Understanding Clinical Studies

Informed Consent, Assent, and What to Expect When Taking Part in a Clinical Study

Explore videos that support general understanding about clinical studies

For children who may interested in a clinical study and their parents or caregivers

For children who may interested in a clinical study and their parents or caregivers Expand/ Collapse
Understanding Informed Assent and eAssent

Transcript video

Understanding Informed Assent and eAssent

Sunny: Hi, I’m Sunny, and this is my friend Maple.

Maple: And these are our pals, Ember and Ziggy. 

Sunny: We'll be your guides as you learn about an important aspect of clinical studies — informed assent.

Maple: Those sound like big words. What do they mean?

Sunny: Informed assent means you agree to join a study after it’s been explained to you, and you understand what will happen.
The doctor will tell you and your parents or guardian about what the study is testing, the study medicine you may take, and what will happen if you join.
 
Maple: So they make sure everyone really understands first?
 
Sunny: Exactly. If you don’t understand something, or if anything makes you nervous, you can always ask questions.
 
Maple: Even small questions?
 
Sunny: Every question matters.
You don’t have to decide right away. Take your time, and talk it over with people close to you.
Remember, being in a clinical study is your choice. No one else’s.
If you decide to join, your parents or guardian will need to give their permission by signing an Informed Consent Form.
 
Maple: Like when they sign my school permission slip?
 
Sunny: That’s right.
And you will likely also need to sign your own shorter form, called an Informed Assent Form.
Sometimes you’ll sign on a computer or tablet instead. That’s called eAssent.
And even if you agree at first, you can change your mind and leave the study at any time. No one will be upset.
If you don’t want to join, your doctor will still take good care of you and talk to you about other treatment options, if available.
Talk to your doctor if you want to know more about informed assent.
 
Maple: Thanks for learning with us today!

What is Informed Assent and eAssent - for children

Learn how informed assent and eAssent help understand participation in a pediatric clinical study.

Understanding Clinical Studies

Transcript Video

Understanding Clinical Studies

Sunny: Hey there! I’m Sunny, and this is Maple. Today, we’re exploring clinical studies.

Maple: I’ve heard about them, but I don’t totally get what they are.

Sunny: Then you’re in the right place. Let’s learn together.
So, clinical studies — or clinical trials — are how doctors and scientists test medicines to see if they’re safe and if they work.

Maple: Are they just for adults?

Sunny: Nope. Medicines can work differently in kids’ bodies, so it’s important they’re studied in kids too.

Maple: Oh, I have so many questions!

Sunny: And that’s totally normal. Whenever you do have a question, just talk to your parents or guardian or ask your doctor or study nurse.

Maple: Like, if I joined a clinical study, would I have to miss school? Or what if something hurts? What if I just don’t want to do it?

Sunny: Joining a clinical study is always your choice.

Maple: Ok, so what happens if a kid like me decides to join?

Sunny: Well, your parents or guardian will give their permission by signing a form called an Informed Consent Form.
And you’ll be asked if you agree too. That’s called giving your assent.

Maple: What happens if I change my mind later? 

Sunny: You can stop at any time. Your regular care won’t be affected, and no one will be upset.

Maple: Ok, so if I say 'yes', what happens next?

Sunny: The study team will talk with you and your parents or guardian about your health and do some tests and checks. This helps them make sure the study is right for you.

Maple: Does everyone who wants to join get in?

Sunny: Not always. Each study is different depending on what's being tested. The study doctor will let you know if you're a good match.

Maple: Ok, so what happens if I am a good fit?

Sunny: If the study is right for you and you agree to join, you might be given a study medicine to take for a certain amount of time.

Maple: And I’ll go to the study doctor’s office, too?

Sunny: Yes. You’ll have visits with the study doctor to check on your health. 
Some of these tests are like the ones you’d have at a regular doctor visit for your health condition, but others will be different and specific to the study.
You might have to miss school or activities sometimes, but these visits are important so the team can see how you’re doing. 
And some visits may even take place over the phone, on your computer, or at home. 
And the study team always does their best to keep you comfortable.
Just know that your study team will explain everything and will keep a close eye on you the whole time. Your health and safety come first.

Maple: What if I have questions during the study? 

Sunny: Don't be afraid to speak up. Your study team is there for you!

Maple: Will being in a clinical study make me feel better?

Sunny: We can't tell for sure. It may or may not. But know that by taking part, you're helping doctors and scientists learn more about medicines that may help other kids around the world!
What we learn from your participation makes a difference.

Maple: That’s pretty amazing.

Sunny: It sure is. Every single person in a study helps shape the future of medicine.

Maple: Thanks for exploring clinical studies with us!

Sunny: If you want to learn more, talk to your doctor.

