Using Pharmacy Extenders to Optimize Non-statin Agents for Secondary ASCVD Prevention Outcomes in a Federally Qualified Health Center
Conditions: ASCVD Management
Sponsor: University of Texas at Austin

 
FORM: IRB Proposal - Standard Submission 
NUMBER 
VERSION DATE 
HRP-UT901 
10/10/25 
 
 
Page 1 of 32 
 
INSTRUCTIONS 
• 
This form is intended for studies that are considered greater than minimal risk (full board), for minimal risk 
research qualifying for expedited review (fits in one or more expedited review categories), OR for any study 
where you are unsure of the appropriate IRB review level.  
o See sections 5.3 and 5.4 of the UT IRB Policies and Guidance page for guidance on what research 
qualifies for expedited (single reviewer) and exempt review. 
o If your study qualifies for exempt review, you are encouraged to instead use the HRP-UT902 Template 
IRB Proposal Exempt Submission Form, which is streamlined for exempt research. You can download 
proposal templates from the Templates tab in UTRMS-IRB Library.  
o If you are ONLY using secondary data that will not be initially collected solely for this research project 
AND you will not interact with participants, you are encouraged to instead use the HRP-UT903 
Template IRB Proposal Secondary Use form which is streamlined for secondary use only projects where 
there is no interaction with participants. You can download proposal templates from the Templates tab 
in UTRMS-IRB Library. 
• 
For studies following a sponsor protocol, please use this guidance to assist in your completion of this form.  
• 
Answer all questions. If a question is not applicable to the research or if you believe you have already answered a 
question elsewhere in the application, state “NA” (and if applicable, refer to the question where you provided the 
information). If you do not answer a question, the IRB does not know whether the question was overlooked or 
whether it is not applicable. This may result in unnecessary “back and forth” for clarification. Use non-technical 
language as much as possible.  
• 
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online does not support Word checkboxes. Please download the file and use your desktop version of Microsoft 
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• 
Do not convert this Word document to PDF. The ability for UTRMS-IRB to implement “tracked changes” is required 
to facilitate efficient review. 
 
INDEX 
General Study Information  
Recruitment & Screening  
Required Disclosures 
Study Element Identification  
Obtaining Informed Consent  
Privacy & Confidentiality  
Study Procedure Description 
Benefits  
Compensation & Costs 
Subject Population  
Risks 
Conflicts of Interest 
 
 
 

Page 2 of 32 
 
 
GENERAL STUDY INFORMATION 
 
Study Title  
 
Include the study title below.  
 
Using pharmacy extenders to optimize non-statin agents for secondary atherosclerotic cardiovascular 
disease (ASCVD) prevention in a federally qualified health center (FQHC) 
 
 
 
1 
Review Type (Choose one) 
 
Please choose which level of review best fits your research. This is an investigator’s assessment of review and 
does not preclude the IRB from alternate determinations. In cases where the investigator and the IRB’s 
determination of review conflict, the IRB’s determination will be considered the official determination.  
 
Note: Expedited review does not refer to the timeliness of the review of your protocol, but specific categories of 
research defined by OHRP. If you would like help determining which type of review best fits your research study, 
please contact the IRB staff in the Office of Research Support & Compliance: 
https://research.utexas.edu/ors/human-subjects/get-help/  
 
a ☐ 
 
Full Board Review – Greater than Minimal Risk Research 
b ☒ 
 
Expedited Review – Minimal Risk Research  
 
2 
Research Hypotheses 
Please describe the research aims and hypotheses in the box below. To input text, click in the box below and 
start typing.  
Note: Procedures will be explained in a separate section below. 
 
 
 
We predict that the utilization of a pharmacist/student pharmacist targeted outreach to initiate the 
optimization of low-density-lipoprotein cholesterol (LDL-C)-lowering medications for secondary ASCVD 
prevention in a FQHC will significantly reduce LDL-C levels and improve the % of patients meeting LDL-
C targets. 
 
Primary Aim 1: To determine if pharmacy extenders’ targeted outreach to patients 
with clinical ASCVD can result in a higher percentage of patients who are meeting 
LDL-C targets after 6 months of intervention 
 
Primary Aim 2: To assess the real world % LDL-C lowering of add-on ezetimibe and/or proprotein 
convertase subtilisin/kexin type 9 (PCSK9) inhibitor’s therapy for patients with clinical ASCVD who are 
not meeting LDL-C targets with maximally tolerated statin 
 
 

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3 
Study Background 
Provide the rationale and the scientific or scholarly background for the proposed activity, based on existing 
literature (or clinical knowledge). Describe the gaps in current knowledge that the project is intended to address. 
 
 
Cardiovascular diseases (CVD) are the most common cause of death in the United States and globally 
(Hammersley et al. 2016). A near 18 million global deaths per year can be attributed to cardiovascular 
disease, such as coronary heart disease (CHD) and stroke (McClellan et al. 2019). A major indicator of 
increased risk of cardiovascular diseases, particularly atherosclerotic cardiovascular disease (ASCVD), is 
dyslipidemia. Dyslipidemia is characterized by suboptimal low-density lipoprotein cholesterol (LDL-C). 
Studies have shown that there is a direct correlation between elevated LDL-C and risk of cardiovascular 
diseases. Patients with a history of clinical ASCVD have a high risk of recurrent CV events, and 
management of dyslipidemia is critical in reducing this risk. Two major US cholesterol management 
publications have been released within the last 4 years including the 2018 AHA/ACC Guideline on the 
Management of Blood Cholesterol and the 2022 ACC Expert Consensus Decision Pathway on the Role 
of Non-Statin Therapies for LDL-Cholesterol Lowering in the Management of ASCVD. Both of these 
publications recommend maximally tolerated statins with second line, add-on therapy including non-
statin agents such as ezetimibe and/or PCSK9 inhibitors to achieve an LDL-C goal of at least a 50% 
reduction or <70 mg/dL for patients with ASCVD and encourages an even lower LDL-C target of at least 
a 50% reduction or <55 mg/dL for patients in the very high-risk category.  
 
Despite the known mortality and morbidity benefits of optimally treating dyslipidemia in patients with 
ASCVD, data reveals that dyslipidemia remains undertreated. This phenomenon is known as 
therapeutic inertia, where therapy is not started or modified to meet patient-specific goals (Lazaro et 
al. 2010). This appears to be the case with primary and secondary prevention of ASCVD. Of patients in 
the U.S. with ASCVD, nearly 80% have not reached their LDL-C goals, despite being on statin therapy 
(Lazaro et al. 2010). According to a 2001 article on clinical inertia, Phillips et al. determined that 
therapeutic inertia may be a result of prescriber's overestimating patient adherence or the prescriber’s 
lack of training in properly using the guidelines to make their clinical decisions. Other causes for 
therapeutic inertia may be due to the nature of the patient’s individual health—with multiple 
conditions, such as diabetes mellitus, thyroid dysfunction, kidney diseases, or cancer, to name a few, 
or prescribers are not prioritizing the patient’s dyslipidemia management (Phillips et al. 2001). 
 
