Frequently Asked Questions
What is a clinical research study?
A clinical research study is a scientific investigation in which people
can help doctors find ways to treat disease and improve healthcare. These
studies are a vital part of the process where new treatments are approved
for use. Before the general public can use drugs and devices, they have
to be tested in smaller groups of people to make sure they are both safe
and effective.
Why would you agree to take part in a clinical research study?
Participating in a clinical research study gives you a chance to play
an active part in your own healthcare and help others, too. It might help
you directly by giving you access to an investigational drug or procedure
you would not otherwise be able to receive at that time. Or, you may agree
to participate just so you can contribute to medical research, even though
you may not receive any direct benefit from the research.
Who can participate?
Before you can take part in a clinical research study, you must first
be “screened” to be sure you are right for the study and that
the study is right for you. All studies will follow established guidelines
describing who should be included in or excluded from the study. Sometimes
a study will be looking for people with a particular medical condition,
and sometimes a study will want healthy volunteers.
How will your safety be protected?
The same ethical and legal requirements that govern the practice of medicine
apply to clinical studies. Clinical research studies are very closely
controlled and have built-in safeguards. Investigators are required by
law to follow very specific procedures. You will be monitored frequently
to check your health and progress. All clinical studies have to be preapproved
by an Institutional Review Board (IRB) before participants can be enrolled.
The IRB is an independent group made up of both medical experts and someone
from the community. It is the IRB’s job to make sure the study is
as safe as possible and worth the risks involved. In addition to reviewing
and approving the study, the IRB will also periodically review its progress.
What should you consider before you participate in a clinical research study?
- What is the study’s purpose?
- Who will be in it?
- What tests and procedures are involved?
- Why do the investigators think the drug or procedure being tested may be
effective? Has it been tested before?
- Am I willing to be assigned (randomized) to either study group? Will I
be satisfied with this decision while I am participating in this study?
- Do I have a strong preference to be assigned to one study group over another?
If you do, a randomized study may not be right for you.
- How do the possible risks and benefits compare with the treatment I am
getting now?
- How might this study affect my daily life?
- How long will the study last?
- Will hospitalization be required?
- Who will pay for the study drug and procedures?
- Will I or my insurance carrier be billed for medical expenses relating
to, or arising from, this study?
- Will I be reimbursed for any expenses?
- What type of long-term care will I receive?
- How will I know if the study drug or procedure is working? Will the results
of the study be provided to me?
- Who will be in charge of my care during the study?
- Who should I contact if I have any questions?