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Research Proposal HSC 4730
Research Proposal HSC 4730
Yassir Colindres
December 4, 2020
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Abstract
Vaccinations have been widely accepted throughout the world as a means of protecting one’s self
and others from various diseases. Although, vaccines are widely accepted; the knowledge most
people have on their effects and reliability is different based on their education-level. It has been
said that those with a four-year college degree in a health-related field may be more
knowledgeable on recommended vaccination practices than those who do not have a college
vaccination rates providing children more protection from diseases that take the lives of millions
of children on an annual basis. This literature review will examine recent studies that have
analyzed the impact of education-level on the vaccination practices of parents. Many of these
studies are supportive of the idea that parents who have a higher-education level have more
knowledge on vaccines, and therefore, follow the appropriate guidelines health professionals lay
out regarding the vaccination of children under six. One study pointed out how cultural norms
may have an underlying effect on vaccination practices of parents coming from various cultural
backgrounds. This study suggested that, along with a lower education-level, a conservative
religious background may also lead to lower rates in certain vaccines. From the studies analyzed
in this literature review, it can be determined that a college education has an immediate impact
on vaccination rates in children under the age of six, however, more studies must be conducted to
Introduction
Vaccinations have been developing in the healthcare field around the globe for centuries;
being used to protect against deadly diseases such as smallpox and measles as early as the 18 th
century. This study analyzes how a college degree in a health-related field impacts the
Although, there is much speculation on the reliability of vaccinations and the effect they can
have on people, the Centers for Disease Control and Prevention’s (CDC) recommendations are
tied to evidence-based research and testing done by professionals in their in the healthcare
industry.
Vaccine Recommendations
The CDC (Centers for Disease Control and Prevention) is the federal agency responsible
for our nation’s health which involves determining whether a certain vaccine is recommendable
for public use. According to the CDC website, “Vaccines are recommended throughout your
child’s life to protect against serious, sometimes deadly diseases.” (CDC, 2019). A variety of
vaccinations such as the hepatitis B vaccine after birth, flu vaccines every year protecting against
influenza types, and many others are recommended throughout life as a means of primary
protection. In the first two months of infancy, the CDC recommends that babies are given their
first dose of the DTaP (Diphtheria, tetanus, and pertussis), the first dose of the Haemophilus
influenzae type b disease (Hib) vaccination, their first polio (IPV) vaccination, and their first
certain vaccines the importance of having these immunizations is paramount, especially for
children. As stated by the Association of American Family Physician (AAFP), “Common local
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reactions to vaccines include pain, swelling, and redness at the injection site. Systemic reactions,
including fever, irritability, drowsiness, and rash, may also occur” (Sanford, 2002, Volume 66,
Number 11). Reactions from vaccinations may be somewhat frustrating for children; however,
the positive effects of vaccines far outweigh the negative side effect. Children are not as aware as
adults when it comes to the process of how bacteria spreads and since a lot of diseases and
viruses spread through the air or by direct-contact, children are generally more susceptible to
becoming infected. Having parameters in place to safeguard our children is extremely important
has been increasingly popular in modern society. The misconceptions surrounding vaccinations
are difficult to validate and the reason for these misconceptions continues to concern healthcare
professionals who know the importance of vaccinations. The Journal of the American Academy
of PA’s states, “To maintain herd immunity and prevent disease outbreaks, an immunization rate
According to a study, which used data from the 1995-2001 National Immunization
Survey, “The most frequent reason for non-vaccination, stated by 69% of the parents, was
concern that the vaccine might cause harm.” (Omer S.B. et. Al, 2009, pg. 1985). These may be
legitimate concerns for parents to have, however, data shows that having a higher level of
education may result in parents making more educated decisions in whether they choose to
vaccinate their children. One study using data from the 2016 Behavioral Risk Factor Surveillance
System (BRFSS), supports the idea that higher education encourages people to stay up to date
with vaccinations. The BRFSS is a public record from self-reported by adults living in the United
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States. According to the Preventative Medicine journal, data from that system found that “65.1%
of individuals with above 4 years of college education were up to date, whereas 50.3% of those
with a grade 11 education or less were up to date…” (Rencken Preventive Medicine, 2020, pg.
