scope

Package leaflet readability testing is not only a matter of methodology. Every decision on sample composition carries legal and ethical responsibility. Sometimes those decisions must be defended before the client and the regulatory authority at the same time.

Objective

To conduct readability testing of the package leaflet for a contraceptive product. The product is registered for use from the age of 12, which formally includes minors. The objective was to define a sample that accurately reflects the target audience of the leaflet without contravening the ethical and legal standards of the Republic of Kazakhstan.

entrypoint defined a sample of women aged 18–49, in accordance with the ethical standards and legislation of the Republic of Kazakhstan. Testing was completed, the results were delivered to the client and agreed.

Following submission, an expert at the assessment organisation raised a deficiency: why minors under the age of 18 had not been included in the sample. The client pressed for the testing to be redone. entrypoint declined and prepared a detailed legal and ethical justification: minors in the Republic of Kazakhstan do not hold full legal capacity, treatment decisions are made by legal representatives, and the inclusion of minors in testing would have required separate approval from an ethics committee. EEC Council Decision No. 88 does not require the inclusion of minors in the sample and permits sample composition to be defined in accordance with national legislation and ethical principles. The justification was accepted by the assessment organisation. The deficiency was withdrawn.

The assessment organisation accepted the justification and withdrew the deficiency. The testing did not require revision: the sample had been correctly defined from the outset. The entrypoint approach received regulatory confirmation.