A Qualitative Analysis of Ethical Perspectives on Recruitment and Consent for Human Intracranial Electrophysiology Studies.
A Qualitative Analysis of Ethical Perspectives on Recruitment and Consent for Human Intracranial Electrophysiology Studies.
复制标题
DOI：
10.1080/21507740.2020.1866098
复制
发表时间：
2021-01
影响因子：
--
通讯作者：
Arias JJ
中科院分区：
文献类型：
--
作者：
Mergenthaler JV;Chiong W;Dohan D;Feler J;Lechner CR;Starr PA;Arias JJ
颅内电生理研究方法，包括在皮层表面或深层结构上应用电极的方法，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，因为人体研究需要接受癫痫和帕金森病等疾病手术的神经系统患者的参与。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研究人员进行了半结构化访谈，这些研究涉及记录或刺激人类头骨。我们引出了关于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成绩单。我们采访了来自19个独立颅内电生理学研究的26位研究者，他们描述了两种研究类型：机会研究（n = 15）和实验研究（n = 4）。受访者描述了招募和同意程序的显著异质性，即使在采用类似技术的研究中也是如此。在一些研究中，临床研究人员被明确禁止获得同意，而在其他研究中，临床研究人员被明确要求获得同意；监管指导不一致。受访者还描述了各种模型的主题选择，同意的时间，并继续同意暂时延长的研究。受访者对参与者的脆弱性和研究相关风险的沟通表达了伦理上的担忧。我们发现在研究者之间缺乏共识关于招募和同意方法在人类颅内电生理学。这可能反映了此类研究的新颖性和复杂性，并表明需要进一步讨论和开发该研究领域的最佳实践。
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 (n = 15) and experimental trials (n = 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.