Within the last 20 years, there has seen a rise in the non-statin medications available to treat patients 
that are not at goal. One particular medication of interest is ezetimibe (Zetia), a non-statin that works 
by reducing the absorption of cholesterol. A large driver for ezetimibe being incorporated early on in 
treatment algorithms for secondary ASCVD prevention come from the IMPROVE-IT trial. This study 
concluded that ezetimibe, when added to statin therapy, resulted in further lowering of LDL-C values 
and improved cardiovascular outcomes by approximately 24% (Cannon et al. 2015). Other 
medications, such evolocumab (Repatha) and alirocumab (Praluent) from the PCSCK9 inhibitor class, 
have also shown significant reductions in LDL-C levels and positive outcomes in ASCVD related events. 
In the 
FOURIER trial, patients who had clinically evident ASCVD, an LDL-C of >70 mg/dL, and were on statin 
therapy received evolocumab to evaluate cardiovascular outcomes when adding evolocumab to 
moderate- or high-intensity statin therapy (Sabatine et al. 2017). Investigators found that evolocumab 
significantly reduced cardiovascular events and had a 59% lowering of LDL-C from baseline compared 
to the placebo. Additionally, in the ODYSSEY trial, patients who had acute coronary syndrome (ACS), an 

Page 4 of 32 
 
LDL-C >70 mg/dL, and on a high-intensity statin or maximally tolerated dose received alirocumab to 
evaluate a potential lower risk of recurrent ischemic cardiovascular events (Schwartz et al. 2018). This 
study found that alirocumab had an average of 62.7% lower LDL-C at 4 months of therapy compared to 
the placebo group and lowered the risk of major adverse cardiovascular events. Thus, with these 
clinically significant trials, ezetimibe, evolocumab, and alirocumab are recommended as an adjunct to 
statin therapy. 
 
Initial findings from Part 1 of this project showed that ezetimibe was underprescribed in patients with 
elevated LDL-C and history of ASCVD at CommUnityCare (CuC). The percentage of patients with clinical 
ASCVD who are meeting LDL targets at CuC (35.9%) is above the national average (16-28%). While CuC 
is 
higher than the national average, there is still an opportunity to optimize cholesterol management. 
Therefore, the purpose of this study is to initiate a clinical pharmacy initiative to increase the number 
of patients on appropriate therapy to achieve LDL-C goals for secondary ASCVD prevention. 
 
Acknowledgements: Paola Pina and Sabrina Guerra for their contributions to the 
background writing and initial findings from part 1 of this study. 
 
Resources: 
1. Grundy, S. M., Stone, N. J., Bailey, A. L., et.al. 2018 
AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the 
Management of Blood Cholesterol: Executive Summary: A Report of the American College of 
Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Journal of the 
American College of Cardiology, 73(24), 3168–3209. https://doi.org/10.1016/j.jacc.2018.11.002 
2. McClellan, M., Brown, N., Califf, R. M., & Warner, J. J. (2019). Call to Action: Urgent Challenges in 
Cardiovascular Disease: A Presidential Advisory From the American Heart Association. Circulation, 
139(9), e44–e54. https://doi.org/10.1161/CIR.0000000000000652 
3.Writing Committee, Lloyd-Jones, D. M., Morris, P. B., Ballantyne, C. M., Birtcher, K. K., Covington, 
A. M., DePalma, S. M., Minissian, M. B., Orringer, C. E., Smith, S. C., Jr, Waring, A. A., & Wilkins, J. 
T. (2022). 2022 ACC Expert Consensus Decision Pathway on the Role of Nonstatin Therapies for 
LDL-Cholesterol Lowering in the Management of Atherosclerotic Cardiovascular Disease Risk: A 
Report of the American College of Cardiology Solution Set Oversight Committee. Journal of the 
American College of Cardiology, 80(14), 1366–1418. https://doi.org/10.1016/j.jacc.2022.07.006 
4. Grundy SM, Stone NJ, Bailey AL, Beam C, Birtcher KK, Blumenthal RS, Braun LT, de Ferranti S, 
Faiella-Tommasino J, Forman DE, Goldberg R, Heidenreich PA, Hlatky MA, Jones DW, Lloyd-Jones 
D, Lopez-Pajares N, Ndumele CE, Orringer CE, Peralta CA, Saseen JJ, Smith SC Jr, Sperling L, 
Virani SS, Yeboah J. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA 
Guideline on the Management of Blood Cholesterol: A Report of the American College of 
Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019 
Jun 18;139(25):e1082-e1143. doi: 10.1161/CIR.0000000000000625. Epub 2018 Nov 10. Erratum in: 
Circulation. 2019 Jun 18;139(25):e1182-e1186. PMID: 30586774; PMCID: PMC7403606. 
5.Cannon CP, Blazing MA, Giugliano RP, McCagg A, White JA, Theroux P, Darius H, Lewis BS, 
Ophuis TO, Jukema JW, De Ferrari GM, Ruzyllo W, De Lucca P, Im K, Bohula EA, Reist C, Wiviott 
SD, Tershakovec AM, Musliner TA, Braunwald E, Califf RM; IMPROVE-IT Investigators. Ezetimibe Added 
to Statin Therapy after Acute Coronary Syndromes. N Engl J Med. 2015 Jun 18;372(25):2387- 
97. doi: 10.1056/NEJMoa1410489. Epub 2015 Jun 3. PMID: 26039521. 
6. Sabatine, M. S., Giugliano, R. P., Keech, A. C., et.al. Evolocumab and Clinical Outcomes in 

Page 5 of 32 
 
Patients with Cardiovascular Disease. The New England Journal of Medicine, 376(18), 1713-1722. 
https://doi.org/10.1056/NEJMoa1615664 
7. Schwartz, G. G., Steg, P. G., Szarek, M, et.al. Alirocumab and Cardiovascular Outcomes after 
Acute Coronary Syndrome. The New England Journal of Medicine, 379(22), 2097-2107. 
https://doi.org/10.1056/NEJMoa1801174 
 
 
 
4 
Design and Methodology 
 
Provide a brief description of the study design or data collection methodologies. Details regarding protocol 
specific research procedures will be discussed in a later section. 
 
 
This will be a prospective intervention study utilizing a mirror image control outcome (reduction in 
LDL-C) after exposure (pharmacist/student pharmacist outreach). 
 
 
 
5 
Data Analysis 
Describe the data analysis plan, including any statistical procedures or power analysis. 
 
 
Descriptive statistics will be used to analyze demographics and percentage-based outcomes. Paired t-
tests will be utilized compare pre-post data. Statistical significance will be based on an alpha of <0.05. 
 
STUDY ELEMENT IDENTIFICATION 
6 
Study Elements 
 
Check each research procedure included in your study. 
A full description of all study procedures should be provided in the Procedures (Details) section below.  
Procedures with highlighted checkboxes and denoted with “*” below have supplemental forms. Navigate to 
the UTRMS-IRB Library, Templates tab to download the applicable supplemental form.  
 
 
☐ 
 
Bio-specimens* 
☐ 
 
Biometrics 
☐ 
 
Registry or Repository* 
 
☐ 
 
Focus Group 
☐ 
 
Genetic Analysis 
☐ 
 
Genomic Data Sharing 
 
☐ 
 
International 
Research* 
☒ 
 
Interview/Survey 
☐ 
 
MRI 

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☒ 
 
Protected Health 
Information* 
☐ 
 
Observation 
☐ 
 
Radioactive Material/PET/Nuc. 
Med 
 
☒ 
 
Record review 
☐ 
 
Sensors  
(Externally Placed) 
☐ 
 
Sensors  
(Inserted) 
 
☐ Audio (only) 
Recording 
☐ Video Recording 
 
☐ 
X-Ray/CT/DEXA 
 
 
 
7 
Study Intervention 
 
Click on the check box (or double click and type an “X” if using Google Docs) if you will implement any of the 
following interventions. 
A full description of all study interventions should be provided in the Procedures (Details) section below.  
* Interventions with highlighted checkboxes and denoted with “*” below have supplemental forms. Navigate 
to the UTRMS-IRB Library, Templates tab to download the applicable supplemental form. 
 
 
☒ Behavioral 
☐ Device* 
☐ Drug/Biologic* 
 
 
8 
Clinical Trial  
 
Click on the following check box (or double click and type an “X” if using Google Docs) if the research meets the 
below definition of a clinical trial.  
 
