Digital Technology to Support Adherence to Hypertension Medications for Older Adults With Mild Cognitive Impairment
Phase: NA
Conditions: Aging, Mild Cognitive Impairment, Hypertension
Sponsor: University of Arizona

Pr 
PROTOCOL 
Digital Self-management System to Support Blood Pressure Medication Adherence 
21 Feb 2024 

IRB Protocol for Human Subjects 
Research 
 
Page 1 of 29 
 
HSPP Use Only: 
IRB Protocol for Human Subjects Research 
v2023-06 
  
Basic Information  
Title of Study: 
Digital Self-management System to Support Blood Pressure Medication 
Adherence 
Short Title: 
Digital Technology to Support Adherence to Hypertension Medication 
Principal 
Investigator 
Name: 
Kathleen C. Insel 
Principal Investigator’s 
Department/Unit: 
College of Nursing/Biobehavioral Health Science 
 
1.0 
Background (Limit 1,000 words):  
Provide the scientific or scholarly background for the proposed Human Research. 
Discuss relevant prior experience or preliminary data (e.g., existing literature). 
The prevalence of hypertension is estimated at 74.1%1 for people ≥ 60 years, and uncontrolled 
hypertension is known to be a risk factor for cognitive decline.2,3-5 Medication adherence decreases the 
potential effects of hypertension on cognition. Medication adherence is defined as using medications as 
prescribed based on a regimen agreed upon between a patient and their provider and is crucial to 
medication benefit. People with mild cognitive impairment (PwMCI) are at risk of medication non-
adherence.  
Mild Cognitive Impairment (MCI) refers to impairment in one or more cognitive domains without fulfilling 
the diagnostic criteria for dementia. It is estimated that approximately 16–20% of people aged 65 or older 
have MCI and are known to be at risk of developing dementia.6,7 Given that the Food and Drug 
Administration (FDA) approved treatment of MCI is limited to intravenous infusion therapy, controlling 
co-morbid health conditions in PwMCI is critical to slow and possibly prevent progression to dementia. 
One of the strategies recommended by the World Health Organization (WHO) Global Action Plan on the 
public health response to dementia 2017– 2025 (WHO, 2017a)8 is to improve the management of 
hypertension, a common co-morbid condition in PwMCI. If it were possible to control vascular risk factors 
by adhering to prescribed hypertension medications, cognitive decline could be potentially prevented or 
modified in PwMCI.9  
Although PwMCI are unimpaired in basic activities of daily living (ADLs) they experience functional 
impairment in complex instrumental activities of daily living (IADLs) such as medication self-
management.10-13 Given that hypertension is asymptomatic and not associated with identifiable cues such 
as pain, it is easy for PwMCI to forget to take medications without regular reminders. The asymptomatic 
nature of hypertension also undermines the ability to sustain adherence because it is difficult to sense the 
improvement in health over time, and cues (e.g., pain) are not available to serve as reminders to take 
medications.14 Thus, an innovative intervention approach is needed to effectively support hypertension 
medication adherence.  

IRB Protocol for Human Subjects 
Research 
 
Page 2 of 29 
 
HSPP Use Only: 
IRB Protocol for Human Subjects Research 
v2023-06 
An appropriate strategy for improving hypertension management for PwMCI is to leverage the advances 
in mobile health (mHealth) technology to foster medication self-management by tapping into preserved 
skill learning and procedural memory15-17 abilities. In terms of health monitoring technology, mobile 
applications (Apps) on smartphones hold strong potential for supporting self-management in older 
adults.18 The number of older adults using smartphones is rising and is currently 81% for adults aged 60-
69 years19,20 making this a viable option for healthcare support. However, none to our knowledge have 
attempted to examine the use of health monitoring technology for medication adherence in PwMCI 
specifically tapping into preserved cognitive abilities such as skill learning and procedural memory.21-23  
In our previous work, we developed and tested the theory-based Multifaceted Prospective Memory 
Intervention (MPMI) aimed at improving hypertension medication adherence.24 The MPMI is the only 
medication adherence intervention that has used prospective memory theory and research to guide the 
intervention development.25,26 The central goal of MPMI is to change medication-taking from an effortful 
process dependent on prospective memory to one more dependent on associative processes that are 
relatively preserved with aging. The MPMI was compared to an education-attention group among older 
adults aged ≥65 years. The MPMI resulted in a 35% increase in adherence to hypertension medications.27 
Our group has developed a mHealth technology called the Medication Education, Decision Support, 
Reminding, and Monitoring System (MEDSReM) to replicate the critical components of the MPMI. 
MEDSReM contains additional functions such as visualizations of adherence patterns over time and 
decision support specifically designed to meet the needs of older adults. Supported by an NIH grant, we 
have further refined the system to meet the needs of PwMCI through needs assessments, cognitive walk-
throughs, heuristic evaluations, and iterative usability testing. This optimized system is called Medication 
Education, Decision Support, Reminding, and Monitoring System-Memory (MEDSReM-M)   
MEDSReM-M system provides medication reminders consistent with the person’s routines and prescribed 
frequency and is tailored to an activity (e.g., breakfast). Encouraging immediate action when reminded to 
take the prescribed medication at the correct time is a central component of MEDSReM-M as even a delay 
in the execution of a prospective memory intention as short as 5 seconds has been shown to lead to 
forgetting to do the intended task.28 Monitoring is another critical component of prospective memory 
strategies, that is, creating the ability to check whether medications were taken as intended.  PwMCI will 
be able to check and monitor whether they are taking their medication as intended using the MEDSReM-
M system. Adherence is monitored over time, and users can see graphical representations of their 
adherence success. This type of feedback is motivating and can improve adherence in the long term.29 The 
decision support tool improves proper adherence and reduces risk by responding to questions about 
whether to take a medication early. The system also offers education about hypertension and health 
management. The goal of the current study is to test the efficacy of MEDSReM-M system for PwMCI in a 
randomized controlled trial (RCT). 
 
 
 
 

IRB Protocol for Human Subjects 
Research 
 
Page 3 of 29 
 
HSPP Use Only: 
IRB Protocol for Human Subjects Research 
v2023-06 
 
References 
1. Stierman B, Afful J, Carroll MD, Chen TC, Davy O, Fink S, et al. National Health and Nutrition Examination 
Survey 2017–March 2020 prepandemic data files—Development of files and prevalence estimates for 
selected health outcomes. National Health Statistics Reports; no 158. Hyattsville, MD: National Center for 
Health Statistics. 2021. DOI: https://dx.doi. org/10.15620/cdc:106273. (accessed 6/13/2023). 
2. Gottesman RF, Schneider AL, Albert M, et al. Midlife hypertension and 20-year cognitive change: the 
atherosclerosis risk in communities neurocognitive study. JAMA neurology 2014; 71(10): 1218-27. 
3. Raz N, Rodrigue KM, Acker JD. Hypertension and the brain: vulnerability of the prefrontal regions and 
executive functions. Behavioral neuroscience 2003; 117(6): 1169-80. 
4. Elias PK, D'Agostino RB, Elias MF, Wolf PA. Blood pressure, hypertension, and age as risk factors for 
poor cognitive performance. Experimental aging research 1995; 21(4): 393-417. 
5. Swan GE, Carmelli D, Larue A. Systolic blood pressure tracking over 25 to 30 years and cognitive 
performance in older adults. Stroke 1998; 29(11): 2334-40. 
6. Roberts R, Knopman DS. Classification and epidemiology of MCI. Clinics in geriatric medicine 2013; 
29(4): 753-72. 
7. Roberts RO, Geda YE, Knopman DS, et al. The incidence of MCI differs by subtype and is higher in men: 
the Mayo Clinic Study of Aging. Neurology 2012; 78(5): 342-51. 
8. Organization WH. Risk reduction of cognitive decline and dementia: WHO guidelines. Geneva: World 
Health Organization; 2019. 
9. Reitz C, Tang MX, Manly J, Mayeux R, Luchsinger JA. Hypertension and the risk of mild cognitive 
impairment. Arch Neurol 2007; 64(12): 1734-40. 
10. Weston A, Barton C, Lesselyong J, Yaffe K. Functional deficits among patients with mild cognitive 
impairment. Alzheimers Dement 2011; 7(6): 611-4. 
11. Allaire JC, Gamaldo A, Ayotte BJ, Sims R, Whitfield K. Mild cognitive impairment and objective 
instrumental everyday functioning: the everyday cognition battery memory test. Journal of the American 
Geriatrics Society 2009; 57(1): 120-5. 
12. Salas M, In't Veld BA, van der Linden PD, Hofman A, Breteler M, Stricker BH. Impaired cognitive 
function and compliance with antihypertensive drugs in elderly: the Rotterdam Study. Clin Pharmacol Ther 
2001; 70(6): 561-6. 
13. Hayes TL, Larimer N, Adami A, Kaye JA. Medication adherence in healthy elders: small cognitive 
changes make a big difference. J Aging Health 2009; 21(4): 567-80. 
14. Granados-Gámez G, Roales-Nieto JG, Gil-Luciano A, Pedro EM-S, Márquez-Hernández VV. A 
longitudinal study of symptoms beliefs in hypertension. International Journal of Clinical and Health 
Psychology 2015; 15(3: 200–7). 
15. Hirono N, Mori E, Ikejiri Y, et al. Procedural memory in patients with mild Alzheimer's disease. Dement 
Geriatr Cogn Disord 1997; 8(4): 210-6. 
16. De Wit L, Marsiske M, O'Shea D, et al. Procedural Learning in Individuals with Amnestic Mild Cognitive 
Impairment and Alzheimer's Dementia: a Systematic Review and Meta-analysis. Neuropsychol Rev 2021; 
31(1): 103-14. 
17. Gobel EW, Blomeke K, Zadikoff C, Simuni T, Weintraub S, Reber PJ. Implicit perceptual-motor skill 
learning in mild cognitive impairment and Parkinson's disease. Neuropsychology 2013; 27(3): 314-21. 

