Angelos Peter, Murphy Timothy F, Sampson Heather, Hollings Darius D, Kshettry Varun
Department of Surgery and MacLean Center for Clinical Medical Ethics, University of Chicago Medical Center, Chicago, IL 60637, USA, and Critical Care Medicine, St Michael's Hospital, Toronto, Canada.
Surgery. 2006 Nov;140(5):740-8. doi: 10.1016/j.surg.2006.06.027. Epub 2006 Sep 27.
The beliefs of research team members about informed consent practices are not well studied, especially in regard to financial aspects of research such as capitation fees. Sponsors of research offer capitation fees for the enrollment of subjects, and although this money is intended to cover the costs of the research it can sometimes be used in other ways. There is no clear consensus about whether this financial aspect of trials should be part of the informed consent process or whether it represents a potential conflict of interest.
We presented several hypothetical cases to members of the American College of Surgeons Oncology Group (ACOSOG) at a semi-annual meeting. ACOSOG is a federally funded clinical trials group evaluating surgical and adjuvant methods of cancer treatment. The meeting included surgeons, nurses, case managers, and others involved in clinical surgical trials.
We found that most respondents believed that it would be a violation of the protocol to enroll a subject who showed lack of recall about the study. Most respondents also favored disclosure of capitation fees, especially if those fees went into discretionary accounts, but there was some disagreement about the benefit of that disclosure to potential participants.
This study shows the need for greater work in ensuring that research team members share common understandings about informed consent. It also shows that most of these research team participants are prepared to make more disclosure about financial aspects of research than current standards in fact require.
研究团队成员对知情同意做法的看法尚未得到充分研究，尤其是在研究的财务方面，如人头费。研究赞助商为招募受试者提供人头费，尽管这笔钱旨在支付研究成本，但有时可能会被用于其他用途。对于试验的这一财务方面是否应成为知情同意过程的一部分，或者它是否代表潜在的利益冲突，目前尚无明确共识。
我们在一次半年会议上向美国外科医师学会肿瘤学组（ACOSOG）的成员展示了几个假设案例。ACOSOG是一个由联邦资助的临床试验组，负责评估癌症治疗的手术和辅助方法。参会人员包括外科医生、护士、病例管理人员以及其他参与临床外科试验的人员。
我们发现，大多数受访者认为，招募对研究缺乏记忆的受试者违反方案。大多数受访者也赞成披露人头费，特别是如果这些费用进入自由支配账户，但对于这种披露对潜在参与者的益处存在一些分歧。
本研究表明，需要做更多工作来确保研究团队成员对知情同意有共同的理解。它还表明，这些研究团队参与者中的大多数人准备在研究财务方面进行比当前标准实际要求更多的披露。
