What method is suggested by ICH for ensuring compliance with confidentiality of medical records during trials?

The suggested method by the International Conference on Harmonisation (ICH) for ensuring compliance with confidentiality of medical records during clinical trials is the disclosure in the informed consent form. This approach is fundamental in maintaining the integrity and confidentiality of participant information.

When participants are informed about the handling of their medical records through the informed consent form, they receive a clear understanding of how their data will be used, who will have access to it, and the measures taken to protect their privacy. This transparency is crucial because it not only builds trust between researchers and participants but also empowers participants to make informed decisions about their involvement in the trial.

Addressing confidentiality through the informed consent process also aligns with ethical research practices, as it ensures that participants are fully aware of their rights regarding their personal medical information. While other methods such as periodic audits or limiting access to research staff have their own merits, they do not specifically address the direct communication of confidentiality practices to the participants, which is a core principle laid out in the ICH guidelines. This makes the informed consent form a key instrument for compliance with confidentiality during trials.