Grant Proposal
Grant Proposal
Grant Proposal
Pregnancy
Madeline Alford
that of the woman who is carrying out the term of pregnancy. When we consider our current
society and health disparities it is important to note and recognize that such disparities carry
heavily into all fields and a clear health scenario where progression of education and care is
necessary is prenatal care. If we specifically consider women of color and the obstacles, they
already face it is important to consider health risks they are exposed to due to no care, inadequate
care, undereducation, fewer resources, and other specific struggles they face during pregnancy.
Women of color face higher rates of death and poorer health outcomes than those white women
face. There must be clear plans for progression to help bridge the gap of these health outcomes
Women have a unique biological contribution to this world and that is to bear children. This
experience requires a certain level of medical care to ensure the safety of the mother and fetus
during gestation. There has been a long-standing care that women undergo while pregnant named
Perinatal (PEC). PEC encompasses pre- (prenatal care, PNC) and post- (postnatal) pregnancy
care for the mother and fetus. The American Academy of Pediatrics (AAP) and American
College of Obstetricians and Gynecologists (ACOG) define appropriate PNC in their Guidelines
for Perinatal Care for an uncomplicated pregnancy to include: a visit every 4 weeks for the first
28 weeks of gestation, every 2 weeks until 36 weeks, and every week thereafter until delivery
(full gestation; approximately 40 weeks) (2017, p. 150). Adherence to these guidelines would
total in 15 visits as an appropriate number of PNC visits. These visits include but are not limited
to, education not only on pregnancy but social determinants of health (SDOH), medical
examinations, and identification of risk factors or underlying diseases that could compromise the
There are severe health implications if PNC is not delivered in a timely or adequate
manner. Appropriate PNC can reduce poor pregnancy outcomes such as: maternal
depression (PPD), and low-birth weight. Also, the adequacy of prenatal care can contribute to the
consistency of medical care an infant receives after birth (Noonan et al., 2013). Many variables
impact proper PNC such as insurance, social economic status (SES), marital status, and
accessibility to care. These variables can be further exacerbated by exposure to two or more of
them or even in ways we often do not consider. In this review, we will be focusing on the risk of
being a woman of color (WOC) during gestation, how this risk can impact PNC, and how this
impact can cause negative health outcomes. In this review when referencing a WOC, it will
Rates of PNC
In a 2009 cross-sectional study, Bengiamin et al., examined receiving PNC in a timely manner.
Their dependent variables were race/ethnicity, nativity (being U.S. born or not), age, education,
and insurance. Regarding race/ethnicity the highest late initiation and adherence were from black
and Asian-Pacific Islander women. The data showed black women had a 22% late initiation rate,
and 50% non-adherence. Asian Pacific Islander women had a 26% late initiation, and a 54.4%
non-adherence. The lowest rate was seen in NHWW, NHWW had 12.2% late initiation rate with
a 42% adherence rate. The rates from WOC surpassed those of NHWW in this variable and
every other variable when examining PNC initiation and adherence. We often consider
insurance as a major factor in medical care but the data from this study also concluded that
insurance does not directly increase initiation or adherence for any other rate except for in
NHWW (with increasing disparities when women are privately insured). Though this study only
included roughly 12% of live births from California from 2002-2004, it still can be used a
sufficient learning tool as it was able to include the state, private, and self-pay rates in their
variable which can distinguish SES. It also was able to examine variables of education and
marital status to determine if they contribute further to disparities though it did not distinguish
A study that was able to distinguish the contribution of race/ethnicity in education (and its effects
on PNC) was Disparity in Prenatal care among women of colour in the USA (Park et al., 2007)
This retrospective study examined findings from a 1997 national survey of PNC and compared
them to a 2001 survey of the same nature. It investigated disparities in timing and total number
of PNC visits. The study focused on 5 settings, one university hospital setting and four
community health clinics (these four clinics were intended to supply care for low and under
insured pregnant women). This is important to note as they were able to derive the level of care
as the data was supplied from a nurse-midwifery database. This is quite significant as it can also
contribute to deriving data and the quality of care that is given at the community-based clinics,
The data from this study determined that late PNC initiation or no care is 2 times greater
in populations of WOC versus NHWW (Park et al., 2007). This can be contributed to accessibility
burdens WOC face in urban areas which cause further disparities in PNC. It also speaks to level
of care as the university clinic provided a full scope of care with the same provider where the
community-based clinics had limited services and rotating providers. The study shows alarming
disparities, for example, regardless of the level of education WOC receive less PNC than
NHWW. The mean number of PNC visits for a NHWW was 11.53, compared to a mean of 9.61
for WOC. Furthermore, 54% of NHWW received care in their first trimester where 46% of
WOC received first trimester care, showing a disparity in initiation. Though comprised of a small
sample size and reference of older data, the comparison between more up to date data (at time of
study) solidifies this study's findings. Both Bengiamin et al., and Park et. Al., show clear
correlations between race/ethnicity and PNC care even when they seem equal in other variables.
