Clinical trials are typically carried out in four phases to verify the safety and efficacy of promising new drugs, medical devices, and surgical techniques, prior to gaining regulatory approval. Such studies depend on the voluntary enrollment of thousands of human participants, who take part in different focused studies that are carried out as part of the multi-tiered clinical trial process.
Informed consent is a prerequisite for enrolling participants in clinical trials. It refers to the process (and the accompanying formal documentation) that ensures that patients (and sometimes their families or caregivers) are fully informed about the key elements of the research study before they decide to participate voluntarily. This process is designed to be interactive, allowing participants time to think of questions and carefully consider their decision. In the United States, it is federal law that clinical trial investigators conduct informed consent procedures and secure a signed informed consent from every human volunteer who will be enrolling in the trial.
The informed consent form is a document that outlines the details of trial participation and documents that the investigator obtained the legally required consent from the participant before enrolling them. The participant’s signature confirms that they have read and understood all of the information that was provided in the document, have had all their questions answered, and have agreed to participate voluntarily in the clinical trial. It’s important for participants to understand that while they will be receiving clinical care during the trial, the safety and efficacy of the intervention is not yet known and that outcomes are not guaranteed.
Elements of informed consent
A typical informed consent document includes the following types of information:
- The voluntary nature of the trial
- A detailed description of the trial objectives
- A detailed description of the treatment or intervention being studied
- Information related to the anticipated length of the study and anticipated time commitments for participants
- Descriptions of the trial schedule, in terms of specific procedures and laboratory tests that will be carried out
- An explanation of potential benefits and risks associated with the research study
- Information about the study investigators and the study sponsor(s)
- Alternatives to participating in the study
- Any costs associated with the trial
- A guarantee that the participant will be informed of important clinical findings developed during the study
- Factors that may allow the participant to be removed from the trial by the investigators (for instance, for failing to comply with required procedures, changes in lab values that fall beyond limits set by the clinical trial protocol, adverse events, and more)
It is imperative that patients who do not understand English be given access to a translator or interpreter, to ensure that they understand the informed consent document before they sign it, and have the opportunity to ask questions and receive answers in their preferred language. The level of literacy must be considered by the trial investigators, as well, and all technical terms must be defined in a way that is clear and concise to a broad audience.
This blog is intended to be informational in nature. The information and other content provided in this blog, or in any linked materials, are not intended and should not be construed as medical advice, nor is the information a substitute for professional medical expertise or treatment.
If you have any questions or concerns, please talk to your doctor. Never disregard professional medical advice or delay in seeking it because of something you have read on this blog or in any linked materials. If you think you may have a medical emergency, call your doctor or emergency services immediately.