 
 
☒ This study meets the definition of a clinical trial according to clinical trials.gov in 
that it involves one or more human subjects who are prospectively assigned to 
one or more interventions (which may include placebo or other control) to 
evaluate the effects of those interventions on health-related biomedical or 
behavioral outcomes. 
 
 
9 
Additional Oversight  
 
Check the box(es) below if you are implementing research procedures that require oversight from additional UT 
committees. 
 
 
 
☐ Energy introduced 
to the subject 
(electrical, 
magnetic, light) 
☐ Human embryonic, 
human induced 
pluripotent, or human 
totipotent stem cells; 
or human gametes or 
embryos 
☐ Radiation exposure without 
direct clinical benefit 
 
 
 
 

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☐ Biological Samples, Biohazards, Recombinant DNA, or Gene Transfer  
 
 
If biological samples are used and stored on UT campus UT IBC approval is needed. 
 
a 
☐ 
UT IBC has (or will have) oversight.  
 
 
Provide UT IBC Number:  
 
 
      
 
 
 
 
 
b 
☐ 
Biological samples collected will not be stored at UT Austin and another 
agency has responsibility for biospecimen safety. 
 
 
10 Alternatives to Participation in This Study 
Provide a description of alternatives to participation in this study, as applicable.  
 
Patients will still have a follow-up phone call from their clinical pharmacy team. They will continue 
receiving usual care and follow-ups from the clinical pharmacy team. 
 
 
 
 
STUDY PROCEDURE DESCRIPTION 
11 Procedure Description 
 
Describe all study procedures, including a step-by-step narrative of what participants will be asked to do or 
allow, and/or how data will be collected and used, such that someone else could replicate the study based 
on this description. Be sure to describe all of the following in detail, as applicable:  
 Description of all research procedures being performed and when they are performed, in sequential 
order.  
 Describe/list all research measures/tests that will be used [NOTE: upload copies of all measures, 
surveys, scripts, data collection forms, etc., in “Other Attachments” in UTRMS-IRB].  
 Secondary data or specimens that will be obtained, how they are collected, how are they used.  
 Where research activities will take place and duration (include expected time commitment of 
participants).  
 Study elements checked in #6 above must all be described here.  
Note: if this is a multi-site or collaborative study include the following:  
 This is a “Multi-site Study that involves more than one site performing ALL aspects of the research 
procedures as outlined above.” OR “This is a collaborative study that involves UT Austin researchers 
working with external researchers who are engaged in performing the following study activities (list 
activities).”  
 For assistance with multi-site/collaborative research, download HRP-UT932 Request to Rely 
Assessment Form from the UTRMS-IRB Library and email irbreliance@austin.utexas.edu. 
 

Page 8 of 32 
 
 
In this prospective study, approximately 1,000 patients with a documented history of clinical ASCVD 
will be identified from Part 1 of the Zetia Project and a new report, generated after IRB approval, to 
capture newly diagnosed patients with ASCVD who may benefit from therapy optimization. This 
population health initiative will occur regardless of the proposed research in this protocol.  
 
CommUnityCare Standard Procedure - Standard of Care 
As part of routine population health care at CuC, clinical pharmacists assess and evaluate for the 
optimization of LDL-C lowering medications according to the 2018 AHA/ACC Guideline on the 
Management of Blood Cholesterol and the 2022 ACC Expert Consensus Decision Pathway on the Role 
of Non-Statin Therapies for LDL-Cholesterol Lowering in the Management of ASCVD. Clinical 
pharmacists will review lipid panels drawn within the past 12 months. If there are no recent lab 
history available, patients will be scheduled for standard of care fasting lipid panel. Labs will be 
collected by CuC phlebotomists, nurses, or other trained healthcare professionals outside of the 
research team. Clinical pharmacists will review, assess, and analyze lipid panel lab results. If LDL 
levels are at goal, the patient will continue their standard lipid-lowering therapy and continue routine 
follow-up with the clinical pharmacy team. This standard of care follow-up may occur either in-
person or through telehealth visits conducted by the clinical pharmacists. The purpose of this routine 
call of clinical management and patient education as part of standard of care is to ensure medication 
adherence, safety, and efficacy per established guidelines. For patients not at goal, clinical 
pharmacists will provide guideline-directed therapy adjustments at a scheduled clinic visit. This may 
involve adjusting the intensity of the statin therapy or adding a non-statin agent, such as ezetimibe or 
a PCSK9 inhibitor, if the patient is not already on the maximally tolerated statin therapy. 
Intensification of statin dose will occur if: (1) LDL is not at goal for respective risk category (LDL ≥ 70 
mg/dL for very high-risk ASCVD patients and LDL ≥55 mg/dL for high-risk patients) and (2) Patient is 
not on maximally tolerated statin therapy. Patients who are on maximally tolerated statins and who 
are not at respective LDL goals will be considered for the initiation of ezetimibe and/or PCSK9 
inhibitors. A follow-up lipid panel will be ordered for 4-12 weeks after therapy adjustments and a 
follow-up clinical pharmacy appointment will also be scheduled within the same timeframe. 
Regardless of participation status in the study, all patients will continue to receive the routine care 
and follow-up from CuC clinical pharmacists described above.  
 
Alterations to Standard Procedure - Intervention 
The research intervention consists of outreach conducted by a Texas-licensed pharmacist intern 
under the supervision of CuC-employed pharmacists. Eligible patients will be contacted by a student 
pharmacist after the clinical pharmacists’ appointment (described above in the standard of care) 
using CuC’s RingCentral telehealth system. During this outreach, student pharmacists will review 
current lipid-lowering therapies, medication adherence, education about lipid-lowering therapies, 
and review of labs. Student pharmacists will not make independent prescribing or care decisions. All 
prescribing authority and therapeutic adjustments remain under the direction of CuC-employed 
pharmacists in accordance with the standard operating procedures. Patients will be informed about 
the research project during the outreach call or during a separate call dedicated to recruitment prior 
to the outreach call. Informed consent will be sent and obtained via either the EHR messaging system 
(MyChart) or text message through the Ring Central application.  
Only data from patients who provide informed consent will be included in the research dataset and 
subsequent chart review. For patients who decline participation after being contacted through the 
telehealth outreach, any information collected during the call will remain part of their standard 
clinical documentation in the EHR and will not be included in the research dataset. These patients will 

Page 9 of 32 
 
continue to receive standard clinical pharmacy care, and no data will be abstracted or analyzed for 
research purposes. Enrolled patients will then be followed through prospective chart review to 
evaluate outcomes at 3-6 months after consent and student pharmacist outreach. 
 
SUBJECT POPULATION 
 
12 
Protected Subject Populations 
Click on the check box (or double click and type an “X” if using Google Docs) each population, if they are 
specifically studied for this research. 
 
 
☐ 
 
Active Military 
Personnel 
☐ 
 
Children/Minors 
☐ 
 
Decisionally Impaired Adults 
 
☐ 
 
Emancipated Minors ☐ 
 
Fetuses 
☒ 
 
Individuals with Limited 
English Proficiency 
 
☐ 
 
Neonates (Uncertain 
Viability) 
☐ 
 
Neonates (Non-
Viable) 
☐ 
 
Prisoners 
 
☐ 
 
Pregnant Women 
☐ 
 
UT Staff/Employees 
 
 
☐ 
 
UT Students 
 
 
13 Research Participant Information 
Describe the general characteristics of the subject populations or groups including gender, health status, and 
any other relevant characteristics. If you have multiple research populations (e.g., teachers and students), 
clearly outline characteristics for each group. 
 
a Adult patients at CommUnityCare in the previous 12 months at time of enrollment, who have a 
documented history of clinical ASCVD, and are not achieving LDL targets (either <55 or <70 mg/dL 
based on risk factors) 
 
 
 
b Minimum Age 
Include the minimum age range for target population. If you have multiple research populations (e.g., teachers 
and students), clearly state the minimum age for each group.  
 
