Rapid Message Testing with Consumer Panel; Clinical Trials Brochure

Data to Support Drug Product Communications as Used by the FDA

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Rapid Message Testing with Consumer Panel; Clinical Trials Brochure

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Research Can Improve
People’s Health

How YOU can become a
research volunteer:

Research helps doctors and scientists better
understand, prevent, and treat diseases.

Ask your doctor or nurse. They might know if there is
a research study that is right for you.

Research also helps scientists find out if
medicines work and are safe for people to
use.

Become a
Research Volunteer
Research needs you
It’s YOUR decision

!
Some other words that
describe research are:
• study
• clinical trial
• protocol

Research has led to important discoveries that
make our lives better.
Some examples are:
• new medicines to treat cancer, diabetes, heart
disease, HIV/AIDS, and other diseases &
conditions
• vaccines
• ways to stop smoking
• faster medical imaging machines

For more information about participating in
research studies please visit or call:
clinicaltrials.gov
www.nih.gov/health/clinicaltrials
OMH@fda.hhs.gov
1-888-INFO-FDA
(1-888-463-6332)
Follow us on Twitter @FDAOMH
www.fda.gov/MinorityHealth

? !
U.S. Department of Health & Human Services
Food & Drug Administration
Office of Minority Health

Why should YOU volunteer?

What are the risks?

Questions YOU should ask:

The medicine being tested may be new, so
you may have side effects the doctor does
not expect.
Many side effects don’t last long and go
away when treatment is stopped.

•	 What is the study trying to find out?

In rare cases, side effects can be serious or
even life-threatening.

•	 How long will the study last?

Before you choose to volunteer, risks
should be fully explained to you.

•	 What are the risks? Will there be any side
effects?

You will be given detailed contact
information in case of severe side effects or
emergency.
If the medicine you receive in the study
turns out to be harmful, the study is
stopped.

How are YOU protected?
Before you agree to volunteer, you need to
get the facts. The research team is required
by law to explain all the study details,
including potential benefits and risks.

It is important for research studies to include
volunteers from diverse populations.
As a volunteer, you can:
•	 benefit society by helping researchers find better
treatments for you and others in the future
•	 help researchers discover better ways to fight
diseases
•	 help researchers find out if people process
medicines in different ways

To show you understand what will
happen during the study, and you agree
to volunteer, you sign a special document
called “informed consent.” You can
obtain help from a representative legally
authorized by you if you don’t understand
the document.
This is not a contract. You can leave the
study at any time for any reason.
Every study is monitored to make sure it is
as safe as possible.
Your study records are private and
confidential. The research team, your
doctor or nurse will have access to your
records.

•	 What exactly will happen to me in the study?
•	 Will the study help me personally?

•	 What are the side effects? Will I get help/
treatment for the side effect if I get any?
•	 Who will pay for my enrollment in the study?
Will it cost me anything personally?
•	 Will I receive money for being in this study?
•	 What other options do I have?
•	 What are the potential risks if I’m pregnant or
become pregnant?

?


File Typeapplication/pdf
File TitleFDA Brochure on Becoming a Research Volunteer
Subjectresearch, clinical trial, volunteer, studies, participant
AuthorFood and Drug Administration, Office of Minority Health
File Modified2014-03-27
File Created2014-03-26

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