By Any Other Name: The Many Iterations of "Patient Advocate" in Clinical Research

satisfactory informed con-sent process for clinicalresearch can be elusiveunder the best of circumstances.Prospective enrollees may be limit-ed in their understanding of theprocess by poor education or seri-ous illness. Conflicts of interestmay bias investigators’ presenta-tions of information. Time con-straints and a host of other factorscan likewise intrude. In view ofsuch challenges, some observershave proposed that, at least forsome kinds of research, prospectiveenrollees should have someone—a“patient advocate” or “researchsubject advocate”—to enhance theprocess. Indeed, one commentator hasinsisted that such advocatesalready have a well-establishedrole. In a recent lawsuit the plain-tiff’s attorney claimed that in theresearch context, patient advocateconstitutes a profession for whichthere is a clear standard of care towhich all members should beheld.