That is true informed consent
You have worked hard on your clinical trial preparations. Throughout you have had the patient in mind. Have you also taken on board the need for informed consent consulting?
The informed consent process is complex with many legal, regulatory and practical considerations. For many investigators, navigating the intricacies of informed consent while also focusing on the scientific aims of the clinical trial can be challenging. They need specialized training. Speid & Associates will guide you designing design the process of obtaining informed consent. There is more to this than designing the informed consent form. It also requires that you train the investigators on how to actually speak to the research subjects.
The Patient Perspective
It is extremely important to understand the challenges the patient is experiencing. They may have received a devastating, or at least, a troubling diagnosis. They are then sitting in a chair in front of the investigator, and they are being told about a clinical trial. They will automatically hope that the drug under study will be able to help them, so that they can get on with their lives. The investigator is excited to be taking part in your study, and so you can understand how the patient could be misled to think that a first in man study is going to eradicate their metastatic disease.
Great care must be taken in how the information in the informed consent document is explained to the patient. We will help you to develop appropriate informed consent forms, information sheets, and multimedia tools for your trial population. We will make sure all research subject materials meet are written in plain language for individuals with varying literacy levels.