Drug Evaluation Committee 2010-53 Necessity of obtaining re-consent following a change in the cost of reducing the burden on test subjects
Related classification: Obtaining consent
Date of first publication: Apr. 2011
Question
Recently, a medical institution decided to change the amount of burden reduction expenses to be paid to subjects during a clinical trial. At the start of the trial, the stipulation was "10,000 yen per visit," but it was discovered during the trial that the transportation costs for subjects coming from distant locations exceeded 10,000 yen, and the investigator decided to increase the amount to 20,000 yen depending on the distance.
Accordingly, the consent explanation document was revised. In this case, is it mandatory to re-consent in writing with the revised consent document?
The site has decided that since the changes to the consent document do not fall under Article 54 of the GCP, it would be sufficient to explain the changes orally to the subject and obtain his/her verbal consent. There are three possible responses as follows, but which one is the most appropriate?
- Obtain written consent from all subjects in ongoing clinical trials using the revised consent document
- Among subjects who are continuing in the clinical trial, obtain written consent from only those subjects who are eligible for an increase in the burden reduction allowance, and obtain oral consent from those subjects who are not eligible for an increase in the burden reduction allowance.
- Provide all ongoing subjects with the revised consent document and obtain verbal consent
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
As stated in GCP Article 51, Paragraph 1, Guidance 1 (17), "If money or other payments are made to subjects, the details of such payments (e.g., arrangements for assessing the amount of payment)," the subject burden reduction payment is a matter to be described in the explanatory document provided to subjects, so if the details of such payments are changed, the explanatory document must be revised. Therefore, if the details of the payment are changed, the explanatory document will need to be revised. Although the increase in the burden reduction payment does not seem to fall under the category of a material change that would necessarily affect the subject's willingness to continue, it would be desirable to explain the change to the relevant subjects using the revised explanatory document and obtain their re-consent. However, if the investigator judges that the changes do not affect the willingness of subjects who are already participating in the clinical trial to continue, there should be no problem in explaining the changes orally to the relevant subjects, confirming their willingness, and recording this.
If the basis for setting the subject cost reduction fee at 10,000 yen per subject is changed, the change must be reviewed by the Clinical Trial Review Committee, as described in question (5) of Clinical Trial 119. Also, depending on the basis for setting the fee, it may be necessary to consider how the fee will be handled in other clinical trials at the site.