IRB Protocol for Human Subjects 
Research 
 
Page 4 of 29 
 
HSPP Use Only: 
IRB Protocol for Human Subjects Research 
v2023-06 
18. Masterson Creber RM, Maurer MS, Reading M, Hiraldo G, Hickey KT, S. I. Review and Analysis of 
Existing Mobile Phone Apps to Support Heart Failure Symptom Monitoring and Self-Care Management 
Using the Mobile Application Rating Scale (MARS). JMIR Mhealth Uhealth 2016; 4(2): e74. 
19. Zettel-Watson L, D. T. Adoption of online health management tools among healthy older adults: An 
exploratory study. Health Informatics J 2016; Jun;22: 1710183. 
20. Kakulla Nelson, B. Older adults keep pace on tech usage. https://doi.org/10.26419/res.00329.001 
NKBJ. 2020 Tech Trends of the 50+. AARP Research 2020. 
21. Hirono N, Mori E, Ikejiri Y, et al. Procedural memory in patients with mild Alzheimer's disease. Dement 
Geriatr Cogn Disord 1997; 8(4): 210-6. 
22. De Wit L, Marsiske M, O'Shea D, et al. Procedural Learning in Individuals with Amnestic Mild Cognitive 
Impairment and Alzheimer's Dementia: a Systematic Review and Meta-analysis. Neuropsychol Rev 2021; 
31(1): 103-14. 
23. Gobel EW, Blomeke K, Zadikoff C, Simuni T, Weintraub S, Reber PJ. Implicit perceptual-motor skill 
learning in mild cognitive impairment and Parkinson's disease. Neuropsychology 2013; 27(3): 314-21. 
24. Insel KC, Cole L. Individualizing memory strategies to improve medication adherence. Applied nursing 
research: ANR 2005; 18(4): 199-204. 
25. Insel KC, Einstein GO, Morrow DG, Koerner KM, Hepworth JT. Multifaceted Prospective Memory 
Intervention to Improve Medication Adherence. Journal of the American Geriatrics Society 2016; 64(3): 
561-8. 
26. Insel KC, Einstein GO, Morrow DG, Hepworth JT. A multifaceted prospective memory intervention to 
improve medication adherence: Design of a randomized control trial. Contemporary clinical trials 2013; 
34(1): 45-52. 
27. Insel KC, Einstein GO, Morrow DG, Koerner KM, Hepworth JT. Multifaceted Prospective Memory 
Intervention to Improve Medication Adherence. Journal of the American Geriatrics Society 2016; 64(3): 
561-8. 
28. McDaniel MA, Einstein GO, Stout AC, Morgan Z. Aging and maintaining intentions over delays: Do it or 
lose it. Psychology and Aging. 2003; 18:823–835. 
29. DiClemente CC, Marinilli AS, Singh M, Bellino LE. The role of feedback in the process of health behavior 
change. American journal of health behavior 2001; 25(3): 217-27. 
2.0 
Lay Summary:  
Provide a brief description of the proposed research using terms that someone who is 
not familiar with the science or discipline can understand. 
Uncontrolled hypertension is known to be a risk factor for accelerated cognitive decline in older adults. It 
is well established that PwMCI with vascular risk factors including hypertension convert to dementia at a 
faster rate compared to peers with no vascular risks. Although blood pressure (BP) medications are good 
at reducing the negative results of uncontrolled hypertension, the benefits of BP medications may not be 
realized due to non-adherence (not taking medications as prescribed). An underlying deficit in prospective 
memory contributes to such medication nonadherence issues in PwMCI. We have developed a digital 
medication self-management system called Medication Education, Decision Support, Reminding, and 
Monitoring-Memory (MEDSReM-M) system based on the unique needs and preferences of PwMCI. This 
system is designed based on the theory-based Multifaceted Prospective Memory Intervention (MPMI), 
which significantly improved older adults’ adherence to BP medications in a previous study. MEDSReM-
M changes medication taking from a complex process of holding information in mind over time to a 

IRB Protocol for Human Subjects 
Research 
 
Page 5 of 29 
 
HSPP Use Only: 
IRB Protocol for Human Subjects Research 
v2023-06 
customized, cue-driven simple process that is mostly preserved in PwMCI. The current project aims to test 
the benefits of using the MEDSReM-M system relative to a standardized educational intervention to 
support medication self-management in PwMCI. 
 
3.0 
Purpose:  
Describe the purpose, specific aims, objectives, questions to be answered, hypotheses, 
and/or primary and secondary study endpoints of this Human Research protocol. 
The purpose of this study is to examine the benefits of MEDSReM-M to support medication self-
management in PwMCI.  
Specific Aim: To determine the efficacy and identify predictors for the adoption of MEDSReM-M for 
PwMCI through a 4-month RCT relative to a standardized educational intervention.  
Objective: To conduct a 4-month RCT to assess improvement in adherence, blood pressure (SBP), and 
technology acceptance in the MEDSReM-M group (N=50) relative to the standardized educational 
intervention group (N=50).  
Hypothesis: We hypothesize that advances in technology can be leveraged in PwMCI to improve 
adherence by harnessing retained cognitive ability for skill learning and procedural memory. 
Outcome: Completed RCT with identification of variables that inform improved adherence.  
4.0 
Funding Information:  
Indicate all sources of funding for the project, including gift funds, departmental funds, 
or other internal funding. For each funder, list the name of the funder, and the 
institutional proposal number or award number you received from Sponsored Projects. 
eIRB tip: For externally funded projects, the institutional proposal or award number 
provided must be linked in the “Study Funding Sources” section in eIRB.  
☐ No Funding 
☒ Federal Funding, including flow-through 
federal funding (i.e., NIH, NSF, DoD, etc.) 
Name of funding source: 
National Institute of Nursing Research/NIH 
Institutional Proposal or Award Number: 
 019618-00001 
eDoc # (for multi-site projects): 
 
☐ Industry Funding 
Name of funding source:  
 
Institutional Proposal or Award Number:  
 
eDoc #: 
 
☐ Foundation Funding 
  
Name of funding source: 
 
Institutional Proposal or Award Number: 
 
☐ Department Funding 
Name of funding source: 
 

IRB Protocol for Human Subjects 
Research 
 
Page 6 of 29 
 
HSPP Use Only: 
IRB Protocol for Human Subjects Research 
v2023-06 
 
5.0 
Resources Available to Conduct the Human Research:  
Describe the resources (facilities, time, emergency resources, etc.) available to recruit, 
consent, conduct study procedures, and analyze data. 
This multisite study involves the University of Arizona and the University of Illinois Urbana-Champaign. 
Potential participants for the proposed research will be identified through multiple avenues.  
Available resources for potential recruitment: Recruitment will occur at varying sites in Arizona and 
Illinois with established partnerships with a variety of medical and community-based organizations. 
Participants will be recruited from neighborhood centers, senior living communities, area senior centers, 
and meal sites, which provide access to a diverse population of older adults in terms of age, sex, ethnicity, 
religion, education, and economic status. Dr. Insel gives talks at health-focused events, such as a public 
lecture series offered at area hospitals and community health fairs, and these events have proven to be 
valuable sources of potential participants. As in previous recruitment successes, the research team will be 
present in person at these sites and events to offer blood pressure screenings to meet potential 
participants and identify those who may be eligible for participation. People who are interested in hearing 
about the study will be asked for contact information through the encounter form (located in the 
appendix). The research staff will follow up with the potential participants ideally the next day, for formal 
recruitment into the study. Additionally, we will identify potential participants through local geriatric, 
cardiovascular, and primary care providers caring for older adults with hypertension who agree to display 
our recruitment brochures in their clinics (please see an example flyer for the language that will be used 
in flyers advertising the study). An ad in local newspapers will be used to reach older people not associated 
with sites or events using the same language as in the flyer. The print materials will contain both email 
and phone contacts of the project team so that participants may use either method with which they are 
most comfortable. 
At Arizona, Banner University Medical Center, El Rio, Tucson Medical Center are potential recruitment 
options for this study. We will use the same language from the flyer and the emails found in the 
appendices to recruit prospective participants for this research study. 
We will also use email to existing registries of people who have agreed to be contacted for potential 
participation in research studies. For example, Dr. Matt Grilli has an ongoing registry among the older 
adult community in southern Arizona.  
We will seek site permission prior to recruitment activities.  
At Illinois, participants will be recruited through Dr. Mudar’s laboratory registry of PwMCI; Carle 
Neuroscience Institute, a recruitment site; and independent living seniors supported by CJE Senior Life in 
Chicago. Dr. Mudar has a registry of PwMCI who are interested in participating in research studies. The 
MCI registry was developed by Dr. Mudar’s research affiliation and ongoing MCI studies with the Carle 
☐ Gift Funding 
Name of funding source: 
 
☒ Other 
Name of funding source: 
 

IRB Protocol for Human Subjects 
Research 
 
Page 7 of 29 
 
HSPP Use Only: 
IRB Protocol for Human Subjects Research 
v2023-06 
Neuroscience Institute, which sees approximately 100 MCI patients per year. Also, participants will be 
recruited in partnership with community partners including CJE Senior Life, which supports about 20,000 
older adults, including PwMCI, who live in independent living communities. Participants will also be 
recruited through various participant registries including the Technologies to Support Aging-in-Place for 
People with Long-Term Disabilities (TechSAge) Participant registry (UIUC IRB #20662), Illinois Health and 
Engagement through the Lifespan Project Registry (I-HELP) research registry (UIUC IRB #08524), and The 
Disability and Education Services (DRES) Research Registry (UIUC IRB #13731). Individuals have signed up 
for these registries because they have expressed an interest in being contacted to participate in research 
studies. None of these recruitment sites will be directly involved in conducting research activities. 
The Site PI will ensure that recruitment, consent, and implementation of study protocol will be conducted 
by study personnel who have completed required human subjects training, Good Clinical Practice (GCP) 
certification, and Conflict of Interest (COI) review. Study staff will also adhere to standardized training in 
the study protocol. With participants’ consent, audio and video (of the Zoom screening) recordings will 
be made of visits with participants and reviewed by the Site PI and project coordinator to ensure fidelity 
to protocol.    
We are contracting with Ephibian, a local computer science and electrical engineering company. Ephibian 
serves as a technical resource to the research team linked to the MEDSReM-M system and will not directly 
interact with participants. Ephibian builds high-performance software solutions and for more than 25 
years has served multiple audiences including the aging population; in particular, the Patient Reported 
Outcomes Consortia (http://c-path.org/programs/pro/). Ephibian helped develop the first version of 
MEDSReM and the advanced design of our MEDSReM-M system. They specifically built the system to 
protect the smartphone's local device information with encryption, protect all data transmissions, require 
pin entry for application access for additional user security, remove any data on user request or 
application uninstallation, and meet HIPAA security requirements.  
6.0 
Study Population: 
6.1 Select all the categories of participants included in the research: 
☐ Healthy adults 
☐ Non-English-speaking subjects 
☒ Non-healthy adults 
☐ UA staff/faculty 
☐ Children (under 18 years old) * 
☐ UA students 
☐ Pregnant women, neonates, and/or 
fetuses* 
☐ Banner employees 
☐ Prisoners* 
☐ Refugees 
☐ Native Americans, Alaskan Native, and 
Indigenous Populations* 
☒ Other – please explain: PwMCI have only 
mild problems with cognition. They can make 
independent 
decisions 
without 
needing 
assistance and are capable of providing 
informed consent. 
 
