1问题和背景

哪些情况需要修改或更新同意书？（源自FDA GCP问答）

Specifically, what types of situations call for a consent form amendment or update?   

2讨论和回答

通常，当新的信息可能影响受试者参与研究意愿时，需要修改同意书。这可能包括关于研究安全性的新信息、受试者面临的风险发生率的增加、受试者在试验中的权利的改变，或研究流程的改变。

Generally,a revised consent form is required when there is new information that might affect a subject’s willingness to participate in the study. This might include emerging information on the study’s safety, an increase in the incidence of risks facing study subjects, a change in the subject’s rights in the trial, or a change in study procedures.

行政变更（包括联系人/电话号码等）通常不需要修改同意书并获得受试者的新同意。但是，应向受试者提供介绍新信息的宣传页，宣传页的发放应该记录每个受试者的文件中，并在文件夹中保存一份宣传页的副本。

Administrative changes (which include contact person/phone number, among others) do not usually necessitate revising the consent form and obtaining new consent from subjects. However, subjects should be provided with a handout with this new information, the provision of the handout should be documented for each subject, and a copy of the handout should be maintained in the regulatory binder.

FDA法规和ICH GCP指南都描述了应修改知情同意书的情况。FDA法规21 CFR 50.25(b)(5) 相对间接地描述了这一点，指出知情同意书（如适用）应“说明在研究过程中产生的可能与受试者继续参与意愿有关的重大新发现将提供给受试者。”FDA官员指出，这种声明通常与单剂量研究或时间非常短的研究无关，除非该信息与长期风险有关。因此，此类信息与持续时间较长的研究最相关，可由IRB确定。

Both FDA regulations and the ICH GCP guidance address situations in which the informed consent document should be modified. FDA regulations at 21 CFR 50.25(b)(5) make a relatively indirect reference, stating that an informed consent document, when appropriate, should provide “a statement that significant new findings developed during the course of the research which may relate to the subject’s willingness to continue participation will be provided to the subject.” FDA officials point out that often such a statement would be irrelevant for either a single-dose study or a study of extremely short duration, unless the information related to a long-term risk. Such information would, therefore, be most relevant for studies of sufficient duration, which can be determined by the IRB.

ICH GCP指南（ICH E6 R2第4.8.2节）更直接：“一旦获得可能与受试者同意相关的重要新信息，应修改书面知情同意书和向受试者提供的任何其他书面信息。任何修改后的书面知情同意书和书面信息应在使用前获得IRB/IEC的批准/同意。”

The ICH GCP guideline (ICH E6 R2 section 4.8.2) is somewhat more direct: “The written informed consent form and any other written information to be provided to subjects should be revised whenever important new information becomes available that maybe relevant to the subject’s consent. Any revised written informed consent form, and written information, should receive the IRB/IEC’s approval/favorable opinion in advance of use.”