18 years old 
 
 
c Maximum Age 

Page 10 of 32 
 
Include the maximum age range for target population. If you have multiple research populations (e.g., teachers 
and students), clearly state maximum age for each group. 
 
No maximum age 
 
 
d Inclusion Criteria 
Describe the specific criteria that will be used to decide who will be INCLUDED in the research from interested or 
potential subjects. Define technical terms in lay language, as applicable. 
 
Adult patients (>18 years) who have seen a CommUnityCare provider in the previous 12 months at 
time of enrollment, who have a documented history of clinical ASCVD, and are not achieving LDL 
targets (either <55 or <70 mg/dL based on risk factors) 
 
 
e Exclusion Criteria 
Describe the specific criteria that will be used to decide who will be EXCLUDED from the research. Define 
technical terms in lay language, as applicable.  
 
Patients will be excluded if they do not have a clearly documented history clinical ASCVD, are already 
achieving LDL targets (either <55 or <70 mg/dL based on risk factors), having cholesterol managed by 
outside provider (e.g. outside cardiologist/lipid specialist), current pregnancy, have not seen a CUC 
provider in the previous 12 months, or otherwise do not qualify for clinical pharmacy intervention 
 
 
f Justification for Target Population(s) 
If the inclusion/exclusion criteria target or exclude a particular segment of the population(s) relevant to the 
research topic, provide a rationale for why this target population is appropriate to address the research 
questions. Specific groups should not be targeted for research based solely on convenience/availability. 
[For example, if only UT students are targeted for research affecting a broader population, explain why this is equitable and 
appropriate for this study.] 
 
Inclusion criteria are appropriate for this study as this population would have benefit from a 
pharmacist/student pharmacist intervention of add-on non-statin therapy for secondary ASCVD 
prevention according to clinical guidelines. Exclusion criteria are appropriate for this study as patients 
either do not require intervention (i.e. they are already at goal an therapy does not need to be 
changed or initiation of therapy is not appropriate due to lack of documented history of ASCVD), do 
not receive cholesterol management at CommUnityCare, and/or may have a drug safety concern due 
to pregnancy status. 
 
 
 
i If the study will involve snowball sampling and/or recruitment of the 
researchers’ students or personal contacts/friends/family, explain how the 

Page 11 of 32 
 
 
 
 
 
RECRUITMENT AND SCREENING 
16 
Recruitment Procedures and Materials 
study procedures will be designed to mitigate potential for coercion or 
undue influence to participate or continue participation.  
 
       
 
14 Total Sample Size 
Enter the total target sample size below.  
 
 
Approximately 1000 
 
15 
Sample size rationale 
Describe your sample size rational below.  
 
 
 
This sample size was based on a prior research study on the prescribing patterns of ezetimibe at 
CommUnityCare (Part 1 of the Zetia Project); however, a new report will be run to have a more up-to-
date list of patients who meet the inclusion criteria.  
 
 
 
 
Select each type of recruitment 
method that will be used AND 
upload copies of all materials to 
UTRMS-IRB in the “Recruitment 
Materials” section.      
Describe when/where/how this 
method will be used, as applicable; 
be sure to address special points 
indicated in the instructions for each 
method. 
Provide the schedule and frequency 
of recruitment attempts using this 
method, when applicable. 
a ☐E-mail/Letter 
     
      
Explain how emails/mailing 
addresses for potential subjects 
will be obtained by the study 
team. 
Describe the initial invitation 
and any follow-up reminders, 
and address if there will be a 
way for recipients to opt-out of 
future emails. Templates should 
include subject line(s).  

Page 12 of 32 
 
b ☐Flyer(s) 
     
      
c ☐Social Media/Web Posts 
     
      
Address which sites and 
accounts will be used to post 
ads. Templates should include 
all text/images that will be 
included in posts. 
d ☐Text/Direct Messaging 
     
      
Describe sites/accounts that will 
be used. Explain how 
participants’ contact 
information is obtained, when 
applicable. Templates should 
include the initial invitation and 
any follow-up reminders. 
e ☐Study-specific Website 
     
      
This refers to websites created 
specifically for this research 
study. Templates should include 
screenshots/mock-ups of all 
aspects of the website that will 
be created; include all 
text/images. 
f ☒ In-Person or Phone 
Scripts/Presentations 
After identifying patients who 
meet the inclusion criteria via 
medical record review, 
recruitment will occur through 
phone outreach by a pharmacist 
student intern using 
CommUnityCare’s phone system 
(Ring Central) with interpreter 
access at the University of Texas 
at Austin. Phone numbers will be 
obtained from the patient’s EHR 
via Epic.  
Approximately 1000 patients will 
be called within 6 months (~17 
patients/week). Each outreach 
will be attempted up to 3 times. 
Explain how phone numbers for 
potential subjects will be 
obtained by the study team, 
when applicable. If researchers 
will be cold-calling subjects, 
provide a rationale for why this 
method is needed to accomplish 
the research. 
g ☐
 
Research Recruitment 
pool 
     
      
Specify which pool will be used 
(e.g. SONA, Prolific, Amazon 
MTurk, etc.) and describe how 
offered studies are advertised to 
users. Provide templates of all 

Page 13 of 32 
 
 
 
18 
Screening Procedures 
Describe the procedures to screen individuals to determine whether inclusion/exclusion criteria are met.  Please 
upload all screening questionnaires/tools in the “Other Attachments” in UTRMS.  
 
From the initial report of individuals, a review of the patients’ EHR will be conducted to determine if 
the patient will need a clinical pharmacy visit for obtaining baseline labs, if there is not a lipid panel 
within the previous 12 months. If the patient is at LDL goal (<55 mg/dl for very high risk ASCVD and 
<70 mg/dl for high risk ASCVD), they will continue therapy, receive standard care, and be excluded 
researcher-provided advertising 
language that will be posted 
and confirm it meets the pool’s 
standards for formatting, 
content, word limits, etc. 
h ☐
 
Newspaper ads/TV 
spots/Radio ads 
     
      
When applicable, include scripts 
and descriptions for planned 
ads; final versions can be 
provided in a modification after 
IRB approval.  
i ☒ 
 
Medical Record Review 
A CommUnityCare clinical 
pharmacist will run an initial 
report through CommUnityCare’s 
EHR system (EPIC) at the 
beginning to identify patients 
with documented history of 
clinical ASCVD. 
An initial report at the beginning 
of the study after IRB approval 
will be run to identify potential 
participants. This report will be 
run only once. 
If your study includes identifying 
potential participants using PHI 
(e.g., a partial HIPAA waiver for 
recruitment is needed), note this 
here and complete HRP-UT907 - 
Template IRB Supplemental 
Form PHI. Download HRP-
UT907 from UTRMS-IRB Library 
Templates. 
j ☐ Other recruitment 
material/method 
     
      
17 
Screening for Eligibility Prior to Consent 
 
Check the box below if this study involves a screening process prior to the informed consent process.   
 
 
☒ This study involves obtaining information or biospecimens for the purpose of 
screening, recruiting or determining eligibility of prospective subjects prior to 
informed consent by either: 
1. Oral or written communication with the prospective subject or LAR 
2. By accessing records containing identifiable private information or stored 
identifiable biospecimens. 

Page 14 of 32 
 
from the study. If not at goal (>55 mg/dl for very high risk ASCVD and >70 mg/dl for high risk ASCVD), 
they will meet the inclusion criteria for the study. Other characteristics screened for will be age (≥18 
years), visit with a CommUnityCare provider in the last 12 months, not pregnant, documented clinical 
ASCVD (as defined as history of coronary artery disease (CAD), ischemic heart disease (IHD), 
myocardial infarction (MI), stroke/transient ischemic attack (TIA), coronary revascularization event, 
stable/unstable angina, peripheral artery disease (PAD)/peripheral vascular disease (PVD)), and lipids 
being managed by a non-CommUnityCare cardiologist/provider. 
 
