• Ajay D Wasan, Simone P Taubenberger, and Walter M Robinson.
• Departments of Anesthesiology and Psychiatry, Harvard Medical School/Brigham and Women's Hospital, Boston, Massachusetts, USA. awasan@partners.org
• Pain Med. 2009 Jan 1;10(1):111-9.

ObjectiveTo ascertain the self-reported reasons for participation in the clinical research of chronic low back pain and to evaluate those reasons in the context of informed consent and the concept of therapeutic misconception. This is the belief that research participation is equivalent to clinical care.DesignQualitative descriptive study with semistructured interviews.SettingPhone interviews with subjects with chronic low back pain after they completed a double-blind controlled trial.ParticipantsFifty-two of 60 (86%) randomized controlled trial completers.ResultsSeventy-seven percent had more than one reason for study participation, including the following: to contribute to research; to seek relief of pain (both short- and long-term); to try a different drug; monetary remuneration; and to have their pain taken seriously. An initial altruistic reason for participation was often followed later in the interview by reasons of personal benefit. In most cases, the single question, "why did you participate?" was insufficient to reveal these multiple reasons. "Personal benefit" had many individual meanings, framed in the context of an illness narrative of coping with chronic pain. Despite reasons of personal benefit, subjects were still able to make the distinction between research and clinical treatment.ConclusionsAssessing the adequacy of informed consent requires a thorough understanding of how subjects viewed a study and their reasons for participation. Quantitative-based surveys may not capture the complexities of reasons for study participation. Reasons of personal benefit, seemingly contradictory reasons for participation, or overriding desire for relief may all affect the quality of informed consent. Yet, these issues may not automatically signal the presence of TM.

25 keywords...

hide…