The Value of Heterogeneity in Practices to Promote Ethical Research.
The Value of Heterogeneity in Practices to Promote Ethical Research.
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实践中异质性对促进伦理研究的价值。
DOI：
10.1080/21507740.2020.1866116
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发表时间：
2021
影响因子：
--
通讯作者：
Pouratian,Nader
中科院分区：
文献类型：
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作者：
Feinsinger,Ashley;Pham,Michelle;Pouratian,Nader
在本文中，Mergenthaler及其同事（2020）征求了进行颅内电生理学研究的研究人员的观点和实践，重点关注手术者的（i）招募和同意的实践以及（ii）伦理问题。作者报告发现“招募和知情同意程序存在显著异质性，即使在采用类似技术的研究中也是如此”（2021，57）以及监管指南的差异。他们报告说，“尽管我们的分析方法和尝试，我们没有确定这些研究中同意和招募的统一理论”（2021，64）。虽然作者顺便指出，这种异质性可能是由于研究的新奇和复杂性造成的，但论文认为，这种缺乏统一性可能存在伦理问题，可以通过标准化来弥补。人类受试者的颅内研究在知情和自由同意方面带来了新的和微妙的挑战。考虑到对大脑的风险和研究人群的脆弱性，这些做法的风险很高。本文件提供的数据是制定此类做法的重要起点。然而，我们建议与作者相比，对数据的解释略有不同。作者认为实践中的差异不是需要统一或同质化的证据，而是颅内研究之间显著差异的指示。在这里，我们探讨的立场，异质性的招募和同意协议可能是可取的，并提供其他调查人员，监管机构和资助者独特的见解，在这一领域的研究伦理意义的区别。然后，我们考虑是否标准化是可取的，最合适的目标，在这些做法的指导。最后，虽然作者认为他们的受访人群是一个潜在的研究限制，但我们补充说，对颅内研究中的伦理实践和问题进行更全面的调查也应包括参与者的观点。
In this paper, Mergenthaler and colleagues (2020) solicit perspectives and practices from investigators who conduct intracranial electrophysiology studies, focusing on investigators’(i) practices of recruitment and consent and (ii) ethical concerns. The authors report finding “significant heterogeneity in recruitment and consent procedures, even among studies employing similar techniques”(2021, 57) as well differences in regulatory guidance. They report,“Despite our analytical approach and attempt, we did not identify a unified theory of consent and recruitment in these studies”(2021, 64). While the authors note in passing that some of this heterogeneity may result from the novelty and complexity of the studies, the paper suggests that this lack of uniformity may be ethically problematic and would be remedied by standardization. Intracranial studies in human subjects create new and nuanced challenges in the areas of informed and free consent. Given the risks to the brain and the vulnerabilities of the study populations, the stakes are high for getting these practices right. The data presented in this paper is an important starting point for developing such practices. However, we suggest a slightly different interpretation of the data compared to the authors. It is possible to interpret the differences in practice that the authors identify not as evidence of something that needs to be unified or homogenized, but rather as indicative of salient differences among intracranial studies. Here, we explore the position that heterogeneity in recruitment and consent protocols may be desirable and offer other investigators, regulators, and funders unique insight into ethically meaningful distinctions in this field of research. We then consider whether standardization is desirable and the most appropriate aim for guidance in these practices. Lastly, while the authors identify their respondent population as a potential study limitation, we add that a fuller investigation into the ethical practices and concerns in intracranial studies should include participants’ perspectives as well.