Frequently Asked Questions:
What is a clinical study?
A clinical research study is also called a clinical trial. Each study tests the
effectiveness, side effects, and safety of an investigational medicine(s) or an
investigational device on a group of volunteers. Clinical trials demonstrating the
effectiveness and safety of new medications are required for the FDA to grant approval
for general use.
Who sponsors a clinical research study?
Private organizations and government agencies sponsor clinical research studies
to find better ways to treat diseases. Drug companies also sponsor studies of
their products and may work together with medical centers, the government, or
doctors' offices.
Who makes sure my rights are protected?
An ethics committee must review clinical research studies before they begin.
In addition, the FDA (Food and Drug Administration), a department of the U. S.
government, sets requirements for drug testing. They also review the results
from certain clinical research studies to decide if an investigational drug
should be made available to the general public.
An ethics group that reviews a clinical research study is called an IRB
(Institutional Review Board). The IRB is a group of doctors, nurses, and people
from the community. The IRB's job is to review all clinical research studies to
help protect participants' rights and safety.
Who conducts a clinical research study?
A research team conducts the clinical research study. The team is led by a
doctor or other researcher, known as the Principal Investigator. The team may
also include nurses, social workers, dieticians, and others. This team may
conduct the clinical research study in a hospital, university, local medical
center, or doctor's office.
Who can be in a clinical research study?
Each clinical research study has different requirements for participants such as
age, sex, or medical condition. It is important that different kinds of people
are involved in the trial, men and women from different races. People respond
differently to medicines and other treatments so it is important to include all
kinds of people.
The research team will look at your medical history and study requirements to
find out if you are eligible. The team will also tell you what it means to be
involved in the study and what the risks and benefits are during the informed
consent process.
What is informed consent?
Informed consent is the process that takes place before you join the study.
A doctor, nurse, study coordinator, or another person on the team will explain
why the study is being done and what you can expect. You can ask any questions
you have about the study.
You will be told about who will see your personal medical information and how
it will be kept confidential. You will also be given a consent form to read.
You should ask questions about any part of the consent form you do not understand.
If you decide to take part in the study, you will be asked to sign the consent
form. Even if you sign the consent form, you can still change your mind and
stop at any time.
What can I expect as a study participant?
During the study, the team will review your medical history, give you
instructions for participating, and monitor your health. Some clinical research
studies may involve more tests and doctor visits than you would normally have
for an illness or condition.
How can I become a study participant?
To learn more about being in a clinical research study, or if you are looking
for a clinical research study that is right for you, please call 801-532-4526 or
send us your name and number and
we will call you.