There are many associated risks with inadequate PNC one is maternal morbidity/mortality. The
purpose of PNC is to be able to identify if there are any risks to these to poor health outcomes
and supply proper care to reduce such health implications. According to Center for Disease
Control and Prevention (Peterson, 2019), “black, American Indian, and Alaska Native women
are two to three times more likely to die from pregnancy-related causes than white women – and
this disparity increases with age”. A review done by the Department of Obstetrics and
Gynecology at the Boston University Medical Center highlighted the impact social determinants
and PNC have on maternal outcome. Gadson et. Al., (2017) reviewed literature and determined
links between PNC and maternal mortality, like the CDC they concluded WOC are more likely
to die of pregnancy related issues but, furthered this statement by concluding these outcomes are
directly impacted by initiation of PNC. Gadson also concluded SES is a driving factor for late
race/ethnicity. Seven hospitals during 2008-2010 derived from a National Inpatient Health Care
database were reviewed, which was monumental for allowing a greater population to be studied.
This study identified 25 key indicators associated with maternal morbidity (Creagna et al., 2014).
diagnostic, delivery, and procedure codes. Data also concluded 22/25 indicators were statistically
significantly higher in WOC. One of the most significant indicators of severe morbidity was
blood transfusions, where NHWW received 79/10000 transfusions and WOC received
149/10000. The authors were able to present data that showed the higher risks WOC faced
during delivery (such as the exposure to blood transfusions). The study did not present data on a
full scope of contributing variables, but the data did include other risks such as SES and
insurance. Neither SES nor insurance explained the higher levels of maternal morbidity/mortality
PNC is essential in the life of the fetus. PTB is the leading cause of neonatal mortality in the
world (Granese et al., 2019), it also exposes the fetus to life-long health implications. To acquire
information on PTB and the link between racial disparities Thurston et al. (2021), investigated
their link to PNC (both initiation and adequacy). The Sacramento study showed key findings in
their population which was low-income women using Medicaid. Their study shows that the
introductions of early and adequate PNC care to WOC (specifically black) does not reduce
disparities in race/ethnicity disparities but, it does reduce PTB rates. This study was not able to
assess level of care or comorbidity analysis for subjects and limited research to single county. It
does however solidify the previous introduced studies as it is able to show clear connections in
Discussion
The U.S. department of Health and Human Services, Healthy People 2030 has an objective set at
80.5% (2020) for PNC, though a great goal is no clear goals within different demographics.
Demographics are important to note as the level of care needs to not only be increasing for all
women but regardless of your race/ethnicity levels of care sure be as equal as possible. There
needs to be more research to conclude if there are other factors increasing the risks for WOC
during pregnancy. There are clear gaps in research such as in Thurston et al. (2021) deriving the
decrease of PTB but not a decrease in disparities when even proper initiation and adequate PNC
is supplied to WOC. Such gaps create the inference that perhaps the true risk is being a WOC,
and the possible structural disparities in healthcare that should be addressed. It is negligible to
assume the current healthcare and racial structure does not contribute to the risks WOC face at a
higher rate than NHWW. Barriers WOC face make them the risk as their counterparts are not
exposed to the same experience. Gadson et al., states “categories of race and ethnicity do not
inequalities implicated in health outcomes.” We must do our due diligence to acknowledge that
these inequalities may have created an entire population (WOC) to be a risk factor. With this
information, we must ask ourselves: Are women of color more at risk during pregnancy due to
Are women of color more suspectable to poor health outcomes during pregnancy in Duval
County? It is our hypothesis that women of color are more at-risk during pregnancy.
pregnant women ages ranging 19-30. Women were asked to complete 1 survey where they
disclosed age, race, income, education, current trimester of pregnancy, prenatal care questions,
and opinions on attitudes of prenatal care. For this preliminary pilot study there was only one
questionnaire given during entire pregnancy to attempt to find a basis for need of more in-depth
research.