OBTAINING INFORMED CONSENT 
 
 
19 
Consent Overview 
 
Check the box(es) for consenting procedures that will be used.  
 
 
☒ 
Obtaining Written Informed 
Consent/Parental Permission 
☐ Requesting a Waiver of Documentation 
(signature) of Informed Consent  
 
☐ 
Requesting a Waiver of 
Informed Consent 
☐ Requesting an Alteration of the Required 
Elements of Informed Consent 
 
☐ 
Obtaining Child Assent 
☐ Obtain Consent Using a Short Form with a 
Witness 
20 
Consent and Assent Processes 
 
Provide a detailed description of consent/assent procedures in the box below. Include: who will obtain consent, 
where will consent be obtained, how is consent obtained, how consent/assent is documented, and when the 
consent process will occur in such a manner that participants will have sufficient time for adequate 
consideration.   
NOTE: Upload copies of all consent/assent/permission forms/scripts to UTRMS-IRB in the “Consent Forms” 
section. This is required for UTRMS-IRB to appropriately stamp consent forms for approval.  
 
 
Informed consent and the research processes will be explained through the phone outreach by the 
pharmacist student intern. If patient is amenable, they will be sent a link via text, email, and/or 
MyChart message to DocuSign to sign the consent form (either in English or Spanish). Signed consent 
forms will be stored through UT DocuSign online platform accessible only to study personnel through 
an online, password protected account. 
 
21 
Research Involving Children - Age of Majority Re-Consent Process 

Page 15 of 32 
 
 
 
 
 
The age of majority is the age at which a person is legally considered an adult and can provide informed consent 
for their own participation on research. In most states, including Texas, the age of majority is 18, but this can 
vary depending on the where the research is conducted.   
 
If the research involves children as subjects, either A or B must be checked: 
 
A ☐ 
 
All study activities with minors will be complete AND all data collected from 
minors will be anonymized before any participants will reach age of majority. 
 
 
 
B ☐ 
 
The study enrolls minors who may reach age of majority while study activities 
and/or research use of their identifiable data is ongoing.  
 
 
If true, specify the method of obtaining adult informed consent from these participants upon reaching 
age of majority. At least one of the following must be checked: 
 
 
i ☐ 
Participants will be re-consented using an adult consent form/script 
 
 
 
Describe the re-consent procedures below. Be sure to upload an adult consent document that 
will be used for this group. If signature will not be collected (e.g. if re-consent is conducted via 
phone or other remote method), please complete the waiver of documentation (signature) 
section later in this form.  
NOTE: Upload copies of all consent/assent/permission forms/scripts to UTRMS-IRB in the 
“Consent Forms” section.  
 
 
 
 
      
 
 
 
 
 
 
ii ☐ 
A waiver of adult re-consent is requested in the Waiver or Alteration of 
Informed Consent section later in this form.  
 
 
 
 
22 
Electronic Consent  
 
Check the box below if this study involves obtaining consent with an electronic signature. Be sure the section 
above is consistent.  
NOTE: This box should NOT be checked participants are responding “yes” or clicking “I Agree” on a consent 
form. This section should only be completed if an electronic signature is being obtained.  
 
 
☒ 
This study involves documenting informed consent/parental permission using 
an electronic signature.  
 
 
 
If true, specify method for obtaining e-consent below (e.g., DocuSign): 
 
 
 
DocuSign 
 

Page 16 of 32 
 
 
23 
Translation for Individuals with Limited English Proficiency  
Check the box below to indicate that consent documents/scripts and other relevant study materials (e.g. 
advertisements, study measures, etc.) will be translated to a language other than English.  
 
 
☒ 
The study population will likely include participants whose limited English 
speaking status requires translation of the consent documents and other 
relevant study materials. 
 
 
 
Translation Process 
If above is checked, complete the below information describing the translation process. Either A or B 
must be checked. 
 
 
A 
☒ 
The consent documents and other relevant study materials will be 
translated by a certified translator. 
 
 
B 
☐ 
A non-certified translator will translate the consent documents and 
other relevant study materials. 
If selected, complete the next two items below. Section describing qualifications must be 
completed and backtranslation (ii) must be true.  
 
 
i 
Describe the translator’s qualifications 
To input text, click in the light grey area below. 
 
 
 
      
 
 
 
 
 
ii 
☐ 
Another individual will confirm that the translation is accurate and 
appropriate  
 
24 
Waiver of Documentation (signature) of Informed Consent  
 
Only complete this section if you are requesting to waive the requirement to collect a written signature of 
informed consent from participants (a full informed consent form/script is still required). To approve a waiver of 
documentation of consent, one of the following options must be appropriate and justified by the researcher.  
 
Please choose one waiver option and provide additional information as prompted.  Waiver option 2 is most 
common.  
 
 
A Waiver Option 1 
 
 
Check the box below for each item (all required – #1-4) and provide protocol-specific information as to 
how the criteria below are met.    
NOTE: This is the only applicable waiver of documentation option for greater than minimal risk 
research. If your study is greater than minimal risk and does not meet Option 1 criteria, you will need 
to obtain written consent.   

Page 17 of 32 
 
1 ☐ 
 
The only record linking the subject and the research would be the consent 
document. 
 i Provide protocol specific information as to how this criterion is met. 
To input text, click in the light grey area below 
 
 
     
 
 
2 ☐ 
 
The principal risk would be potential harm resulting from a breach of 
confidentiality. 
 i Provide protocol specific information as to how this criterion is met. 
To input text, click in the light grey area below 
 
 
     
 
 
3 ☐ 
 
Each subject will be asked whether the subject wants documentation 
linking the subject with the research, and the subject’s wishes will govern. 
 i Provide protocol specific information as to how this criterion is met. 
To input text, click in the light grey area below 
 
 
     
 
 
4 ☐ Describe the mechanism for documenting that informed consent was 
obtained 
  
Briefly explain how the researcher will document that consent was obtained from participants.  
  
     
 
 
 
B Waiver Option 2 
 
Check the box below for each item (all required – 1-3) and provide protocol-specific information as to 
how the criteria below are met.    
1 ☐ 
 
The study is minimal risk. 
 i Provide protocol specific information as to how this criterion is met. 
To input text, click in the light grey area below 

Page 18 of 32 
 
 
 
     
 
 
2 ☐ 
 
Written consent would not be required outside the research context. 
 i Provide protocol specific information as to how this criterion is met. 
To input text, click in the light grey area below 
 
 
     
 
 
3 ☐ Describe the mechanism for documenting that informed consent was 
obtained 
  
Briefly explain how the researcher will document that consent was obtained from participants. To 
input text, click in the light grey area below. 
 i 
     
  
 
C Waiver Option 3 
 
Check the box below for each item (all required – 1-4) and provide protocol-specific information as to 
how the criteria below are met.    
1 ☐ 
 
The subjects or legally authorized representatives are members of a distinct 
cultural group or community in which signing forms is not the norm 
 
i 
Describe the cultural group or community. 
 