3). Rural areas all around the United States are known for having higher rates of school dropouts
and higher rates of teenage pregnancies. When students are dropping out of school before the end
of their senior year, they are missing the education that is needed to make it out of young
adulthood and succeed in later life, especially in those rural areas. It was found in a study in
South Florida, that rural communities generally do not have enough knowledge of specific
important vaccines and require support in making a change in those communities. According to
an article, “Community leaders, healthcare providers and researchers noted HPV vaccination has
been studied in rural Florida such as Hendry and Glades counties, also known as the ‘rural spine
of the state’ where the main industry is agriculture and historically there is a lack of resources
Immunotherapeutics, 2019, pg. 1667). This statement reiterates the fact that these communities
may have a disadvantage due to social stigma, but still deserve equal access to healthcare and
education.
The reasoning behind the growing stigma surround vaccines is not supported by scientific
evidence. This is the main reason why the people who refuse to get vaccinated are in the
minority and statistics show that vaccinations do indeed work, and very well for that matter.
When looking back at measles outbreaks that used to ravage the United States with hundreds of
thousands of deaths annually and comparing those rates to today, a drastic difference can be
recognized. This drastic change was the before and after of not having a vaccine to developing a
vaccination in the late 80s. According to a study published in The New England Journal of
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Medicine, “In the United States, the reported number of cases dropped from an average of
500,000 annually in the era before vaccination (with reported cases considered to be a fraction of
the estimated total, which was more than 2 million) to a mean of 62 cases per year from 2000
through 2007.” (Omer S.B. et. Al, 2009, pg. 1984). When we look at measles cases today, they
are almost completely non-existent and in the cases that do arise most patients were either not
vaccinated or did not have a history of immunization. According to the same journal, “Outbreaks
of vaccine-preventable disease often start among persons who refused vaccination…” (pg.1984).
Parents must try to do their own research on the effect vaccines have had in our past in order to
protect their children. Without herd-immunity children could not live the care-free life every
child deserves, and the general public would live in constant fear of outbreaks. The numbers that
comprise the data make it very clear that vaccinations do a phenomenal job in preventing the
spread of disease and without vaccines the world today would be a different place.
When looking at how far our public health professionals have taken us in making the
United States a safer place for our children, we must appreciate the effort that is put into the
work they do. There is plenty of work to be done in improving the communities that are left in
the dark went it comes to community health and education. We must push community leaders to
improve the education systems that keep smaller, poorer communities on the back burner.
Encouraging our young adults to strive for a four-year college degree will not only increase the
rates of vaccinations but also start to break down the stigma around vaccinations that is ever-
growing. This study will reflect that education-level is associated with the vaccination habits of
parents, and whether they are able to make an informed decision regarding the vaccination of
their children.
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In this study, the proposed research question is: What impact does a college degree in a
health-related field have on parents’ willingness to vaccinate their children under six? The
hypothesis suggests that a higher-education level, and more specifically a degree in a health-
Pilot Study
The preliminary survey, posted to a UNF parent blog on November 2, 2020, had a total of
53 participants who gave responses. The survey utilized included parents who attended or had
previously attended the University of North Florida within a four-year timeframe. The only
limiting factor of our participants, was that they must be parents living in Duval County with at
least one child under the age of six. Survey participants were asked to answer a series of
questions including their number of children, what area of residence in Duval County they live
in, the highest level of education achieved, which degree-major (if applicable), their familiarity
of vaccination recommendations from the CDC, their opinion on whether vaccines cause autism,
whether they vaccinate their child(ren), likelihood of their child receiving a variety of
The data collected from the survey showed most parents having one child. Most of the
survey respondents lived either in Southside, or at the Beaches. Many respondents had some
college education or a degree, mostly pursuing a major in public health. Surprisingly, when
asked about their familiarity with the CDC’s recommendations regarding vaccines, parents had a
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wide variety of responses. Almost all the parents who participated did not believe that vaccines
cause autism, although, three answered that they do believe vaccines cause autism and eight
respondents didn’t know. Oddly, when asked whether parents do vaccinate their children, there
were less parents who did not vaccinate their child than parents who thought that vaccines cause
autism.