☐ Adults unable to consent (i.e., cognitively 
impaired adults) * 
6.2 For each of the above selected categories, describe the inclusion and exclusion criteria. 
Indicate age range, gender, and ethnicity.  

IRB Protocol for Human Subjects 
Research 
 
Page 8 of 29 
 
HSPP Use Only: 
IRB Protocol for Human Subjects Research 
v2023-06 
PwMCI will meet the following general inclusion criteria: i) 60 years or older, ii) community-dwelling, iii) 
fluent in English, iv) have adequate self-reported visual and hearing ability to interact with others and with 
the smartphone, v) self-reported memory problems, (vi) the Modified Telephone Interview for Cognitive 
Status (TICS-M)1 score between 27-37, vii) self-managing at least one antihypertension medication, viii) 
no diagnosis of dementia or other neurological disorders such as stroke, traumatic brain injury (TBI), and 
Parkinson’s disease, ix) no major history of depression or other mental health diagnoses, and x) use a 
smartphone. Participants who do not meet these general inclusion criteria will be excluded. 
Participants who meet general eligibility criteria and express interest in enrolling will be scheduled for a 
video screening. Electronic informed consent will be obtained from all participants using REDCap. After 
providing informed consent, participants will complete a background questionnaire. The Montreal 
Cognitive Assessment (MoCA)2 will be administered to assess global cognition. The Geriatric Depression 
Scale (GDS)3 will be administered to screen for elevated depressive symptoms. Participants with MoCA 
cut-off scores between 20 to 26 will be invited to participate in the study. If they agree to participate, they 
will be scheduled for in-person consenting for the RCT and baseline assessment. If a participant does not 
qualify or prefers not to participate despite being eligible, they will be thanked for their participation. The 
session will last approximately 45 minutes. All participants regardless of eligibility will be paid $15 for the 
video screening session. 
Participants will not be excluded based on gender or ethnicity. Both women and men will be included, 
and both groups will be equally targeted for recruitment into the RCT. This project will include all potential 
participants regardless of their racial/ethnic background, limited only by the available population. 
 
1. Welsh KA, Breitner J. C. S., Magruder-Habib KM. Detection of dementia in the elderly using telephone 
screening of cognitive status. Neuropsychology 1993; 6(2): 103-10. 
2. Nasreddine ZS, Phillips NA, Bédirian V, et al. The Montreal Cognitive Assessment, MoCA: a brief 
screening tool for mild cognitive impairment. Journal of the American Geriatrics Society 2005; 53(4): 695-
9. 
3. Yesavage JA, et al. Development and validation of a Geriatric Depression Screening Scale: A preliminary 
report. Journal of Psychiatric Research 1982; 17(1): 37-49. 
 
6.3 Describe the total number of subjects to be enrolled locally under this IRB approval. If 
obtaining specimens, specify the maximum number of specimens needed for this 
project.  
A total of 100 PwMCI will be recruited. There will be two treatment arms: N=50 in the MEDSReM-M 
intervention group, which will be henceforth referred to as MEDManage-S, and N=50 in the standardized 
educational group, which will be henceforth referred to as the MEDManage-P. This is a multi-site project, 
and our local (University of Arizona) enrollment goal is n=60 participants. The research team at the 
University of Illinois Urbana-Champaign aims to enroll n=40 participants. 
7.0 
Recruitment Methods: 
7.1 Select the methods used to recruit individuals. 
☒ Email 
☐ Screening of the Electronic Medical 
Record (EMR) 

IRB Protocol for Human Subjects 
Research 
 
Page 9 of 29 
 
HSPP Use Only: 
IRB Protocol for Human Subjects Research 
v2023-06 
☒ Face to face 
☒ Social media 
☒ Flyers 
☐ SONA System 
☒ In person presentations 
☒ TV, Radio, Print 
☒ Online advertisements 
☒ Other – please explain: research 
registries 
☐ Phone calls 
 
7.2 Explain the recruitment process. Describe how potential subjects will be identified, 
where recruitment will take place, when recruitment will occur, and the methods that 
will be used to recruit individuals.  
We will use our well-established multi-pronged recruitment strategies, which include word-of-mouth, 
email, and telephone scripts to members of established registries; flyers and brochures shared by 
community organizations and partners; advertisements in newspapers and newsletters; potential 
opportunities on the radio and television and personal visits to community events. All recruitment 
materials will be pre-approved by the IRB.  
 
• 
Emails will be used to contact people who have expressed an interest in participating in 
research studies and are in an existing registry (as in the appendix). 
• 
The same language used in the flyer will be used in flyers (as in the appendix), bookmarks, 
and brochures. We will work on the graphics to provide these additional means of 
advertising the study, but the language will not vary from what is shown on the flyer in 
the appendix. 
• 
If a participant leaves a phone contact, we will call them and share information about the 
study. 
• 
We will share information about the study at talks given for community centers. We will 
use the encounter forms if people are interested in learning more about the study.  
• 
Social media: using the same language as in the flyer, we will publicize the study on social 
media, television and print. 
  
At Illinois, participants will be recruited through Dr. Mudar’s (Co-PI) laboratory registry of PwMCI, Dr. 
Rogers’s (Co-investigator) Technologies to Support Aging-in-Place for People with Long-Term Disabilities 
(TechSAge) Participant registry (UIUC IRB #20662), the Illinois Health and Engagement through the 
Lifespan Project Registry (I-HELP) research registry (UIUC IRB #08524), and The Disability and Education 
Services (DRES) Research Registry (UIUC IRB #13731). Individuals have signed up for these registries 
because they have expressed an interest in being contacted to participate in research studies. Participants 
who are enrolled in these registries will be contacted about the study and inclusion criteria. These 
individuals will be emailed (see email drafts of the short announcement and study introduction in our 
recruitment materials) about the study and asked to contact our staff if interested in learning more about 
the study. Additionally, participants will be recruited from Carle Neuroscience Institute in collaboration 
with Dr. Daniel Llano (co-investigator), Staff Neurologist at Carle Hospital, and other local providers. 
Participants will also be recruited through community partners such as CJE Senior Life. CJE Senior Life 
supports about 20,000 older adults, including PwMCI, who live in independent living communities.  

IRB Protocol for Human Subjects 
Research 
 
Page 10 of 29 
 
HSPP Use Only: 
IRB Protocol for Human Subjects Research 
v2023-06 
Phone Screening: Potential participants will undergo an initial phone screening to determine eligibility for 
the next step (the video screening). During this call, the research staff will gather information using the 
phone screening questionnaire and provide information about the study. The research staff will ask for 
the potential participant’s verbal consent to retain information collected during the screening. If potential 
participants decline verbal consent, the research staff will not retain data from this call. TICS-M will be 
administered to screen for global cognition. Participants who score between 27-37 on TICS-M and meet 
the eligibility criteria will be invited to participate in a video screening. The research staff will clearly 
explain the time commitment, expectations for participation, and answer any questions the participant 
asks. If eligible individuals express interest in enrolling, the team will schedule an appointment for the 
video screening.  
Video Screening: Electronic informed consent will be obtained from all participants using REDCap prior to 
conducting video screening. PwMCI will have no deficits in global cognitive functioning, as determined by 
TICS-M. Subtle cognitive changes observed in these individuals do not impact their ability to provide 
informed consent; therefore, no proxy consent will be required. After obtaining online informed consent, 
participants will complete a background questionnaire. The Montreal Cognitive Assessment (MoCA) will 
be administered to assess global cognition. The Geriatric Depression Scale (GDS) will be administered to 
screen for elevated depressive symptoms. Researchers will review and determine final eligibility for 
participation. Those who meet eligibility including a MoCA cut-off score between 20 to 26 will be invited 
to participate in the study. If they agree to participate, they will be scheduled for in-person consenting for 
the RCT and baseline assessment. If a participant does not qualify or prefers not to participate despite 
being eligible, they will be thanked for their participation. The session will last approximately 45 minutes. 
All participants regardless of eligibility will be paid $15 for the video screening session. 
8.0 
 Diversity, Equity, and Inclusion 
8.1 Explain how the research plan (recruitment, study population, data collection, etc.) is 
equitable and represents the demographic makeup for the location in which the 
research will be conducted.    
There will be no discrimination based on sex/gender or racial/ethnic status.  
Both women and men will be included. The proposed RCT is focused on examining the efficacy of 
MEDSReM-M with female and male older adults (≥ 60 years). Therefore, both groups will be equally 
targeted for recruitment into the RCT. We consider sex as a biological variable and will examine through 
point biserial correlations with adherence and BP. 
 
