The Myriad Challenges of Informed Consent

July 1, 2007

Virginia Sun outlines the elements that must be included in an informed consent document for clinical research. The purpose in stipulating such categories is to ensure that an individual receives, both in writing and during the discussion, sufficient information to make a decision about participation in the research study.

In her cover article (p. 11), Virginia Sun outlines the elements that must be included in an informed consent document for clinical research. The purpose in stipulating such categories is to ensure that an individual receives, both in writing and during the discussion, sufficient information to make a decision about participation in the research study.

Even as oncology nurses who are not involved in research, we may find ourselves participating in this process by answering questions and guiding patients and families as they make their decisions. As we do this, we must be able to present information without bias so as to preserve patients' right to make decisions about their own care as autonomous individuals.

In addition, it's also important to acknowledge the emotional element of informed consent for patients and their families. As Ms. Sun observes, patients offered the opportunity to enroll in a trial may feel a sense of altruism, or anxiety, or unrealistic hope. It is important for nurses to understand and be sensitive to these emotional elements.

Because advancements in oncology occur as a result of clinical trials, participation in these studies is crucial to the future of all cancer prevention, diagnosis, and treatment interventions. Thus, public knowledge about the value of clinical trials is critical to making continued progress against cancer. Education begins, then, not only with descriptions of specific study regimens, but also with information about the purpose of clinical trials themselves, their role in medical research, and how results build incrementally throughout each phase of clinical investigation.

It would be wonderful if all oncology nurses were prepared to discuss clinical trials in a general way with patients and their families. To do this, there are some steps to take. First, we must inform ourselves. Nurses should be able to answer basic queries about trial phases, study designs, who is providing the funding for a particular clinical trial, and what protections are in place for research participants. A wonderful resource for this information is the National Cancer Institute's web site, www.cancer.gov/clinicaltrials.

The issue of informed consent is a crucial one for clinical trials, but it is equally relevant to decision-making about cancer care generally. Each component—the right to be informed and the right to consent to actions taken on one's own person—is a hallmark of ethical clinical care.

As oncology nurses we have both an opportunity and a responsibility to take a leading role in ensuring that informed consent is at the center of every patient's cancer treatment plan. Patient education is at the heart of oncology nursing practice. We should remind ourselves daily about the importance of information provided in a way that leads to understanding and ultimately to informed decision making by the patients in our care.

—Mary McCabe, RN, MA
Editor-in-Chief