Information for Study Volunteers
The following information is provided to orient potential
study volunteers to the clinical research process. If you have
already participated in a study, or are currently in a study, we
would like to hear from you about your experience. We are
interested in your feedback for purposes of quality improvement.
If you would like to provide feedback you may either complete
the
Research Participant Feedback Form
(Word), or send an
e-mail to our Office. Forms or e-mails should be sent to
gibb@uchc.edu. You can also fax comments to the attention of D. Gibb at
860-679-1005.
If you have questions regarding your rights as a volunteer in
a research study you may call the Institutional Review Board
Office at the University of Connecticut Health Center at
860-679-1019.
Frequently Asked Questions
Clinical research is designed to evaluate health risks and to
test new approaches to the diagnosis, treatment and prevention
of specific diseases or disorders. Clinical research may help to
improve the quality of healthcare or may involve gathering
information about health risks. The knowledge that may be gained
from this type of work can be of great value to our society.
To ensure the safety of volunteers who enroll in clinical
studies, each project must be approved by an Institutional
Review Board (IRB) before it can begin. During the review
process, the IRB evaluates the potential risks and benefits
associated with the study and decides whether or not to approve
it.
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All types of people are eligible to participate in research
studies. Volunteers include adults, children, healthy
individuals, and individuals with illness. Each study has a
specific set of criteria that determines who is eligible to
participate. People who choose to participate in clinical
research studies may do so in hopes of improving their own
health or advancing scientific knowledge about the cause,
treatment and prevention of disease. Some people may benefit
directly from participating in a study, for example if a drug
being used in the study proves to be effective. Some people may
not benefit directly, but their participation may help to
advance knowledge that could benefit others in the future.
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As stated in the brochure from the Office of Biotechnology
Activities (OBA), thousands of genes are found in every cell in
your body. Each of these genes contains a set of instructions
that are read by the cell, allowing your body to make the
proteins it needs. However, in may individuals, a gene's
instructions aren't written properly, which can result in
disease. In a gene transfer study, new genes are inserted into a
person in an attempt to treat the disease. This is a relatively
new area and researchers are trying to learn more about it to
make sure it is safe to use in people and to see if it works.
The gene transfer brochure
(PDF) published by OBA contains more
information.
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Your eligibility may be determined by various factors,
depending on the nature of the study. If you meet the screening
conditions, you will be given an “Informed Consent Form”
containing a detailed written description of the project, any
risks involved, and your rights as a participant. If the
screening process involves any type of intervention, such as
obtaining a blood sample or documenting personal health
information , the consent process will be conducted prior to the
screening to ensure that you are informed of what will be
required of you and of any potential risks to your well-being.
By signing and returning the consent form you agree to
participate. If you should have second thoughts about
participating, or become uncomfortable during the study, you
have the right to withdraw at any time without any penalty
whatsoever.
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Each study has a Principal Investigator (PI) who is in charge
of the project. The PI may be a physician, a dentist, a basic
research scientist or other faculty member. Colleagues of the PI
from either within or outside the institution may also be
involved with conducting the study. In addition to the PI and
colleagues, a Research Coordinator or a Nurse, who is specially
trained in clinical research, could be involved with conducting
a study. The Research Coordinator or Nurse usually serves as
your main point of contact regarding scheduling issues and any
questions or problems you may have relating to the study.
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Participating in clinical research may have a significant
impact on your life. It is important that you are well informed
and feel confident about your decision. You may want to consult
with your doctor, family members and the research staff of the
project to discuss any concerns you may have. Before finalizing
your decision, be sure you know the answers to the following
questions:
- What are the major goals of the study?
- What will be required of me?
- What are the risks, how likely are they to occur and what will
be done to minimize them?
- What role will I play in the study – healthy volunteer or
patient volunteer?
- Is the study likely to benefit me directly?
- What are the potential benefits to others?
- How long is my participation required?
- What discomforts, inconveniences and costs are involved?
- Do I want to participate in this study?
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As a research participant, you are guaranteed certain rights
to ensure that you are treated in an ethical and respectful
manner. The following list identifies your basic rights. These
rights are explained in greater detail during the informed
consent process.
As a research participant, you have the right to:
- Be treated with respect
- Know the risks involved with the study
- Know what alternatives are available
- Withdraw from the study without penalty
- Make your decision without feeling any pressure from the
research staff
- Know the name, credentials and contact information of the
Principal Investigator
- Know the purpose of the study
- Know who will have access to your information
- Know what procedures may be performed and what drugs may be
used.
- Seek additional help or clarification during the informed
consent process, or at any time during the study.
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In addition to complying with the specific requirements of a
study in which you may enroll, you will also be expected to
adhere to a general set of responsibilities that pertain to all
research participants. These responsibilities include:
- Arriving for all scheduled appointments or calling ahead if
you are unable to keep an appointment
- Arranging your own transportation to and from the study site(s)
- Following the directions of the researchers
- Making sure your contact information is up to date
- To the best of your ability, providing accurate information
about your past/present medical history if it is relevant to the
study
- Seeking healthcare for any medical conditions unrelated to the
study
- Asking the researchers to completely answer any questions you
may have at any point
- Informing the research staff of any adverse events you
experience while enrolled in the study
- Informing the Institutional Review Board Office if you feel your
rights as a subject are being violated. The phone number for the
IRB is provided below and also in the informed consent form.
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Helpful Links
Brochures
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