Information For Study Volunteers
So, you’re considering becoming a volunteer.
While each research center
has its own characteristics, which reflect the unique strengths
of its parent institution as well as the interests and needs of
the participating researchers, they all have many things in
common, as well. Not least among the similarities is their need
for research subjects. All clinical research centers throughout
the nation are
dependent upon volunteers who can take part in the research
studies being conducted and, through their participation, help
to advance healthcare.
You could be one of those
volunteers. If you are visiting this website, it’s likely that
you already have an interest in volunteering. Maybe someone who
has been a volunteer in the past has encouraged you to
volunteer. Or perhaps you have a health problem that’s related
to one of the studies currently being conducted at the UConn
Health Center (UCHC) Clinical Research Center (CRC).
There are probably as many
reasons to volunteer as there are volunteers for our research
studies. We welcome your interest and we encourage you to apply
to become a volunteer.
You’ve probably got some
questions. Here are some of the things many potential volunteers
want to know about.
What is clinical research and why should I volunteer to
participate in it?
We conduct clinical
research to evaluate health risks and to test new ways to treat
and prevent specific diseases and disorders. Clinical research
can improve the quality of healthcare. Often it involves
gathering information about health risks. The knowledge
resulting from clinical research is of significant value to
society. Without it, healthcare in our nation would almost
certainly be different than it is today.
By volunteering as a
participant in one of the CRC studies, you’ll have the
satisfaction of knowing that you are making a contribution to
the improvement of healthcare for our society. Moreover, many
volunteers report additional personal benefits from
participating in our studies. Sometimes, for instance,
participants in a study are able to receive experimental
treatments that have a beneficial effect on diseases or
disorders from which they are suffering. The stories of some CRC
volunteers who’ve had positive experiences are presented on this
Is it safe?
The studies conducted at
UConn’s CRC are approved according to federal, state and UCHC
guidelines. In fact, no study can even begin before it has been
approved by the Institutional Review Board (IRB), which
carefully scrutinizes the potential risks and benefits of the
study before approving it. The safety and protection of
volunteers participating in the studies is of paramount concern.
Whenever anyone applies to
be a volunteer participant, (s)he is given an informed consent
form that spells out the nature of the study and any risks that
are involved and clarifies his/her rights as a participant. If
any kind of intervention will be involved – such as obtaining
blood samples or documenting the participant’s health history –
a careful consent process is conducted before the person
actually becomes involved in the study. This ensures that the
volunteer knows what is expected and any possible risks.
Completing and returning
the consent form means the person agrees to volunteer. But if
the volunteer then has second thoughts, (s)he can simply
withdraw from the study. There is no penalty for withdrawing.
Additionally, the CRC
research team includes a research subject advocate (RSA), whose
job is to represent the interests of the volunteers who
participate in our studies. The research subject advocate is
available to provide information to patients and volunteers who
are participating in any studies in the CRC.
Other responsibilities of the advocate include:
Review research plans to identify safety
and/or ethical concerns before a study begins;
Serve as an unbiased observer and counsel to
potential subjects and research study staff on
the informed consent process, as requested;
Advise investigators in the development and
implementation of Data and Safety Monitoring
Facilitate investigator’s reporting of adverse
Review protocols and consent forms of ongoing
CRC studies to confirm IRB-approval and
communicate any changes to the CRC Scientific
Advisory Committee (SAC);
Serve as a resource to research participants,
study coordinators, investigators, and nurses
for consultation, education, and research
Who participates in clinical research studies?
Because clinical studies
focus on a wide range of diseases and disorders, all kinds of
people are needed as volunteers. Volunteers can include both
healthy people and people with an illness. Every study has its
own unique criteria for who is eligible to participate.
Are you eligible to participate?
That depends upon a variety
of factors, such as the nature of the study and whether you meet
the screening requirements. You will know more about the study
and whether you qualify when you receive the informed consent
form, which will provide you with a thorough description of the
project and any risks to participants.
If you decide that you
would like to volunteer for a study, the CRC staff will
determine if you meet the study’s requirements. Those
requirements may involve your age, physical condition, race or
Who will conduct the study?
Each study conducted at the
Center has a principal investigator (PI) who is the person in
charge of the study. The PI may be one of a number of different
kinds of healthcare professionals. He or she will assemble a
team of research professionals who will also be involved in
managing the study.
What should you consider before deciding to be a participant?
Even if you are eligible to
participate in a study, you should give it careful thought
before deciding to become a participant. While you may benefit
in a host of ways from participation, you should also be aware
that participating could impact your life in many ways, as well.
It’s important for you to
make an informed decision. So, you may want to consult with your
personal physician and members of your family before making a
commitment. If you have any concerns about the project, you
should also discuss them with the research team working on the
project. Here are some questions you’ll want answered before
making a decision:
What are the goals of the study?
What will I be required to do as a participant?
Are there any risks? How likely are they to occur
and what is done to reduce the likelihood of their occurring?
What role will I play in the study?
Am I likely to benefit directly from participating
in the study?
What are the study’s potential benefits to other
people and to society as a whole?
How long will my participation in the study be
What discomforts, inconveniences or costs will I
experience as a participant?
What are your rights as a participant?
All volunteers who
participate in studies at the CRC are guaranteed rights that
ensure they are treated professionally and respectfully. When
you take part in one of the Center’s studies you have the right
Be treated with respect.
Know the risks of participation in 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 study’s 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 or medicines may be used.
Seek additional help or clarification during the
informed consent process and at any time during the study.
What are your responsibilities as a participant?
All volunteers who
participate in studies at the Center are expected to comply with
the specific requirements of the study. In addition, study
participants are expected to adhere to a general set of
requirements that apply to all participants. They 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
Following the directions of the researchers.
Making sure your contact information is up to date.
Providing – to the best of your ability – accurate
information about your medical history if it is relevant to the
Seeking healthcare for any medical conditions
unrelated to the study.
Asking the researchers to completely answer any
questions you may have at any time during the study.
Informing the research staff of any negative
experiences you have while participating in the study.
Informing the research subject advocate (at
860/679-3276) and, if necessary, the Institutional Review Board
(at 860/679-1019 or 4851) if you feel your rights as a study
subject have been violated.
Can you learn the results of a study?
Many study participants
wish to review the results of studies in which they have
participated. Once a study is complete, participants may be
informed of their results and given advice concerning their
future medical care. You should be aware that this may not occur
for some time after a study is complete, while all research data
are being analyzed.