 
      
 
 
 
2 ☐ 
 
The research presents no more than minimal risk of harm to subjects. 
 i Provide protocol specific information as to how this criterion is met. 
To input text, click in the light grey area below 
 
 
     
 
 

Page 19 of 32 
 
 
3 ☐ 
 
There is an appropriate alternative mechanism for documenting that 
informed consent was obtained. 
 i Provide protocol specific information as to how this criterion is met. 
To input text, click in the light grey area below 
 
 
     
 
 
4 Describe mechanism for documenting that informed consent was obtained 
To input text, click in the light grey area below 
       
 
25 
Waiver or Alteration of Informed Consent  
 
Only complete this section if a waiver or alteration of consent is requested. To approve a waiver or alteration 
of consent, all of the following criteria must be appropriate and justified by the researcher. All boxes must be 
checked.  
SKIP THIS SECTION IF NOT REQUESTING A WAIVER/ALTERATION OF CONSENT 
 
 
A 
☐ 
 
The research involves no more than minimal risk to the subjects.  
 
 
i 
Provide protocol specific information as to how this criterion is met.  
 
 
 
To input text, click in the light grey area below 
 
 
 
      
 
 
 
 
 
 
B 
☐ 
 
The waiver or alteration will not adversely affect the rights and welfare of 
the subjects.  
 
 
 
i 
Provide protocol specific information as to how this criterion is met.  
 
 
 
To input text, click in the light grey area below. 
 
 
 
      
 
 
 
 
 
 
C 
☐ 
 
The research could not practicably be carried out without the waiver or 
alteration (it is impracticable to perform the research if obtaining consent 
is required and not just impracticable to obtain consent).  
 
 
 
i 
Provide protocol specific information as to how this criterion is met.  

Page 20 of 32 
 
 
 
 
 
Acceptable justifications should be based on the study's scientific design rather than issues of 
time or inconvenience.  
To input text, click in the light grey area below. 
 
 
 
      
 
 
 
 
 
 
D 
☐ 
 
If the research involves using identifiable private information or 
identifiable biospecimens, the research could not practicably be carried 
out without using such information or biospecimens in an identifiable 
format.  
 
 
 
i 
Provide protocol specific information as to how this criterion is met.  
 
 
 
To input text, click in the light grey area below. 
 
 
 
      
 
26 Deception/Incomplete Disclosure and Debriefing 
Only complete the sections below if requesting an alteration of informed consent for research that involves 
deception/incomplete disclosure.  
Deception (as applies to research) means intentionally giving research subjects false information in order to 
establish false beliefs during the course of a research study. 
Incomplete disclosure means that the principal investigator withholds some information about the real purpose of 
the study or the nature of the research procedures. 
See IRB Policies and Procedures Section 15 for a description of deception. 
If this study does not involve deception/incomplete disclosure, skip this section. 
 
A 
☐ It is appropriate to provide additional pertinent information to the subject 
after research activities are complete (e.g., the researcher needed to deceive 
the subject to the nature of the study). 
 
B 
☐ Research participants will have the opportunity to withdrawal their data 
during the debriefing. 
 
C 
Describe the nature of deception/incomplete disclosure and why it is necessary 
to conduct the research. 
To input text, click in the light grey area below. 
 
 
      
 
 
 
 
 
D 
Describe debriefing procedures. 

Page 21 of 32 
 
BENEFITS 
27 
Benefits to Society 
Describe the scientific and societal benefit(s) below. 
 
 
The majority of patients with clinical ASCVD fail to achieve their LDL targets to prevent secondary 
ASCVD events. Cholesterol management is one of the mainstays of secondary ASCVD prevention. This 
project’s pharmacist/pharmacy student’s initiative to optimize cholesterol pharmaceutical therapy 
through guideline directed medical therapy of maximizing current lipid-lowering therapy or add-on, 
non-statin therapy has the potential to significantly reduce ASCVD risk and prevent secondary ASCVD 
events in CuC patients. Additional benefits include improving patients’ quality of life, reducing 
healthcare costs for patients, improving medication adherence and management, and improving 
health outcomes in underserved populations. Adequate interventions, monitoring, and follow-up by 
the clinical pharmacy team for cholesterol management has the potential to improve health-related 
outcomes. Upon significant findings of utilizing pharmacy extenders to optimize non-statin agents to 
achieve LDL goals and prevent secondary ASCVD events at CommUnityCare, patients at other 
federally qualified health centers may benefit from this study’s initiatives. 
 
28 
Potential Direct Benefits to Participants 
Click on the applicable check box. A or B must be checked.  
 
 
A 
☐ 
There is no anticipated direct benefit to participants. 
 
 
B 
☒ 
There are anticipated benefits to participants. 
 
 
 
i 
If applicable, describe the potential direct benefits to participants. 
To input text, click in the light grey area below. NOTE: Upload the debriefing form to UTRMS-IRB in the 
“Consent Forms” section.  
 
 
      
 
 
 
 
Although the percentage of patients with clinical ASCVD who are meeting LDL targets at 
CuC is above the national average, the opportunity to focus on cholesterol management 
remains. This project’s pharmacist/pharmacy student’s initiative to optimize cholesterol 
pharmaceutical therapy through guideline directed medical therapy of maximizing 
current lipid-lowering therapy or add-on, non-statin therapy has the potential to 
significantly reduce ASCVD risk and prevent secondary ASCVD events in CuC patients. 
Additional benefits include improving patients’ quality of life, reducing healthcare costs 
for patients, improving medication adherence and management, and improving health 
outcomes in underserved populations. 

Page 22 of 32 
 
 
 
 
Describe potential direct benefits to participants below.  
 
RISKS 
29 
Describe the risks associated with each activity in this research 
To input text, click in the light grey area below. Note: Risks should also be outlined in the consent form(s).  
 
 
For this project, the risk is minimal for CuC patients and is no higher than standard care given 
medications changes will be implemented in alignment with current guidelines and clinical 
pharmacist therapy protocols/collaborative practice agreement. Minimal risk of loss of privacy may 
occur with very low chance of data being leaked and would provide minimal impact to the patient. 
 
 
 
30 
Describe how each risk is mitigated/minimized. 
To input text, click in the light grey area below. Note: Risks mitigation should be outlined in the consent form(s), 
as applicable.  
 
 
Any potential risk regarding standard of care will be mitigated via clinical pharmacist monitoring and 
follow-up. Any potential risk of loss of privacy will be mitigated by storing patient data in UT Box, 
which is password-protected and HIPAA compliant. Access to data will be limited only to individuals 
who need access for purposes related directly to this research study. 
 
 
 
31 
Data Safety Monitoring 
For additional information regarding data safety monitoring boards and data safety monitoring plans, please 
see Section 21 of our Policies and Procedures. 
One of the following must be checked (A, B, or C).  
 
 
A 
☒ 
 
In the investigator’s opinion, this study is minimal risk and does not 
require a Data Safety Monitoring Plan (DSMP) or a Data Safety 
Monitoring Board (DMSB). 
PLEASE NOTE: The IRB may determine minimal risk studies do require data safety monitoring 
under certain circumstances (e.g., if there is a known risk with an expected frequency).  
 
 
B 
☐ 
 
This study does not have a Data Safety Monitoring Board, but 
researchers have an internal plan to monitor for safety (Data Safety 
Monitoring Plan (DSMP)). 
Complete Data Safety Monitoring Details  
 
 
C 
☐ 
This study has a Data Safety Monitoring Board (DSMB). 
 

Page 23 of 32 
 
 
Complete Data Safety Monitoring Details section below or upload this study’s Data Safety 
Monitoring Board’s charter that contains the information below.  
 
 
32 
Data Safety Monitoring (Details) 
Complete this section if the study has a Data Safety Monitoring Plan. SKIP this section there is not a 
DSMP/DSMB. 
If the study has a DSMB, ensure all items below are addressed in the charter (and charted uploaded to UTRMS-
IRB) or provide additional information below, as needed.  
 
 
A 
How is safety information collected? 
To input text, click in the light grey area below. 
 
 
 
      
 
 
 
 
 
B 
When will safety data collection start (for each participant or for the whole 
study, as applicable)? 
To input text, click in the light grey area below. 
 
 
 
      
 
 
 
 
 
C 
How frequently will safety data be collected? 
To input text, click in the light grey area below. 
 
