Drug Evaluation Committee 2011-41 Recruitment of human subjects via the Internet
Related classification：Recruitment of human subjects
Date of first publication: Apr. 2012
Question
The Internet makes it possible to disseminate various types of information, such as blogs and Twitter.
If the investigator (director) posts the following information on the "Director's Blog" linked from his/her hospital's website, is prior review by the Clinical Trial Review Committee required as a subject recruitment procedure?
Content to be included in the blog
- Target disease
- Request for cooperation in clinical trials
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Information on clinical trials is provided through various means, including posters, newspapers, magazines, flyers, television, radio, and Internet homepages. In addition, the scope of information provided, items described, expressions, etc., vary depending on the purpose of providing the relevant clinical trial information (e.g., the difference between an advertisement for the purpose of recruiting subjects for a specific clinical trial and an advertisement for the purpose of introducing the medical institution itself). As you know, if the information is provided for the purpose of recruiting subjects, it must be reviewed by a clinical trial review committee (GCP Article 32, Paragraph 1, Item 2). In the case of your question, it would be necessary to determine whether or not a review by a clinical trial review committee is required based on the purpose and content of the information to be provided. In addition, whether or not information is provided for the purpose of recruiting test subjects does not depend on the form of the blog, Twitter, etc.
Advertisements for the purpose of recruiting test subjects are clinical trial-related activities to which GCP applies, so they must be conducted in a manner for which the site or sponsor can take responsibility.
For more information on "Provision of Information for the Recruitment of Subjects for Clinical Trials," please refer to this document from the Pharmaceutical Manufacturers Association of Japan (PMAJ).