Drug Evaluation Committee 2018-28 Necessity of Subject Consent at the Time of Submission of Additional Specimens from Stored Tumor Tissue
Related classification: Obtaining consent
Date of first publication: October 2018
Question
A clinical trial started in 2016 and 15 tumor specimens were submitted for screening. The monitor told us that the number of specimens was set at a larger number due to the fact that biomarkers are measured in addition to the main purpose of the test.
This clinical trial is still ongoing, but I received a request from the sponsor to resubmit slides of tumor specimens for biomarker measurement. The client asked us to provide additional slides because it was decided to measure a biomarker that had not been determined at the start of the trial, and the test could only be performed if the slides were made within one year of the start of the trial. The sponsor decided that since the subject would not be biopsied again and the slides were stored at the hospital, there was no need to revise the explanatory document for the subject, no need to obtain consent again, and no need to inform the subject him/herself. Although not specified in the clinical trial protocol, they consider the phrase "measuring biomarkers" alone to be within the scope of coverage. We told the sponsor that the data is stored at our hospital but originally belongs to the subject, but they responded that it is a requirement within the scope of the clinical trial protocol.
When we incorporated the specimen into the clinical trial, we explained to the subject for the purpose of the trial and submitted 15 tumor specimen slides, is there any ethical issue with submitting additional specimens without asking?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
The collection of biological samples from subjects and their provision to the sponsor, including the provision of specimens already stored at the medical institution, must be conducted within the scope of the subject's prior consent. Whether or not the subject's re-consent is required for the additional provision of the biospecimen (tumor specimen) in this case should be determined based on the contents described in the explanatory document.
On the other hand, the method of preparation and the quantity of biological specimens to be submitted for a clinical trial should be stipulated in the protocol or its annex, and agreed upon by the investigator in advance. If the provision of the additional tumor specimen is outside of these regulations, it will be a new matter to be agreed upon. The investigator should determine whether or not the provision of the additional tumor specimen can be agreed upon, taking into consideration the necessity of the additional biomarker measurement and the reason why the measurement item could not be determined before the start of the clinical trial. If necessary, it would also be a good idea to ask the opinion of the Clinical Trial Review Committee.