临床试验互联网广告和帖子是否都需要伦理审批

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互联网时代，信息发布效率化和透明化，也成了临床试验的招募信息或基本信息的重要发布渠道。今天一起来了解FDA对于临床试验互联网广告和帖子是否都需要伦理审批的建议。 

问题8.96 如果申办者计划在一个多中心试验中使用多个伦理委员会，互联网广告必须得到所有伦理的批准？   If a sponsor plans to use multiple IRBs for its multicenter study, must an Internet advertisement be approved by all involved IRBs?

答复：当申办者在试验中使用多个IRB时，必须遵守每个IRB的要求   -  在 次。如果某个IRB要求批准广告（仅一些IRB 要求申办方将广告发送到 IRB  —  一种被动类型的批准），那么申办方在互联网上发布广告之前必须等待获得每个伦理的批准。为了了避免每次伦理审批都要进行微小更改，申办者可以在广告或电话脚本中包括有关其国家使用的信息以及伦理审批中必要和禁止的信息。 When sponsors use multiple IRBs for their studies, they must adhere to the requirements of each IRB—no small undertaking at times. If an IRB requires active approval of advertising (some IRBs only require that sponsors send the advertisement to the IRB—a passive type of approval), then the sponsor must wait for the approval of each IRB that requires pre-approval before posting the advertisement on the Internet. To avoid minor changes by each reviewing IRB, the sponsor may include, with the advertisement or telephone script, information about its national use and the IRBs that have or have not granted approval.

但是， 互联网帖子 与广告不同，不需要IRB审查 。根据FDA题为 “受试者 招募 ”的信息表 ， “ IRB审查和批准的 互联网 临床试验列表不会提供额外的保障，并且在 系统格式将限定为提供基本试验信息， 例如：标题;研究目的;方案摘要;基本的入排标准;研究中心地点;以及如何联系研究中心以获取进一步的信息。不需要 需事先获取IRB批准 的临床试验列表的例子无，包括前国家癌症研究所 的 癌症临床试验列表（PDQ）和政府赞助的艾滋病临床试验信息服务（ACTIS）和政府强制要求的clinicalTrials.gov 登记 。但是，当数据库系统不限定可以添加额外的描述性信息时，IRB审查和批准可以确保附加信息不承诺或暗示治愈或其他超出方案和 知情同意书 中包含的利益的确定性。 Internet postings, which are not the same as advertisements, do not need IRB review, however. According to the FDA Information Sheet titled, “ Recruiting Study Subjects ,” “IRB review and approval of listings of clinical trials on the internet would provide no additional safeguard and is not required when the system format limits the information provided to basic trial information, such as: the title; purpose of the study; protocol summary; basic eligibility criteria; study site location (s); and how to contact the site for further information. Examples of clinical trial listing services that do not require prospective IRB approval include the former National Cancer Institute’s cancer clinical trial listing (PDQ) and the government-sponsored AIDS Clinical Trials Information Service (ACTIS) and the government mandated clinicalTrials.govlisting. However, when the opportunity to add additional descriptive information is not precluded by the data base system, IRB review and approval may assure that the additional information does not promise or imply a certainty of cure or other benefit beyond what is contained in the protocol and the informed consent document.”