Survey results were based off a total of 53 survey participants who fit the criteria for this
preliminary study. Out of all participants, 33 (63%) had one child, 12 (23%) had two children, 5
(9%) had three children, two (4%) had four children, and one (2%) parent had five children. Of
the survey participants, four (8%) lived in Arlington, 19 (36%) lived at the Beaches, three (6%)
lived on the Northside, seven (13%) lived on the Westside, 13 (25%) lived on the Southside, and
seven (13%) parents lived in another area in Duval County. Figure 1 shows the results of the
question asking parents to disclose their highest level of education. When questioned on their
highest level of education, only one (2%) parent completed graduate school, 29 (55%) completed
their undergraduate degree, 20 (38%) took some college classes without completing a degree,
and three (6%) completed high school. Of the survey participants who completed their college
degree, 45 (90%) had a public health concentration, two (4%) had a political science degree, and
three (6%) selected ‘other’. Figure 2 shows the results of the question asking parents about their
familiarity with vaccination recommendations from the CDC. When questioned on their
familiarity, 12 (23%) were very familiar, 16 (30%) were somewhat familiar, six (11%) were
neutral, 11 (21%) were somewhat unfamiliar, and eight (15%) were very unfamiliar. Of the
survey respondents, 42 (79%) did not believe that vaccines cause autism, three (6%) believed
that vaccines do cause autism, and eight (15%) did not know whether vaccines cause autism. Out
of all the survey respondents, 38 (72%) do vaccinate their child(ren), 12 (23%) do not, and three
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(6%) vaccinate sometimes. When questioned regarding the likelihood for parents to have their
child(ren) be vaccinated for specific diseases, a variety of responses were recorded. When
questioned regarding the Hepatitis B vaccine; 30 (73%) parents said they’re very likely, five
(12%) were somewhat likely, four (10%) were neither likely nor unlikely, one (2%) was
somewhat unlikely, and one (2%) more was very unlikely. When questioned regarding the
Rotavirus vaccine, 29 (71%) parents said they’re very likely, seven (17%) were somewhat likely,
four (10%) were neither likely nor unlikely, and one (2%) more was very unlikely. When
questioned regarding the DTaP vaccine, 32 (78%) parents said they’re very likely, 5 (12%) were
somewhat likely, three (7%) were neither likely nor unlikely, and one (2%) more was very
unlikely. When questioned regarding the haemophilus influenzae type B (Hib) vaccine, 30 (73%)
parents said they’re very likely, 6 (15%) were somewhat likely, three (7%) were neither likely
nor unlikely, one (2%) more was somewhat unlikely, and one (2%) more was very unlikely.
When questioned regarding the polio (IPV) vaccine, 31 (76%) parents said they’re very likely, 5
(12%) were somewhat likely, four (10%) were neither likely nor unlikely, and one (2%) more
was very unlikely. Of the survey respondents, 35 (66%) said their child’s school/care facility
does have vaccination requirements, four (8%) said they do not, and 14 (26%) said the do not
know whether their child’s school/care facility has vaccination requirements or not.
Figure 1
Figure 2
Graph showing responses to parents’ familiarity with vaccine recommendations from the CDC
Figure 3
Graph showing responses to whether parents vaccinate their child
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Research Methods
Throughout this study the Principal Investigator (PI) who will be responsible for doing
research is Yassir Colindres. The PI will be the individual preparing data, conducting research,
and analyzing results in this research study with the assistance of one research assistant. This
study will be ongoing for a duration of approximately six months, unless the PI believes further
research is needed. The proposed study is being conducted to further understand the link between
This study will require all participants to be a minimum of 18 years of age and a parent
and/or guardian of a child or children under the age of six. In order to safeguard the population
and the data collected, surveys will be conducted in a private setting, participants may start/stop
participation in the survey at any time, participants will not have to disclose any personal
information (names, DOB, address, phone number, etc.), and data collected will be stored on a
key-protected file which only the PI and research assistant will have access to.
