国产一线天精品视频_亚洲欧美一区二区日韩高清_亚州中文无码av在线_欧美羞羞视频网站高清_无遮挡吃胸膜奶免费网站_日韩欧美中文字幕在线地址一_九九热视频国产精品_国产黄片免费在线看_亚洲色喷福利在线观看_欧美一级中文字幕

1問(wèn)題和背景

哪些情況需要修改或更新同意書(shū)？（源自FDA GCP問(wèn)答）

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

2討論和回答

通常，當(dāng)新的信息可能影響受試者參與研究意愿時(shí)，需要修改同意書(shū)。這可能包括關(guān)于研究安全性的新信息、受試者面臨的風(fēng)險(xiǎn)發(fā)生率的增加、受試者在試驗(yàn)中的權(quán)利的改變，或研究流程的改變。

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.

行政變更（包括聯(lián)系人/電話號(hào)碼等）通常不需要修改同意書(shū)并獲得受試者的新同意。但是，應(yīng)向受試者提供介紹新信息的宣傳頁(yè)，宣傳頁(yè)的發(fā)放應(yīng)該記錄每個(gè)受試者的文件中，并在文件夾中保存一份宣傳頁(yè)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法規(guī)和ICH GCP指南都描述了應(yīng)修改知情同意書(shū)的情況。FDA法規(guī)21 CFR 50.25(b)(5) 相對(duì)間接地描述了這一點(diǎn)，指出知情同意書(shū)（如適用）應(yīng)“說(shuō)明在研究過(guò)程中產(chǎn)生的可能與受試者繼續(xù)參與意愿有關(guān)的重大新發(fā)現(xiàn)將提供給受試者?！盕DA官員指出，這種聲明通常與單劑量研究或時(shí)間非常短的研究無(wú)關(guān)，除非該信息與長(zhǎng)期風(fēng)險(xiǎn)有關(guān)。因此，此類(lèi)信息與持續(xù)時(shí)間較長(zhǎng)的研究最相關(guān)，可由IRB確定。

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節(jié)）更直接：“一旦獲得可能與受試者同意相關(guān)的重要新信息，應(yīng)修改書(shū)面知情同意書(shū)和向受試者提供的任何其他書(shū)面信息。任何修改后的書(shū)面知情同意書(shū)和書(shū)面信息應(yīng)在使用前獲得IRB/IEC的批準(zhǔn)/同意?！?/span>

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.”