Chanaud Cheryl M
Memorial Hermann - Texas Medical Center, Houston, Texas, USA.
Contemp Clin Trials. 2008 Jul;29(4):501-6. doi: 10.1016/j.cct.2007.11.006. Epub 2007 Dec 8.
Clinical Investigators conducting biomedical research involving human participants in the U.S. are responsible for the content of the consent document(s) and for the conduct of the informed consent conference(s) with the human participants. The content of the consent forms and consent process may be governed by two different sets of U.S. regulations and may be impacted upon by separate, generally accepted, international guidelines. It can be difficult and confusing for an Investigator to determine which set(s) of regulations or guidelines apply to which studies. This article compares the two sets of U.S. regulations and two sets of well-respected international guidelines with respect to their requirements for the content of the consent document and consent conference. A practical decision tree is proposed as a tool to assist Investigators in determining which set(s) of requirements is applicable to a particular study.
在美国,开展涉及人类受试者的生物医学研究的临床研究人员负责同意书的内容以及与人类受试者进行知情同意会议。同意书的内容和同意程序可能受两套不同的美国法规管辖,并且可能受到各自普遍认可的国际准则的影响。对于研究人员而言,确定哪套法规或准则适用于哪些研究可能既困难又令人困惑。本文比较了两套美国法规和两套备受推崇的国际准则在同意书内容和同意会议要求方面的差异。文中提出了一个实用的决策树作为工具,以帮助研究人员确定哪套要求适用于特定研究。