7.3.2 Enrolling Patients in Clinical Research
Daryl Pullman, PhD, and Andrew Latus, MD, PhD
- To explore the notion of informed consent in research settings.
- To appreciate the ethical challenges clinicians face when their patients are also their research subjects.
- To understand the concept of "therapeutic misconception."
Jane Simmons, age 57 years, has a two-year history of rheumatoid arthritis (RA). Despite early initiation of methotrexate, both of her hands are severely affected and attempts to reduce the burden of clinical inflammation and radiologic damage have been largely unsuccessful. Jane is a highly motivated patient as her condition makes it virtually impossible for her to continue her career as a painter. She has the financial resources to try new treatments, including biological agents, but is discouraged as she has seen little benefit from previous interventions.
Dr. Fraser, Jane's rheumatologist, is currently enrolling patients in a Phase III trial of a new biological agent that targets a novel cytokine implicated in the pathogenesis of RA. Based on her reading of the preliminary research, Dr. Fraser is optimistic about its potential for patients like Jane. At Jane's next appointment Dr. Fraser explains the details of this 24-week, double-blind, placebo-controlled study. She says, "There's no guarantee this treatment will be successful, but I have a good feeling about it." Jane enthusiastically agrees to take part.
The study protocol requires visits every two weeks. Over the next several weeks Dr. Fraser notices a clear improvement in Jane's mood and in Jane's perception of her own symptoms, although there is no objective evidence of this. By the end of the study, however, there is an observable improvement in Jane's condition, particularly in her right "painting hand," and Jane has resumed painting. She makes frequent references to the "new lease on life" this "new treatment" has given her. On reflection, Dr. Fraser realizes that she also sometimes refers to Jane's improvement as resulting from the new agent, even though neither she nor Jane knows whether Jane is receiving the study drug or placebo.
As the trial comes to an end, Jane becomes increasingly concerned about what will happen when she stops receiving "this wonderful new drug." She begins to pressure Dr. Fraser to find a way to continue her access to it.
- How do standards of consent differ between research and treatment settings?
- What is meant by "therapeutic misconception" and how is it relevant to the current case?
- What are the key elements of the consent process in the research context?
- Would it be appropriate for Dr. Fraser to attempt to obtain the new biological agent for Jane when the trial ends?
- Halushka v. University of Saskatchewan et al. 53 DLR (2d) 436 (Sask. CA) 1965.
- Tri-Council Policy Statement. Ethical conduct for research involving humans. Ottawa: Interagency Secretariat on Research Ethics; 2005. Available from: http://www.pre.ethics.gc.ca/english/pdf/TCPS%20October%202005_E.pdf.
- Reibl v. Hughes (1980) 114 DLR (3d) 1 (SCC).
- Canadian Medical Protective Association (CMPA). Consent: A guide for Canadian physicians, 3rd edn. Ottawa: CMPA; 1996.
- Kimmelman J. The therapeutic misconception at 25: Treatment, research, and confusion. Hastings Center Report 2007; 37: 36–42.
- Pullman D. Subject comprehension, standards of information disclosure and potential liability in research. Health Law Journal 2001; 9: 113–27.
- Weijer C, Dickens B, Meslin EM. Bioethics for clinicians: 10. Research ethics. Canadian Medical Association Journal 1997; 156: 1153–7.