Q（Question）

Regarding principle ④, since there are cases where it is not possible to determine from the literature, or it is not easy to confirm, whether external research complies with the 'Ethical Guidelines for Medical Research Involving Human Subjects,' is it correct to understand that companies are required to confirm compliance to the extent possible?

A（MHLW answer）

On the premise that principle ③ is satisfied, that understanding is correct. However, companies must be in a position to explain that they have conducted confirmation to the extent possible.

So what (meaning): When a literature source does not clearly state its ethical compliance, companies may still cite it — provided principle ③ is met and the confirmation efforts made are documented and explainable upon request.

So why (rationale): Requiring explicit ethical compliance statements in all literature would unduly restrict legitimate scientific communication; the balance struck is reasonable effort plus documented process, rather than a binary pass/fail on disclosure.

Commentary — background, application, practical notes

There are in practice many cases where a paper does not explicitly state approval by an ethics review committee or compliance with the ethical guidelines for medical research involving human subjects. This omission appears particularly in retrospective observational studies and older literature. This Q&A provides a practical answer that is neither automatic prohibition due to unconfirmability nor unconditional permission: the framework is 'reasonable confirmatory effort plus documentation.'

Concrete steps for verification include: (1) checking whether an ethics review approval number is registered in a study registry such as UMIN or ClinicalTrials.gov; (2) contacting the authors or the publishing journal; and (3) inquiring with the institutional ethics committee. If compliance cannot be confirmed after these steps are taken, the question of whether to proceed with citation becomes an individual judgment call, contingent on principle ③ (objective third-party evaluation and verification being possible) being satisfied.

The situation that most easily goes wrong is the absence of a record stating 'I checked and could not confirm compliance.' The Q&A's requirement to 'be in a position to explain that confirmation was conducted to the extent possible' means that evidence of the confirmation process itself must be maintained. In the event of a regulatory inspection or a problem arising, the inability to demonstrate what specific steps were taken to verify compliance may mean that reasonable effort is not considered to have been made.