Patient Info: Participation
Safety, Rights and Responsibilities
Clinical research is impossible without the generous and selfless
participation of patients. The MUSC Digestive Disease Center is
dedicated to safe, ethical and professional behavior when conducting
a clinical trial. Therefore, it is very important
that patients understand their rights and what to expect
if they decide to participate in a clinical research study.
(Left to right) Coordinators April Williams, Rebekah Whichard, Christine Davis and Janice Freeman pose on atrium stairs in the Ashley River Tower.
Safety
Once
U.S. Food and Drug Administration (FDA) or
National Institutes of Health (NIH) has given approval for a
research study of a medication, device, procedure to start, the
individual hospital or research center must then receive another
approval from an Institutional Review Board (also called an IRB).
There are a few things to consider before participating in a
research study:
- Check with your personal doctor — Your
doctor can be a source of information about the risks and
benefits of participating in a clinical trial.
- Have a good understanding about your current state
of health — You will be told about the known side
effects and other health risks of the treatment(s), but not all
of the risks can be known when you decide to participate in a
trial. Also, be sure you report all the normal medications you
are taking, including vitamins and herbal.
- Ask lots of questions — Before you make
a decision whether or not to participate in a clinical trial,
ask lots of questions. If possible, read the information given
to you about the study. Ask if you can take it home to read if
you need more time. Sometimes it is helpful to make a list of
questions in advance to ask the study coordinator or doctor.
Rights
Informed Consent — Before you decide to
participate in a clinical trial, a research coordinator, clinician
or physician will discuss the research study with you. This
discussion will include a detailed explanation of the purpose of the
trial and the type(s) of treatment to be studied, your chances of
receiving a given treatment, the known risks and benefits of each
treatment, and any costs related to the study that you may be
responsible for paying.
You will always be given a chance to ask any questions you may
have and enough time to make an informed decision. If you decide to
participate in a clinical research study, you will be required to
review and sign an Informed Consent document (the consent form),
which will also let you know whom to contact for more information
and fully explains your rights during the trial.
Confidentiality — In addition to signing an Informed
Consent, you will also be given a form called a HIPAA authorization.
You will be asked to review and sign this form before you can
participate in a clinical trial.
Right to Withdraw From a Study — Your
participation in a clinical trial is totally voluntary. You are not
obligated to participate and you have the right to withdraw from a
study at any time.
For more information on your rights,
follow this link.
Responsibilities
Study Requirements — The study coordinator
and/or doctor will discuss the study with you to make sure: (i) all
questions were answered to your satisfaction; (ii) you voluntarily
agreed to enroll in the study; and (iii), you accept the
responsibilities involved with being a research subject on this
particular study.
When you sign an informed consent you are agreeing to enroll in a
clinical trial and attend all study visits. It also means you agree
to follow the requirements of the study.
You will always have the right to withdraw from the study at any
time.