This project will include all potential participants regardless of their racial/ethnic background, limited only 
by the available population. Racial/ethnically, Arizona is approximately 4.9% Black or African American, 
30.9% Hispanic or Latino (primarily of Mexican American heritage), 55.5% Non-Hispanic White, 3.4% 
Asian, 5.4% American Indian and Alaska Native, and 2.8% more than one race. Illinois is approximately 
14.7% Black or African American, 17% Hispanic or Latino, 61.7% Non-Hispanic White, 5.5% Asian, 0.6% 
American Indian and Alaska Native, and 1.9% more than one race. Since over 30% of the community is of 
Hispanic heritage in Arizona, specific efforts will be made to enroll members of this community including 
using staff familiar with the culture and community. The neighborhood centers, senior centers, and meal 
sites used for recruitment provide services for a significant number of older adults who reflect such an 
ethnic ratio because these sites are in various locations in the community serving ethnically diverse 

IRB Protocol for Human Subjects 
Research 
 
Page 11 of 29 
 
HSPP Use Only: 
IRB Protocol for Human Subjects Research 
v2023-06 
populations. Furthermore, the study will be advertised using widely reaching methods including 
partnerships at community centers serving senior citizens throughout the community.   
 
Prior experience and the establishment of social relations will improve participation. In fact, several 
investigations found that people of Hispanic heritage were more likely to participate than those of other 
racial/ethnic backgrounds and attributed the cooperation to cultural factors such as the simpatica social 
script that promotes positive social relations.1 Prior relationships, clear elucidation of goals and procedures, 
the establishment of legitimacy, and familiarity of staff with the community, will each work in positive ways 
to encourage participation from diverse locations in the community. 
 
1. Marin, G., & Marin, B. V. (1991). Research With Hispanic Populations. Newbury Park, California: Sage 
Publications. 
8.2 Describe whether non-English speaking subjects will be included in the study. If yes, 
please explain how your research team is prepared to meet the needs of the population. 
If not, please explain why non-English speakers will be excluded from the study 
population. 
Non-English speakers will be excluded from the study population because study materials (MEDSReM-M 
app and portal, screening tools, etc.) and standardized measures are in English. Future projects will seek 
funding to translate study materials and protocols into other languages, including Spanish.  
8.3 What methods will you use to collect demographic information from participants? If 
you will not collect demographic information, please explain why not. 
During the initial phone screening, verbal consent will be obtained, and limited demographic information 
to determine general eligibility (e.g., age, sex, education, race/ethnicity, living situation, comorbidities, 
and medications) will be collected from participants. Following the phone screening, the research staff 
will obtain informed consent from individuals who qualify for the video screening. During the video 
screening, the research staff will administer a background questionnaire.  
9.0 
Consenting Process: 
9.1 Indicate the informed consent process(es) and/or document(s) for the study. Check all 
that apply. 
Written Consent 
☒ Informed Consent (ICF) – written or electronically signed form 
☐ Parental Permission – written or electronically signed form 
☐ Assent (participants under 18) – written or electronically signed form 
☐ Combined ICF/PHI Authorization – written or electronically signed form 
☐ Protected Health Information (PHI) Authorization – written or electronically signed  
☐ Translated Consent/Assent – written or electronically signed form(s) 
☐ Short Consent Form – written or electronically signed form (see guidance on Short Form 
process) 
☒ Debriefing Script or Form – document used to properly inform subjects of the study’s 
purpose when intentionally deceived  

IRB Protocol for Human Subjects 
Research 
 
Page 12 of 29 
 
HSPP Use Only: 
IRB Protocol for Human Subjects Research 
v2023-06 
 
Oral/Online/Unsigned Consent  
☒ Informed Consent – oral script/online/unsigned 
☐ Parental Permission – oral script/online/unsigned 
☐ Assent – oral script/online/unsigned 
☐ Translated Consent/Assent – oral script/online/unsigned 
 
Waivers of Informed Consent and/or PHI Authorization 
☐ Waiver of Consent 
☐ Full Waiver of PHI Authorization 
☐ Partial Waiver of PHI for Screening Purposes 
 
9.2 Describe in detail the consent processes checked above, including any waiting period 
for subjects to sign the consent, steps to minimize the possibility of coercion or undue 
influence, and the language used by those obtaining consent. 
The consent process and forms will be presented to participants in English, as all individuals recruited for 
the study will speak, read, and understand English.  
 
Verbal Consent for Phone Screening: At the beginning of the phone screening, we will obtain verbal 
consent from potential participants to retain the limited data collected during this brief conversation. The 
research staff will explain that declining consent to retain information obtained during screening will not 
have any influence on the eligibility assessment for the study. If potential participants decline verbal 
consent, the research staff will not retain data from this call. During phone screening, the research staff 
will clearly explain the time commitment, expectations for participation, and answer any questions the 
participant asks. If the person meets general eligibility criteria and expresses interest in enrolling, the 
team will schedule an appointment for conducting a video screening. 
 
Informed Consent for Video Screening: Electronic informed consent will be obtained from all participants 
using REDCap to participate in a screening session over Zoom. Participants will provide a digital signature 
on a unique link sent to them. PwMCI will have no deficits in global cognitive functioning, as determined 
by TICS-M. Subtle cognitive changes observed in these individuals do not impact their ability to provide 
informed consent; therefore, no proxy consent will be required. Those who meet eligibility as determined 
by the video screening will be invited to enroll in the RCT. If a participant does not qualify or prefers not 
to participate despite being eligible, they will be thanked for their participation. All participants regardless 
of eligibility will be paid $15 for the video screening session. 
Informed Consent for RCT: Following the video screening, if eligible individuals remain interested and 
meet the general inclusion criteria, study staff will set up an initial in-person meeting and baseline 
assessment at a convenient time and location for participants (at their home, the university, or another 
location of their choice, e.g., community center with site permission). Prior to this meeting, we will call 
and mail or email the time details to potential participants and attach a copy of the Informed Consent 
Form so they will have time to read it and prepare any questions for the meeting. We have found it helpful 
working with older adults to give them an opportunity to review the consent form in their home and ask 

IRB Protocol for Human Subjects 
Research 
 
Page 13 of 29 
 
HSPP Use Only: 
IRB Protocol for Human Subjects Research 
v2023-06 
family/significant others to review it. In this way, they know what is involved and are not trying to 
understand the procedures when under what may be perceived as time constraints.  
 
The consent form will include: 1) The purpose of the study; 2) Who will be asked to participate; 3) How 
many people are involved; 4) Study procedures to be used; 5) The length of the study; 6) The benefits and 
potential risks; 7) How confidentiality will be assured using a code number rather than names on  
documents; 8) Planned destruction of the link associating the subject’s name to the unique code number; 
9) The participant’s right to withdraw from the study at any time; 10) Encouragement of participant to 
notify the primary care provider if they experience symptoms that they feel are in any way associated 
with their illness or medications; and 11) Access to the data by representatives of the sponsor that support 
the research study and representatives of regulatory agencies (e.g., The University of Arizona Human 
Subjects Protection Program).  
 
Informed consent will be completed in-person in a private space with potential participants by research 
staff who are trained in Human Subjects Protection. The participant will be given a copy, and the research 
staff will use another copy to guide the participant through the consent information. Each section of the 
consent will be reviewed. Participants will be encouraged to ask questions and the research team will 
respond to the questions. Individuals who decide to join the study will be asked to sign the consent. A 
copy of the consent will be provided to the participant. 
No data will be collected unless consent is obtained from the participant. If the individual needs more 
time to make a decision about whether to participate or not, we will schedule a subsequent meeting to 
obtain the signature before beginning data collection. The participant will be provided with a copy of the 
consent form. Phone numbers for the Site PI, study team, and the IRB will be provided on the consent 
form if participants have questions or would like to discuss the study or any concerns. 
9.3 Where will the original signed consent and PHI authorization documents be stored?  
The original signed consent documents will be stored in the locked MEDSReM-M Research Team office at 
the University of Arizona College of Nursing building Rm 418E, and a scanned version will be placed in Box 
(folder). At the University of Illinois Urbana-Champaign site, the team will follow the same storage 
procedures and will store original signed consent documents in a locked office in the Speech and Hearing 
Science Building (Rm 209) and a scanned version will be placed the in Box.  
 
 
9.4 Acknowledgement of consent form storage. 
☒ I will store original signed consent and/or PHI authorization documents for at least 6 years 
past the time the study is concluded. 
☐ For studies involving minors, I will store original signed consent and/or PHI authorization 
documents for at least 6 years after the youngest participant turns 18. 
☐ Not applicable – I am not collecting signed documents. 
 
 

IRB Protocol for Human Subjects 
Research 
 
Page 14 of 29 
 
HSPP Use Only: 
IRB Protocol for Human Subjects Research 
v2023-06 
10.0 Research and Data Collection Procedures: 
 
10.1 Select the methods of data collection that will be used in this study (select all that 
apply): 
☒ Anthropometric measures (e.g., height, 
weight, waist circumference, 
etc.): arm circumference for selection of 
appropriate blood pressure cuff size 
☐ Participant observation 
☒ Audio/video recording 
☒ Screening data 
☐ Benign interventions 
☒ Self-health monitoring (e.g., pedometers, 
food diaries, etc.): medication log sheet and 
blood pressure monitoring for those in the 
intervention group 
☐ Biological specimens – blood draws 
☒ Surveys – paper 
☐ Biological specimens – clinically discarded 
blood or specimens 
☒ Surveys – internet (including online and 
email-based data collection) 
☐ Biological specimens (urine/feces, tissue, 
saliva, skin, hair, nails, nasal swab) 
☒ Surveys – telephone 
☐ Clinical Data Warehouse (CDW) 
☒ 
Randomization 
with 
control 
and 
experimental groups 
☒ Cognitive or behavioral measures, including 
daily diaries  
☐ Records – billing 
☒ 
Data 
collected 
using 
other 
communication/electronic devices (e.g., cell 
phones, 
pagers, 
and 
texting 
devices): 
MEDSReM-M system 
☐ Records – educational 
☐ Data previously collected for research 
purposes 
☐ Records – employee 
☐ Deception 
☐ Records – lab, pathology and/or radiology 
results 
☐ Instrumentation, equipment, or software not 
approved by the FDA 
☐ Records – mental health 
☐ Interviews – focus groups 
☐ Records – substance abuse 
☒ Interviews – in person 
☐ Research imaging protocols 
☒ Interviews – virtual/online 
☐ Recombinant DNA 
☐ Medical records review 
☐ Social networking sites 
☐ MRI/ultrasound with contrast 
☐ Stem cells 
☐ MRI/ultrasound without contrast 
☐ Radiation Scans (X-Ray, CT Scans, etc.)  
☐ Non-invasive instruments (e.g., external 
sensors applied to the body) 
☒ Other activities or interventions – 
describe: use of a blood pressure device   
 

