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This FAQ has been designed to answer our participants' most
commonly asked questions.
What is a clinical study?
Why do manufacturers test products
with you?
How can I take part in studies for
you?
How can I find out about upcoming studies?
What if I don't qualify for a study or I drop during a study?
What if I don't show up for my first study visit?
How many studies can I do at one time?
Who monitors your studies?
Do you sell my personal information?
Why do I have to give you my Social Security Number?
(United States only)
Can I bring my child to a study visit?
Some facts about study
participation
A clinical study is a careful plan that involves people like you receiving
product treatment under the close supervision of research professionals.
Participants may use the test product once or many times while trained
evaluators determine how well the product performs, how it reacts with the
participant’s body, and sometimes what kind of feelings you have about the
product. Studies differ in length from one day to over two years. Most of our studies on average last about a week or two. Studies can also differ in the
number of visits to the research site and the requirements. The study’s plan,
also called a protocol, has very specific instructions and requirements. We are hired by major personal care or pharmaceutical companies to conduct
clinical studies.
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Companies test products with us for a variety of reasons. Primarily,
companies place studies with us in order to test the safety of
their products or to support claims that they wish to make about their products.
Safety tests determine whether a product causes significant or unexpected
reactions with study participants. Other studies conducted by us support
claims. These tests are designed to document the efficacy of a product or
population preference. These results are commonly used in advertising.
Commercials that tout a stronger antiperspirant or a more efficient moisturizer
are making claims proven by research data collected by facilities such as us.
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You must first qualify for a study in order to participate. All studies have
specific entrance criteria. This criteria varies from study to study. To take
part in a study, call the Study Information Center. A Study Specialist will ask
you a series of questions to determine your eligibility. Once you are screened
over the phone and pre-qualify, you will be given an appointment time. You must
then report to our facility at your appointed time. At the time of
enrollment you must meet the following criteria to complete the enrollment
process:
- You must sign an informed consent at your first study visit.
- You must meet eligibility standards on the first day of the study
including basic enrollment criteria and be in good health established by a
medical history and, in some cases, vitals.
- You must agree to follow all study instructions and commit to all study
visits.
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There are many ways to find out about upcoming studies that you may qualify
for.
- You can call the Study Information Center 7 days a week at 1-800-874-7550
or locally in Cincinnati at 513-831-2240.
- You may wish to check back with our website frequently to see what studies
you may qualify for
- We can arrange to send you emails about upcoming studies.
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You are free to drop from a study for any reason at any time. Since we cannot
use incomplete data, we ask that you contemplate the study prior to enrolling to
ensure that you can commit to the study and attend all study visits. If you do
drop and are entitled to monetary compensation, you will receive a check in the
mail after the study has completed. However, as with any time a participant does
not fulfill a commitment to complete a study, dropping off of a study may impact
your privilege of participating in future studies.
If you do not qualify for a study because you have not met the eligibility
requirements or the study has been previously filled, you will only be
compensated for your time and travel. Our policy is to enroll each study on a
first come first serve basis, and consequently, sometimes over-recruiting a
study is unavoidable.
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If you do not show up for a study or provide insufficient notice, it will be
noted in your file and you may lose the privilege of participating in future
studies. Usually, you may not be eligible for another study until the study that
you had been recruited for has completed. The viability of our studies depend
upon the commitment of our participants. We ask that you call the Study
Information Center at least 48 hours in advance if you are unable to make your
appointment so that we may find a replacement.
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You are only allowed to enroll in one study at a time. The government and our
clients have strict rules about participating in more than one study at a time.
When studying how any product affects humans, there may be several criteria that
we are evaluating. If in rare circumstances, you do have a reaction to the
product, we need to isolate what product or what ingredient of the product is
causing that reaction. Participants are not allowed to do two studies
concurrently whether they are conducted with us or another research
facility. Participants are only eligible for future studies once they are
released from their current study.
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We follow all Good Clinical Practices [GCP] mandated by the
US Food & Drug Administration [FDA] and International Conference on
Harmonization [ICH] guidelines where the rights, safety, and well-being of the
participant prevail over the interests of science. Study participant information
is kept confidential by us. However, the sponsoring company whose product
is being tested will receive study records that are coded to protect your
identity. The sponsoring company, the Institutional Review Board [IRB] and the
FDA may inspect all study records. Study information may be used for medical or
scientific publication, but your identity will always remain confidential.
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No, your personal information within our database is never sold to outside
companies. Further, every one of our associates signs confidentiality agreements to
protect both study sponsors and study participants.
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In order to pay you, we must have your social security number in our
computer. You may give us your number over the telephone, or you must give it to
us on the first visit of your study when you are required to complete a W-9
form. Each January, we will send 1099s to anyone who makes $600 or more in
one year.
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Our lab is not set up for any childcare. Additionally, the safety of our
participants and the accuracy of the scientific procedures of our studies are
absolute. If you bring a child with you to the study visit, in most
circumstances, we will have to drop you from the study. Sometimes we do
studies for children’s products. Parents must attend study visits with the
child, but only children who are enrolled on the study will be allowed into the
research site.
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According to CenterWatch, a company providing study participants and their
advocates with a variety of information about clinical research, 3.5 million
people participated in clinical studies in the United States in 1999, and that
number grows annually. Most study participants have very positive experiences,
and three out of four volunteers (75%) say that they would definitely
participate in a clinical trial again; while another 22% said that they might
participate again. Finally, 61% of the general public report that they would
likely get involved in a clinical trial. (CenterWatch. A Word from Study
Volunteers-Opinions and Experiences of Clinical Trial Participants. Pamphlet.
2002)
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