Auray-Blais Christiane, Patenaude Johane
Service of Genetics, Department of Pediatrics, Faculty of Medicine and Health Sciences, Université de Sherbrooke, 3001, 12th Avenue North, Sherbrooke, Qc, J1H 5N4, Canada.
BMC Med Ethics. 2006 Apr 6;7:E4. doi: 10.1186/1472-6939-7-4.
The work of Research Ethics Boards (REBs), especially when involving genetics research and biobanks, has become more challenging with the growth of biotechnology and biomedical research. Some REBs have even rejected research projects where the use of a biobank with coded samples was an integral part of the study, the greatest fear being the lack of participant protection and uncontrolled use of biological samples or related genetic data. The risks of discrimination and stigmatization are a recurrent issue. In light of the increasing interest in biomedical research and the resulting benefits to the health of participants, it is imperative that practical solutions be found to the problems associated with the management of biobanks: namely, protecting the integrity of the research participants, as well as guaranteeing the security and confidentiality of the participant's information.
We aimed to devise a practical and efficient model for the management of biobanks in biomedical research where a medical archivist plays the pivotal role as a data-protection officer. The model had to reduce the burden placed on REBs responsible for the evaluation of genetics projects and, at the same time, maximize the protection of research participants.
The proposed model includes the following: 1) a means of protecting the information in biobanks, 2) offers ways to provide follow-up information requested about the participants, 3) protects the participant's confidentiality and 4) adequately deals with the ethical issues at stake in biobanking.
Until a governmental governance body is established in Quebec to guarantee the protection of research participants and establish harmonized guidelines for the management of biobanks in medical research, it is definitely up to REBs to find solutions that the present lack of guidelines poses. The model presented in this article offers a practical solution on a day-to-day basis for REBs, as well as researchers by promoting an archivist to a pivotal role in the process. It assures protection of all participants who altruistically donate their samples to generate and improve knowledge for better diagnosis and medical treatment.
随着生物技术和生物医学研究的发展，研究伦理委员会（REB）的工作，尤其是涉及遗传学研究和生物样本库的工作，变得更具挑战性。一些伦理委员会甚至拒绝了那些将使用带有编码样本的生物样本库作为研究不可或缺部分的研究项目，最大的担忧是缺乏对参与者的保护以及生物样本或相关基因数据的无节制使用。歧视和污名化风险是一个反复出现的问题。鉴于对生物医学研究的兴趣日益浓厚以及由此给参与者健康带来的益处，必须找到切实可行的办法来解决与生物样本库管理相关的问题，即保护研究参与者的权益，同时确保参与者信息的安全和保密。
我们旨在设计一种实用且高效的生物医学研究生物样本库管理模式，其中医学档案管理员作为数据保护官员发挥关键作用。该模式必须减轻负责评估遗传学项目的伦理委员会的负担，同时最大限度地保护研究参与者。
提议的模式包括以下几点：1）保护生物样本库中信息的方法；2）提供途径以提供所要求的有关参与者的后续信息；3）保护参与者的机密性；4）妥善处理生物样本库中涉及的伦理问题。
在魁北克省建立政府管理机构以保障研究参与者的保护并为医学研究中生物样本库的管理制定统一指导方针之前，肯定要由伦理委员会来找到解决当前缺乏指导方针所带来问题的办法。本文提出的模式为伦理委员会以及研究人员提供了日常实用的解决方案，通过促使档案管理员在这一过程中发挥关键作用。它确保保护所有无私捐赠样本以生成和增进知识用于更好诊断和治疗的参与者。