Data will be collected from voluntary participants from three colleges in the study area,
Duval County, Florida. The cooperation of these universities will be necessary as surveys will be
conducted both on campus and through student email addresses obtained through each school.
The three colleges are The University of North Florida, Florida State College of Jacksonville,
and The Jacksonville University. The focus group of this study will include parents that are
incoming freshman, sophomores, juniors, seniors, and alumni from the three universities. The
information coming from incoming freshman will be regarded as the population who has
completed high-school as their highest level of education, sophomores and juniors will be
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represent those with some college education, and alumni will represent those participants who
have graduated and may have a graduate degree from the universities.
return the survey either through email. Data will be collected and analyzed through a Qualtrics
database which will group data between participants in four groups: those who have completed
high school, some college but no degree, college/university degree, and/or graduate degree. This
data will then be compared to the data collected regarding vaccination practices of the same
parent participants. The design of this study will be involving two or more variables from the
data collected through a population in Duval County, making it a correlational study. Data
collected will examine the relationship between education-level and vaccination practices of
Data Analysis
The proposed method for data analysis in this study will be a using multivariate analysis
of data and an independent t-test comparing multiple groups varying in education-level. The
multivariate analysis used in the study will guarantee that multiple data variables can be
considered at the same time. These purposed methods of data analysis will be utilized to
determine whether education-level has an impact on parents’ vaccination practices and beliefs.
Dissemination of Findings
As the data collected and analyzed in this study will pertain to the interests of parents to
young children. The findings in the study will be paramount in protecting the health of children
and the overall public which emphasizes the need for findings to be published in a peer-reviewed
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journal. The data will also be released to the Florida Department of Health in hopes to tackle the
globe, the need for higher-education and focus on public health is crucial in protecting the
public’s health.
References
Holroyd, T. A., Sauer, M. A., & Limaye, R. J. (2020). Vaccine decision-making among parents
of children on Medicaid with and without autism spectrum disorder. Vaccine, 38(43), 6777-
6784. https://10.1016/j.vaccine.2020.08.041
Omer, S. B., Salmon, D. A., Orenstein, W. A., deHart, M. P., & Halsey, N. (2009). Vaccine
Refusal, Mandatory Immunization, and the Risks of Vaccine-Preventable Diseases. The New
Rencken, C. A., Dunsiger, S., Gjelsvik, A., & Amanullah, S. (2020). Higher education associated
Sanford, K. R. (2002, December 1). Vaccine Adverse Events: Separating Myth from Reality.
Stein-Zamir, C., Shoob, H., Abramson, N., & Zentner, G. (2012). Who are the children at risk?
Lessons learned from measles outbreaks. Epidemiology and Infection, 140(9), 1578.
https://10.1017/S095026881100238X
Thomas, T. L., Caldera, M., & Maurer, J. (2019). A short report: parents HPV vaccine
knowledge in rural South Florida. Human Vaccines & Immunotherapeutics: HPV Vaccination:
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From Seroprevalence to Public Health Policy and Everything in Between, 15(7-8), 1666-1671.
https://doi.org/10.1080/21645515.2019.1600986
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Appendix A
Pilot Study Survey on Education-level and Impact on Parents’ Vaccination practices
Criteria: Individual must be a parent or guardian to a child, or children, under the age of six, that
lives in Duval County.
Purpose: The purpose of this study is to identify how a college degree in a health-related field
may influence the decision for parents to vaccinate children under the age of six.
