Drug Evaluation Committee 2010-36 Necessity of Revision of Explanatory Documents for Subjects Due to Change in Location of Clinical Trial Review Committee, etc.
Related classification: Obtaining consent
First published: Jan. 2011
Question
We have received a notice that the location of the investigational review committee (external) to which we have requested a review will be changed.
- Establisher
- Position title/applicant has changed
- Location
- Office moved to a nearby location
Please tell us about the measures to be taken by the site, mainly the necessity of revising the explanatory documents and IRB deliberation, and the necessity of re-consenting the subjects.
We believe that if we obtain a document from the investigational review committee regarding the change, provide the information to the subject who is currently enrolled in the study, and keep a record to that effect, there is no need to revise the explanatory document, discuss it with the IRB, or obtain the subject's re-consent. Is there any problem with the above response?
JPMA's Opinion
We believe that the change in the establisher and location of the Investigational Review Board described in the explanatory document constitutes a change in the administrative matters of the clinical trial. Therefore, we do not believe that it is necessary to obtain written re-consent since it is not considered to be information that would affect the will of the subjects participating in the clinical trial to continue the clinical trial. If you are referring to a Clinical Trial Review Committee that has a procedure manual and other documents available for public inspection at its office, it would be desirable to provide information to subjects in a manner similar to that described in your question.
Also, after this change, it will be necessary to provide subjects who will participate in the clinical trial with an explanatory document that contains the latest information and obtain their consent.