National Cancer Institute NCI Cancer Bulletin: A Trusted Source for Cancer Research News
July 24, 2012 • Volume 9 / Number 15

Special Issue: Oncology Nursing

A Balancing Act: Nursing and Ethics in Clinical Trials

White rocks on wooden balance beam.
Nurses working on clinical trials must balance their obligations to patients with their obligations to research.

Clinical trials straddle the worlds of laboratory research and patient care. From research nurses who help manage trials to advanced practice nurses focused solely on patient care, oncology nurses involved in trials bump up against a host of ethical issues not encountered outside the world of clinical research.

“As nurses, our professional obligation is to the patient and providing the best possible clinical outcome for that patient,” said Dr. Connie Ulrich, associate professor of nursing and bioethics at the University of Pennsylvania.

But clinical trials are run to develop new knowledge to help others, not for the benefit of individual participants (although participants might benefit from the study), and “ethical issues can overlap to some degree. As a nurse, our obligation is still to the patient, but we also have obligations to the research. It’s a balancing act,” Dr. Ulrich added.

Uncovering Misconceptions

Although some participants may benefit from taking part in a trial—even attaining a cure in some cases—no promise can ever be made that an experimental treatment will benefit any one participant.

A trial’s principal investigator and support staff, including nurses, must explain this to potential participants through the informed consent process. Even after consenting to take part in a trial, however, many patients remain under the impression that the research team enrolled them for their personal benefit—an error called therapeutic misconception.

This widespread misunderstanding can cause ethical discomfort for nurses, noted Dr. Ulrich. “I have found that informed consent seems to be a major concern for nurses—whether [they think] patients are adequately prepared to undertake the research, and how to best prepare them for that research.”

Informed consent seems to be a major concern for nurses—whether [they think] patients are adequately prepared to undertake the research, and how to best prepare them for that research.

—Dr. Connie Ulrich

On the positive side, explained Dr. Clare Hastings, chief nurse officer at the NIH Clinical Center, nurses are uniquely positioned to discover whether patients harbor therapeutic misconception and to help them better understand the purposes of a trial.

“A person going into a trial may think: “It’s research; it’s got to be something that’ll help me,’” said Dr. Hastings. “Because a nurse goes through a lot of conversations with that person about the process of participating, and what that participation will require, they may be the one on the clinical team who uncovers that [person’s misconception].”

“The public trusts nurses so much that they feel comfortable asking them [questions such as: ‘What’s the benefit to me?’],” said Dr. Ulrich. “My worry is, do nurses have the knowledge and expertise to address those questions, and I’m not sure that they always do.” Most nursing school curricula do not cover issues nurses might face in caring for patients participating in clinical research. (See the box below.)

Protecting the Patient’s Investment

This gap in nursing education can cause ethical difficulties not only because nurses may not feel comfortable discussing trials or helping patients work through the consent process, but because patient care within a trial has to be more regimented and more documented than normal clinical care, explained Dr. Hastings.

To support a patient’s participation, “a nurse has to have very specific timing [for data collection], to do certain types of complete documentation…. If you don’t do that correctly and the data collected are not valid, that person’s investment could be lost,” she said. “That really is an ethical issue, because how can you allow someone to participate and then essentially drop them out of the analysis because [you] didn’t follow the protocol?”

Although clinical research nurses receive substantial on-the-job training in these issues, many clinical bedside nurses, who often help with blood draws and other tests, may not. “Those of us in clinical research recognize that it’s important that, say, blood be drawn at a particular time because the research being done related to the metabolism of that drug is tied to getting that sample on time,” said Annette Galassi, a nurse and public health advisor with NCI’s Office of Communications and Education.

“But if you don’t have clinical research in the forefront of your mind, you may not recognize that,” since there’s much more flexibility in regular clinical care about when things can get done, she added.

Improving the Patient Experience

Dr. Sandra Mitchell, a nurse scientist and program director in the Outcomes Research Branch of NCI’s Division of Cancer Control and Population Sciences, sees access to oncology nurses as an ethical imperative in clinical trials.

Many people who may not receive any direct therapeutic benefit from trial participation have an improved patient experience as a result of the extensive contact with members of the health care team during the course of the trial, explained Dr. Mitchell.

It's an ethical obligation that all patients participating on a trial have sustained access to an oncology nurse.

—Dr. Sandra Mitchell

People enrolled in a trial “typically get very expert and sustained attention, including attention from oncology nurses, and, as a result of the supportive care components, can often have improvements in symptoms and sense of well-being,” she said. “I see improving the patient experience for those participating in a clinical trial as an important ethical obligation.”

Oncology nurses also play an important role in helping patients manage known and new side effects from experimental treatments during a trial. This can be vital when patients achieve a level of tumor control in a trial but may need to have side effects carefully managed and monitored to allow them to remain on that treatment, said Dr. Mitchell, who is helping to develop better systems to collect patient-reported outcomes, including symptomatic treatment toxicities.