You may start and/or stop taking this survey at any time in the survey and participation is
completely voluntary.
c. Theology
d. Other:
6. How familiar are you with the recommend vaccinations from the CDC for children under
6?
a. Very unfamiliar
b. Somewhat unfamiliar
c. Neutral
d. Somewhat familiar
e. Very familiar
7. Do you believe that vaccinations cause autism?
a. Yes
b. No
8. Do you prefer to vaccinate your child?
a. I prefer to vaccinate my child
b. I prefer not to vaccinate my child
c. I prefer to give some/certain vaccinations to my child
****if ‘A’ or ‘B’, skip to question 19, if ‘C’ answer the following questions****
9. How likely are you to give your child the Hepatitis B (HepB) vaccine?
a. Very likely
b. Somewhat likely
c. Neutral
d. Somewhat unlikely
e. Very unlikely
10. How likely are you to give your child the Rotavirus (RV) vaccine?
a. Very likely
b. Somewhat likely
c. Neutral
d. Somewhat unlikely
e. Very unlikely
11. How likely are you to give your child the Diphtheria, tetanus, & acellular pertussis
(DTaP) vaccine?
a. Very likely
b. Somewhat likely
c. Neutral
d. Somewhat unlikely
e. Very unlikely
12. How likely are you to give your child the Haemophilus influenzae type B (Hib) vaccine?
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a. Very likely
b. Somewhat likely
c. Neutral
d. Somewhat unlikely
e. Very unlikely
13. How likely are you to give your child the Polio (IPV) vaccine?
a. Very likely
b. Somewhat likely
c. Neutral
d. Somewhat unlikely
e. Very unlikely
Appendix B
Pilot Study Codebook
# Survey Question Names Label Code Label
1 How many children 1 1 child
do you provide care 2 2 children
for under the age of 3 3 children
six? Children 4 4 children
under 5 5 children
Children under six 6 6 children
six number 7 More than 6 children
2 In what area of Duval 1 Arlington
do you reside? 2 Beaches
3 Northside
4 Westside
Reside 5 Southside
Duval_area Duval 6 Other
3 What is the highest Less than highschool
level of education do Highschool
you have completed? 1 Some college but no
2 degree
Highest 3 College/university
Highest_educat educatio 4 degree
ion n name 5 Graduate degree
4 What was your 1 Public Health
major? 2 Political Science
3 Social Sciences
Major 4 Theology
Major name 5 Other
5 How familiar are you
with the Very likely
recommended 1 Somewhat likely
vaccinations from the 2 Neither likely nor
CDC for children 3 unlikely
under 6? Recommended Familiar 4 Somewhat unlikely
vaccines vaccines 5 Very unlikely
6 Do you believe that
vaccinations cause Vaccine 1 Yes
autism? Vaccines_autis s cause 2 No
m autism 3 I don't know
7 Do you vaccinate 1 Yes
your child? Vaccinat 2 No
Vaccinate e child 3 Sometimes
8 Select likelihood your
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Appendix C
Human Subject Plan
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The study that we are conducting is referred to as “Education Levels of Parents with
Children their Stance of Vaccinating Children Under the Age of Six.” The research question is
“How is education level associated with the vaccination practices by parents for children under
the age of six in Duval County?” The method that we used was a via telephone survey asking a
variety of questions such as how many children under the age of six they have, their furthest
education level, if they're familiar with CDC vaccination recommendations, if they vaccinate
their children, etc. We choose from a pool of telephone numbers with their identities being
hidden, so the study responses will still be anonymous. This method would be more time and
cost-efficient. We collected data through a software that broke down the responses by each
question. Our group will be seeking full board Institutional Review Board (IRB) approval due to
Individuals that will be included in our study are parents/guardians that have at least one
child under the age of six. Although our study doesn’t focus on one’s race/ethnicity, they must
reside in Duval County, Florida to be eligible to participate in this survey. Another demographic
characteristic that we are taking into consideration is what the parent/guardian's furthest
Individuals that will not be included in our study are individuals without children under
the age of 6. Individuals without children under 6 will not be able to express if they allow those
reside in Duval county will also be excluded because access to this study is limited to residential
areas in Duval county. Without these criteria, the results of the study would become inaccurate in
relation to the research question. There will be no incentives given in this study.
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For this study, the major health outcome will be CDC vaccine recommendations for
children under 6. These subjects are considered children because they are under the age of 18.
