Why Volunteer

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Why Volunteer?
Each year, millionsof people volunteer to
participate in clinical research studies.
Without volunteers, there would be no new
therapies for diseases illness. .
bms/ukcro/9-2007
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What Is a Clinical Research Study? A clinical
research study (or clinical trial) is a research
study in human volunteers to answer specific
health questions. Carefully conducted clinical
trials are the fastest and safest way to find
treatments that work in people and ways to
improve health. Who conducts clinical research ?
Studies are typically conducted by a qualified
investigator, usually a physician, and a research
team.
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Interventional trials determine whether
experimental treatments or new ways of using
known therapies are safe and effective under
controlled environments.
The medical treatment could be a procedure, drug
or device. Studies are done to see if a product
is safe and effective for people to use. Doctors
and other health professionals run these studies
according to strict rules set by the U.S. Food
and Drug Administration (FDA). 
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Some research studies may evaluate something
other than a medical condition or clinical
treatment. Some may look at behavior or examine
common practices and may just involve completing
a survey or questionnaire. Regardless, you
should be informed as to how your information
will be protected and kept confidential.
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How Are Studies Approved for Volunteer
Participation? Prior to testing on people,
medications must go through years of laboratory
testing. Before it is approved for use in
volunteers, the FDA reviews the laboratory data
and study plan to determine if the drug or device
should be tested in people.  FDA also inspects
scientists and research sites to make sure
volunteers are being protected and the study is
being done correctly.
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Institutional Review Board
Protecting Study Volunteers
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. 
Sample Informed Consent Form
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Informed Consent

• For most studies, the informed consent process
  means that you will
• receive detailed information about this study,
• be encouraged to ask questions and take time to
  decide before you sign the form
• be asked to read, sign and date an informed
  consent form, once you understand the study and
  wish to participate
• be given a copy of this signed and dated form to
  keep for your own records
• Some survey or questionnaire type studies will
  have approval to waive the actual form or
  documentation of informed consent but you still
  have a choice regarding participating.

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Is Volunteering for You?

• Few people are even aware that they may be
  eligible to volunteer for a research study.
  Research studies enroll healthy volunteers as
  well as patients with medical conditions.
• To determine if you qualify for a study, you may
  need to answer some questions regarding your
  medical history and all medications you take.
  There may also be a screening phase of the study
  to further determine if you meet the study
  criteria.

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Top 10 things to consider when deciding about
participating in a research study.

• What is the study trying to find out?
• What will be done to me in the study?
• Is there a chance I could get a fake treatment
  (placebo) or no treatment?
• How much time will the research take?
• What are the possible bad things (risks) that
  could happen to me?
• Are there any possible good things (benefits)
  that could happen to me?
• What are my other treatment choices?
• Will it cost me anything or will I be paid
  anything to be in the study?
• 9. How will my privacy be protected?
• 10. Who can I call if I have problems or further
  questions?

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Clinical research with children involves
additional regulations and protections enforced
by the IRB. Children 6 and older should be
involved in the decision to participate. For
children to participate in a clinical research
study, the parent/guardian must provide
permission (consent)and the child must agree to
participate (assent).
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Be aware that your relationship with the research
doctor is different from your relationship with
your personal physician. Your personal
physician tailors the treatment of your specific
problem expecting that it will benefit you. The
research doctor treats all participants under a
specific protocol to obtain general knowledge
with an understanding that you may or may not
benefit from being in the study.
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Recommended flow of informationEducate me
about.
the disease
the standard treatment
the clinical research study
then review Informed consent
Source St. Jude Childrens Research Hospital
www.Cure4Kids.org
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• Remember
• ? Before you agree to take part in a study, you
  must be given complete information about the
  study, including possible side effects and
  benefits.
• ? You should ask lots of questions to be sure you
  understand the study.
• ? The researcher must obtain Informed Consent
  and/or Assent from a parent and child before
  taking part in the study.
• ? The Informed Consent is not a contract.
• ? Study volunteers can leave the study at any
  time.

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• The UK Office of Research Integrity offers
  information and links for parents at
  http//www.research.uky.edu/ori/human/participants
  .htmlParents
• Volunteer concerns or suggestions 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 obtain information or
  offer input with an informed individual who is
  unaffiliated with the specific research protocol.
  At UK the toll-free phone number
  is1-866-400-9428.

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Volunteer Opportunities

• To find clinical research opportunities at the
  University of Kentucky visit www.UKclinicalresear
  ch.com or call 859-323-8545.
• For more information on clinical research
  studies and to search nationally for study
  opportunities, visit www.clinicaltrials.gov

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Learn more about how you can make a difference in
tomorrows health care by being a volunteer.