UCSF neurologist and interventional pain specialist, Prasad Shirvalkar, facilitated a case discussion about the ethical dilemmas he and his team encounter in their ongoing research on adaptive deep brain stimulation (aDBS) for chronic pain. Informed by the 2016 Neuromodulation article, “Unexpected complications of novel deep brain stimulation treatments: ethical issues and clinical recommendations” by Hannah Maslen et al., we deliberated how to obtain consent for unintended side-effects, and how to manage the investigator-participant relationship in highly collaborative, small-n trials.
Prasad’s study aims to identify new targets for chronic pain and develop a more personalized brain stimulation paradigm. However, stimulation of cortical targets at high intensities, which may be required for pain relief, increases seizure risk. The potential for this adverse side-effect complicates various elements of the consent process, from capacity assessment to weighing benefits and costs. In seminar, we discussed novel models of informed consent including teach-back and teach-to-goal strategies to assess participants’ comprehension of risks and disrupt the traditional doctor-patient social script, whereby patients accept doctors’ recommendations without question. We also recognized that participants’ ability to vividly imagine their lives with seizures may be skewed by their lack of having personally experienced a seizure, and/or their present focus on alleviating their chronic pain.
The nature of this research setting, where patients are naturally focused on potential therapeutic benefits of aDBS and often view research staff as care team members, muddles the distinction between researcher and clinician. We shared our views on how researchers ought to navigate interactions with participants, particularly in response to medical complaints and requests for non-immediate clinical services. Where a legal perspective might call for a rigid study protocol and emphasize the importance of terminological distinctions (e.g., “participant” rather than “patient”), an academic outlook might tolerate some blurring of the researcher-clinician boundary depending on the research question and design. We recognized the value of developing rapport with research participants while simultaneously upholding professionalism by judging when to redirect them to appropriate clinical resources.