We decided to use children under 6 because between the ages of a newborn and 6 years old most
children are usually required to receive their shots. This can be due to school, childcare facilities,
or disease prevention. Our group also decided to exclude age groups that include pre-
adolescents, adolescents, young adults, and older adults. This is because at these ages’
vaccinations become a choice rather than a requirement. For example, vaccines such as HPV
help protect the body from sexually transmitted diseases so recommendations for it are usually
As the focus of the study is centered around the education levels of parents and its effects
on parents’ vaccination practices, the impact of sex/gender does not compromise the goals of the
study. Therefore, gender representation is not necessary for the planned distribution of subjects
in the study and the survey instrument used does not ask participants to disclose their biological
sex whether male, female, or other. As the ethnic and racial origins of survey participants
(parents of children under the age of six) are not requested in the survey instrument for this
study, the racial and ethnic origin of study participants cannot be accurately determined.
However, race and ethnicity have historically played a role in the inequality of access to higher
education and could be a factor in studying the impact of education-level on parents’ vaccination
practices. To conduct a valid and inclusive analysis in studying how education-level influences
parents’ willingness to vaccinate their children, the involvement of different racial and ethnic
groups is necessary for this study. A proposed outreach program to recruit minorities could be
focused on local human service organizations that reach underprivileged minorities living in
communities that are seeking social welfare assistance. Another proposal that target’s a wide
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range of ethnic groups could be starting a social media campaign on the importance of
vaccinating children.
The two largest risks involved in this study is the protection of privacy and medical
records. The survey is anonymous, however, due to the participants being asked to complete a
follow-up survey, this is harder. To protect the participant's identification, there will be no
questions pertaining to age, gender, social security, or any other identification documents.
Telephone numbers will be deleted after the follow-up call to add an additional level of
protection. The survey also deals with medical records being discussed verbally, so there will be
an option to not answer any question the participant may not want to answer. The participants
being anonymous and being asked for verbal consent before the survey begins helps ensure that
the survey complies with the Health Insurance Portability and Accountability Act (HIPAA)
Privacy Rule. There are no physical, financial, psychological, or social risks involved in this
survey. This survey is a way of getting information on individuals' stances on vaccinations, and
every participant is asked to verbally give consent to begin the survey and they all have the
Vaccinating children under the age of six has many benefits. Diseases associated with
vaccines include mumps, measles, chickenpox, hepatitis B, etc. These diseases have symptoms
associated with them that could potentially be deadly for children. Especially since children have
very fragile immune systems due to them not being exposed to many things because they are so
young. Vaccines do have cons associated with them, but the pros out way them especially when
it comes down to keeping children disease-free. Vaccinating children can not only keep one child
safe but many other children too. If one child gets vaccinated, they can prevent a mass spread of
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a disease saving the world from another pandemic. Vaccines were made for a reason to fight the
Appendix D
AUTHORIZATION
to Collect, Use, and Disclose Protected Health Information (PHI)
Title of this study: Education Levels of Parents and their stance on Vaccinating Children
under the Age of six.
Why the study is being done and what will happen to you if you take part in the
study:
This study is being conducted in order to analyze the impact that education level has on parents and
their stance on vaccinating children under the age of six. Researchers assume that having a college
education related to health care provides individuals with the education necessary to make an
informed decision regarding the vaccination of children by following the guidance of health
professionals and scientific evidence. In order to support the protocol of the study, participants will
be asked to complete a digital questionnaire on a laptop consisting of nine multiple choice
questions. The survey questionnaire given will ask participants to disclose information such as
number of children, highest level of education, area of residence, likelihood of vaccinating their
child, etc. The information given will be used in our research and will remain anonymous.
Southside, Westside, Arlington, and the Beaches. Participants will also be limited to parents that
have a child(s) under the age of six.
How your study records will be maintained and who will have access:
Study records that are disclosed in this study will be maintained on a secure laptop that will
have program software installed to safely collect all data from participants. The data collected
throughout the study will be maintained by the research lead and kept on a secure Excel
document.