 
 
      
 
 
 
 
 
D 
Who will review the data for safety? 
To input text, click in the light grey area below. 
 
 
 
      
 
 
 
 
 
E 
How frequently will data be monitored for safety concerns? 
To input text, click in the light grey area below. 
 
 
 
      
 
 
 
 
 
F 
What data will be reviewed? 
To input text, click in the light grey area below. 

Page 24 of 32 
 
 
 
 
      
 
 
 
 
 
G 
State the frequency or periodicity of the review of cumulative data. 
To input text, click in the light grey area below. 
 
 
 
      
 
 
 
 
 
H 
State any conditions that would trigger an immediate suspension of the 
research. 
To input text, click in the light grey area below. 
 
 
 
      
 
 
33 
Early Withdrawal 
Only complete this section if there are planned conditions under which a participant will be withdrawn from 
the study. If not applicable, skip to next section. Include this information in your consent form. 
 
 
A 
List the criteria for withdrawing individual participants from the study (e.g., 
safety or toxicity concerns, emotional distress, inability to comply with the 
protocol, or requirements from study sponsor). 
To input text, click in the light grey area below. 
 
 
 
Drug side effects and laboratory monitoring, inability to comply with protocol 
 
 
 
 
 
B 
Describe any necessary procedures for ensuring the safety of a participant 
who has withdrawn early. 
To input text, click in the light grey area below. 
 
 
 
Patients can voluntarily withdraw from the study at any time, which will not affect their 
ongoing care at CommUnityCare. Patients withdrawn from the study will not have further 
data collected, and past data will be filed and stored in a password protected, encrypted 
cloud software (UT Box) that restricts access to only relevant personnel. Patient safety will be 
monitored according to standard of care by clinical pharmacists by patient reports of side 
effects and laboratory monitoring. Upon findings of adverse responses due to therapy, 
patients will be immediately discontinued ezetimibe and/or PCSK9i and reassessed for an 
alternative LDL-lowering medication. 
 
 
 
 

Page 25 of 32 
 
34 
Describe any pre-specified criteria for stopping or changing the study protocol due 
to safety concerns. 
To input text, click in the light grey area below. 
 
 
      
 
REQUIRED DISCLOSURES 
 
PRIVACY AND CONFIDENTIALITY 
35 
Required Consent Disclosures  
Identify each element below that may require additional information to be disclosed in the consent form. 
Click on the check box (or double click and type an “X” if using Google Docs).  
 
 
A 
☐ It is reasonable that researchers could discover or suspect child or elder abuse. 
Add appropriate disclosure in consent form(s). 
 
B 
☐ It is reasonable that researchers could learn of an incident that could require 
reporting under Title IX. 
Add appropriate disclosure in consent form(s). See Title IX and Research Guidance for information and 
download the Title IX Reporting Form on the Special Topics page.  
 
C 
☐ It is reasonable that researchers could discover incidental findings or other 
information of medical interest about a participant's previously unknown 
condition. 
Add appropriate language to consent form(s).  
 
i 
Articulate methods for addressing and reporting incidental findings, if 
applicable. 
Ensure appropriate information is in consent form(s), as applicable.  
 
 
N/A 
 
36 
Participant Privacy 

Page 26 of 32 
 
 
Privacy refers to an individual’s right to control how others view, record, or obtain information about them. 
Privacy protections apply to people, while confidentiality protections (addressed in the section below), apply to 
data. 
In this section, describe how the study team will protect participants’ privacy throughout all phases of the 
research, including during identification, recruitment, screening, the consent process, the conduct of the 
study, and dissemination of data. 
For example, consider the locations where you will approach and question participants, the locations where 
data will be viewed/analyzed, how data collection procedures will limit the amount of sensitive or invasive data 
collected to only what is necessary to answer the research questions, how participants will be described in 
publications/presentations, etc.  
 
The initial report will only be viewed by the study team and be stored in the study’s secure UT Box 
folder. During the recruitment process via phone outreach by the pharmacy student, protection of 
patient privacy will be ensured in that only the pharmacy student and/or clinical pharmacist will hear 
the content of the call. Study participants will consent to PHI collection and usage in the study by 
agreeing and signing the informed consent form as outlined above. All data will be filed and stored in 
a password protected, encrypted cloud software (UT Box) that restricts access to only relevant 
personnel. At time of intervention, patients will be randomly assigned ID numbers to keep track of 
therapy adherence and pertinent lab values. 
 
37 
Data Confidentiality and Security Plan 
Confidentiality refers to the way private information about a participant or defined community is maintained 
and shared. It describes how the study’s research materials (data, specimens, records, etc.) are protected from 
unauthorized access.  
 
In this section, describe whether any participant identifiers (e.g. names, contact info, etc.) will be collected 
during the conduct of the research and if identifiers will be linked to research data for any period of time. 
Include the following, as applicable: 
• 
If identifiers will be used for contact or compensation purposes only, and will never be linked to specific 
responses, describe the methods used to accomplish this. 
• 
If identifiers will be coded/pseudonymized to protect confidentiality, describe whether or not a code key 
will be created linking study IDs/pseudonyms to identifiers, who will have access to the key, and how it 
will be stored separately from the research data. 
 
PHI anticipated to collect: 
 
Demographics: Age, gender, race and/or ethnicity, language 
 
Past medical history 
 
Past social history: smoking status and alcohol consumption 
 
Medications: current medications, current lipid-lowering and triglyceride-lowering 
medications (including statin, ezetimibe, PCSK9i, bempedoic acid, inclisiran, fibrate, 
icosapent ethyl, omega-3 fatty acids, niacin, bile acid sequestrants) 
 
Labs: Results of current/most recent lipid panels 
 
Social determinants of health 
 
Kept appointments with PCP and/or clinical pharmacist 
 
Notes from appointments with clinical pharmacist 

Page 27 of 32 
 
 
% days covered (if information available from EPIC Willow) for cholesterol lowering 
medications during the study period 
At time of intervention, patients will be randomly assigned ID numbers to keep track of therapy 
adherence and pertinent lab values. All data will be filed and stored in a password protected, 
encrypted cloud software (UT Box) that restricts access to only relevant personnel. 
 
 
A Electronic Materials - Storage and Access 
In this section, select all methods that will be used to protect the confidentiality of research data.  
At least one of the following must be checked, select all that apply.  
 
☒  
Electronic data and records will be stored in UT Box, which is password-
protected and HIPAA compliant. Access to data will be limited only to 
individuals who need access for purposes related directly to this research 
study. (Strongly recommended) 
 
 
 
☐ 
Electronic data and records will be stored on another password-protected 
cloud service that is approved by UT Austin’s Information Security Office (ISO).  
Access to data will be limited only to individuals who need access for purposes 
related directly to this research study. 
 
 
Guidance on UT Austin ISO approved platforms and security requirements is available here: 
https://security.utexas.edu/iso-policies/cloud-services/decision-matrix  
 
 
 
☐ 
Electronic data and records will be stored on a third-party cloud 
service/platform that is not currently approved for research data storage by UT 
Austin’s Information Security Office (ISO).  
 
 
 
 
☐ 
The PI attests that the service/platform will be submitted for security 
assessment by UT Austin ISO and if the ISO determines the platform is 
not acceptable to store research data, a modification will be 
submitted to the IRB to update the protocol. 
 
 
 
☐ 
Other method(s) of storing and limiting access to electronic data and records, 
describe in the text box below:  
 
Examples might include use of a platform approved by a collaborating institution, use of non-cloud-
based electronic storage methods (e.g. hard drive), etc. 
 
 
      
 
 
 
 
B Physical Materials – Storage and Access 
One of the following must be checked. 

