Neuro-Oncology Patients as Human Research Subjects: Ethical Considerations for Cognitive and Behavioral Testing for Research Purposes

SIMPLE SUMMARY: Previous publications have elaborated on the exposure of ethical issues surrounding the enrollment and neurological testing of brain cancer patients into clinical studies. Existing literature has been tailored to provide insight on how to overcome ethical challenges for clinical team members but not for the research component that runs in parallel. The aim of this paper is to highlight the obstacles that researchers encounter when obtaining informed consent and administering language, cognitive or behavioral tasks for the sole purpose of research. Researchers should be encouraged to practice their best judgment and effectively communicate the purpose of the study while emphasizing the voluntary participation of neurologically impaired cancer patients. The solutions proposed in this paper can serve as future reference and a guide on maintaining a transparent balance between research and clinical testing for both researchers and clinical team members in the neuro-oncology field. ABSTRACT: Language, cognition, and behavioral testing have become a fundamental component of standard clinical care for brain cancer patients. Many existing publications have identified and addressed potential ethical issues that are present in the biomedical setting mostly centering around the enrollment of vulnerable populations for therapeutic clinical trials. Well-established guides and publications have served as useful tools for clinicians; however, little has been published for researchers who share the same stage but administer tests and collect valuable data solely for non-therapeutic investigational purposes derived from voluntary patient participation. Obtaining informed consent and administering language, cognition, and behavioral tasks for the sole purpose of research involving cancer patients that exhibit motor speech difficulties and cognitive impairments has its own hardships. Researchers may encounter patients who experience emotional responses during tasks that challenge their existing impairments. Patients may have difficulty differentiating between clinical testing and research testing due to similarity of task design and their physician’s dual role as a principal investigator in the study. It is important for researchers to practice the proposed methods emphasized in this article to maintain the overall well-being of patients while simultaneously fulfilling the purpose of the study in a research setting.