Department of Epidemiology, University of Washington, Seattle, WA, USA.
Genet Med. 2012 Feb;14(2):236-42. doi: 10.1038/gim.2011.57. Epub 2012 Jan 12.
Genetic research involving human participants can pose challenging questions related to ethical and regulatory standards for research oversight. However, few empirical studies describe how genetic researchers and institutional review board (IRB) professionals conceptualize ethical issues in genetic research or where common ground might exist.
Parallel online surveys collected information from human genetic researchers (n = 351) and IRB professionals (n = 208) regarding their views about human participant oversight for genetic protocols.
A range of opinions were observed within groups on most issues. In both groups, a minority thought it likely that people would be harmed by participation in genetic research or identified from coded genetic data. A majority of both groups agreed that reconsent should be required for four of the six scenarios presented. Statistically significant differences were observed between groups on some issues, with more genetic researcher respondents trusting the confidentiality of coded data, fewer expecting harms from reidentification, and fewer considering reconsent necessary in certain scenarios.
The range of views observed within and between IRB and genetic researcher groups highlights the complexity and unsettled nature of many ethical issues in genome research. Our findings also identify areas where researcher and IRB views diverge and areas of common ground.
涉及人类参与者的遗传研究可能会提出与研究监督的伦理和监管标准相关的具有挑战性的问题。然而，很少有实证研究描述遗传研究人员和机构审查委员会（IRB）专业人员如何概念化遗传研究中的伦理问题，或者可能存在哪些共同点。
平行的在线调查从人类遗传研究人员（n=351）和 IRB 专业人员（n=208）那里收集了关于他们对遗传方案中人类参与者监督的看法的信息。
在大多数问题上，两个组内都观察到了一系列不同的意见。在两个组中，少数人认为人们可能会因参与遗传研究或从编码遗传数据中被识别而受到伤害。两个组都有多数人同意，在提出的六个场景中的四个场景中，需要重新同意。在一些问题上，观察到组间存在统计学上的显著差异，更多的遗传研究人员受访者信任编码数据的保密性，较少人期望重新识别会造成伤害，并且在某些情况下认为重新同意没有必要。
在 IRB 和遗传研究人员组内和组间观察到的观点范围突出了基因组研究中许多伦理问题的复杂性和未解决的性质。我们的研究结果还确定了研究人员和 IRB 观点分歧的领域和共同点的领域。
