Frequently Asked Questions
Why should I participate in
clinical research study?
New medical treatments and equipment must have FDA
approval before they can become available to the public.
Clinical studies that demonstrate efficacy are a part of
the required government approval procedure. Individuals
who volunteer to join these studies can have a great
impact on the lives of thousands of people. Volunteer
involvement allows research trials to proceed and helps
to clear the way for advanced treatments to be
accessible to those who need them.
As a volunteer participant, you also may have some
significant health benefits:
- A thorough medical history, physical exam and
laboratory services (if needed) will be done for you
at no cost.
- Depending on the type of study, free monitoring
supplies for certain health conditions (such as
diabetes) may be available to you if appropriate.
- You may have early access to a new and advanced
You will also be gratefully appreciated for your
contribution to the advancement of medical science
and health care.
Who will take care of me during
a clinical research study?
Your study-related care is provided by our team
of physicians, nurses, research coordinators and
other medical professionals.
How are my personal
information and my health protected?
and other personal information, including that which
pertains to your health, medical care and study
participation, are protected according to the
regulations set forth by both the United States and
Texas state governments.* These rules do permit the
sharing of some of your information with the
research sponsor and certain government officials
under very specific circumstances. This allows the
sponsoring organization to consult with us about the
progress and result of the study and also
contributes to the protection of both your health
and privacy during your participation. Research
organizations are also subject to inspections by the
FDA and the research sponsor, and to questioning by
Institutional Review Boards and Data Monitoring
Committees. Confidentiality regulations apply in
these situations. There are also other legal and
ethical guidelines that must be followed by medical
professionals as well as their office staff.
In addition, we are required by law to provide
you with detailed information about the study so
that you may give your “informed consent” to become
a study volunteer. These details will discuss study
purpose, procedures, duration, possible risks and
benefits, protection of your health and privacy,
optional health treatments that you may wish to
consider, treatment of any health problems that
could be encountered as a result of study
participation and other important information.
We will also answer your questions about these or
any other study-related topics when you visit our
* For more information about medical privacy
regulations, please visit
Will there be any cost to me to
participate in a clinical trial or will I be
compensated for my participation?
There is no cost to participants in a clinical
study. All medical care, medications and equipment
related to the research investigations are provided
at no charge. Most participants are reimbursed an
amount to cover time and travel for office visits.
The reimbursement rate varies with each study and
will be discussed with you for your consideration
before you give your written consent to participate.
Can I withdraw from a study or
must I continue to participate until it ends?
You may discontinue participation at any time for
any reason. The informed consent document that you
must sign is not a contract and does not state that
you must remain in a research study. You may be
offered suggestions about how to leave the study,
especially if trial medication needs to be stopped
gradually or you need to return study medication or
other materials. It could be helpful, although not
required, to inform the researchers about your
reasons for the decision to discontinue. This
information may assist researchers in improving the
clinical trial process and make the results of the
study more reliable. Your reasons for withdrawal
will be kept confidential in accordance with
professional ethical guidelines and government
Will the study doctors continue
to take care of me when the research ends?
Most clinical trials include medical care related
only to the purpose of the study and do not offer
extended or total primary or specialty health care.
You should continue seeing your primary and/or
specialty medical professionals during and after the
completion of your study participation.