What are clinical studies - for children

Learn what pediatric clinical studies are, how they work, and what children, parents, and caregivers can expect.

For adults considering a clinical study

For adults considering a clinical study
Understanding the Informed Consent Process in Clinical Trials

Transcript video

Understanding the Informed Consent Process
 
When considering whether to join a clinical study, the first and most important step is the Informed Consent Process. 
You must be able to make an informed decision about joining the study before enrolling.
 
To help you with this, the study team will give you an Informed Consent Form, or ICF, and review and thoroughly discuss it with you. 
This form explains what to expect, possible benefits and risks, as well as your rights.
 
The study, study design, and ICF are reviewed and approved by an ethical committee and regulatory authorities. 
They make sure the study is scientifically sound and that the well-being and rights of the participants are protected. 
They also make sure the ICF includes the information you need in order to make an informed decision about participation.
 
Before agreeing to take part, ask questions and make sure you understand all aspects of the study.
 
Before making your final decision, you can take the information home and read through it at your own pace. 
Talk it over with family, friends, or your family doctor.
 
After you understand the study, and if you agree to voluntarily join, you’ll give your permission, or consent, by signing the Informed Consent Form, or providing electronic consent, also called eConsent.
 
After signing, you’ll need to answer questions and have some tests to see if you’re eligible to participate in the study. 
If you qualify, you can take part in the study.
 
Taking part in a clinical study is voluntary–it's your choice.
Even after providing consent, you can withdraw from the study at any time and for any reason. This will not affect your regular healthcare. 
 
You should let your study doctor know if you decide to withdraw from the study.
 
If you decide not to join the study, your doctor will tell you about other available treatment options if they are available.
END Speak to the study team for more information or if you have any questions. 
Thank you!

What is the informed consent process in clinical studies - for adults

Learn what informed consent means, what information you will receive, and what to expect before deciding whether to join a clinical study.

What are Clinical Studies

Transcript Video

What Are Clinical Studies?

Clinical studies are carefully monitored research studies that help doctors and scientists explore ways to detect, diagnose, treat, and protect against diseases and health problems.
Before study medicines, also known as investigational medicines, are tested in people, they are first studied in detail in laboratory experiments and in animal models.

The most promising study medicines then move into clinical studies to make sure they are safe and work in people. 

Clinical studies may also test new ways to take existing medicines, or study them in new populations or for other medical conditions.
If you're considering joining a clinical study, the doctor will first give you an Informed Consent Form, or ICF. 

They will review the information you need to decide if it's a good fit for you and will answer any questions.

Being in a clinical study is completely voluntary, and your decision will not affect your regular healthcare.

If you decide to join, you’ll sign the Informed Consent Form.
You’ll then answer questions about your health and have tests to determine if you meet the study requirements. This is called Screening.
If you are eligible for the study, you will be assigned to a study treatment. 

Depending on the study’s goals, different treatment groups, or arms, may be used to compare the study medicine to an existing treatment or to a placebo. 

A placebo looks like the study medicine but has no active ingredients. It’s sometimes given with standard treatment. 
Comparing data across these different treatment arms helps researchers better understand the true effects of the study medicine. 
If the study has more than one treatment arm, you will be assigned to one by chance. 

You and your doctor MAY not know which study arm you are in. 

This helps ensure fair comparison of the treatment arms. 
Throughout the study, you’ll have regular visits with the study team to monitor your health and safety and to see how the study medicine may be affecting you. 

You can bring someone with you to provide support if it makes you more comfortable.
The total study duration and number of clinic visits you will have will be different for each study.

 In some studies, you may have the option to have certain visits take place virtually, at home, or at a location closer to home.
Many of the tests you’ll have are similar to ones you’d have at a typical doctor visit for your condition. 

You may have some tests more often or additional tests that are specific to the clinical study. 

The study tests vary depending on what’s being studied.

If you decide to join a study, know that your safety is the top priority.
Clinical studies follow strict rules and processes to protect the rights and well-being of every participant.

Clinical studies also aim to include diverse participants to make sure new medicines are safe and effective for all the people that may use them.
This is important because diseases, medicines, and vaccines can affect people differently, depending on many factors.

Each participant’s role in a clinical study is important toward advancing healthcare for people all around the world.

Talk with your doctor to learn more or to see if a clinical study may be right for you. 

Thank you!

What are clinical studies - for adults

Learn what clinical studies are, how they work, and what to expect during participation.

Educational materials for the public to support you and your family

  • Building trust: Clear information and transparent processes help to feel more confident when considering a clinical study.
  • Improving understanding: Educational resources help better understand what clinical trials are, how they work, and what to expect.
  • Improving accessibility: These materials help make clinical studies easier to understand and highlight common features, such as home visits or transportation support, that may be available in some studies, so you can better evaluate participation options.