And why participation is important
Why We Research
And why participation is important
We need you
If you’ve ever thought about participating in a clinical study, now is the time. Clinical
studies are what allow all medications to come to market, including drugs that treat infections, cancer,
lung disease and heart disease. Without clinical studies, no medications would be available
for use. Your participation is extremely important – here’s why.
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You can give the ultimate gift
Did you know you have the power to alter lives? When you make the decision to enroll in a clinical
study, your participation helps to shed light on diseases, their progression and precisely how to
treat them. Your participation helps bring life-changing medications to those who need them.
That’s a gift that has profound impact – today and tomorrow.
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You can help those you love and others
They could be family members, or they could be people you never get to meet. But because of
you, people will be living better, healthier lives. Your participation helps advance scientists’
understanding of the disease or illness. Making new or improved treatments available means
more treatment options for everyone, maybe even you or someone you know.
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You can have access to new treatments
Participating in a clinical study may give you access to experimental, cutting-edge treatment
options. Plus, as a participant, you’ll have access to an expert medical team that carefully
monitors your disease and your overall health.
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What to expect
1
Pre-Screening
If you’re interesting in participating, you’ll be pre-screened by our staff,
either over the phone or at our facility. This initial conversation will
help our staff determine if you’re eligible to enroll and your level of
interest in a study.
FIND A STUDY
2
Informed consent
Before you agree to participate in a clinical study, you have the right to
know and understand what will take place during the study period. This is
called “informed consent,” and it’s a very important aspect of clinical
study participation. This represents a serious commitment, so you should
carefully review the forms that explain your rights and obligations as a
participant. This is where you’ll decide if enrolling in a study would be
right for you. More questions?
Get answers
3
Screening
The purpose of this step is to ensure that all volunteers meet the
requirements for a clinical study. The specific eligibility criteria are
established by the study protocol, and they will vary depending on the type
of trial being conducted as well the overall focus for the research. If
you’re interested in participating in a study, you may be asked to come to
our clinic for lab tests, physical exams, blood tests and any other
necessary screening procedures. Ready to participate?
FIND A STUDY
4
Enrollment and randomization
Once you’ve passed all screening evaluations, and been chosen to
participate, you’ll be assigned to a specific group for the duration of the
study. You could be one of the participants receiving the experimental
treatment or therapy, or you may be assigned to the group being administered
a placebo.
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5
Scheduled study visits
Depending on the protocol, you’ll have a set number of
clinic visits. Some studies don’t require any. These visits
could be scheduled on a daily, weekly, monthly or annual
basis, depending on the prescribed treatment period. The
protocol will also outline what you’ll do at each visit, but
visits typically include having physical exams, blood work
or even filling out a brief questionnaire. What else would
you like to know?
Get answers
Volunteer Safety & Privacy
The US Congress passed The Health Insurance Portability and Accountability Act Of 1996 (HIPAA) Privacy and Security Rules. This law protects your personal health information and requires that you give permission, in writing, for the use or transfer of that information. When you sign the Informed Consent at screening, you’re also granting permission for your Protected Health Information to be collected and used inside and outside the United States for research at ICON.
You won’t be identified (by name, street address, etc.) in any information used outside Of the clinic unless required by law. While you’re in the clinic, you’ll be identified by your initials and date of birth to protect your privacy. You may request your medical records from ICON at any time.
The safety of study volunteers is our top priority at ICON. Across the globe, clinical trial conduct is governed by the International Conference on Harmonization and Good Clinical Practice (ICH/GCP). The ICH mandate is to create International harmonization, aimed at ensuring that good quality, safe and effective medicines are developed and registered in the most efficient and cost-effective manner. Good Clinical Practice is outlined by the ICH and describes the ethical principles for medical research that must be observed to ensure volunteer safety. In the United States, the Food & Drug Administration (FDA) is the government agency that regulates clinical research. In addition to federal oversight, ICH/GCP also requires that all clinical research is overseen by a local Institutional Review Board (IRB) that includes both clinical experts and members of the community.
It’s important to understand that there is a certain level of risk involved with clinical research studies. The safety and well-being of participants is always the number one priority at ICON. During the screening process, you will be asked to provide information about your medical history. To minimize your risk as a study participant, it’s important that you provide a thorough and accurate account of your past and present medical history. As a volunteer, you have the right to remove yourself from a study at any time, for any reason, with no penalty or loss of benefits to which you are entitled.
SEE OUR PRIVACY NOTICE
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Meet some of our extraordinary people and discover what ICON means to them!
About ICON
We’re committed to the drug development process because we understand how it impacts the lives of patients and their families. At the end of the day, we’re not just researchers. We’re patients. We’re survivors. We’re family members.