"At Least It Was My Way of Fighting Back"

In one of the first studies of its kind, University of Pennsylvania School of Nursing researchers have identified what cancer patients consider the "benefits and burdens" of participating in clinical research trials. From their findings, the researchers developed a model of the five elements of decision-making (physical, psychological, economic, familial, and social) that patients with cancer use to determine whether to participate or remain in a clinical trial.

These findings can help researchers address factors leading to research participation and in ensuring voluntary, informed consent in clinical trials, explained lead author Connie M. Ulrich, PhD, RN, of Penn Nursing, in The American Journal of Bioethics Primary Research. "Clinical research is imperative to generate knowledge that will reduce the morbidity and mortality of human disease," she wrote.

Dr. Ulrich, a bioethicist, pointed out the relevance of these findings to informed consent: "Understanding the benefit-burden balance involved in the voluntary consent of human subject is a fundamental tenet of research and important to ensure that subjects have made an informed decision regarding their decision to participate in clinical research."

Until now, little has been known about how research participants make their decisions. This study shows that both benefit and burden influence research participation, including recruitment and retention, in clinical trials. Such comments as "at least it was my way of fighting back" and "it pushes me to the limit" are examples of the advantages and disadvantages that patients with cancer consider when deciding to participate or remain in a research program.

Participation in research programs requires obligations of cancer patients that may add to the burden of cancer diagnosis and treatment. For some, wrote Dr. Ulrich, this "added burden" may not be acceptable while for others, participation is a way to "actively take control of a situation that is perceived to be out of control."

The University of Pennsylvania School of Nursing is one of the premier research institutions in nursing, producing new knowledge in geriatrics, pediatrics, oncology, quality-of-life choices, and other areas. Researchers here consistently receive more research funding from the National Institutes of Health than any other private nursing school, and many Master’s programs are ranked first in the country.

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Source: University of Pennsylvania School of Nursing