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 Investigator Site has decided to revise the consent document and has instructed that new subjects may not be entered into the study from the time the revision of the consent document is reported to the investigator until approval by the Investigator Site's Investigational Review Board (IRB). 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 consent to the new consent document as soon as possible after the IRB approval for the revision.
JPMA's Opinion
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 IRB-approved explanatory document. Although it is difficult to know what kind of revision has been made to the explanatory document, if the head of the Investigator Site has instructed that "entry of new subjects is not permitted" after considering the importance of the revised content, it is necessary to follow the 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.