Drug Evaluation Committee 2010-23 Entry of new subjects up to the approval of the Investigational Review Committee for the revised version of the Instructions for Use
Related classification: Obtaining consent
First published: August 2010
Question
The IRB is held monthly, but new subject entry is not allowed until the investigator's approval. Although the IRB is held monthly, the timing of reporting to the investigator or the deadline for submission of the revised version of the consent document has become a burden for sponsors who frequently revise the consent document, causing them to miss out on potential subjects.
As an alternative to the above, would it be a problem to obtain consent using the current consent document and verbally explain the revisions to potential subjects and obtain their verbal consent for the revisions? I think that there should be no problem for the safety and ethics of the subjects if we obtain their re-consent to the new consent document as soon as possible after the IRB's approval for the revision.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
If we refer to the method of dealing with subjects in ongoing clinical trials in GCP Article 54, Paragraph 2/3 Guidance 1, the method of obtaining consent for new subjects as described in your question can be considered as one method.
However, the guidance allows this only for "subjects already participating in a clinical trial" because promptly communicating new important information is an action that should take precedence over the procedure of IRB approval. When obtaining consent from a "potential subject," it is basically necessary to explain and obtain consent using the revised explanatory document approved by the IRB. We are not sure what kind of revision has been made to the explanatory document, but if the head of the institution has instructed that "new subject entry is not permitted" after considering the importance of the revision, we believe that it is necessary to follow that instruction.
The starting point for suspending the entry of new subjects is considered to be the time when the investigator decides to revise the explanatory document.