What does ICH E6 require the sponsor to verify regarding subject consent?

The International Council for Harmonisation (ICH) E6 guidelines emphasize the importance of obtaining informed consent from study participants. This requirement ensures that individuals are fully aware of the nature of the study, any potential risks, and the use of their medical information.

Option B is correct because it specifically highlights the need for consent regarding direct access to the subjects' medical records. This access is crucial for the sponsor to ensure that the safety and efficacy of the investigational product can be accurately assessed, and to monitor and report any adverse events related to the study. Informed consent in this sense is not just about agreeing to participate in the study, but also includes understanding who will have access to their medical information and under what circumstances. This element of consent aligns with ethical practices and regulatory requirements aimed at protecting human subjects involved in clinical trials.

Informed consent processes are comprehensive and typically require that participants are informed about various aspects, including privacy considerations. Therefore, it is essential for sponsors to verify that this specific consent regarding access to medical records has been obtained to maintain ethical standards and comply with regulations regarding patient confidentiality.

The other options do not accurately reflect the requirements set forth by ICH E6. The guideline calls for documented consent that includes an understanding of medical records access,