Transcript Your Clinical Research Knowledge

Your Clinical Research
Knowledge
 B Smith, ORI, 2012
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Clinical research is subject to
federal regulations, ethical
review, and university policies all
of which are designed to provide
protections and safeguards for
clinical research participants.
True
False
A
True. Two of the main safeguards for study
volunteers are the Institutional Review Board (IRB)
and Informed Consent Process.
The IRB is a committee consisting of health care
professionals, scientists, and non-medical people
from the local community who review all studies to
ensure that the participants’ safety is protected,
their personal rights are respected, and they are
informed fully about the research study.
To help you decide if you want to be in a study, you
will be given complete information about the study
before you agree to take part. This is known as the
informed consent process.
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INFORMED CONSENT INVOLVES A
PARTICIPANTS AGREEMENT TO JOIN
AND REMAIN IN A CLINICAL
RESEARCH TRIAL.
True
False
A
False, While informed consent
is designed to provide you with
the knowledge to make an
informed decision on
volunteering for a study, you
are ALWAYS free to choose to
leave the study at any time.
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IF A STUDY PARTICIPANT HAS A
CONCERN OR COMPLAINT THAT THEY
ARE NOT COMFORTABLE REPORTING
TO THE STUDY DOCTOR, THE
INFORMED CONSENT FORM
PROVIDES A PHONE NUMBER TO CALL
THAT IS SEPARATE AND INDEPENDENT
OF THE STUDY DOCTOR.
True
False
A
TRUE! It is IRB policy to provide a
safe confidential, and reliable way
for current, future, or past research
participants to discuss problems,
concerns, and questions.
Call toll-free at 1-866-400-9428 to
speak with a research integrity
representative who is not
associated with any specific
research study.
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Medical Research is the
same as Medical Treatment.
True
False
A
Source: Adapted from Alz.org
False. Doctors choose medical treatment
with some expectation regarding safety
and effectiveness.
Medical research is done according to a
specific plan to answer a question.
The fact is you may or may not benefit
from being in the study.
While the results may help others in the
future, you should to be informed
regarding both the potential risks and
benefits involved in order to decide if
you wish to participate.
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If I join a treatment clinical
trial, I could get a placebo.
True
False
A
True, in certain types of clinical trials ,
some of the participants will receive
an inactive placebo as part of the trial
design. This is done “randomly” or by
chance like flipping a coin.
HOWEVER, other studies compare the
study treatment to a standard
treatment already available and
approved by the Food and Drug
Administration (FDA).
ASK QUESTIONS IF YOU AREN’T CLEAR ABOUT YOUR CHANCES OF RECEIVING A PLACEBO!
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IF THERE IS A CLINICAL
TRIAL THAT COULD HELP
ME, MY DOCTOR WILL TELL
ME ABOUT IT.
True Unsure False
A
While physician referral is typically listed as
the “preferred” source of clinical trial
information, most surveys indicate that
people find out about studies from other
resources such as the media or direct or
internet advertising.
Your physician may be unaware of all the
research studies in your area.
For the most up-to-date information about
University of Kentucky Clinical Research visit
www.ukclinicalresearch.com or browse a
National database at www.clinicaltrials.gov.
Source: Center for Information and Study on Clinical Research Participation http://ciscrp.org/
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AN ESTIMATED________% OF
MEDICATIONS APPROVED BY
THE FOOD AND DRUG
ADMINISTRATION (FDA) ARE
LABELED FOR USE IN
CHILDREN.
20 - 30 40 - 50 70 - 80
Source: FDA Consumer Information
www.drugs.com/fda-consumer/should-your-child-be-in-a-clinical-trial-60.html
A
Historically, only 20-30% of FDA approved
drugs are labeled for use in children.
Since children aren’t “little adults” research
is important to better understand how best
to treat children.
However parents must make informed
decisions about their child’s participation in
clinical trials. Children also have the right to
agree to participate.
Learn more at the FDA website, Should Your
Child Be in a Clinical Trial? To learn from the
experiences of parents, experts, and
children who have participated, view the
NIH Children & Clinical Studies Videos .
Congratulations on completing the
Clinical Research Participation Quiz
For more information on clinical research and protection of study
volunteers visit www.research.uky.edu/ori/human/participants.html
www.research.uky.edu