Frequently Asked Questions
Clinical Research Process
What is clinical research?
Clinical research is the study of health and disease in humans.
- Clinical research is important to discover and improve disease screening, treatment, and healthcare.
- Both healthy people and people with an illness are important to clinical research.
- Research staff need your permission (verbal or written) before you can take part in research.
What are the different types of clinical research studies?
There are many different types of clinical research studies. Some studies:
- Test medications in people with disease (treatment trials).
- Look for ways to prevent disease (prevention).
- Test better ways to identify a disease (diagnostic).
- Try to find the best way to detect a certain disease or health program (screening).
- Find ways to improve quality of life for those with long-lasting diseases (behavioral).
- Learn who gets a disease by researching how genes and illness may be related (genetic studies).
- Look to find patterns and causes of disease in groups of people (epidemiological studies).
If I decide to participate in a study, what happens next?
Once a person decides to take part in a clinical trial, they may wonder what comes next. You can expect a few things:
- Your will need to give your signature or verbal permission to show that you agree to participate. You will also need to give this permission to show that you know your rights and role in the study
- A member of the research team will talk to you about the details of the study. He or she will tell you exactly what will happen next
- If the study involves biobanking, your samples will be stored until needed for research
- Researchers may reach out to you for future studies
- You can always ask questions if you do not know what to expect!
What are the different phases of clinical trials?
A clinical trial may fall into one of four different phases. The four phases of clinical trials are:
- Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to test safety, side effects, and dose.
- Phase 2: Drug or treatment is tested with a larger group of people to see if it works and to check safety.
- Phase 3: Drug or treatment is given to a larger group of people to check that it works, track any problems, and compare it to usual treatments.
- Phase 4: Studies are done after a drug or treatment has been approved. Information is collected on effects in different groups and any problems with long term use.
Will I find the results of the research?
- Depending on the study, you may or may not receive the results of the research. Ask research staff if you’re interested in the results of the study,
- Researchers may publish results of the study in medical journals. If this happens, the results will not have any personal information about you.
Who can see my information?
Research staff can see your information. These researchers received special training about how to protect your privacy.
- Sometimes researchers share study details with other researchers. These details will not have information that can identify you.
- Before you can join a study, you need to sign a consent form. This form shows that you have talked to the researchers about the study and that you agree to participate. When you sign this form, it means that you understand your rights and your role in the study. This might mean researchers can put your information in a secure database.
- Some studies collect information that can identify you. Researchers will keep this information separate from other information. Information that can identify you has extra levels of protection to keep it safe.
- Your consent form lists people who can see your information.
What are my rights as a research participant?
Your rights are to:
- Be treated with respect.
- Be fully informed in different aspects of your treatment plan.
- Decide not to take part in a study.
- Leave a study at any time.
- Ask for information in the language of your choice or ask someone to help you interpret.
- These are your rights whether you choose to take part in a study or not.
- Those with special needs can receive assistance.
Can I change my mind?
- You can choose to take part in a study, or you may choose not to be part of a study.
- You can decide to leave a study at any time.
- It is important to talk to you doctor about your concerns before leaving a study. Your doctor can tell you about any medical risks due to leaving a study.
- If you change your mind in the middle of a study:
- The consent form has details on how to leave the study, including a telephone number. [You get a consent form when a researcher explains the study to you. You have to sign a consent form before you join a study.]
- Research staff can also help you leave a study.
How is my identity protected?
- Researchers must follow federal laws that protect your privacy.
- Only approved study team members can see your personal health information.
- Some studies collect information that can identify you. Research staff will remove this information so that it cannot be linked to you. For example, research staff may replace your name with a special code that is not connected to you.
- Researchers will not publish information that can identify you.
How does the study affect my health care?
Participating in a study will not:
- Affect your diagnosis or your treatment
- Change the quality of your medical care
- Deny you care at your medical institution
- Change your relationship with your doctor
What is a healthy volunteer?
A healthy volunteer is someone with no known health problems who chooses to take part in research. This research could test a new medicine, device, or intervention.
Many healthy people choose to volunteer in research. The NIH alone has nearly 3,500 healthy volunteers in its research studies every year.
Why are healthy volunteers important?
Healthy volunteers have always played an important role in research. Reasons healthy volunteers are important to research include:
- Used as a comparison for those with illness or disease. This can be to:
- Compare a group of healthy people to a group of people with a disease or illness
- Compare someone healthy directly to someone with an illness who has similar characteristics (sex, age, family relationship, etc.)
- Determine normal results (for example, when testing a new blood test).
- Learn why some people get a disease and other people do not.
- Help researchers understand why some medicines work well for some people but do not work well for others.
- Help people in the future.
If I am healthy, why should I participate in a study?
Healthy people can choose to take part in a clinical trial. Some reasons healthy people may take part include:
- Receiving a thorough physical exam or free health services depending on the study.
- Receive compensation.
- Contribute to improving healthcare.
- Feeling good about helping someone who is suffering or may suffer in the future from illness or disease.
- Help provide information for developing new treatments.
Why would I not want to participate in a study?
People can decide not to take part in a clinical trial. Some things to consider when making that decision include:
- Risks specific to that study
- How long a person needs to take part in the study
- Where the appointments are
- You may have concern about the accidental release of your personal information. Every study must have security measures to prevent this from happening
- Risks are different for each study. A recruiter will discuss these with you.
How do healthy volunteers find the right study?
There are a few ways people who want to be healthy volunteers can find the right study:
- Search the word “healthy” in clinicaltrials.gov or clinicalstudies.info.nih.gov
- Join the registry for the Clinical Research Volunteer Program. This registry has been around since 1995. It connects volunteers to matching clinical research studies at the NIH Clinical Center.
- If you find a study you want to join, make sure to read the study overview and requirements to take part.
- Parents or guardians must be present for participants under 18 years old.