A total sample size of N=23 was used for this study, there will be data that does not
include the full sample size as there was missing data from respondents. The age group for this
study varied but all participants were pregnant women in the age groups of 19-30 (N=23). Any
Asian (Chinese, Filipino, Japanese, Vietnamese, or other Asian), 2 participants (8.7%) identified
identified as Native American or Alaska Native, Native Hawaiian or other Pacific Islander.
Of the respondents who answered (n=22) the portion to identify their current trimester,
participants (9.09%) identified they were in their 1st trimester, 3 (13.64%) participants identified
being in their 2nd trimester, and 1 (.45%) participant answered as being in her 3rd trimester.
Respondents answered for their highest level of education (n=22) with most respondents
50% (11 respondents) reporting having some college experience (no degree attained). Of the
Bachelors), and 13.64% (3 respondents) reported having a high school diploma or GED.
Study participants were asked to disclose if they planned on seeing the same provider for
every visit. 2 respondents did not complete this portion leaving the qualifying sample size for
this question at n=21. Of respondents who answered, 9 (42.86%) did not plan on seeing the same
provider and the majority 12 respondents (57.14%) did have plans to see a single provider during
Participants were asked to disclose the amount of scheduled doctor's visits missed; of 23
The above chart represents participants ethnicity (x, axis) and the number of visits they are
comfortable having during gestation (y, axis). The upper buffer for number of visits is 15 which
is the recommended amount suggested by The American Academy of Pediatrics (AAP) and
for Perinatal Care (2017, p. 150). Ethnicity was given a numerical value in which respondents
chose:
1: White
2: Black/African American
5: Hispanic or Latino
7: Other Non-White
Analysis of Initial Findings
After review of the data and collection of responses the need for a more comprehensive and
educated prenatal experience is apparent. This study was unable to gauge the true complexity of
need for women of color as there is a need to conduct such a study in a more diverse pool of
women. The data however clearly supports findings of a previous retrospective study (Park et al.,
2007) that investigated disparities in timing and total number of PNC visits and was able to
associate level of education which such disparities. There are clear indicators of improper health
management by participants due to their lack of knowledge with data showing a disproportionate
number of women not knowing their current trimester (72.73%) and never having a scheduled
PNC visit (63.64%). More in-depth analysis needs to be done to be able to show the connection
between women's SES and other factors that also contribute to such health risks.
Data collected from this serves as small stepping-stone into a much bigger problem
women (in a particular WOC) face during pregnancy. There were no questions requiring
respondent to divulge level of knowledge of adequate care but with data collected there is
evidence the women in this study did not have a clear understanding of the implications that
could arise from not attending PNC visits at the recommended rate.
Proposed Study
Research Methods
This study will focus on a group of 15 pregnant women in Duval County (Jacksonville, FL) who
are aware of their pregnancy within the first four weeks of conception (first missed menstrual
cycle). This study will commence August 2021 and run through August 2022 (1 full calendar
year). Women will be in good health standing with no known risks which would deem a high-
risk pregnancy. Limitations may be placed if PCM discovers a high-risk pregnancy as this
color. This will be a cross-sectional study that also covers a longitudinal cohort aspect as the
women will need to be followed through gestation. 75% of women will be women who identify
participants will be required to have a PCM that is not covered by study. Participants will be
required to maintain all appointments scheduled with their PCM during entire study. PCM’s
Participants will be given a tablet for correspondence with researchers that will be
covered by study to be able to keep track of care and surveys. There will be an onboarding
survey, surveys given each trimester (total of 3 trimesters), and one final survey after delivery of
fetus. Surveys will ask questions about perceived care, attitudes knowledge, practices, and level
personal socio-economic status data that is relevant for purposes of this study. Each trimester the
participants will fill out the same survey. There will be three focus group meetings to provide
any additional information or answer questions the participants may need clarity on. Discussions
on care and supplemental resources (provided free by DUVAL COUNTY) will be supplied for
women if requested). There will be bus passes available free for participants if needed so they
Data will be analyzed by lead researcher, assistant researcher, and the two graduate students.
