Vaccine Study FAQ's
What is a clinical research study/trial?
A clinical research trial evaluates the safety and effectiveness of a new
medication, biologic or vaccine by monitoring its effect on large
groups of people. The National Institutes of Health (NIH) defines a clinical
trial as, “a prospective biomedical or behavioral research study of human
subjects that is designed to answer specific questions about biomedical or
behavioral interventions (drugs, treatments, devices, or new ways of using
known drugs, treatments or devices)”. Clinical trials are used to evaluate
new biomedical or behavioral interventions for safety, efficacy, and
effectiveness.
Who
can participate?
Each study may have a differing criteria for volunteers. Some may seek young,
healthy volunteers while others may need people from a different age group with
certain risk factors. For example, many of the nation's current COVID vaccine
studies are looking for volunteers over the age of 18 who are at risk of
getting COVID or at risk for having complications from COVID if they are
infected.
What
is the time commitment?
This also varies from study to study. In-person screening and study visits may
take several hours while follow-up visits and remote check-ins after
vaccination are typically of shorter duration. Most of the COVID vaccine trials
currently progressing nationally involve a series of 2 vaccines one month apart
with 8 follow-up study visits and 2 phone calls over a two year period.
Will
I receive any compensation?
Every vaccine study is different, but most studies do involve some type of
compensation for participation. Payments are typically made throughout the
course of the study.
How
do I know that a vaccine is safe?
All clinical trials, including vaccine development studies, are designed to be
as safe as possible for human volunteers. However, there are risks involved in
participation in any clinical study. Often, one of the objectives of studies is
to evaluate the medication, biologic or vaccine for safety, efficacy and
effectiveness. In the development of most medications or vaccines, the products
will have first been tested in animals to see if it is safe and to see if it generates an immune response (stimulates the body to fight the infection). Then, after a long process of data review and further approval by the FDA, vaccine trials are conducted in humans in “clinical trials”.
In
addition, before a new “investigational product” (medication, biological,
vaccine) is given to human subjects, its use must be approved by the U.S. Food
and Drug Administration (FDA). Following approval by the FDA, the study must be
approved by the University’s Institutional Review Board (IRB), a committee
that consists of physicians, pharmacists, nurses, other scientists, and
community members, who are “responsible for reviewing and overseeing all
research activities in order to ensure protection of individuals who
participate in research projects.” The IRB requires that each study lists all
known potential risks in an Informed Consent Form, which must be read,
understood, and signed by the volunteer before study participation.
Complicated
studies also have a safety oversight group which reviews data on an interim
basis as another check for subject safety.
It
is important to know that approvals by safety and ethics committees cannot
eliminate risk in human studies. The individual volunteer must read and
understand the potential risks in each trial and determine for themselves
whether they would like to participate.
What
if I decide I don’t want to continue in the study after I’ve signed the
informed consent?
You are free to leave the study at any time. If you have received a medication,
vaccine or biologic product, however, the study team will request that they are
able to contact you to be sure you remain healthy.
Does
every volunteer receive the vaccine?
Again, each study is different. A volunteer may receive the vaccine or may
receive a placebo. This would be explained before you signed a consent to
participate in any study activity.
Will
I be told whether I received the vaccine or placebo? If so, when?
This is different with each study and would be explained to you before the
consent is signed.
How
can I sign up?
We are not recruiting for a specific study at this time; however, when the Vaccine Testing
Center is recruiting, we will make those opportunities known on the home page. If you are interested in the studies to being conducted nationally
for a COVID vaccine, you can learn more at the NIH's National Institute of Allergy and
Infectious Diseases Vaccine
Research Center or explore and register your interest in volunteering
at their COVID-19
Prevention Network Volunteer Information website.
What
happens at a screening appointment?
First, the volunteer will learn about the study’s goals and requirements, have
an opportunity to ask questions, and read and sign the informed consent form if
interested in participating. Second, the screening process is used to determine
if you are eligible to be in the study. The study team (coordinators, nurses,
doctors) will ask you questions about your medical history, perform a brief
physical exam and obtain samples for blood and/or urine testing. The blood and
urine testing will help ensure that you are healthy and qualify for the study.
If
I am eligible after attending the screening appointment and would like to
participate, what happens next?
After the end of the screening visit, the study team will contact the volunteer
to review the laboratory data. If the volunteer qualifies for the study, they
will be invited to participate.
What
can I expect at dosing day?
Dosing day includes review of the study and a subject’s eligibility followed by
a brief physical exam and blood draw and/or urine testing. Following
these pre-dosing procedures, you will receive either the vaccine or a placebo
either as an injection in your upper arm or as an oral vaccine, depending on
the type of vaccine being studied. You are required to stay for 30 minutes for
observation and education post vaccination. The dosing day visit typically
lasts about two hours.
What
happens after dosing day?After the dosing day, subjects will be expected to return to the research clinic for follow up visits. The number of visits and duration of each visit varies depending the study. Some studies also require subjects to complete a diary of any symptoms they have after vaccination and/or record their temperature.