|
(05/21/2014) 问题1: 我希望得到FDA对于公正见证人看法的反馈。总的来说，我想知道FDA是否接受受试者的家属作为知情同意过程中可接受的公正见证人。 回答1: 一般情况下，知情同意过程中的见证人是见证给受试者或受试者法定代理人传递信息的过程以及知情同意书的签署。见证人的目的通常是确保信息准确传达，问题得到回答，而且受试者自愿同意签署知情同意书。在某些情况下，当受试者难以理解所讲内容时，见证人可以帮助澄清这些信息。1981年《知情同意条例》序言指出：“……见证人必须在场，以证明知情过程的充分性和受试者同意的自愿性。”参见46 FR 8949，评论52，1981年1月27日（链接：www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ucm113818.htm）。因此， FDA希望见证人在整个知情面谈过程中均在场，而不仅仅是签署文件。 FDA法规对于谁可以作为知情同意过程的见证人没有明确规定，但是FDA建议由一个公正的第三方作为见证人，而不是与这项临床研究相关的人员。一般来说，为了公正起见，见证人不应与受试者有任何关系，同时与这项临床研究不相关的人员。为了实现见证人的角色作用（如确保信息准确传达），作为公正见证人需要理解研究的医学及设计方面内容，以证实所讨论的信息是对研究的充分表述。 参见下面的链接以获得知情同意指南。在本指南中也提到了见证人。 指南>知情同意书指南-信息表 www.fda.gov/RegulatoryInformation/Guidances/ucm126431.htm 译自FDA Good Clinical Practice (GCP) Q&A 欢迎批评指正！ FDA Advice Requested on Impartial Witness (05/21/2014) Question 1: I would like to obtain your feedback on FDA's position on Impartial witness. Generally I would like to know if FDA accepts family members of a subject as an acceptable impartial witness for an Informed consent process. Answer 1: In general, the witness to the consent process witnesses the delivery of information given to the subject or the subject's legally authorized representative as well as the signature on the consent form. The purpose of the witness is generally to ensure that the information was accurately conveyed, questions were answered, and the subject voluntarily consented through signing the form. In some cases the witness may help to clarify information when a subject has difficulty understanding something being said. The 1981 preamble to the informed consent regulations states that "...a witness must be present to attest to the adequacy of the consent process and to the voluntariness of the subject's consent." See 46 FR 8949, comment 52. January 27, 1981 (link: www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ucm113818.htm). Thus, FDA expects the witness to be present during the entire consent interview, not just for signing the documents. FDA's regulations are silent as to who can serve as a witness to the informed consent process, but FDA recommends that an impartial third party, not otherwise connected with the clinical investigation, serve as the witness. Generally, in order to be impartial, the witness should not have a relationship with the subject as well as being unconnected with the clinical investigation. In order to fulfill the role of a witness (such as ensuring that information was accurately conveyed), the person acting as the impartial witness would need to understand the medical and design aspects of the study in order to attest that the information discussed was an adequate description of the study. See link below to A Guide to Informed Consent. The witness role is also mentioned in this guidance. Guidances > A Guide to Informed Consent - Information Sheet www.fda.gov/RegulatoryInformation/Guidances/ucm126431.htm (责任编辑：sff1229) |