Cancer clinical trials are a necessary component of the effort to improve cancer prevention, diagnosis, and treatment. Essential to this process is the informed consent of the individuals who participate in these research studies. The purpose of this article is to describe patient, provider, and informed consent process issues with presentations of data reported in the current literature. The role of nursing in the facilitation of informed consent is discussed.
Virginia Chih-Yi Sun and Tami Borneman clearly articulate the vital contributions oncology nurses make to our patients, to the ethical conduct of clinical trials, and ultimately, to society. They preface their article by defining the clinical trial as the translational link between the laboratory and improved methods for preventing, diagnosing, and treating cancer. At the heart of clinical trials are the participants, our subjects. It is of utmost importance, therefore, that ethics drive our clinical trial considerations. This brings us to the core of their discussionthe nurse's role in the informed consent process.
As Sun and Borneman explain, a wealth of literature documents subjects' misconceptions surrounding cancer clinical trials. These include not only misunderstandings about factual details, but also conceptual misunderstandings regarding how the experimental intervention differs from standard treatment, the concept of randomization, overestimation of benefits or under-appreciation of risks, and failure to recognize the primary purpose of the trial. When such misconceptions exist, can we say that the subject has been properly informed?
Stryker et al  report that "participants who do not believe they fully understand the implications of trial participation ... may ultimately regret their decision to participate."
Can we do a better job of teaching and informing? We must, say Sun and Borneman, if we embrace the ethical principles which guide biomedical research. The authors cite numerous studies conducted in an attempt to understand how and why misconceptions about clinical trials occur. Barriers include overwhelmed participants, miscommunication, misunderstanding, and complex consent forms. Acknowledging these barriers has helped investigators to explore potential improvements to our consent processesand here the oncology nurse plays a vital role.
Flory and Emanuel  conducted a meta-analysis of 42 studies that compared standard informed consent processes vs interventions designed to improve clinical trial participants' understanding. Like Sun and Borneman, they concluded that "extended discussion" intervention studies (spending more time talking one-to-one with subjects about the clinical trial) were effective. Hietanen et al  concluded that subjects need clear information, enough time to consider the options, and psychological support.
Oncology nurses are superb teachers who recognize patients' needs for adequate time to digest, discuss, reflect, share with family, ask questions, and ask again. They know, as Sun and Borneman elegantly state, that the informed consent process is not a single interaction that ends with signing the document, rather, it is an ongoing dialogue; and they recognize the need to be truthful without extinguishing that precious seed of hope. Oncology nurses know the importance of continued assessment of patients' clinical trial understanding and that it is just as important as health assessment. Finally, they are keen observers who recognize patients' nonverbal cues and respond with support every step of the way: Do their patients want to continue on a trial? Do they want to stop? And nurses tell them that, whatever the decision is, it is "okay."
1. Stryker JE, Wray RJ, Emmons KM, et al: Understanding the decisions of cancer clinical trial participants to enter research studies: Factors associated with informed consent, patient satisfaction, and decisional regret. Patient Educ Couns 63(1-2):104-109, 2006.
2. Flory J, Emanuel E: Interventions to Improve Research Participants' Understanding in Informed Consent for Research. JAMA 292:1593-1601, 2004.
3. Hietanen P, Aro AR, Holli K, et al. Information and communication in the context of a clinical trial. Eur J Cancer 36(16):2096-2104, 2000.