University of California.
Yale University.
AJOB Neurosci. 2021 Jan;12(1):57-67. doi: 10.1080/21507740.2020.1866098.
Intracranial electrophysiological research methods, including those applying electrodes on the cortical surface or in deep structures, have become increasingly important in human neuroscience. They also pose novel ethical concerns, as human studies require the participation of neurological patients undergoing surgery for conditions such as epilepsy and Parkinson's disease. Research participants in this setting may be vulnerable to conflicts of interest, therapeutic misconception, and other threats to valid recruitment and consent. We conducted semi-structured interviews with investigators from NIH-funded studies involving recording or stimulation inside the human skull. We elicited perspectives on study recruitment and consent procedures, and analyzed transcripts using a modified grounded theory approach. We interviewed 26 investigators from 19 separate intracranial electrophysiology studies, who described two study types: opportunity studies ( = 15) and experimental trials ( = 4). Respondents described significant heterogeneity in recruitment and consent procedures, even among studies employing similar techniques. In some studies, clinician-investigators were specifically barred from obtaining consent, while in other studies clinician-investigators were specifically required to obtain consent; regulatory guidance was inconsistent. Respondents also described various models for subject selection, the timing of consent, and continuing consent for temporally extended studies. Respondents expressed ethical concerns about participants' vulnerability and the communication of research-related risks. We found a lack of consensus among investigators regarding recruitment and consent methods in human intracranial electrophysiology. This likely reflects the novelty and complexity of such studies and indicates a need for further discussion and development of best practices in this research domain.
颅内电生理研究方法，包括在皮质表面或深部结构应用电极的方法，在人类神经科学中变得越来越重要。它们也带来了新的伦理问题，因为人类研究需要参与那些因癫痫和帕金森病等疾病而接受手术的神经科患者。在这种情况下，研究参与者可能容易受到利益冲突、治疗误解和其他对有效招募和同意的威胁。我们对来自美国国立卫生研究院资助的涉及颅内记录或刺激研究的调查人员进行了半结构化访谈。我们引出了他们对研究招募和同意程序的观点，并使用改进的扎根理论方法分析了转录本。我们采访了来自 19 项不同颅内电生理研究的 26 名研究人员，他们描述了两种研究类型：机会研究（ = 15）和实验性试验（ = 4）。受访者描述了招募和同意程序的显著异质性，即使在使用类似技术的研究中也是如此。在一些研究中，临床医生调查员被特别禁止获得同意，而在其他研究中，临床医生调查员被特别要求获得同意；监管指导意见不一致。受访者还描述了各种受试者选择模型、同意的时间以及对时间延长的研究的持续同意。受访者对参与者的脆弱性和与研究相关风险的沟通表示了伦理关注。我们发现，在人类颅内电生理学的招募和同意方法方面，调查人员之间缺乏共识。这可能反映了这些研究的新颖性和复杂性，并表明需要在这一研究领域进一步讨论和制定最佳实践。
