The 3 fundamentals of informed consent.
1. Decision capacity and competency
2. Documentation of consent
For informed consent to occur, the doctor or treatment provider must provide enough information about the procedure so the patient can reasonably consent. While this disclosure doesn’t include every detail, it must have enough so the patient is making an informed decision.
Statement about the project
The first section describes the overall purpose of the research project, what the goals are, how long it will take, and what the expectations of the participants will be. For example, if this were a drug trial, it would clearly identify itself as such, outline the various effects of the drug in question, and also point out how participants will interact with the trial. Think of this as an information sheet for the participant and keep things easy to read.
This section summarizes the research backing the trial, who the principal investigators are (the researchers), and what will be studied within the trial. It includes the purpose of the research, how long it will take, and the procedures that will occur within the scope of the trial.
In this section, you should outline what the possible side effects and potential risks and discomforts of the trial are. This is the most critical part of the informed consent form, as this is where the signee decides if the benefits outweigh the risks.
Use this section to describe what can be expected to come from the research and the direct benefits that the patient might experience from the drug trial or research.
Alternative procedures or additional treatments
If there are parts of the trial that are reliant upon treatment with other medications or therapies, it’s important that these are outlined as well, so the patient can consent to them. Finally, you end with a signature field, which is where Adobe Acrobat Sign comes in.