Drug Evaluation Committee 2009-29 Matters that must not be included in the Explanatory Document

Related classification: Obtaining consent

Initial release date: January 2010
Revised publication date: March 2021

Question

I would like to ask a question regarding matters to be described in GCP.

Q1 Disclaimer in the explanatory document

Article 51 states the following.

2 The explanatory document must not include any statement that waives the rights of a prospective subject, or any statement that causes suspicion of such waiver, or any statement that exempts or reduces the responsibility of the sponsor, the person who conducts the clinical trial him/herself, the site, or the investigator, or any statement that causes suspicion of such waiver or reduction of the responsibility.

On the other hand, there are descriptions in the indemnity explanation that may indeed imply exemption from liability, so please tell us what specific cases we should assume.

Q2 Agreement on direct inspection

The guidance in Article 13, Paragraph 1 states as follows

12 The sponsor shall obtain an agreement with all parties prior to the start of the clinical trial to allow monitoring and auditing by the sponsor and direct inspection by regulatory authorities of all sites and all clinical trial-related records, including source documents, prior to the start of the clinical trial.

Is there anything else that the sponsor does in this regard other than writing in the contract, writing in the protocol, and obtaining consent from the subjects? Please explain.

Q3 About substitute consenters

Regarding a surrogate, it is defined in Article 2, but can you please explain the difference from a legal representative?

Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)

Q1 Disclaimer in the explanatory document

We believe that Article 51, Paragraph 2 of the GCP requires that the contents not include any statement that unilaterally and unconditionally waives the rights of the person who is to be the subject of the study. On the other hand, with regard to compensation, it is common for disclaimers to be included for cases in which the subject is held liable (e.g., willful failure to follow dosage and administration, failure to follow physician's instructions, etc.). This disclaimer statement is not considered to be in conflict with the above GCP provisions.

Q2 Agreement on direct inspection

We believe that it is sufficient to enter into a clinical trial agreement, obtain agreement on the study protocol, and obtain the subject's consent, as you have stated in your question.

Q3 About substitute consenters

A legal representative is "a person who is designated by law to have the right of representation. In the case of a minor, a person with parental authority falls under this category. In the case of an adult, a guardian may be selected through legal proceedings. A GCP surrogate does not necessarily have to be a legal representative, as long as the surrogate has the best interests of the subject in mind. For children, a surrogate is usually a person with parental authority, but an adult sibling or grandparent may serve as a surrogate depending on family circumstances. For adults, the surrogate is usually a spouse or next of kin, and no legal procedures are required.