Many Parkinson’s Research Participants Cannot Recall Study Risks
Over the last decade, more studies have included neurosurgical patients as human subjects. “These studies utilize the intraoperative neurosurgical setting to conduct research to advance basic science,” explains Anna Wexler, PhD, a neuroethicist and assistant professor in the department of medical ethics and health policy at the University of Pennsylvania Perelman School of Medicine.
Such patients already are undergoing procedures to implant electrodes in their brains for clinical purposes. For researchers, this is a unique opportunity to obtain valuable data. “Scholars had begun to discuss some of the unique ethical issues that arise in these types of the studies. But there had been no empirical examination of these concerns among research participants,” Wexler says.
Wexler and colleagues surveyed 22 patients with Parkinson’s disease who had agreed to participate in research during surgery to learn more about the effectiveness of the informed consent process.1 “None of the research participants had a therapeutic misconception,” Wexler says.
In other words, all participants correctly understood the research had no possibility of direct therapeutic benefit to them. However, just one week after the informed consent discussion had taken place, only 23% of the patients could recall either of the two risks that had been conveyed to them — higher risk of infection and possible loss of confidentiality caused by researchers sharing their data.
This raised the question of how the informed consent process could have been handled differently so participants would recall the risks about which they were informed. For example, rather than consenting the individual in the office during the presurgical visit, at a time when the patient was already receiving a large amount of information, the outreach could be conducted by phone later. This would give the subject time to carefully review the study materials. “More attention is needed to consider how the informed consent process for these studies is conducted,” Wexler says.
- Wexler A, Choi RJ, Ramayya AG, et al. Ethical issues in intraoperative neuroscience research: Assessing subjects’ recall of informed consent and motivations for participation. AJOB Empir Bioeth 2022;13:57-66.
Rather than consenting an individual in the office during the presurgical visit, at a time when the patient was already receiving a large amount of information, the outreach could be conducted by phone later. This would give the subject time to carefully review the study materials.
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