Page 28 of 32 
 
 
☐ 
Physical data/records/specimens (e.g. Signed research consent forms, paper 
surveys/notes, physical recordings, samples etc.) will be stored in a secure 
location with access limited only to authorized study personnel at all times.  
 
 
☒ 
N/A – no physical materials 
38 
Research Records Retention Attestation 
 
Confirm that research records will be maintained in compliance with all relevant records retention policies.  
 
UT Austin’s research record retention policy requires that data and copies of relevant study documents (e.g. 
consent forms, protocol, recruitment materials, etc.) be maintained for at least 3 years.  Note that researchers 
are NOT required to maintain identifiers linked to data for 3 years.  To protect confidentiality, identifiers can 
be unlinked from study data and destroyed as soon as feasible (described in the next section). UT Austin’s 
records retention policies are available here:  https://records.utexas.edu/utrrs 
 
Some research may be subject to other retention policies that require longer retention periods and retention 
of other specific data or materials (e.g. collaborating institutions, funding agencies or sponsors, FDA, HIPAA, 
etc.). For example, studies that involve use of protected health information (PHI) covered by HIPAA must 
retain all relevant records for at least 6 years. 
 
Check the box below to acknowledge the above information and confirm the study team will comply with 
UT Austin’s policy as well as any other records retention policies that apply to this research.  
 
This box must be checked.  
 
☒ 
Confirm 
 
 
 
39 
Destruction of Identifiable Information 
One of the following must be checked.  
 
A ☒ 
Identifiable information will be destroyed.  
If checked, describe at what point in the research process identifiable information about participants will 
be destroyed (e.g. after data collection is complete, after the study is completed, etc.).  
If identifiable information is never obtained during the conduct of the study, check this box and note 
“NA” below. 
i PHI will be destroyed at least 6 years after the study is completed. Identifiers will be unlinked 
from the study data and deleted from the UT Box folder after data collection completion. 
Participants will be randomly assigned ID numbers to keep track of therapy adherence and 
pertinent lab values. Consent forms will be kept in the password protected UT Box 
folder for three years following completion of the study, then the entire folder will be deleted. 
 
 
B ☐ 
Identifiable information will not be destroyed.  
If checked, explain the rationale for retaining identifiers indefinitely and specify if identifiers will remain 
linked to research data (either directly or indirectly via a code key).   
 

Page 29 of 32 
 
 
40 Data Sharing and Future Use 
 
Check the box below that best describes your plans for use and sharing of data beyond the scope of the current 
research. You are strongly encouraged to consider the broadest possible future plans you might have. One of 
the following must be checked. 
 
A ☒ There are no plans to use or share data/specimens for other research purposes 
not related to this study. 
B ☐ Data/specimens may be shared with other researchers or banked for future 
research purposes not related to the current research. 
 
ii       
 
i Describe data sharing plan/future use and state whether researchers 
plan on sharing/banking identifiable, coded, or anonymized data. 
To input text, click in the light grey area below. Ensure that data sharing and future use is 
addressed in the consent form(s).  
 
NOTE: If private, identifiable research data will be banked indefinitely for future, unspecified 
research by this study team or other researchers, then the study involves a registry. Registry 
information should be included in the consent form(s) when applicable, and you must complete 
HRP-UT910 - Template IRB Supplemental Form Registry-Repository. Download HRP-UT910 from 
UTRMS-IRB Library Templates 
 
      
 
41 
Certificate of Confidentiality  
Click on the check box (or double click and type an “X” if using Google Docs) to identify each element below that 
may require additional information to be disclosed in the consent form. 
If a Certificate of Confidentiality is not applicable for this study, skip this section.  
 
 
A 
☐ 
 
NIH has issued a Certificate of Confidentiality for this study. 
Ensure CoC language is included in the consent form(s).  
 
B 
☐ 
 
A Certificate of Confidentiality has not been obtained, but there are plans to 
apply for one. 
Ensure appropriate CoC language is included in consent form(s). Apply for a CoC for non-NIH funded 
research here: NIH Certificate of Confidentiality System. Once CoC is granted by NIH, you must update 
the consent form language and ensure a copy of the CoC approval (only for non-NIH funded research) 
is uploaded to UTRMS-IRB.  

Page 30 of 32 
 
COMPENSATION AND COSTS 
 
42 
Compensation  
Click on the check box (or double click and type an “X” if using Google Docs). A or B must be checked.  
 
 
A 
☐ 
 
Subjects receive compensation. 
 
 
 
i ☐ Confirm: Amount of compensation and its form is reasonable for this 
population for the activities requested of them. 
 
 
 
 
ii Total Amount of Compensation  
Include the total amount of compensation below.  
 
 
     
 
 
 
iii Type of Compensation  
 
 
☐ Cash  
☐ 
 
Check  
☐ 
 
Gift Card 
 
 
☐ Course Credit 
☐ ClinCard 
☐ Tango Card 
 
 
☐ Other 
 
 
 
Describe other form of compensation below.  
 
 
      
 
 
 
 
 
iv Proration Schedule  
Describe the proration schedule for multi-visit/session studies. Skip if not applicable.  
 
 
     
 
 
 
B 
☒ 
 
Subjects will not receive compensation. 
43 
Costs 
A or B must be checked.  
 

Page 31 of 32 
 
 
CONFLICTS OF INTEREST 
This section is required for all studies. Please confirm that all research personnel who meet the definition of “covered 
individuals” are designated as such in the Local Study Team Members section of the SmartForm application in UTRMS-
IRB.  
 
 
A 
☐ 
Participants will have no costs associated with this study 
 
B 
☒ 
Participants will have the following costs associated with this study.  
 
 
 
☒Standard of care procedures 
contributing to study data 
 
☐ Research procedures not 
associated with standard of 
care 
 
 
 
☐Administration of drugs / devices  
☐ Study drugs or devices 
 
 
 
☐Transportation and parking  
i 
Describe all costs below. 
To input text, click in the light grey area below. 
 
 
 
 
 
 
 
Cost of standard of care clinic visits and medications depends on insurance/health plan 
coverage 
 
 
 
 
44 
Financial Conflicts of Interest 
Financial interest includes utilizing your licensed intellectual property in the study; serving as a paid consultant, or 
advisory board member, or officer/director with a related entity; and equity or business ownership in a company 
that is related to this project.  Additional guidance on financial conflicts of interest is available on the COI website 
 
A or B must be checked.  
 
 
 
A 
☐ 
The PI and/or other covered individual(s) has/have a financial interest 
related to this study  
i 
If A is checked above, please provide the name(s) of the covered 
individuals involved, and briefly describe the interest: 
 
 
 
To input text, click in the light grey area below. 
 
 
 
      

Page 32 of 32 
 
 
 
 
B 
☒ 
To the best of your knowledge, no one on the study team has financial 
interest related to this study  
45 
Non-financial Conflicts of Interest 
Non-financial Interests could include such things as: 
- utilizing your unlicensed intellectual property in the study, 
- serving as an unpaid advisory board member or officer/director with a related entity,  
- equity or business ownership in a company that has yet to make a profit and is related to this project, 
- conflict of time/effort, 
- personal and professional relationships/affiliations, 
- intellectual passions or personal beliefs 
- other factors that could create bias in the study  
 
A or B must be checked.  
 
 
A 
☒ 
The PI and/or other covered individual(s) has/have a non-financial interest 
related to this study  
i 
If A is checked above, please provide the name(s) of the covered 
individuals involved, and briefly describe the interest: 
 
 
 
To input text, click in the light grey area below. 
 
 
 
Investigators of this study are employed or hold clinical practice at the study site: 
Morgan Stewart - CommUnityCare 
Kathryn Litten - CommUnityCare 
 
B 
☐ 
To the best of your knowledge, no one on the study team has non-
financial interest related to this study