Edwards Sarah J L
Centre for Ethics in Medicine, 73 St. Michael's Hill, Bristol BS2 8BH, UK.
Bioethics. 2005 Apr;19(2):112-30. doi: 10.1111/j.1467-8519.2005.00429.x.
Most ethics committees which review research protocols insist that potential research participants reserve unconditional or absolute 'right' of withdrawal at any time and without giving any reason. In this paper, I examine what consent means for research participation and a sense of commitment in relation to this right to withdraw. I suggest that, once consent has been given (and here I am excluding incompetent minors and adults), participants should not necessarily have unconditional or absolute rights to withdraw. This does not imply that there should be a complete absence of rights, or, indeed, an abandonment of the right to withdraw. The point of this paper is to show that the supposed unconditional or absolute nature of these rights may be self-defeating and so fail to respect the autonomy of participants. In addition, and on a more positive note, I suggest that, attaching certain conditions on the right to withdraw, may better respect the autonomy of these participants by underlining the idea that autonomy is more than mere whim or indifference to the fate of others. On the contrary, research staff are currently unable to 'push' participants, who may merely have logistical difficulties unrelated to the research itself, but who really want to stay the course, for fear of coercing them. Furthermore, researchers now try to 'screen out' people they think may be unreliable to protect the science of the study and so groups at risk of dropping out may be unfairly denied access to research treatments. I conclude that on-going negotiation between the relevant parties could be on balance the only truly acceptable way forward but concede certain important limitations to take into account.
大多数审查研究方案的伦理委员会坚持认为,潜在的研究参与者有权在任何时候无条件或绝对地“退出”,且无需给出任何理由。在本文中,我探讨了同意参与研究意味着什么,以及与这种退出权相关的承诺感。我认为,一旦给予同意(在此我将无行为能力的未成年人和成年人排除在外),参与者不一定应拥有无条件或绝对的退出权。这并不意味着应该完全没有权利,或者实际上放弃退出权。本文的要点在于表明,这些权利所谓的无条件或绝对性质可能会适得其反,从而无法尊重参与者的自主性。此外,从更积极的方面来看,我认为,对退出权附加某些条件,可能会通过强调自主性不仅仅是一时兴起或对他人命运漠不关心这一观念,更好地尊重这些参与者的自主性。相反,研究人员目前无法“推动”那些可能仅仅存在与研究本身无关的后勤困难,但实际上想坚持到底的参与者,因为担心会强迫他们。此外,研究人员现在试图“筛选出”他们认为可能不可靠的人,以保护研究的科学性,因此可能会不公平地拒绝那些有退出风险的群体获得研究治疗。我的结论是,相关各方之间持续的协商总体上可能是唯一真正可接受的前进方式,但也承认需要考虑某些重要的限制因素。