What must the consent form include regarding access to medical records?

The consent form must include a statement about authorized access to records to ensure that participants are fully informed about who will have access to their medical information and for what purposes. This is essential for maintaining transparency and respecting the participants' rights. It helps to clarify that their medical records may be accessed by the research team, regulatory agencies, and ethics committees, as needed for the study, while ensuring that confidentiality is preserved.

Informed consent is a key principle in clinical research, and including this information in the consent form reinforces the concept that participants are providing permission for their data to be used in a specific manner. This promotes trust and compliance with ethical standards governing human subject research, as individuals need to understand the implications of sharing their health information.