Alternatives to project-specific consent for access to personal information for health research: insights from a public dialogue.
Alternatives to project-specific consent for access to personal information for health research: insights from a public dialogue.
复制标题
DOI：
10.1186/1472-6939-9-18
复制
发表时间：
2008-11-19
影响因子：
2.7
通讯作者：
Thabane L
中科院分区：
文献类型：
--
作者：
Willison DJ;Swinton M;Schwartz L;Abelson J;Charles C;Northrup D;Cheng J;Thabane L
同意对研究使用健康信息的作用是有争议的。大多数讨论都集中在何时可以放弃项目特定的同意，但最近，已经考虑了更广泛的同意选项，包括限制多项研究的广泛选择，以及选择退出的通知。我们试图在这个问题上引出公共价值观，并通过审议性的公共对话，就同意将个人信息用于健康研究的共同方法达成一致。我们进行了为期七天的公开对话，涉及加拿大各地的98名参与者。在每次对话之前和之后，参与者完成了一份固定回答的问卷，评估个人对3种抽象同意方法的支持，以及他们对使用个人信息的5种健康研究方案的同意选择。他们还评估了不同的保障措施使他们感到他们的信息被负责任地使用的信心。广泛选择同意使用个人信息在摘要中获得了最大的支持。当呈现特定的研究场景时，没有一种同意的方法占主导地位。当利润被引入到场景中时，同意选择转向对使用的更大控制。尽管进行了活跃和建设性的对话，在个人层面上的意见也发生了相当大的变化，但最终，在意见上没有实质性的总体变化。个人控制是提高人们对负责任地使用其信息进行研究的信心的最常见方法之一。由于没有一种同意的方法能满足甚至简单多数的对话参与者，而且个人控制的重要性，因此应制定一种机制来记录不同类型研究的同意选择，包括个人检查谁出于临床护理以外的目的访问了他们的医疗记录的方法。例如，这可以通过基于网络的患者门户网站来完成，以获得他们的电子健康记录。研究人员和政策制定者应继续让公众参与，以促进公众对研究过程的更好理解，并寻找可行的替代方案来替代现有的针对特定项目的观察性研究同意方法。
The role of consent for research use of health information is contentious. Most discussion has focused on when project-specific consent may be waived but, recently, a broader range of consent options has been entertained, including broad opt-in for multiple studies with restrictions and notification with opt-out. We sought to elicit public values in this matter and to work toward an agreement about a common approach to consent for use of personal information for health research through deliberative public dialogues. We conducted seven day-long public dialogues, involving 98 participants across Canada. Immediately before and after each dialogue, participants completed a fixed-response questionnaire rating individuals' support for 3 approaches to consent in the abstract and their consent choices for 5 health research scenarios using personal information. They also rated how confident different safeguards made them feel that their information was being used responsibly. Broad opt-in consent for use of personal information garnered the greatest support in the abstract. When presented with specific research scenarios, no one approach to consent predominated. When profit was introduced into the scenarios, consent choices shifted toward greater control over use. Despite lively and constructive dialogues, and considerable shifting in opinion at the individual level, at the end of the day, there was no substantive aggregate movement in opinion. Personal controls were among the most commonly cited approaches to improving people's confidence in the responsible use of their information for research. Because no one approach to consent satisfied even a simple majority of dialogue participants and the importance placed on personal controls, a mechanism should be developed for documenting consent choice for different types of research, including ways for individuals to check who has accessed their medical record for purposes other than clinical care. This could be done, for example, through a web-based patient portal to their electronic health record. Researchers and policy makers should continue to engage the public to promote greater public understanding of the research process and to look for feasible alternatives to existing approaches to project-specific consent for observational research.