Drug Evaluation Committee 2011-42 Recruitment of Subjects via the Internet (Part 2)
Related classification：Recruitment of human subjects
Date of first publication: Apr. 2012
Question
With the approval of the Clinical Trial Review Committee, we received the invitation for subject recruitment on the hospital's website.
A clinical trial investigator posted a message on his/her blog, "We are conducting a clinical trial for ... . Please refer to this link for details. This blog is used as a tool for communicating information among physicians, but it can also be viewed by the general public, and sometimes information is sent out to patients.
Thus, do we need to undergo another review by the Clinical Trials Review Committee in order to post a link on a different website or blog based on a website for recruiting test subjects that has been approved by the Clinical Trials Review Committee? Or, if the base advertisement has been approved by the IRB, do I need IRB approval to link to it?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
One of the documents to be reviewed by the investigational review board (IRB) is the "documents related to the procedure for recruiting subjects" as GCP Article 32, Paragraph 1, Item 2.
In your question, you mentioned that you have already obtained IRB approval for the "invitation to recruit subjects on the hospital's website," but if the staff members involved in the clinical trial are using tools such as blogs to invite the general public to the website for the purpose of recruiting subjects to participate in a specific clinical trial, is this considered to be one of the means of inviting the public to the website? If this is done as one of the means to attract the general public to the website for the purpose of recruiting people to participate in a specific clinical trial, it may be considered as part of the recruiting procedure. On the other hand, if the purpose is not a specific clinical trial, but to raise awareness of participation in clinical trials in general, it may not be considered as a subject of review for the clinical trial. In other words, the necessity of review should be determined based on the purpose and content of the blog.
In general, confidentiality obligations are imposed on clinical trial information in clinical trial contracts, so even personal blogs should be used with caution when disseminating information on clinical trials.
Please refer to this Pharmaceutical Manufacturers Association document regarding "Provision of Information for Recruitment of Subjects for Clinical Trials. Also, please refer to Question No. 2011-41.