Department of Pharmacovigilance, Pierre-Fabre Laboratory, Boulogne-Billancourt, France.
Therapie. 2012 Jul-Aug;67(4):289-94. doi: 10.2515/therapie/2012045. Epub 2012 Nov 1.
The handling of conflicts of interest in the area of healthcare products and technology has become a major issue for all of those involved in healthcare. Round Table N°4 at the Giens Workshops 2011 has put forward concrete proposals to clarify and optimise the handling of conflicts of interest. Conflicts of interest cannot be defined by the individuals consulted or applying for funds since each institution, whether public or private, that puts out a call for projects or that requests advice, analyses or expert testimony in the healthcare field has different degrees of what it defines as a conflict of interest, depending on the context of the proposal or specific request that it puts out. In contrast, each individual has ties of personal interest that can and must be openly disclosed. The ties are much more diverse than what is commonly found in the conflict of interest statements of large institutions operating in the healthcare field and are not limited to financial and operational ties between companies and individuals. In addition, the statements are difficult to manage because of their sheer number. The Round Table recommends that each individual should openly disclose all of his or her ties of personal interest in a Single Statement of Ties of personal Interest (SSTI). The SSTI would be updated regularly and accessible on line. Each institution could then determine whether or not the reported ties represent a conflict in the context of the mission proposed. Each institution could publish in advance the conditions that would give rise to a conflict and, in this way, an individual could refrain from applying for the mission. Other practical approaches to handling conflicts of interest were put forward.
医疗产品和技术领域的利益冲突处理已成为医疗领域所有相关人员的主要问题。2011 年 Giens 研讨会圆桌会议 4 号提出了具体建议,以澄清和优化利益冲突的处理。利益冲突不能由咨询或申请资金的个人来定义,因为无论是公共机构还是私营机构,只要发布项目征集或请求医疗领域的分析、意见或专家证词,都会根据其提出的建议或具体请求的背景,对利益冲突有不同程度的定义。相比之下,每个人都有个人利益的联系,可以并且必须公开披露。这些联系比在医疗领域运营的大型机构的利益冲突声明中通常发现的联系更为多样化,并且不限于公司和个人之间的财务和运营联系。此外,由于数量众多,这些声明很难管理。圆桌会议建议,每个人都应在一份个人利益联系单一声明(SSTI)中公开披露其所有个人利益联系。SSTI 将定期更新,并可在线获取。然后,每个机构都可以根据所报告的联系是否代表拟议任务中的冲突来确定。每个机构都可以提前公布可能引发冲突的条件,这样个人就可以避免申请该任务。还提出了其他处理利益冲突的实用方法。