Bio-equivalence Studies

It is not true all the time

The length and complexity of consent forms for people enrolling in clinical trials don't affect the ability of the participants to understand the key points of the study.

This is true for Bio equivalence studies in USA as well.

In this new study, U.S. researchers had volunteers read either a standard or a concise consent form for a low-risk phase 1 study of a marketed drug. The participants' comprehension levels were similar with both forms, and the shorter form didn't appear to harm the quality of informed consent, the study authors found. The researchers also noted that paid participants had slightly higher comprehension than unpaid participants. This challenges a common assumption that people who are paid to enroll in research may be "blinded by money" and thus ignore important details about the study when reading the consent form.

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