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1. Is there a Patients’
Bill of Rights?
Yes. Any person who has decided to volunteer in a clinical trial
treating with medicine or an instrument, or anyone who is deciding for
another person (i.e. child) to participate in a clinical trial, has the
right to:
- Be informed of the nature and purpose of the research
study.
- Be given an example of the tests to be done in the
research study and to be told of any instrument or experimental research
medications to be used.
- Be given an idea or an example of any discomforts
or risks associated with participation in the study.
- Be given an idea of the benefits associated with
participation in the study.
- Be given an idea of any other methods, medications
or instruments that might be worthwhile and good for them (or their
child), and their relative risks and benefits.
- Be informed of other avenues for medical treatment,
if any, that are available to them (or their child), either during or
after the completion of the clinical trial.
- Be given time to ask questions concerning the experimental
research medication or instrument or the medical tests involved.
- Be aware that they (or their child) may drop out
from the clinical trial at any time without any criticism.
- Be given a copy of the signed and dated informed
consent form.
- Be given the time to decide to consent or not to
consent to the clinical trial without pressure, force or deception.
2. How much time is involved?
It depends on the research study, but we do our best to work around your
personal schedule.
3. How much will this cost me?
Nothing. All study-related procedures and medications are provided for
you.
4. Is there a chance
I could be given a placebo?
With some research studies, yes; however, your health is our first priority,
and our study doctors and study staff make every effort to ensure your
well-being.
5. Will I know what medicine I am on?
Probably not. In the event of a medical emergency, the treating doctor
must know what you are taking. There is a process in place to give your
doctor the name of the study medication you are taking.
6. What happens to the information collected through the course
of the research study?
The data collected from your records tells researchers how well the specific
treatment is working. In the early stages of testing a new medication,
pharmaceutical companies evaluate the information and plan future studies.
If a medication is proven to be safe and effective, the company submits
the information to the Food and Drug Administration (FDA). When the medication
is FDA approved, then it is available by prescription from a doctor.
7. What happens if I
cannot continue in a study?
Our studies are completely voluntary
and you are allowed to withdraw without penalty at any time. Our study
staff will follow up with you to make sure that you are in good health.
8. Do I need a referral from my personal doctor to participate
in a clinical trial?
No. Participation is strictly up to you. However, we encourage you to
discuss the research study with your personal doctor and family before
deciding to volunteer for a research study. Study doctors are on hand
to answer any questions about experimental study medications and drug
interactions with you.
9. Are there risks involved?
There are always risks involved when taking any kind of medication. We
inform you of any possible risks and side effects prior to your enrollment
in a research study.
10. Are there benefits?
Yes. You will receive education and excellent care by study doctors and
study staff. You will also receive the benefit of knowing that you are
helping provide the medical community with important knowledge about your
disease and its treatment.
11. How do I get in touch with the Clinical Research Program
about these research studies?
Please feel free to contact the CRP at 601-815-1328
or send an e-mail
(umcstudies@medicine.umsmed.edu)
with your comments. We will get back with you as soon as possible.
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