Participating in a Clinical Trial? Learn about Informed Consent
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.
About BioPharma Services Inc.
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 volunteer hub today.
What are early phase clinical trials?
Clinical Trials are divided into 4 phases. Phase 1 and 2 trials constitute early phase trials, Phase 3 and 4 research studies are late-phase trials.
The primary objective of Phase 1 studies is to determine the correct drug dosage by evaluating drug safety and determining if there are any side effects. Phase 1 trials are conducted in healthy volunteers.
Phase 2 studies also study the safety of a drug but focus on evaluating its effectiveness. These studies can be conducted in healthy volunteers or in individuals who have a certain disease or condition.
What is a clinical trial?
A Clinical trial is a process which is performed to determine whether an investigational drug, device or therapy is safe and effective. In early phase research (i.e. Phases 1 and 2), the safety and effectiveness of the drug will be evaluated in healthy volunteers.
What is an investigational drug?
An investigational drug can also be called an experimental drug and is being studied to see if your disease or medical condition improves while taking it. Scientists are trying to prove in clinical trials:
- If the drug is safe and effective.
- How the drug might be used in that disease.
- How much of the drug is needed.
- Information about the potential benefits and risks of taking the drug.
Why do you need to take blood draws and how many blood draws will be required?
In order to evaluate the drug profile, we need to understand its pharmacokinetics. This is essentially how the body reacts to a drug after its administration through the mechanisms of absorption, distribution, as well as the metabolic changes. Therefore, blood draws are collected at various time points to better understand this mechanism. Each study requires a specific number of blood draws and total blood volume. These values will be provided to you and clearly stipulated in the informed consent form (ICF). The amount of blood that will be taken is outlined in the ICF.
Should I expect to experience any side-effects while doing studies?
As every study is testing an investigational product, there may be side effects. You will be provided with a list of side effects that have been reported in previous trials (if any), so you can make an informed decision whether or not to participate in the trial. During the trial you will be required to immediately inform clinic study staff of any adverse effects that you are experiencing. These side effects usually resolve upon discontinuation of the study drug.
Will I be compensated for doing a clinical study?
Volunteers are compensated and the amount varies depending on the length of the clinical trial, length of stay and number of follow-up visits. The compensation is not specifically related to the risks or type of drug involved in the trials or studies. Every study is different and therefore, the compensation will vary. Study volunteers may receive between $1000 to $4000 for a trial (based on the factors listed above).
Are food and accommodation provided over the course of the trial?
Food – Clinical trials are conducted in a controlled setting which means that all food is provided and trial volunteers receive standardised meals. Individual meal plans or meal preferences cannot be provided. If you have any food allergies or hypersensitivity to food product(s) that are clinically significant or life-threatening you may not be able to participate in a trial. Please contact us to discuss any food issues.
Accommodation – During your in-clinic stay you will share sleeping areas with other volunteers who are of the same gender. Similar to a hospital setting, supervision will be provided to ensure that your health and safety are being monitored.
What is the length of a study and do I have to complete all the visits?
What is informed consent and how is it carried out?
Before you decide whether or not to take part in a clinical research study, you will be required to read and understand the information provided in an Informed Consent Form (ICF). The ICF describes the clinical research study and the nature of the investigational product to be used, including:
- Your rights and responsibilities as a study participant.
- What you will be asked to do during study participation.
- The potential risks that you should be aware of.
During this process, you will have the opportunity to discuss and ask questions related to the conduct of the clinical research study with the study doctor/ study staff. You are under no obligation to participate and your decision to take part in a clinical trial is voluntary.
Can I bring my own device?
Yes, we encourage you to bring items that will help to pass the time while you are in the clinic. You can use the time to study or work or catch up on the movies you’ve been meaning to watch.
What do I need to pack?
When do I receive compensation for taking part in a study?
You will receive compensation as outlined during the Informed Consent process. Typically, you will receive compensation once all study visits have been completed. If, for any reason, you do not complete all study visits, your compensation will be on a pro-rated basis (i.e. for the time that you have participated in the trial)
Where will I sleep during the clinical study?
Can I bring my own food?
All aspects of clinical trials are closely monitored including the food and drink consumed by participants. While you are in the clinic, you will be provided with all meals as per the study guidelines. You will need to eat all the food provided to ensure the guidelines are met. Watch video