IRB Protocol for Human Subjects 
Research 
 
Page 15 of 29 
 
HSPP Use Only: 
IRB Protocol for Human Subjects Research 
v2023-06 
10.2 Description of research procedures. 
To test the MEDSReM-M intervention efficacy, we will conduct a RCT. This is a multi-site study led by MPIs 
Dr. Kathleen Insel and Dr. Raksha Mudar and includes research staff at the University of Arizona (UofA) 
and the University of Illinois Urbana-Champaign (UIUC). Throughout the study, research personnel at both 
UofA and UIUC will adhere to the same study procedures as listed chronologically below: 
 
Phone Screening: Phone screening will not be recorded. Formal recruitment will be completed via phone 
to ensure privacy and individual attention. The research staff will follow up with interested potential 
participants who have shared their telephone contact information, ideally the next day for recruitment 
into the study. The team will document all attempts to contact potential participants and will vary the day 
and time of contact attempts if the person is not reachable on the first attempt. During the screening call, 
verbal consent will first be obtained prior to asking questions to determine eligibility. The research staff 
will confirm that participants meet the following criteria: i) 60 years or older, ii) community-dwelling (that 
is not in an assisted living situation) iii) able to speak and read English, iv) have adequate self-reported 
visual and hearing ability to interact with others and the smartphone, v) self-reported memory problems, 
vi) managing at least one hypertension medication, vii) no self-reported diagnosis of dementia or other 
neurological disorder such as stroke, TBI, and Parkinson’s disease, viii) no major history of depression or 
other mental health diagnoses, and ix) experience using a smartphone. If participants are eligible, they 
will complete the Modified Telephone Interview for Cognitive Status (TICS-m); eligible participants will 
score between 27-37. The research staff will clearly explain the time commitment, expectations for 
participation, and answer any questions the participant asks. If the person expresses interest in enrolling 
and is eligible, the participant will be scheduled for a video screening. The phone screening will span 
approximately 5-15 minutes.  
   
Video Screening: After providing electronic informed consent, participants will complete video screening. 
The video screening will be recorded.  Video screening will include the Montreal Cognitive Assessment 
(MoCA), and Geriatric Depression Scale (GDS). Participants will also complete questionnaires on 
demographic information (age, gender, education, race/ethnicity, income, living situation, comorbidities, 
and medications), nature of support received by a caregiver, and health status. Responses to these items 
can be entered by the data collector directly into an electronic file.   Participants with MoCA cut-off scores 
between 20 to 26 will be invited to participate in the study and complete an in-person baseline 
assessment. If they agree to participate, they will be scheduled for in-person consent for the RCT and 
baseline assessment. If a participant does not qualify or prefers not to participate despite being eligible, 
they will be thanked for their participation. The video session will last approximately 45 minutes. All 
participants regardless of eligibility will be paid $15 for the video screening session. 
Visit 1 Baseline Assessment: The baseline assessment will be scheduled within three months of the video 
screening. Informed consent will be completed in-person for the RCT in a private space by research staff 
who are trained in Human Subjects Protection before study procedures are administered. Upper arm 
circumference will be measured to determine the appropriate-sized blood pressure monitor cuff. To 
obtain blood pressure readings (BP), the research staff will use the Omron 3 Series Upper Arm Blood 
Pressure Monitor (FDA approval: https://fda.report/GUDID/00073796100315) or the A&D UA-789 (FDA 
approval: https://fda.report/PMN/K062027), if participants require an XL BP cuff. Utilizing the 2017 
American College of Cardiology/American Heart Association’s guidelines for home blood pressure 
measurement (HBPM), BP readings will be obtained both standing and sitting. If a problem is detected 

IRB Protocol for Human Subjects 
Research 
 
Page 16 of 29 
 
HSPP Use Only: 
IRB Protocol for Human Subjects Research 
v2023-06 
during the visit, for example an elevated BP (>180 mm Hg systolic or 110 mm Hg diastolic), or an unusually 
low BP reading (<90 systolic), or BP that drops more than 20 mmHg when standing, the research staff will 
encourage participants to contact their primary care provider. 
The research staff will administer a background questionnaire (Modified TechSAge Background 
Questionnaire (TBSQ) (REDCap Version for PwMCI) and hypertension knowledge questionnaire 
(Hypertension Knowledge-Level Scale (HK-LS) 1. Measures to characterize cognitive abilities and 
intervention outcomes will be administered, including the: Rey Auditory Verbal Learning Test (RAVLT 
verbal)2; Benson Complex Figure Copy Test and recall (BCFT) (Visual)3; Trail Making Test (TMT): A &B4; 
Multilingual Naming Test (MINT)5; Craft Story 216; Medication Adherence Report Scale (MARS-5)7; Mobile 
Device Proficiency Questionnaire (MDPQ-16)8; Delis Kaplan Executive Function System (D-KEFS) Verbal 
Fluency and Color-Word Interference9; National Alzheimer’s Coordinating Center (NACC) Number Span 
Text, 10; and Prospective and Retrospective Memory questionnaire (PRMQ)11.  
Participants will be given a MEMS® medication bottle and cap (AARDEX Group, Liège, Belgium) that will 
track hypertension medication-taking to establish baseline adherence. Participants will be given a 
handout on MEMS® medication bottle and cap. If the participant takes more than one hypertension 
medication, one randomly selected hypertension medication will be monitored via MEMS® cap for 4 
weeks for each participant. The names of all hypertension medications will be individually written on a 
slip of paper of the same size, and all placed in an opaque envelope. One randomly drawn paper will be 
used to determine the medicine that will be monitored using the MEMS®. The selected medication will 
be transferred to a MEMS® container by the participant. Participants will be given an adhesive label and 
asked to write their name, medication name, dosage, and administration instructions from their original 
hypertension medication bottle. They will be asked to place the completed label onto the MEMS® 
container. The newly labeled MEMS® bottle will be checked against the original medication bottle label 
by the research staff to ensure accuracy of the transcribed information. Participants will also be asked to 
place future refills in the same container. If medicines change, participants will be asked to call the study 
staff to obtain a new MEMS® cap and container.  
The participant will be asked to record any time in which the participant could not use the container 
(hospitalizations, vacations, etc., or if they intentionally chose not to take the medication) on a medication 
log sheet. If a participant is currently using a medication organizer, the organizational strategy will be 
preserved using a box with seven compartments, each the size of the MEMS® container, for the monitored 
medication. The seven compartments will be labeled with the days of the week (SMTWTFS), which will 
allow the participant to move the MEMS® container to the next day after the medication has been taken. 
If the monitored medication is prescribed more than one time per day, a second box will be provided. In 
this way, the MEMS® cap can be used for all participants without interfering with their organizational 
strategies. This ability to maintain the participant’s organizational structure was successfully used by the 
study investigators during previous MPMI and MEDSReM studies.  
 
Visit 1 will be recorded and will take approximately 90-120 minutes. At the completion of the assessment 
visit, enrolled participants will be compensated ($30).  Research staff will schedule an appointment with 
participants for Visit 2, four weeks later. 
 

IRB Protocol for Human Subjects 
Research 
 
Page 17 of 29 
 
HSPP Use Only: 
IRB Protocol for Human Subjects Research 
v2023-06 
Visit 2 – Intervention (will be audio recorded to ensure fidelity): Visit 2 will involve collecting adherence 
data and introducing participants to the intervention groups. Adherence data by MEMS® monitoring will 
be downloaded to a study laptop from all participants’ MEMS® caps via a USB connected MEMS® cap 
reader/communicator. The research staff will review the participant’s medication log sheet. The research 
staff will take both standing and seated BP. If elevated BP (>180 mm Hg systolic or >110 mm Hg diastolic) 
or unusually low BP reading (<90 systolic) or BP drops more than 20 mmHg between sitting and standing 
measurements, the research staff will encourage participants to contact their primary care provider. After 
these measures are obtained, staff will determine the participant’s group assignment (MEDManage-S or 
MEDManage-P) based on randomization.  
 
Randomization Process:  The randomization process is designed to achieve the appropriate generation of 
the random allocation sequence and concealment of the allocation sequence. A researcher who is not 
involved in phone screening, video screening, or informed consent will generate the randomization list 
prior to the screening of the first person for the randomized, controlled trial. The randomization list will 
use computer-generated random numbers and will use block randomization. The block size will vary 
randomly between 4 and 6. Research personnel who perform phone screening, video screening, informed 
consent, or assessments will not be able to access the randomization list.  
 
For participants randomized into the MEDManage-S intervention arm (MEDSReM-M app + Standardized 
Education via the portal; n=50), research staff will walk participants in this group, through the process of 
downloading the MEDSReM-M app to their phones and accessing the portal. The portal has standardized 
information on hypertension and medications and links to vetted resources (e.g., the American Heart 
Association, National Heart, Lung and Blood Institute pages) for laypersons on their phones. Participants 
in the MEDManage-P control arm (Standardized Education Group without the MEDSReM-M app; n=50) 
will receive education on hypertension and antihypertensive medications and the link to the participant 
portal that has the standardized information on hypertension and medications websites resources that 
have been vetted (e.g., the American Heart Association, National Heart, Lung and Blood Institute pages) 
for laypersons. The research staff will walk them through the process of accessing the portal on their 
phones. Participants in both groups will be recorded and checked for consistency. If drift from the initial 
intervention protocol is detected, the project coordinator will make a note of the session in the participant 
file on REDCap. The coordinator will meet with the study staff to review the audio recording, discuss areas 
in which the intervention strayed from the protocol, and conduct retraining. Please see screenshots of 
the app added to the appendix.  
 
