Drug Evaluation Committee 2015-04 Scope of document on procedures for recruitment of subjects
Related classification：Recruitment of human subjects
First published: July 2015
Question
Article 32 of GCP (Responsibilities of the Clinical Trial Review Committee) specifies "materials related to procedures for the recruitment of subjects" as review-based materials. Please explain the following points regarding the interpretation and handling of such materials.
- Even if the principal person responsible for recruiting in large-scale advertisements, etc., is not the site site (i.e., the name and contact information of the site are not listed), does the advertisement still need to be reviewed by the site's investigational review board (IRB)? If so, is another review necessary even if recruitment is already underway or has already taken place?
- When posters, leaflets (pamphlets), and web advertisements are used as recruitment media, the locations where they are placed (facilities where they are posted, websites where they are posted, etc.) are often unspecified or subject to change. Since we consider the "recruitment procedures" to be the "media and their contents" that patients view, we did not think it was necessary to review the location of the media, but questions 2014-43 and 2011-42 mentioned the location of the media. Even if the head of the implementing medical institution determines that the place of publication is not ethically or socially problematic, do we need to review all of them?
- Is it correct to interpret that articles in newspapers, magazines, etc. by physicians of the implementing medical institution fall under "recruitment procedures" that should be reviewed by the IRB, even if there is no intention to recruit, as long as they include two points: "recruitment is underway" and "contact information is listed"?
- Does the provision of clinical trial information during recruitment to physicians at conferences, lectures, or through appealing, etc. fall under "recruitment procedures"? We do not think that the precursor steps (how the referring physician learned about the clinical trial information) fall under "recruitment procedures".
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
The documents that a clinical trial review committee obtains from the head of the site for review in order to fulfill its duties include "materials related to procedures for recruiting subjects" (in the same guidance, "materials related to procedures for recruiting subjects (advertisements, etc.)") (GCP Article 32, Paragraph 1). In other words, not only the content of the advertisement for subject recruitment itself, but also the entire recruitment procedure must be subject to review. In addition, regardless of who is the subject of the recruitment, any recruitment that is intended to attract potential subjects who wish to participate in a clinical trial being conducted at your hospital must be approved in advance by your hospital's Clinical Trial Review Committee.
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If recruitment is conducted with the intention of bringing in potential subjects who wish to participate in a clinical trial being conducted at your hospital, it is subject to review by your hospital's Clinical Trial Review Committee, regardless of who is responsible for the recruitment, so prior approval by the relevant Clinical Trial Review Committee is required. In addition, if you learn after the fact that such recruitment has already taken place, the Clinical Trials Review Committee will need to review the recruitment promptly. In your question, you mentioned "cases in which the name and contact information of the site are not posted," but cases in which referrals are made to your hospital through the inquiry window are subject to review by your Clinical Trials Review Committee.
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Since "recruitment procedures" are subject to review, the place (and method) of recruitment should also be reviewed.
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Whether or not the article is applicable to recruitment of subjects will need to be determined on an individual basis depending on the content of the article.
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As stated in previous Opinions 2008-31 and 2012-47, it would depend on the scope of information provided to other physicians and the patient referral procedure.