Search for Answers
Drug trials create
ethical balancing acts
 
What do you think?
Email us at
editor@
nurseweek.com		    
     
     
have your cake and a job, too
    
     
   
     

Pick Your Paradigm

Society’s shifting attitudes toward human clinical trials have reflected the drama and emotions of the second half of the 20th century.

The Nuremburg Code on Scientific Research, which followed the Nazi doctors’ trials in 1948, was a watershed in the history of medical ethics. A “patient protection paradigm” grew out of the Nuremburg Code, said Alexander Capron, professor of law and medicine at the University of Southern California and co-director of the Pacific Center for Health Policy and Ethics.

This protection paradigm gained steam in the 1960s and ’70s, in the wake of the Tuskegee Syphilis Study and other notorious research abuses, Capron said. At that point, the government enacted strict protections for human research participants.

But the pendulum swung away from patient protection in the 1980s, when activists for patients with AIDS and other incurable diseases demanded more access to clinical trials. “They felt there were blockades to participating in trials. There was a major shift toward fairness and justice and giving people as many opportunities to get into research studies as possible,” Capron said.

Current events—like the temporary shutdown of medical research at prestigious Duke University—may indicate a return to the patient protection paradigm, however. “We may be seeing a return to concerns about the primacy of needing to protect research subjects from being abused consciously or unconsciously,” Capron said.

~ Megan Flaherty
   

By Megan Flaherty
Photo: Corbis
August 30, 1999

The boom in pharmaceutical research over the last several years has produced promising discoveries and restored hope to countless patients. But it has also given new urgency to an old concern: How can researchers and clinicians balance the interests of individual patients with the broader interests of science?

The research explosion

The ethical issues involved in clinical trials are nothing new, but they are steadily affecting more people. The sheer volume of clinical trials—as well as the number of patients and professionals involved in them—has escalated in recent years. There were fewer than 7,000 new drug trials conducted in 1990. In 1997, there were more than 15,000. In the past, trials were primarily conducted out of research institutions; now they’re spreading to other hospitals, as well as clinics and physician offices.

Nurse researchers, nurses who administer protocols in clinical research units, and nurses who care for patients enrolled in trials are among the health professionals who may be most affected by the tension, experts say. “In some ways, nurses who work with research participants have more ethical obligations than other health professionals. We’re a profession that identifies with patient advocacy as a first responsibility,” said Dianne Bartels, MA, RN, associate director at the University of Minnesota’s Center for Bioethics.

“There has been a tremendous change in the last 20 years. Because of the increased emphasis on large, multi-center studies, more hospitals are involved in research,” said Marianne Chulay, DNSc, RN, FAAN, director of practice and research at the Moses Cone Health System in Greensboro, N.C. “Hospitals that wouldn’t traditionally design and implement their own research studies are serving as data collection sites.”

Physicians who don’t work at academic medical centers are getting into the act, too. Pharmaceutical companies have begun paying them “finder’s fees” for enrolling their patients in drug studies, a practice the inspector general at the Department of Health and Human Services began investigating in July for possible conflicts of interest. Government regulators have recently increased their scrutiny of research practices at major research institutions, as well. In May, the federal Office for Protection from Research Risks temporarily shut down medical research at North Carolina’s prestigious Duke University because the school wasn’t properly documenting steps taken to protect research participants. (The problem was quickly resolved.)

Shades of gray

The issues related to clinical trials generally can’t be painted in black and white, said Annette Wysocki, PhD, RN, scientific director of the division of intramural research at the National Institute of Nursing Research. “In clinical trials you’re trying to look for a balance point between the risks and the benefits. The key is to protect people from unnecessary risks,” she said.

Before people are enrolled in clinical trials, federal regulations require researchers to explain to them all the benefits and risks of—and alternatives to—participation, and participants must provide informed consent. After they’re enrolled, however, participants may forget exactly what the trial entails or may become alarmed as a procedure becomes progressively more invasive.

Patients sometimes share their confusion or concern about their involvement in a clinical trial with a nurse, said Laurie Badzek, MSN, JD, RN, director of the Center for Ethics and Human Rights at the American Nurses Association. It’s a nurse’s duty to bring these concerns to the trial’s primary investigator and urge him or her to address them, she said.

Study participants sometimes have a hard time grasping the fact that enrollment in a clinical trial does not automatically mean they’ll get the experimental drug they hope will help them. “There’s a lot of concern that people don’t understand about randomization of controls,” said Baruch Brody, PhD, director of the Center for Medical Ethics and Health Policy at the Baylor College of Medicine in Houston. “Often a person’s motivation for getting into a clinical trial is to get a new drug, but they don’t always get it.” Researchers who obtain informed consent from trial participants need to make sure patients understand they could receive a placebo or an existing treatment, Brody said.

“We should be concerned if people are under the impression that clinical trials offer the latest, newest, or best treatment,” said Alexander Capron, professor of law and medicine at the University of Southern California and co-director of the Pacific Center for Health Policy and Ethics. Such an attitude reflects a “fundamental confusion” about what it means to be in a clinical trial, he said. “Participating in a trial means being a research subject first and a patient second. A research subject’s course of treatment will be set in part or entirely by the terms of the protocol, and the protocol would be seriously compromised if highly individualized variations were made based on a clinician’s view of what is best for an individual,” Capron said.

Of course, participants have the “absolute right” to drop out of a clinical trial at any time and for any reason, Bartels said. Nurses shouldn’t be shy about reminding people that their involvement is basically an altruistic act and that they don’t have an obligation to continue in a trial, she said.

Striking a balance

During the course of a clinical trial, nurses’ observations are invaluable to researchers, Chulay said. “There are innumerable times that I’ve heard a nurse recommend removing someone from a study. It’s not because the researchers are negligent, but because the nurse is there 24 hours a day, seven days a week. They are the first to see the effects of a device or medication. It’s very common for a nurse at the bedside to raise the issue first.”

Investigators should always provide clinicians, patients, and family members with copies of research protocols that include details about the study and specific instructions, such as when to stop interventions, said Sandra K. Hanneman, PhD, RN, FAAN, associate dean for research and evaluation at the University of Texas-Houston School of Nursing. Clinicians and family members—as well as patients themselves—all play a part in ensuring a patient’s welfare is never superseded by research interests, Hanneman said. In the best-case scenarios, studies include an impartial clinician whose only role is to monitor the research and intervene if a patient is at risk, Hanneman said.

Good relationships between clinicians and researchers are essential to the success of clinical trials. “In the past there was a belief that it was clinicians vs. researchers,” said Betty Ferrell, PhD, RN, FAAN, research scientist at the City of Hope National Medical Center in Duarte, Calif., where a large number of cancer patients are enrolled in clinical trials or experimental treatments. “As nurses we need to get past that. Health care will be improved because of research. We shouldn’t think research is bad and our goal is to protect patients from it. We need to protect our patients’ autonomy and make sure they are making independent decisions, but our goal should be to facilitate it.”