When or if you may be told about new findings which may affect your willingness
to keep taking part in this study:
If at any given time throughout the study, new studies or findings are released that may affect
participants willingness to continue participation in the study, participants will be notified
immediately.
If you agree to participate in this study, you will be given a signed copy of this
document.
You may contact Yassir Colindres at (888) 888-8888 at any time if you have questions
about the research or if you think that you have been hurt by the research.
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You may contact the Institutional Review Board at the University of Mid-Florida Health
Science Center at (999) 999-9999 if you have questions about your rights as a research
subject or what to do if you are injured.
You may choose not to be in this study, or you may quit being in the study at any time
and there will be no penalty and no loss of any benefits you are entitled to.
If you agree to participate in this study, Yassir Colindres will create, collect, and use private
information about you and your health. This information is called protected health
information or PHI. In order to do this, the Principal Investigator needs your authorization.
More specifically, the following information may be collected, used, and shared with
others:
How many children do you provide care for under the age of six?
In what area of Duval do you reside?
What is the highest level of education do you have completed?
What was your major?
How familiar are you with the recommended vaccinations from the CDC for
children under 6?
Do you believe that vaccinations cause autism?
Do you vaccinate your child?
Vaccinations your child has received in the past. -- (HepB, RV, DTaP, Hib, IPV)
This information will be stored in locked filing cabinets or in secure computer servers with
security passwords.
Your PHI may be collected, used, and shared with others for the following study-related
purpose(s):
To determine what vaccines children should be receiving according to Centers for
Disease Control and Prevention (CDC) recommendations
To determine if parents’ previous vaccination history determines their practices for
vaccinating their child(ren)
To determine if there is a correlation between education level and parents’
willingness to vaccinate their children under the age of six
Once this information is collected, it becomes part of the research record for this study.
Only certain people have the legal right to collect, use and share your research records,
and they will protect the privacy and security of these records to the extent the law allows.
These people include:
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the study Principal Investigator, and research staff associated with this project.
other professionals at the University that provide study-related treatment or
procedures
University of Mid-Florida Institutional Review Board (IRB; an IRB is a group of
people who are responsible for looking after the rights and welfare of people
taking part in research).
Sponsor
United States and foreign governmental agencies who are responsible for
overseeing research, such as the Food and Drug Administration, the Department
of Health and Human Services, and the Office of Human Research Protections
Government agencies who are responsible for overseeing public health concerns
such as the Centers for Disease Control and federal, state and local health
departments
Otherwise, your research records will not be released without your permission unless
required by law or a court order. It is possible that once this information is shared with
authorized persons, it could be shared by the persons or agencies who receive it and it
would no longer be protected by the federal medical privacy law.
Your PHI will be used and shared with others until the end of the study (or alternative).
Once this research study is completed, any information that could identify you might be
removed from any identifiable private information or identifiable biospecimens collected
and that, after such removal, the information or biospecimens could be used for future
research studies or distributed to another investigator for future research studies without
additional informed consent from you or your legally authorized representative.
You are not required to sign this consent and authorization to allow researchers to collect,
use and share your PHI. Your refusal to sign will not affect your treatment, payment,
enrollment, or eligibility for any benefits outside this research study. However, you cannot
participate in this research unless you sign this consent and authorization.
You have the right to review and copy your protected health information. However, we
can make this available only after the study is finished.
You can revoke your authorization at any time before, during, or after your participation in
this study. If you revoke it, no new information will be collected about you, but information
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that was already collected may still be used and shared with others if the researchers
have relied on it to complete the research. You can revoke your authorization by giving a
written request with your signature on it to the Principal Investigator.
Signing this document means that the research study, including the above information,
has been described to you orally and/or that you have read this document, and you
voluntarily agree to take part.
________________________________ ______________
Signature of Person Obtaining Consent Date
________________________________ ______________
Consent and Authorization of Patient Date
29
Appendix E
Budget-
Research Timeline-
2021
Activity Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec
Appendix F
31