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Strategies for training and supporting CR nurses
Basic research ethics education needed
Clinical trial (CT) sites should be providing research nurses and other staff with the best possible foundation in clinical research ethics, as well as helping them make the transition from clinical care to research trials, experts say.
Here are some suggestions to improve their training and provide adequate support:
1. Get rid of the term "guinea pig."
Clinical trial nurses and coordinators sometimes will hear CT participants or fellow medical workers call research subjects "guinea pigs," and it's up to investigators and CT sites to dispel this myth.
"When nurses perceive clinical trial subjects as guinea pigs, then we have the stage set for a problem," says Carlton A. Hornung, PhD, MPH, a professor of medicine in the department of epidemiology and population health and the director of the Office of Education and Career Development in the Clinical and Translational Science Institute of the University of Louisville (KY).
"Patients and subjects in clinical trials are not guinea pigs," he contends. "We start clinical trials from the basic ethical principle of equipoise, meaning we don't really know what the best care is, and we don't really know the best way to do something." Since researchers don't know what the best treatment is, it's most ethical to randomize patients to Treatment A and Treatment B with their informed consent, he explains.
"When we obtain informed consent, we explain to them that we don't know which treatment is best and their participation in the trial will help to answer that question for future patients," Hornung says.
"When nurses don't understand this concept, we end up with situations where they think they might know better, but they don't because nobody knows the answer," he adds. "So the idea that patients in clinical trials are guinea pigs is just not true."
2. Teach research nurses about placebo- controlled trials.
New research nurses should be told about how placebo-controlled trials work, and they can be reassured that the ethics and appropriateness of such studies are thoroughly reviewed by an institutional review board (IRB), says Mark Rothstein, JD, director of the Bioethics Institute at the University of Louisville School of Medicine.
"I think there are many misconceptions about the role of the IRB and what kind of research is approved," Rothstein says. As part of the educational program at the University of Louisville School of Medicine, the Bioethics Institute might bring in the IRB chair of a research administrator to talk with nurses about the IRB's criteria for approval, Rothstein says.
"We would also have them discuss the criteria that are used when a study is terminated, because it's either causing adverse consequences," he adds. "Or maybe it's been so successful that it can be extended to treat people in the control group when we have findings that a treatment has extraordinariy value."
3. Explain the concept of informed consent.
"I think nurses can understand the concept that they're supposed to respect the autonomy of the patient — that's part of their code of ethics," Rothstein says.
"You shouldn't enroll people in research studies unless they have all the information that's relevant to making a decision about whether or not to participate," Rothstein says. "And participants give their knowing, informed consent to do this, so they're willing to accept certain risks of harm because there is either a possibility of benefit to them or because it's an act of altruism."
4. Train CT nurses when a new trial begins.
As soon as a clinical trial begins, the site should provide CT nursing staff and coordinators with a schedule of each protocol activity, suggests Pamela Normandin, RN, MSN, CCRC, a clinical nurse specialist in the office of research at Iowa Lutheran Hospital in Des Moines.
"I make schedule cards for nurses," Normandin says. "I write on these exactly when things have to happen, and I write in direct orders that the physician will sign."
A CT coordinator or investigator should take time to make tables, write orders, and provide notes about the study . . . all for the purpose of reminding nurses of their CT tasks, she says.
"I do everything I can to remind nurses," Normandin says. "I call nurses and give them a little personal attention, and if I know there's a less-experienced nurse, I'll be a little more vigilant."
Normandin also speaks with nurses about evidence-based practice, and she's provided educational sessions for continuing education unit (CEU) credit. "If you give them CEUs, nurses will come," she adds.
5. Give nurses someone to call if they have any questions.
"I encourage my nurses to always ask me questions if they have any concerns," Normandin says. "I think it's important for them to be able to call me 24/7."
Normandin answers their questions as best she can.
6. Reinforce the message that CT care is different from standard medical care.
CT investigators and administrators need to teach nurses that the main difference between CT research and clinical care is that there will be a different kind of intervention than would normally be the case, Rothstein says.
"The intervention might be more efficacious for the patient as in the case of a new drug that might be more effective with fewer side effects and lower doses," he explains. "But you never know unless you actually try it on patients, and you need controlled clinical trials to evaluate the effectiveness of the drug."
Also, they should teach nurses that before an investigational drug reaches the clinical trial stage, it has successfully gone through many other stages that research goes through, Rothstein adds.
"It's only at that point of the clinical trial where there's a reasonable knowledge of the benefits and risks," he says.
"It's easy to get that point across," Rothstein says. Plus, it's important to remind nurses that many common treatments they take for granted are, in fact, experimental as well.
"There are certain areas of medicine where if we took out research uses, we'd have nothing to offer patients," he adds. "For example, most of the drugs that are used in pediatric oncology are not approved for that use; they're approved for adults, and yet we have to use them for children."
Even many frontline therapies for adults are investigational or off-label uses of other approved drugs, Rothstein says.
"Many clinicians, nurses, and some doctors would be very surprised at the high percentage of research treatments that affect standard therapy," he adds.