Visit 2 will take approximately 90-120 minutes, and all participants will receive $30 in compensation 
through checks, cash, e-codes, or gift cards based on participant preference. During this visit, participants 
in both intervention arms will be provided a blood pressure monitor to enable regular monitoring at 
home. The study staff will provide instruction on the 2017 American College of Cardiology/American Heart 
Association’s guidelines for home blood pressure.  
Online/Phone Session: Within a week of Visit 2, a telephone or Zoom visit will be held to assess, reinforce, 
and/or re-teach the use of the app and/or portal for MEDManage-S group to ensure solid understanding 
and use capability. Participants assigned to the MEDManage-P group will be asked how they are using the 
portal to ensure that the participant is comfortable using the portal for educational resources. This remote 
session will take approximately 15-20 minutes.  

IRB Protocol for Human Subjects 
Research 
 
Page 18 of 29 
 
HSPP Use Only: 
IRB Protocol for Human Subjects Research 
v2023-06 
Visit 3 Post-Intervention Assessment (will be recorded): Four weeks after Visit 2, both MEDManage-S 
and MEDManage-P groups will complete an outcome assessment visit during which all outcome measures 
(adherence, BP, technology acceptance) including structured interviews will be administered. The 
interview will be audio-recorded for analysis. Along with the outcome measures, hypertension knowledge 
(HKLS) will be measured. Research staff will collect medication adherence data via the MEMS® tracking 
caps. Participants in both arms of the trial will continue to use the MEMS® medication cap and bottle that 
track hypertension medication adherence. During all the study visits, sitting and standing BP will be taken, 
and the medication log sheet will be reviewed. If there is elevated BP (>180 mm Hg systolic or >110 mm 
Hg diastolic) or unusually low BP reading (<90 systolic) or BP drops more than 20 mmHg between sitting 
and standing measurements, the research staff will encourage participants to contact their primary care 
provider. Visit 3 will take approximately 90-120 minutes and participants will be compensated $30 
through checks, cash (for in-person visit), e-codes, or gift cards based on participant preference.   
Visit 4 Follow-Up (will be recorded): Eight weeks after Visit 3, the research staff will conduct the final 
visit. Data will be collected regarding adherence and BP. Research staff will collect medication adherence 
data via the MEMS® and will collect the MEMS®cap and pillbox. Seated and standing BP will be measured 
and the medication log sheet collected. This close-out visit will take approximately 30-45 minutes and 
participants will be compensated $30.  
If participants are unable to meet for Visit 4, the research staff will provide a postage-paid envelope and 
ask participants to return the MEMS® cap to the study office. The participants will be compensated ($30) 
for study completion through checks, cash (for in-person visit), e-codes, or gift cards based on participant 
preference. The research staff will offer an optional meeting remotely via Zoom to do the wrap up. 
1. Erkoc, S. B., Isikli, B., Metintas, S., & Kalyoncu, C. (2012). Hypertension Knowledge-Level Scale (HK-LS): 
a study on development, validity, and reliability. International journal of environmental research and 
public health, 9(3), 1018-1029.  
2. Rey, A. (1958). Memorisation d'une serie de 15 mots en 5 repetitions. In A. Rey (Ed.), L'examen clinique 
en psychologie. Paris : Presses Universitaires de France. 
3. Possin, K.L., Laluz, V.R., Alcantar, O.Z., Miller, B.L. and Kramer, J.H., 2011. Distinct neuroanatomical 
substrates and cognitive mechanisms of figure copy performance in Alzheimer's disease and behavioral 
variant frontotemporal dementia. Neuropsychologia, 49(1), pp.43-48. 
4. Reitan RM. Validity of the Trail Making Test as an indicator of organic brain damage. Perceptual and 
Motor Skills, 1958; 8(3): 271–6. 
5. Gollan TH, Weissberger GH, Runnqvist E, Montoya RI, & Cera CM (2012). Self-ratings of spoken language 
dominance: A Multi-Lingual Naming Test (MINT) and preliminary norms for young and aging Spanish-
English bilinguals. Bilingualism, 15, 594–615. 
6. Craft, S., Newcomer, J., Kanne, S., Dagogo-Jack, S., Cryer, P., Sheline, Y., Luby, J., Dagogo-Jack, A. and 
Alderson, A., 1996. Memory improvement following induced hyperinsulinemia in Alzheimer's 
disease. Neurobiology of aging, 17(1), pp.123-130. 
7. Chan AHY, Vervloet M, Lycett H, Brabers A, van Dijk L, Horne R. Development and validation of a self-
report measure of practical barriers to medication adherence - the Medication Practical barriers to 
Adherence Questionnaire (MPRAQ). Br J Clin Pharmacol 2021. 
8. Roque NA, Boot WR. A new tool for assessing mobile device proficiency in older adults: The Mobile 
Device Proficiency Questionnaire. Journal of Applied Gerontology, 2016; 26. 

IRB Protocol for Human Subjects 
Research 
 
Page 19 of 29 
 
HSPP Use Only: 
IRB Protocol for Human Subjects Research 
v2023-06 
9. Delis DC, Kaplan E, Kramer JH. Delis-Kaplan Executive Function System (D–KEFS): APA PsycTests; 2001. 
10. Wechsler D. Wechsler Adult Intelligence Scale--Fourth Edition (WAIS-IV): Pearson Assessment, 2008. 
11. Crawford, J., Smith, G., Maylor, E., Della Sala, S., & Logie, R. (2003). The Prospective and Retrospective 
Memory Questionnaire (PRMQ): Normative data and latent structure in a large non-clinical 
sample. Memory, 11(3), 261-275.  
 
10.3 Specify the total estimated time commitment for subject participation, and the 
estimated time commitment for each activity. 
Research Activity 
Participant Estimated Time Commitment 
Phone Screening 
5-15 minutes 
Video Screening 
45 minutes 
Visit 1 Baseline Assessment 
90-120 minutes 
Eligible PwMCI who agree to participate in the study will be enrolled for 
approximately 4 months after randomization.  
Visit 2 Training  
90-120 minutes 
Remote Teach-back Session 
15-20 minutes 
Visit 
3 
Post-Intervention 
Assessment 
90-120 minutes 
Visit 4 
30-45 minutes 
TOTAL 
365-485 minutes (6-8 hours) 
 
10.4 If any biological specimens (blood, urine, tissue, etc.) are being collected for research, 
state the amount (ml/tsps./tbsp, etc.), method, frequency, and type of specimen to be 
collected and what the specimen will be used for.  
N/A. No biological specimens will be collected for this research.  
10.5 If the study is a clinical trial, confirm registration with https://clinicaltrials.gov/ has 
been completed: 
This study is not a clinical trial: ☐ 
Registration complete: ☐ 
Registration pending: ☒ 
 
 
11.0 Potential Benefits to Subjects: 
11.1 Describe the anticipated benefits of this study to society, academic knowledge, or both.  
If we find the MEDSReM-M system (app + portal) effective, then we will be able to offer the first theory 
and evidence-based adherence system, specifically designed for and tested among older adults with 
hypertension and MCI to the larger population of PwMCI. MEDSReM-M has the potential to improve 
hypertension medication adherence, which can improve blood pressure, prevent complications, and 
improve the quality of life of the users. 

IRB Protocol for Human Subjects 
Research 
 
Page 20 of 29 
 
HSPP Use Only: 
IRB Protocol for Human Subjects Research 
v2023-06 
11.2 Describe any benefits that individuals may reasonably expect from participation (not 
including compensation, which cannot be considered a benefit of participation). 
If the participant is eligible for the study, they will receive information on hypertension and medications. 
Participants may also improve their medication taking. 
12.0 Risks to Subjects: 
12.1 Describe all physical, psychological, social, legal, and/or economic risks that could be 
associated with participation in this research.  
The primary risks of the evaluations and observations are fatigue and frustration due to the difficulty of 
some tasks. We will provide encouragement, scheduled breaks, and a supportive environment to make 
participation an interesting and beneficial experience. 
There is a risk related to inadvertent loss of confidentiality of one’s health-related information. Potential 
participants will be informed of the risks inherent in participating in this project and of the procedures to 
minimize any of these risks from occurring. The topic of the proposed research is not deemed to be 
particularly sensitive or emotionally charged. MEDSReM-M does not change the participants’ 
medications. Although this study includes a technology designed to improve medication adherence and 
standardized educational intervention for the comparison group, we do not anticipate any health risks 
resulting from participation in the MEDSReM-M intervention or Standardized Education control group.  
For participants who currently use a pillbox or organizer the use of the medication bottle with the special 
cap may interfere with their existing strategies to remind them to take their medications. To mitigate this 
interference, those who use a pillbox or organizer will be supplied a box that allows them to move the 
MEMS® container from one day to the next. All participants in the MEDSReM-M intervention will be 
provided with a pillbox and encouraged to use it. The box will be labeled with the day of the week, 
consistent with pill organizers. 
12.2 Discuss what steps will be taken to minimize risks to subjects/data. 
We will provide encouragement, scheduled breaks, and a supportive environment to make participation 
an interesting and beneficial experience and minimize fatigue during assessments. 
To protect against loss of confidentiality, no participant names will be used on any forms for data 
collection, only project identification numbers. Only the Site PIs and the research coordinators will have 
access to the Master List that links personal and project identification numbers. All hard copy data files 
will be kept in locked files in the data storage area at the respective sites, while all electronic files will be 
stored in Box. Audio recordings and transcriptions obtained to assess fidelity will be stored in Box. All 
electronic communication between project staff in Illinois and Arizona will use project identification 
numbers that contain no personal information about participants. The information on specific individuals 
collected in this project will be used for research purposes only. In reference to such information in 
publications, presentations, or reports (i.e., individual case studies), no personal identifiers will be used. 
Reports will only use aggregated data. No report of individual data will be provided. The Co-PIs and Co-
Investigators will be responsible for monitoring data to ensure the safety of participants. A Data Safety 
Monitoring Committee will monitor any safety concerns and adverse events related to the RCT following 
the protocol. The DSMB will be established prior to IRB approval and subject recruitment. 
 