There will be a set program to de-identify participants set up on surveys so that researchers can
analyze data without compromising participants privacy. Using a thematic analysis data will be
coded and to compare ethnicity to all levels of care and knowledge (prior and knowledge given
to participants by their PCM). All notes and data from focus groups will be coded and graduate
students will provide a transcript of communication during focus groups. Data will be analyzed
to determine the impact of ethnicity in prenatal care by comparing all variables asked during
Proposed Dissemination
After final focus group and recouping of all materials research will compile all data into a peer-
reviewed journal. Data will also be provided in PDF file of findings will all statistical and
important finding for the Duval County Health Department. Participant may fill out request to
have their information released to them upon request and finalization of all research.
References
AAP Committee on Fetus, and Newborn, ACOG Committee on, Obstetric Practice, Kilpatrick,
S. J., Papile, L., Macones, G. A., & Watterberg, K. L. (2017). Guidelines for Perinatal
Bengiamin, M. I., Capitman, J. A., & Ruwe, M. B. (2010). Disparities in initiation and adherence
to prenatal care: impact of insurance, race-ethnicity and nativity. Maternal & Child Health
Creanga, A. A., Bateman, B. T., Kuklina, E. V., & Callaghan, W. M. (2014). Racial and ethnic
Gadson, A., Akpovi, E., & Mehta, P. K. (2017). Exploring the social determinants of
Granese, R., Gitto, E., Gabriella D’Angelo, Falsaperla, R., Corsello, G., Amadore, D., Calagna,
G., Fazzolari, I., Grasso, R., & Triolo, O. (2019). Preterm birth: seven-year retrospective
10.1186/s13052-019-0643-9
Noonan, K., Corman, H., Schwartz-Soicher, O., & Reichman, N. (2013). Effects of Prenatal Care
on Child Health at Age 5. Maternal & Child Health Journal, 17(2), 189-199.
10.1007/s10995-012-0966-2
Park, J., Vincent, D., & Hastings-Tolsma, M. (2007). Disparity in prenatal care among women of
Petersen, E. E. (2019, May 9). Vital Signs: Pregnancy-Related Deaths, United States ... Centers
https://www.cdc.gov/mmwr/volumes/68/wr/mm6818e1.htm?s_cid=mm6818e1_w
Pregnancy and Childbirth - Healthy People 2030 | health.gov. (2020). U.S. Department of
data/browse-objectives/pregnancy-and-childbirth
Thurston, H., Fields, B. E., & White, J. (2021). Does increasing access to prenatal care reduce
10.1016/j.pedn.2021.01.012
Appendix A: Pilot Study Survey
https://forms.office.com/Pages/ResponsePage.aspx?id=-rIp3ymJL0idu2D_TfIkxAic-
6YqY5pAvfe_dCYaZl1URUhaV1pFNE1YVkxLNFk2NEdESTNIRzdKRy4u
Appendix B: Pilot Study Codebook
Dataset Survey
Survey Variables Categories
Question Survey Code Label
No. Question Names Label
How old are Patients age text
1 you? Age in years
What is Patients 1 White
your Race/Ethnici
2 ethnicity? Race/ETH ty
2 Black/Africa
n American
3 Native
American or
Alaska
Native
4 Asian
(Chinese,
Filipino,
Japanese,
Korean
Vietnamese
or other
Asian)
5 Hispanic or
Latino
6 Native
Hawaiian or
Other
Pacific
Islander
7 Other non-
White
Are you 0 No
fluent in Proficiency
3 English? FluentENG in English
1 Yes
What is 1 No
your highest schooling
level of Level of
12 education? EDU Educatio
2 Below 8th
grade
3 Some high
school (no
diploma)
4 High school
diploma or
GED
5 Some
college (no
degree)
6 College
degree or
trade
(vocatoinal
cert./degree
up to
bachelors)
7 Master's
Degree or
higher
(beyond
bachelor's)
1 Single,
Marital Marital Never
13 Status MS status Married
2 Married/Do
mestic
Partnership
3 Widowed
4 Separated
