Wolf Leslie E, Catania Joseph A, Dolcini M Margaret, Pollack Lance M, Lo Bernard
University of California, San Francisco.
J Empir Res Hum Res Ethics. 2008 Dec;3(4):99-111. doi: 10.1525/jer.2008.3.4.99.
WE EVALUATED 55 IRB CHAIRS' perspectives on ethical issues in a hypothetical study involving mental health-related genomics research using stored specimens to identify potential barriers and solutions to such research. Most Chairs identified the ethical issues of consent and confidentially as important. The majority of Chairs expressed concern about using materials in new research, especially concerning a mental health condition, that was not discussed in the original consent. Few Chairs considered permissible strategies, such as deidentification and waiver of consent, which could allow the proposed research to go forward without consent. Chairs who reviewed more protocols and had attended conferences on human subjects protection identified more of the salient ethical issues in the scenario. Our study could not determine whether Chairs were not familiar with the strategies of de-identification and waiver of consent, or believed that they did not adequately protect participants who had provided specimens for research. Thus, our findings suggest that investigators and IRBs should consider future use of specimens and obtain appropriate consent before collection of specimens. Furthermore, our findings suggest that IRBs can improve review of genomics research involving stored specimens by redesigning forms to prompt IRB members to consider some strategies, such as de-identification and Certificates of Confidentiality, that are recommended for this type of research and by sending members to conferences on human subjects protections and research ethics.
我们评估了55位机构审查委员会（IRB）主席对于一项假设性研究中伦理问题的看法，该研究涉及使用存储样本进行与心理健康相关的基因组学研究，以确定此类研究的潜在障碍和解决方案。大多数主席认为同意和保密的伦理问题很重要。大多数主席对在新研究中使用材料表示担忧，特别是涉及在原始同意书中未讨论的心理健康状况的材料。很少有主席考虑过诸如去识别化和同意豁免等可行策略，这些策略可以使拟议的研究在未经同意的情况下进行。审查过更多方案并参加过人类受试者保护会议的主席在该场景中识别出了更多突出的伦理问题。我们的研究无法确定主席们是不熟悉去识别化和同意豁免策略，还是认为这些策略不能充分保护为研究提供样本的参与者。因此，我们的研究结果表明，研究人员和IRB应该考虑样本的未来用途，并在收集样本之前获得适当的同意。此外，我们的研究结果表明，IRB可以通过重新设计表格以促使IRB成员考虑一些为此类研究推荐的策略，如去识别化和保密证书，并派成员参加人类受试者保护和研究伦理会议，来改进对涉及存储样本的基因组学研究的审查。