IRB Protocol for Human Subjects 
Research 
 
Page 21 of 29 
 
HSPP Use Only: 
IRB Protocol for Human Subjects Research 
v2023-06 
 
13.0 Costs, Compensation, and Injury: 
13.1 Describe any costs, monetary and non-monetary, that subjects may incur. This includes 
time. 
There are no costs involved with participating in the study, apart from the participants’ time:  
 
Research Activity 
Participant Estimated Time Commitment 
Phone Screening 
5-15 minutes 
Video Screening 
45 minutes 
Visit 1 Baseline Assessment 
90-120 minutes 
Eligible PwMCI who agree to participate in the study will be enrolled for 
approximately 4 months after randomization.  
Visit 2 Training  
90-120 minutes 
Remote Teach-back Session 
15-20 minutes 
Visit 
3 
Post-Intervention 
Assessment 
90-120 minutes 
Visit 4 
30-45 minutes 
TOTAL 
365-485 minutes (6-8 hours) 
 
Discuss the amount of compensation (monetary and/or non-monetary) subjects may receive. 
Describe if compensation will be prorated. 
To promote the highest retention rate possible, participants will receive incentives at each data collection 
session for their time and participation in the study. The incentives vary in amount depending on the 
portion of the study and the amount of data collected during the session. Based on participants’ 
preference, compensation will be rendered via checks, cash, e-codes or gift cards. Participants can 
withdraw at any time and will be paid a prorated rate of $15/hour for the hours spent in direct contact 
with the research team as part of the assessments or training. 
 
Research Activity 
Participant Compensation 
Video Screening 
$15 
Visit 1 Baseline Assessment 
$30 
Visit 2 Training  
$30 
Visit 3 Post-Intervention Assessment $30 
Visit 4 
$30 
TOTAL 
$135 
 
14.0 Privacy of Subjects and Confidentiality of Data: 
14.1 Describe steps, if any, to protect the privacy of the subjects throughout their 
participation (e.g., during the recruitment process, consent process, and/or research 
procedures). 

IRB Protocol for Human Subjects 
Research 
 
Page 22 of 29 
 
HSPP Use Only: 
IRB Protocol for Human Subjects Research 
v2023-06 
To protect against loss of confidentiality, participants’ names will be replaced by project identification 
numbers. Only the site PIs and the research coordinators will possess the Master List that links personal 
and project identification numbers. All hard copy data files will be kept in locked files in the data storage 
area at the respective sites, while all electronic files will be stored in Box. Audio recordings and 
transcriptions obtained to assess fidelity will be stored in Box. All electronic communication between 
project staff in Illinois and Arizona will use project identification numbers that contain no personal 
information about participants. The information on specific individuals collected in this project will be 
used for research purposes only. In reference to such information in publications, presentations, or 
reports (i.e., individual case studies), no personal identifiers will be used. 
14.2 Will data be kept for future research, including unspecified future research and 
genetics?       Yes ☒     No☐ 
14.3 If yes to the above question, describe future use plans here including any storage in a 
repository (if applicable), and what data will be retained/reused.  
Within the Informed Consent document, there is a section that asks participants if the study staff may 
contact them in the future for other unspecified research participation opportunities. If the participants 
check “no,” the study staff will not retain their contact information for future research. For those 
participants who provided permission by checking “yes,” their contact information (name, phone 
number, email address) will be kept in a secured electronic file in Box. No data associated with this study 
will be stored with the contact information. 
14.4 Discuss how study results will be shared with subjects, families, and/or the institution, 
both immediately and long-term. 
Participants will be thanked for their involvement with the study and provided feedback on their blood 
pressure. Participants may also benefit from improved knowledge about health technology mobile 
applications for older adults but will also help us to further develop this system to support older adults 
in successfully managing their antihypertensive medications. It has been our practice to send a summary 
of the study findings to all study participants once the data has been collected and analyzed along with 
the thank you for participating in the study from the Site PI.  
14.5 Indicate if the research team will be accessing any of the following records.  
☐ Substance abuse records (HIPAA and 42 CFR Part 2) 
☐ Medical records (HIPAA)  
☐ Educational records (FERPA)* 
☐ Employee records (ABOR Policy 6-912)* 
☐ Other, specify: Click or tap here to enter text. 
14.6 For each record source selected above, summarize the data elements to be accessed, 
who will access them, and how the information will be obtained. 
N/A. We will not be accessing any records listed in 14.5. 
 

IRB Protocol for Human Subjects 
Research 
 
Page 23 of 29 
 
HSPP Use Only: 
IRB Protocol for Human Subjects Research 
v2023-06 
14.7 Indicate where data will be stored: 
☐ Box@UA 
☐ OnCore 
☒ Box@UA Health 
☐ PACS medical imaging software 
☐ Clinical Data Warehouse (CDW) 
☐ Password Protected Drive 
☒ Cloud Server  
☒ REDCap 
☐ Department Drive 
☒ 
Transmitting/receiving 
subject 
data 
to/from an outside group 
☒ Department Office 
☐ UA Records Management & Archives 
☐ Encrypted Drive 
☐ Banner Server/Platform, specify:  
☒ External Drive (hard drive, USB, disk) 
☐Soteria  
☐ Google Suite for Education 
☐HIPAA Research Computing Service 
☐ Other, specify: Click or tap here to enter 
text. 
14.8 For EACH of the storage locations checked above, discuss the type of data to be stored, 
including if the data is identifiable, coded, or de-identified upon storage, and who may 
have access to the data. 
We will be using computer-based data collection procedures for assessment via REDCap. Information 
about this research study will remain confidential. All participants will be assigned a participant code 
that is not related to their personal information in any way. This participant code will be used for all in-
person data collection. There will be one master sheet linking participant names and device usernames 
to the participant code. This sheet will be electronically stored on Box with restricted access to the 
research team. Any electronic copies of the data including audio files will be stored by participant code 
that only the research team has access to, including the interview recordings. Once recording files are 
uploaded to Box, these files will be deleted from the initial recording device. Strict security will be 
maintained to access Box. No identifying information will be mentioned in any presentations or 
publications. 
 
Ephibian, our contracted MEDSReM (iOS app and portal) developer, uses Microsoft’s Azure cloud 
services platform to host and support the necessary MEDSReM servers and corresponding operating 
systems and software. MEDSReM's required servers include database, web, and Application 
Programming Interface (API) servers. Azure supports HIPAA compliance and incorporates all the 
necessary safeguards to ensure HIPAA requirements can be satisfied. Microsoft provides a secure VPN 
and web portal to connect to Azure, so any data uploaded to or downloaded from Azure is encrypted 
and all data stored in its cloud instances are encrypted. HIPAA requires access controls to be 
implemented to limit who can access Box. Azure offers these controls and uses Active Directory to allow 
permissions to be set. Azure includes detailed logging, so administrators can see who accessed, or 
attempted to access Box.  
 
The MEMS® cap records and stores the date and time when the participant opens the study bottle. 
During the study visits a MEMS® USB NFC (Near Field Communication) reader will be used to transfer 
the time-stamped medication taking events from the MEMS® cap to a password protected laptop only 
accessed by study staff. These data will be uploaded and stored in Box. 

IRB Protocol for Human Subjects 
Research 
 
Page 24 of 29 
 
HSPP Use Only: 
IRB Protocol for Human Subjects Research 
v2023-06 
 
 
 
14.9  Storage of research records (research records should be maintained for whichever of 
the following time periods is the longest, select one): 
☒ I will store research records for at least 6 years past the time the study is concluded. 
☐ For studies involving minors, I will store research records for at least 6 years after the 
youngest participant turns 18. 
☐ I will store research records for the length of time required by law or study sponsor, please 
specify:  Click or tap here to enter text. 
 
14.10 Describe what security controls (e.g., administrative, physical, technical) are in place 
to make sure data/specimens are secure.  
To protect against loss of confidentiality, participants’ names will be replaced by project identification 
numbers. Only the Site PI and the research coordinators will possess the Master List that links personal 
and project identification numbers. All hard copy data files will be kept in locked files in the data storage 
area at the respective sites, while all electronic files will be stored in secured university Box. 
14.11 Indicate how data/specimens will be shared with collaborating entities: 
☐ Data and/or specimens will not be shared between UA and any outside group or 
collaborating entity. 
☐ Data/or specimens will be transmitted and/or disclosed to an outside group or a 
collaborating entity. 
☒ Data and/or specimens will be received from an outside group or a collaborating entity.  
☐ PHI will be transmitted to or received from an outside group or a collaborating entity. * 
☐ A Limited Data Set will be transmitted or received from an outside group or a collaborating 
entity. * 
☐ Data/specimens will be sold to pharmaceutical companies. 
 
Describe what information will be shared, who it will be shared with, and how it will be 
shared (e.g., secure file transfer, REDCap, etc.). Also include information about future 
use sharing and repositories Specify if the shared data will be identifiable, coded, a 
limited data set, or de-identified. 
 
The MEDSReM-M system records a username, an email address associated with the provided username, 
and reported medication taking event times. These data will be uploaded to Box, stripped of the 
username, and relabeled with the participant code. All electronic communication between project staff 
in Illinois and Arizona will use project identification numbers that contain no personal information about 
participants. The information on specific individuals collected in this project will be used for research 

IRB Protocol for Human Subjects 
Research 
 
Page 25 of 29 
 
HSPP Use Only: 
IRB Protocol for Human Subjects Research 
v2023-06 
purposes only. In reference to such information in publications, presentations, or reports (i.e., individual 
case studies), no personal identifiers will be used. All hard copies of the consent forms will be kept in 
locked files. Data from the MEDSReM system will be uploaded to Box, stripped of the username, and 
relabeled with the participant code. 
 