5 Divorced
Are you Employmen 0 No
14 employed? EMP t status
1 Yes
Yearly 1 No income
Household household
15 Income HI income
2 $1-$9999
3 $10000-
$24999
4 $25,000-
$49,999
5 $50,000-
$64,999
6 $65,000-
$74,999
7 $75k or
more
What is 1 Governmen
your current Insurance t or State
16 insurance? INS Provider Insurance
2 Private
Insurance
3 No
Insurance
17 What is the CPNV
minimum
number of Number of
prenantal Prenatal
visits you visits
would be patient is
comfortable comfortable
having? with 1 1-3
2 4-7
3 8-11
4 11-14
5 15 or more
Missing
Data value
will be
coded : 999
Sur A R Fl F N F C T S M O E M E H I C P P P P P PR PR
vey g a u R u R R L C is N D S M I N P R R R R R OV O
Nu e c e T m T T V H s E U P S N O O O O O _ V_
e
e n d V V V
/ t _ P _ _ _ V
E E P P T V A R U V A T _ M SA
mb T N R C R R S S P O N _L P R H TS M
er F G G H N I T T T V V D IS P S C ND E
2
1 1 1 1 0 0 4 4 0 1 9 1 5 1 1 3 3 1 3 3 3 3 3 3 0
2
2 0 1 1 0 1 1 3 4 1 8 1 5 1 1 5 2 2 1 2 1 2 1 2 1
2
3 3 1 1 1 0 4 4 0 1 9 1 5 2 1 4 1 2 2 3 2 3 3 3 1
9
9 99 99
4 9 7 1 0 0 4 4 0 0 9 1 5 1 1 7 2 2 3 1 1 1 1 9 9
2
5 1 2 1 0 0 4 4 0 0 9 0 6 1 1 3 2 3 1 3 3 2 2 3 1
3
6 0 1 1 0 0 4 4 0 0 9 0 6 1 0 0 3 5 3 3 3 3 3 3 0
2
7 0 1 1 0 0 1 1 0 0 8 1 5 1 1 3 2 1 1 1 1 1 1 1 1
2 99
8 0 1 1 0 0 4 4 0 0 9 1 6 1 1 3 2 5 2 3 3 3 3 3 9
2
9 2 4 1 0 0 4 4 0 0 9 1 5 1 1 4 2 3 2 2 2 1 1 3 1
2
10 1 5 1 0 0 4 4 0 0 9 0 5 1 1 5 1 2 2 2 1 2 1 3 0
2
11 1 1 1 0 0 4 4 0 0 8 1 6 1 1 1 2 3 2 2 2 2 1 3 1
2
12 1 4 1 0 0 4 4 0 0 9 0 5 1 1 1 2 1 3 3 3 3 3 3 0
9
1 9 99
13 9 1 1 0 0 4 4 0 0 9 9 6 1 1 1 2 2 2 1 3 2 2 3 9
2
14 0 5 1 1 0 1 4 3 2 8 1 4 2 1 5 2 3 3 3 2 3 2 2 1
9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9
2 9 9 9 9 9 9 9 9 9 9 9 9 9 9 99 9 9 9 99 99
15 0 1 1 9 0 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9
2
16 1 1 1 0 0 4 4 0 0 9 0 5 1 0 0 2 1 3 3 3 3 3 3 1
9 9 9
2 9 9 9 99 99
17 0 1 1 9 0 4 4 9 0 9 0 4 1 0 7 3 9 2 2 2 2 2 9 9
18 2 1 1 0 0 1 1 I 1 8 1 5 1 1 1 2 4 2 1 1 1 1 1 1
0 d
o
k
n
o
w
k
n
o
w
2
19 2 2 1 1 0 4 2 3 2 8 0 5 1 1 4 2 2 2 2 2 1 2 1 1
2
20 3 2 1 0 0 4 4 0 0 9 0 6 1 1 4 2 3 3 3 3 3 3 3 0
2
21 1 1 1 1 0 4 4 0 0 9 1 6 1 1 2 2 2 2 2 2 2 2 3 1
2
22 0 1 1 1 0 1 2 2 2 1 0 4 1 1 4 1 3 2 1 1 3 2 2 1
2
23 0 1 1 1 0 1 2 4 4 8 1 6 2 1 6 2 3 1 1 1 1 1 1 1
Health Risks in Women of Color. This study will be compiled of pregnant women (in their first
trimester, must be four weeks or less into gestation. Range of ethnicities will be varied with an
emphasis (more than 75%) on participants who identify as women of color (non-white). The
study sample will be compromised of 15 women (N=15) who are deemed to be in good health
and not have any pre-existing conditions that would make their pregnancy at risk. All
participants will be seen at their exclusive PCM. This is to ensure women are being seeing in an
environment they would normally visit to be able to gauge level of care and education being
provided. Participants must visit same PCM for duration of gestation. Outreach programs (free
by county) will be provided to ensure women are able to address basic needs during gestation,
but researchers will not impede or assist more than in a recommendation for assistance as data
needs to be collected based upon status of current education and care provided by participants
PCM. Participants will adhere to PCM guidelines for visits necessary and such recommendation
will be discussed in surveys and focus groups. There are zero risks for participants as all
information will be decoded as to safeguard their medical conditions and attitudes towards care.
