样本数据中的利益冲突和保密性

(四)样本数据中的利益冲突和保密性

1.利益和保密声明(DOICU)

根据EUnet HTA第二次联合行动标准操作流程(SOP)对利益冲突的处理。由于利益冲突的保密性,利益冲突声明将从作者和评审者中收集,主要合作伙伴使用利益和保密声明(Declaration of Interest and Confidentiality Undertaking,DOICU)表格进行具体评估(见附录六)。声明利益冲突的作者和评论者不能参与该项评估。但是,他们仍可以参与其他评估。

主要合作伙伴使用利益冲突(Conflict of Interest,COI)表格收集有关外部专家的第四工作包(WP4)利益冲突声明,声明利益冲突的外部专家会被排除在这项评估之外。但是,他们仍可以参加其他评估。

2.处理机密数据

假定保密协议是雇用第四工作包(WP4)组织或机构员工的标准。因此,不会为参与试点的员工编写单独的保密协议。第四工作包(WP4)合作伙伴组织或机构(不是协调机构或EUnet HTA秘书处)负责提供和维护参与评估的保密协议。

利益相关者(STK)参与的透明度将通过明确的流程、方法、模板和反馈描述以及处理利益冲突声明的明确过程而加强。

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⑨ WP5 Procedure Manual draft,Version 2,2013.Available at EUnet HTA JA2 Intranet.