medical care and trial-related interventions.
This question will not be resolved here. I will primarily use the term "patient" simply because "patient advocate" rather than "subject advocate" or another term is typically the term used to identify the roles and activities examined here. Nevertheless, "patient" is admittedly problematic. More will be said about this later.
IRB. 2004;26(6) © 2004 The Hastings Center
Cite this: By Any Other Name: The Many Iterations of "Patient Advocate" in Clinical Research - Medscape - Nov 01, 2004.
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