If you’re planning to participate in a clinical trial, you may have a lot of questions about the process and everything that this participation entails. From communicating with the team for the trial, the duration of the study, possible risks, and so on. You may have also heard of the term “informed consent,” which is a mandatory part of every clinical trial. In fact, it’s one of the most important steps in the study process as it’s centered around you being able to make an informed decision before deciding to participate in the study. So, what is informed consent?
According to the FDA, “informed consent means that the purpose of the research is explained to the participants, including what their role will be, and how the trial would work.” Essentially, the study protocol is explained which includes the study purpose and objectives, the process and timelines, and the safety measures the study site will be utilizing for your protection. Here are some things that you can expect to see in the protocol:
- Clinical trial eligibility – who can participate?
- The number of people that will participate in the trial
- What treatment will be provided to the study participants based on what is being studied
- What medical tests will be involved during the course of the trial and when they will be performed
- How the research team will evaluate whether the treatment is working
- What information will be gathered from the participants and how that information will be analyzed
While the informed consent requirements are bound by different rules across the world, their purpose is the same: to provide prospective study participants with all the relevant and important information before they voluntarily decide to join the trial. In Canada, as an example, the format of an informed consent document typically follows below structure:
- Study title, investigator(s), and sponsor information
- Background/Rationale of the study
- Study Design
- Use of Placebo (if relevant)
- Study Procedures
- Risks and Discomforts
- Reproductive Risks
- Alternative to Participation
- Cost to Patients
- Withdrawal from Study
- Ethical Review
While the above list may seem daunting at first glance, a competent study site will ensure this process is conducted without any time constraints and you have the ability to understand each step appropriately. Note, just as we do with our studies, BioPharma always recommends to ask any questions at this stage to ensure you have full disclosure and are making an informed decision. This is not a document containing information that you need to review and sign, but an active discussion process.
More importantly, always remember that your participation in clinical trials is voluntary. You may decide to stop participating in the study at your own discretion, at which point you will have to communicate this with the study site. Any implications of stopping participation would be reiterated as per the informed consent document. An example could be that if the study had compensation paid out based on duration of participation, you may not be entitled for full payout.
In summary, informed consent is an important process that is the first step before you are officially part of a clinical study. It is the right time for you to engage with your point of contact and ask questions until you’re comfortable making the decision to join or not.
For more information about Canada’s requirements for informed consent, visit the Government of Canada resource hub by clicking here. For US’ requirements, visit the American Medical Association website by clicking here.
BioPharma Services Inc. is a contract research organization that conducts research studies across all medical disciplines. Our offices and study sites are located in Toronto, Ontario and Columbia, Missouri. For our current research studies visit our study hub today.