Impact of Next Generation Sequencing on the Organization and Funding of Returning Research Results: Survey of Canadian Research Ethics Boards Members

Research Ethics Boards (REBs) are expected to evaluate protocols planning the use of Next Generation Sequencing technologies (NGS), assuring that any genomic finding will be properly managed. As Canadian REBs play a central role in the disclosure of such results, we deemed it important to examine the views and experience of REB members on the return of aggregated research results, individual research results (IRRs) and incidental findings (IFs) in current genomic research. With this intent, we carried out a web-based survey, which showed that 59.7% of respondents viewed the change from traditional sequencing to NGS as more than a technical substitution, and that 77% of respondents agreed on the importance of returning aggregated research results, the most compelling reasons being the recognition of participants’ contribution and increasing the awareness of scientific progress. As for IRRs specifically, 50% of respondents were in favour of conveying such information, even when they only indicated the probability that a condition may develop. Current regulations and risk to participants were considered equally important, and much more than financial costs, when considering the return of IRRs and IFs. Respondents indicated that the financial aspect of offering genetic counseling was the least important matter when assessing it as a requisite. Granting agencies were named as mainly responsible for funding, while the organizing and returning of IRRs and IFs belonged to researchers. However, views in these matters differ according to respondents’ experience. Our results draw attention to the need for improved guidance when considering the organizational and financial aspects of returning genetic research results, so as to better fulfill the ethical and moral principles that are to guide such undertakings.研究伦理委员会（Research Ethics Boards, REBs）应评估规划使用下一代测序技术（Next Generation Sequencing, NGS）的研究方案，确保所有基因组研究结果均得到妥善管理。鉴于加拿大研究伦理委员会在此类研究结果披露中发挥核心作用，我们认为有必要考察研究伦理委员会成员对当前基因组研究中汇总研究结果、个体研究结果（Individual Research Results, IRRs）及偶然发现（Incidental Findings, IFs）返还相关的看法与实践经验。基于此目的，我们开展了一项网络问卷调查。结果显示，59.7%的受访者认为传统测序向NGS的转变绝非单纯的技术替代；77%的受访者认可返还汇总研究结果的重要性，其中最具说服力的理由为认可研究参与者的贡献，以及提升公众对科学进展的认知。针对个体研究结果而言，50%的受访者支持返还此类信息，即便仅能告知受试者某一病症的发病概率。在考虑返还个体研究结果与偶然发现时，现行监管规范与受试者风险被认为同等重要，且其重要性远高于经济成本。受访者指出，在评估遗传咨询是否为必要环节时，其涉及的经济成本是最不重要的考量因素。资助机构被认为主要负责经费支持，而个体研究结果与偶然发现的整理与返还工作则由研究人员承担。但受访者在这些问题上的看法因自身从业经验不同而存在差异。本研究结果提醒学界，在考虑返还基因组研究结果的组织与财务相关事宜时，亟需完善相关指导规范，以更好地遵循指导此类研究的伦理与道德准则。