Ponder M, Statham H, Hallowell N, Moon J A, Richards M, Raymond F L
Centre for Family Research, University of Cambridge, Cambridge, UK.
J Med Ethics. 2008 Sep;34(9):690-4. doi: 10.1136/jme.2006.018564.
To study the consent process experienced by participants who are enrolled in a molecular genetic research study that aims to find new genetic mutations responsible for an apparently inherited disorder.
Semi-structured interviews and analysis/description of main themes.
78 members of 52 families who had been recruited to a molecular genetic study.
People were well informed about the goals, risks and benefits of the genetic research study but could not remember the consent process. They had mostly been recruited to take part by trusted clinicians or their relatives but had little memory of, or concern about signing consent forms. Families appeared to regard the research as a continuation of their, or their relatives', clinical care.
Ethical review should be more flexible in its attitude to consent forms and written information sheets for some sorts of research. For rare genetic disease studies where research has been discussed fully within the clinical setting then the consent obtained at that time could suffice rather than needing extra consent at a later stage. However, clinician-researchers will need to ensure that their duty of care extends for the duration of the research and beyond.
研究参与一项分子遗传学研究的受试者所经历的知情同意过程，该研究旨在寻找导致一种明显遗传性疾病的新基因突变。
半结构化访谈以及对主要主题的分析/描述。
招募至一项分子遗传学研究的52个家庭的78名成员。
人们充分了解了基因研究的目标、风险和益处，但记不起知情同意过程。他们大多是由值得信赖的临床医生或亲属招募来参与研究的，但对签署知情同意书几乎没有记忆或关注。家庭似乎将该研究视为他们自己或亲属临床护理的延续。
对于某些类型的研究，伦理审查在对待知情同意书和书面信息表时应更加灵活。对于在临床环境中已充分讨论过研究的罕见遗传病研究，当时获得的同意可能就足够了，而无需在后期额外获取同意。然而，临床研究人员需要确保他们的照护职责在研究期间及之后都能延续。