“I think it’s an ethical obligation that all patients participating [in] a trial have sustained access to an oncology nurse. That’s an important health policy issue, particularly in today’s [environment] of shrinking resources and expanding need,” she stressed.

Easing Transitions of Care

Unfortunately, many patients, especially those in early-phase trials, eventually have to leave a trial because their cancer progresses or they experience dangerous side effects. If no other experimental options exist, that often means a transition to palliative or end-of-life care.

“There are issues that are unique to research that nurses struggle with,” said Dr. Christine Grady, chief of the NIH Clinical Center’s Department of Bioethics. “When is the time to take somebody off a research trial? Is this really the best thing for this person to continue to do? How do you transition somebody from a research trial to something else—something new, or to hospice, whatever the next step is?”

Oncology nurses can help alleviate the psychological distress that can arise from such transitions—and ease ethical discomfort felt by the patients, their families, and the health care team—by ensuring that such transitions are not abrupt, explained Rose Ermete, coordinator of the Oncology Nursing Society’s Clinical Trial Nurse Special Interest Group.

“The time for preparing somebody for [a transition] isn’t when they progress. When you approach patients about oncology treatment and research, you have to lay the foundation for them so that they’re prepared,” she said. “If all of a sudden you say, ‘that’s it, there’s nothing more we can do for you,’ that would not go well. But starting that discussion early as opposed to later allows them time to think and allows for a smooth transition,” she added.

When is the time to take somebody off a research trial? Is this really the best thing for this person to continue to do?

—Dr. Christine Grady

Some of the hardest conversations occur when a patient experiences substantial benefit from a new drug but also experiences side effects that don’t cause outward symptoms, such as reduced liver functioning, that makes it unsafe to continue taking a drug that may have seemed like “an answer to [that patient’s] prayers,” said Ermete.

“A drug can cross over from being beneficial to being harmful, and you have to prepare patients for that point throughout their journey,” she continued.

Nurses can alleviate some stress by explaining how much state-of-the-art supportive and palliative care can do to relieve pain and other symptoms associated with cancer and its treatment, added Dr. Mitchell. Sometimes patients faced with a transition to palliative care say “I don’t want to stop active treatment,” said Dr. Mitchell, “and I say, palliative care is a very active treatment approach! It can be a very reasonable choice for people at any point along the cancer treatment continuum, and oncology nurses have a key role in helping people learn what that choice represents, and what kind of therapies are available to them with aggressive palliative care.”

For many patients, the transition away from active tumor-directed treatment or trial discontinuation also involves a transition back to care in their community. “Facilitating a smooth transition across settings and care providers is a tremendous responsibility and can be a labor-intensive process, but at the same time a smooth transition is incredibly important in alleviating the psychological effects of disease progression and trial discontinuation,” stressed Dr. Mitchell.

“Oncology nurses, including nurse practitioners and clinical nurse specialists, have an important role in coordinating the transition of services, and it’s the kind of work at which oncology nurses excel," she said. We’re moving [patients] to that next set of treatment goals, but in a way that really preserves their autonomy and sense of control. That’s really the heart of what we try to do.” 

Sharon Reynolds

Teaching about Trials

In 2009, while helping NCI find ways to improve the clinical trial system, Annette Galassi and her colleagues in NCI’s Office of Communications and Education “started to think about the fact that nurses could really be a powerful force in raising the level of awareness about clinical research with patients,” said Galassi.

The important question that arose for the team was: Had nurses been taught enough about clinical research to be able to teach their patients?

“We [realized] that we learned very little about clinical research and clinical trials when we were in nursing school,” she recalled.

With colleagues from NCI’s Center for Cancer Research and Division of Cancer Prevention, as well as the NIH Clinical Center and the Johns Hopkins School of Nursing, the team collected the opinions of nursing school faculty members, hospital staff development directors, nurse executives, practicing nurses, and a focus group of deans from 28 nursing schools.

“While everyone [agreed] that nurses need to know more about how to care for clinical research participants and the issues surrounding clinical research, the nursing school faculty didn’t have the expertise to teach this content, and there wasn’t a whole lot of room in the curriculum to add it,” said Galassi.

The schools did say they would be interested in such a class if they had access to a package of materials they could use “out of the box” to add to an existing course. The team developed an educational package, including exercises, handouts, and test questions.

In June, they approached the deans and directors of six nursing schools near NIH about collaborating on a pilot of their content. To their pleasant surprise, the reaction was, “Sign us up!” said Galassi. The team will work with the nursing schools this fall and in the spring of 2013 to test and refine the class materials.

“We believe that every nurse should have beginning-level competency about clinical research so that he or she can appropriately care for these patients and effectively answer a patient’s questions about clinical research participation,” she concluded.