While there are many important aspects of a clinical research trial, the trial itself wouldn’t happen without research participants. Running a successful trial depends on recruiting and retaining clinical research participants – if there aren’t any participants, a trial can’t continue. In order for individuals to participate in a study, they must first go through the informed consent process. Aside from being a regulatory and ethical requirement, informed consent is a good way to ensure participant knowledge and satisfaction throughout the trial.
Informed consent is defined as the process of giving subjects important information pertaining to the clinical trial, including possible risks and benefits. The information is intended to help participants make an informed decision on whether or not they want to start or continue with a clinical trial.
When is Informed Consent Obtained?
Simply put, a participant’s informed consent form (ICF) needs to be on file at any given time during a clinical trial. Participants must know the protocol in its entirety, and understand their involvement in the trial is voluntary at all times. They can withdraw from the study at any given moment, without reason.
Research staff should not only obtain informed consent before any trial-related procedures, but also consistently throughout the trial. Often there are changing elements to the trial that may impact the participants’ decision to keep moving forward. While they might have agreed to the protocol the last time, it doesn’t guarantee they will agree to keep moving with the study if it is amended. It’s essential to have those conversations with subjects, and ensure they continue to understand the protocol in full.
Conversely, there are times when informed consent is not needed, although these cases are rare. Informed consent is typically waived during emergency situations when it’s unfeasible to obtain consent from the subject – such as a critically ill subject. It’s important during these situations for doctors to act in the subject’s best interest, even if it means ultimately deciding not to obtain informed consent.
Why is Informed Consent Obtained?
There are many reasons why a participant decides to join a clinical trial – they might want to advance science or they may see it as their best option for treatment. Regardless of their reasoning, participating is voluntary, and subjects can opt out at any time without any given reason.
Since it’s voluntary, a research participant needs to go through the informed consent process on a consistent basis. Informed consent is obtained to assure the researcher that the participant knows every aspect of their participation in the trial – what the procedures or treatments are going to look like and the potential outcomes, including the benefits and the risks.
Obtaining informed consent also benefits the research staff. The more up to date a research participant is, the better participant they will be. If they understand the trial in full, they will be more likely to stick with the trial for its entirety. The more participants stay with the trial, the less recruitment research staff will have to do in the long run.
How is Informed Consent Obtained?
There are two main ways consent is obtained: traditionally on paper and in electronic format. While there are similarities and differences to both, no matter how it’s done there are common elements to making sure informed consent is obtained and understood in full.
Paper consent is collected in person with a research professional and the participant, whereas electronic consent (eConsent) uses hyperlinks, videos and assessment tools, ensuring understanding of the consent document. To ensure proper informed consent is given, information is received by a physician or by other individuals (i.e. researchers) with appropriate scientific training and qualifications.
However, it’s important for the consenter to break down the ICF in simple terms for their participants to understand. Oftentimes, participants do not have a scientific or medical background and have questions or need clarifications. Participants may also want to meet outside of the initial meeting so they can ask any questions they might have thought of after the fact, or to address any concerns.
Ultimately, if the participant feels comfortable and educated during the trial, they will be more likely to stick through the trial. Knowing the basics of when, why and how informed consent is obtained provides a great foundation for ensuring participant satisfaction.