As stated, all medical care will be administered by participants PCM and not researchers. All
information discussed and disclosed will deidentified immediately for safety and privacy
purposes. Participants will be allowed to disclose and divulge at their discretion and
Appendix D: Consent
INFORMED CONSENT FORM
to Participate in Research, and
AUTHORIZATION
to Collect, Use, and Disclose Protected Health Information (PHI)
· Why the study is being done and what will happen to you if you take part in the study:
This study is being taken place to help retain information on the prenatal experience of women to see if
there are areas of improvement that may be needed to assist with better care and health outcomes.
How long you will be in the study: Entire gestation period from first realization of conception to
delivery of fetus.
The possible foreseeable risks, discomforts, and benefits of this research: Benefits
of this research will be used as a guiding to educate implement proper prenatal care for women. There are
no foreseeable risks as most information will be taken in survey form or pilot groups for discussion of care
purposes only.
Alternatives to being in the study: Participants must choose to fulfill entire study or not
participate as full prenatal care time is imperative for study purposes.
How your study records will be maintained and who will have access: All study
records will be maintained by primary care providers (when it is reference to participants health and will
only be disclosed if participant gives consent and will only be used to help gauge education for after study).
All other private information will be kept locked in a secure facility only to be used during study and
discussions with participants to further files.
If it will cost, you anything to take part in this study: This study will be at no cost to
participants.
When or if you may be told about new findings which may affect your willingness
to keep taking part in this study: All finding are from this study will be used to create guidelines
and education for women in pregnancy, any new findings that pertain to individual participants will be
disclosed immediately by supervisors or primary care facilitators.
If you agree to participate in this study, you will be given a signed copy of this
document.
You may contact Madeline Alford 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.
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, Madeline Alford 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:
· 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).
Your PHI may be shared with:
· 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 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.
________________________________ ______________
Consent and Authorization of Patient Date
Appendix E: Budget and Timeline
Budget
Equipment and
Supplies
Tablets $200 N/A N/A $3,000
(technology) (x15:
1 per participant)
Office Supplies $1,000 $1,000
Communications $0 (included in
(email, text, technology
phone budget)
communication)
Travel & Fuel to $1,000 N/A N/A $1,000
location
Facility to hold $3,000 $3,000
focus group
meeting
Bus Passes for $1,000 $1,000
those without
transportation
Food/water for $1,000 $1,000
focus group
meeting
Total Direct Costs $180,000
Total Indirect $86,400
Costs
Research Timeline
2021 2022
J F M A M J J A S O N D J F M J J A S O N D
Activity a e a p a u u u e c o e a e M Apr a u u u e c o e
n b r r y n l g p t v c n b a y n l g p t v c
Onboarding
First survey at
beginning of
1st trimester
1st focus group
Second survey
(beginning of
2n trimester)
2nd focus group
3rd survey
(beginning of
3rd trimester)
Final survey
(end of
gestation)
Final Focus
group
Off-boarding
Researchers
analyze
complied data
Study Area
Maps of World. (n.d.). [Illustrative]. Maps of World.
https://www.mapsofworld.com/usa/states/florida/counties/duval-county-map.html