Bioethicists are reminding sponsors and investigators that patients are due support for participating in clinical trials. After all, in many cases, a patient’s insurance policy may lack adequate coverage to participate in a study. Moreover, in most cases, these studies are experimental and the risks are anything but certain. And as research now enters new scientific ground with testing of gene editing/Cas9 breakthrough on patients with cancer, blood disorders or inherited blindness, as an example, researchers and sponsors should consider paying not only the costs of the experimental treatment but also for any treatment needed for treating side effects—including those that may materialize later.

Although there are cases where clinical trial participants are simply trying to find a “miracle cure,” the reality is that there are considerable risks associated with most experimental drugs, reports Laurie Zoloth, a bioethicist with the University of Chicago. In this role, reports Science News, she explains her mission is “to make sure that human progress goes forward in a way that is safe and ethical.”

High Standards

Clinical trials are held to a high ethical standard that standard work in the lab, reports Zoloth. She considers, “Having a human being as a subject means you have  different obligations that you would do to an animal or a petri dish.” In Zoloth’s view, scientists should actually be responsible for such a patient ongoing.

Ethical Duty to Pay

From this point of view, this means that sponsors of research should cover not only the experimental treatment but any other treatments associated with the experimental study. This could include some costs in the future if they are associated with the actual study.  In many cases, insurance policies will limit the patient coverage for clinical trials. Zoloth and professionals like her will review clinical trials research applications to ensure that they are fair, balanced and factor in the ethics and associated responsibilities when human subjects are involved in research.

Rules to Remember

Researchers do follow guidelines for clinical trials, comments Zoloth. These practices include not making elaborate or exaggerated claims as to the benefits of the study, for example. She understands that many patients could consider clinical trials “godsends” as the prospective research subject may face a life or death threatening condition—and the trial may be their only hope. But researchers must remember the patient fits into a different category—namely “human subject,” and with this category, comes a heightened responsibility and duty to this individual.

She reminds researchers that, in most cases, patients will probably not benefit from the intervention nor will they gain financial help from participating in a study.  Patients are contributing to a critically important cause and they “shouldn’t alone have to bear the burden of a severe adverse event.”

Comment

The responsibilities should be well understand through ethical standards, appropriate laws and guidelines. A risk-based approach should be employed. For example, in situations where there is little to no risk and significant patient gain, then the ethical considerations may differ than when there is considerable risk in a given study.  

Lead Contact

Laurie Zoloth, Senior Advisor to the Provost for Programs on Social Ethics

Source: Science News

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