Perhaps you have seen those notices for clinical research trials in New York and New Jersey looking for participants. For some individuals, those trials are a good idea. However, certain protocols must be in place prior to any treatment or research, including the participant’s informed consent. Below are four principles that describe details of that consent.
Principles of informed consent
- The patient must be mentally competent to give consent.
When participating in a clinical trial, undergoing a research experiment or receiving medical treatment, the patient must be able to make an informed consent. Thus, he must be of a sound mind. He must also be of legal age: otherwise, his legal guardian must consent on his behalf.
- Details of the research experiment or treatment must be fully disclosed.
Informed consent means that the patient must be fully apprised of the research experiment or procedure. The details must be clear so that the patient fully understands what his participation means. The healthcare professional must inform the test subject or patient of what is going to occur and what could potentially happen as a result. Side effects must also be divulged. Omitting pertinent information relating to the research does not beget a full-faith consent.
- The patient must indicate his understanding of the information he received.
The patient must acknowledge that he understands the in-depth information communicated to him regarding his treatment. This means that he fully comprehends the process, the procedure and the possible side effects. Acknowledgment of comprehension assures the healthcare provider that the patient is consenting to treatment fully informed.
- The patient must comprehend that his participation is voluntary.
The patient cannot be coerced or forced into treatment or clinical research. He has to willingly agree with a thorough understanding of the plan and possible outcome. It is only under this circumstance that informed consent occurs when he signs on the dotted line to affirm his participation.
Doing due diligence
Taking the time to explain the details of the patient’s treatment and verifying comprehension better ensures that the patient is truly able to consent to any procedures. They know what they are getting into and accept the terms of the research.