15.0 Additional Questions (complete as applicable): 
15.1 Subject Injury: If the research involves more than minimal risk to subjects, describe the 
provisions for medical care and available compensation in the event of research related 
injury. If the Human Research has a clinical trial agreement, this language should reflect 
what is stated in the agreement. 
There is no risk of injury to participants in this study. The participants’ medications will not be changed by 
the intervention. The research staff will not alter the participants’ standard of care in any way. If a problem 
is detected during a visit with participants, such as elevated BP (>180 mm Hg systolic or 110 mm Hg 
diastolic), an unusually low BP reading (<90 systolic) or BP that drops more than 20 mmHg when standing, 
the research staff will encourage participants to contact their primary care provider. At the participant’s 
request, the research staff will assist with contacting the participant’s healthcare provider, but the 
research staff is not altering the participant’s standard of care in any way.   
15.2 Withdrawal of Subjects: Discuss how, when, and why subjects may be removed from 
the study.  If abrupt withdrawal is necessary, discuss how subjects will be withdrawn so 
that they are not put at increased risk. Discuss what happens if a subject is withdrawn 
from one part of the study but asked to continue with other parts, such as ongoing 
follow-up. 
Participants can withdraw at any time from the study without any hard feelings or interfering with any 
care or service. We will retain data from any participants who withdraw since we plan to use intention to 
treat analysis. Participants will be paid a prorated rate of $15/hour for the hours spent in direct contact 
with the research team as part of the assessments or training. 
 
15.3 Monitoring for Subject Safety: Provide a brief lay discussion of your plan to monitor for 
subject safety. Describe what safety information will be collected, including serious 
adverse events, how safety information will be collected, and the frequency of 
collection including a timeline of when the data and review(s) will occur, who will 
review the information, and the plan for reporting findings.  
If there will not be a way to monitor for subject safety, please explain. 
We will follow a MEDSReM-M Safety Monitoring Schedule as the quality assurance process to verify 
data integrity and validation. Before the start of the RCT, the Safety Monitoring Committee (SMC), 
including a geriatrician and biostatistician, will review the full study protocol. Any recommendations for 
adjustment will be discussed with the Site PI and program coordinators. The SMC will continue to review 
the research protocol, progress on trial, data integrity, recruitment/enrollment/retention, participant 
risk vs. benefit, and safety factors as needed throughout the study. Each month, the program 
coordinator will be responsible for auditing 10% of participant records for compliance with the IRB and 
informed consent requirements, verification of source documents, and integrity of data collected to 

IRB Protocol for Human Subjects 
Research 
 
Page 26 of 29 
 
HSPP Use Only: 
IRB Protocol for Human Subjects Research 
v2023-06 
ensure adherence to the study protocol. A summary of the audits will be presented to the MPIs Drs. 
Kathie Insel and Raksha Mudar and SMC at bi-yearly meetings or as needed and any adjustment to the 
study protocol will be discussed. 
We will identify, review, and report any adverse events and unanticipated problems to the University of 
Arizona IRB, NINR and FDA (if adverse drug event). Although this is a clinical trial, minimal adverse events 
are anticipated as the participant’s hypertension medication regimen is not altered by the intervention. 
We will report any adverse incidents observed during the study that result from their medical conditions 
or treatment according to the NIH Guidance on Reporting Adverse Events to Institutional Review Boards 
for NIH-Supported Multicenter Clinical Trials (http://grants1.nih.gov/grants/guide/notice-files/not99-
107.html). All study personnel will be trained to identify and accurately document any participant 
reports of study-related adverse events and report them to the Site PI.  
Since adherence may increase during the study, reducing BP further. BP will be taken during each study 
visit for both groups. BP will be measured twice, both sitting and standing. Sitting BP will be measured 
first while the participant is seated with his/her arm extended at the heart level. The participant will 
then be asked to stand for 1 minute prior to the standing BP measurement. The BP measures will be 
obtained after the participant has been seated for at least 15 minutes using a digital BP monitoring 
device 
(Omron 
3 
Series 
Upper 
Arm 
Blood 
Pressure 
Monitor, 
FDA 
approval: 
https://fda.report/GUDID/00073796100315; or A&D UA-789 Blood Pressure Monitor, FDA approval: 
https://fda.report/PMN/K062027 ). The sitting and standing BP measures will be taken 5 minutes apart 
following the procedures outlined in the 2017 ACC/AHA High Blood Pressure Clinical Practice Guideline. 
If elevated BP (>180 mm Hg systolic or >110 mm Hg diastolic) or unusually low BP reading (<90 systolic) 
or BP drops more than 20 mmHg between sitting and standing measurements, the research staff will 
encourage participants to contact their primary care provider. If participants experience problems such 
as symptoms of lightheadedness, dizziness, or syncope (fainting), they will be instructed to contact their 
primary care provider and/or the prescribing provider (if the primary care provider and prescriber 
differ). No serious adverse events have occurred in the research team’s prior studies of older people 
with hypertension. 
All study personnel will be trained to identify and accurately document any participant accounts of 
unanticipated problems and report them to the program coordinator, who will be responsible for 
reporting the event to the Site PI. Participants will be instructed to call the research team if any 
medication changes occur. They also will be asked to record medication changes, life events (e.g., new 
diagnosis, vacation without MEMS® bottle), and adverse event experiences on their medication log 
sheet. The program coordinator will report the incident to the MPIs, Drs. Kathleen Insel and Raksha 
Mudar, to determine if the incident is truly unanticipated or study related. Any severe unanticipated 
problem will be reported to the University of Arizona IRB and National Institute of Nursing Research 
(NINR) Program Officer within 24 hours of the report of incident. The Site PIs will present unanticipated 
problems to the SMC during quarterly meetings. The SMC will determine if changes to the research 
protocol are warranted to mitigate risks, such as modification of inclusion or exclusion criteria, addition 
of procedures for monitoring subjects, suspension of enrollment and/or research procedures, 
modification of informed consent, and provision of additional information regarding recognized risks. 
The summary of the unanticipated problems will be sent to the University of Arizona IRB and NINR post-
SMC meeting by the PI, Dr. Insel. The summary will also be included in the project’s annual report to the 
University of Arizona IRB and NINR, submitted by Dr. Insel. 
 

IRB Protocol for Human Subjects 
Research 
 
Page 27 of 29 
 
HSPP Use Only: 
IRB Protocol for Human Subjects Research 
v2023-06 
 
 
15.4 Data Management Plan: Please discuss the data management plan, if required by your 
funder. For additional resources, reference the HSPP Data Management webpage. If 
your sponsor/funding agency requires a Data Management Plan, please upload the 
approved copy in eIRB.  This section and the informed consent form should contain all 
pertinent information including:  
• What data/metadata will be shared (imaging, survey; raw data or derived; 
protocol, data form; etc.) 
• What repository will be used (if known) 
• How will data be stored (in a de-identified or identifiable format)  
 
 
The investigators will comply with the letter and spirit of policies on data sharing, and on sharing of 
unique research and product resources in connection with the proposal that do not harm the intellectual 
property position of either party. Both the University of Arizona and the University of Illinois commit to 
complying with the Bayh-Dole Act and will rely on NIH (National Institutes of Health) policies in this 
regard; specifically with the NIH policies on Data Sharing and Sharing of Research Resources. 
 
Data coordination among team members occurs in several ways. Resources will be shared among the 
team members through online collaboration tools. Both the universities use Box and we have already set 
up a sharing system for files related to the project. These are complementary elements to guarantee 
proper interaction and data sharing among the members of the project. 
 
Data and resources generated during the performance of the project will be shared with the research 
community primarily via conference presentations, journal articles, and summary reports made available 
on laboratory and company websites. Technical manuals created during the project may be made 
publicly available via websites geared towards sharing resources in the research community or licensed, 
as appropriate, and after University review. Completely de-identified final data will be shared with 
existing and new collaborators of the laboratories participating in this project, using HIPAA-compliant 
file transfer methods (i.e., Box) once the investigators complete a data-sharing agreement. The data-
sharing agreement will ensure that privacy, confidentiality standards, and data security will be 
maintained at the recipient site and will prohibit manipulation of data. 
 
 
 
 
 
 
 

IRB Protocol for Human Subjects 
Research 
 
Page 28 of 29 
 
HSPP Use Only: 
IRB Protocol for Human Subjects Research 
v2023-06 
 
15.5 International Research: Describe site-specific regulations or customs affecting the 
research, local scientific and/or ethical review structures that differ, and if community 
advisory boards are involved. If so, describe their composition and involvement. For 
research being conducted outside of the US, please explain any local laws, regulations, 
or customs the IRB needs to be aware of.  
 
 N/A. We will not conduct any research outside of the United States.  
 
 
 
 
 
 
 
 

IRB Protocol for Human Subjects 
Research 
 
Page 29 of 29 
 
HSPP Use Only: 
IRB Protocol for Human Subjects Research 
v2023-06 
Additional items needed for review: 
• 
Word versions of applicable subject materials: Consents, PHI Authorization Form(s), Recruitment 
Materials, Data Collection Materials, additional Participant Materials 
• 
Current PI CV or bio sketch 
• 
Advisor approval (if the PI is a student or medical resident) 
• 
Department/Center/Section Review approval 
• 
Scientific/Scholarly review approval  
• 
Responsible physician approval and CV (if the PI is conducting medical procedures for which 
he/she is not clinically certified to perform) 
• 
Additional approvals, as needed (e.g., RIA/Banner feasibility, Export Control, Radiation, COI, CATS, 
SRC, school district approval, tribal approval, etc.)  
 
Other items as applicable: 
• 
HSPP Appendices 
• 
Data Monitoring Charter and Plan  
• 
Drug/Device information 
o Applicable drug or device appendix 
o Investigator's Brochure, drug product sheet, device manual, user's manual, instructions 
for use, package insert, IND/IDE documentation, FDA 1572 form, 510k indication, FDA 
exemption, sponsor determination of device risk, etc. 
• 
Multi-site information (for sites engaged in research where the UA is the IRB of record)  
o Appendix for Multi-Site Research for each site 
o Documentation of reliance  
o CV and medical license (if applicable) of site PI 
o Human Subject Training Verification for site PI and site staff 
• 
Sponsor protocol and MOPs that are used in the study (if applicable)