Piloting an Evidence-based Mobile Mindfulness Practice to Support Self-management Among Underserved and Racial Minority Adults With Pulmonary Hypertension
Phase: NA
Conditions: Hypertension, Pulmonary
Sponsor: State University of New York at Buffalo

 
University at Buffalo Institutional Review Board (UBIRB) 
Office of Research Compliance | Clinical and Translational Research Center Room 5018 
875 Ellicott St. | Buffalo, NY 14203 
UB Federalwide Assurance ID#: FWA00008824 
Page 1 of 43 
 
Complete Research Protocol (HRP-503) 
 
Table of Contents 
Template Instructions ....................................................................................................... 2 
1.0 
Study Summary ........................................................................................................ 4 
2.0 
Objectives* .............................................................................................................. 5 
3.0 
Scientific Endpoints* ............................................................................................... 6 
4.0 
Background* ............................................................................................................ 6 
5.0 
Study Design* ........................................................................................................ 13 
6.0 
Study Intervention/Investigational Agent .............................................................. 13 
7.0 
Local Number of Subjects ..................................................................................... 14 
8.0 
Inclusion and Exclusion Criteria* .......................................................................... 15 
9.0 
Vulnerable Populations* ........................................................................................ 16 
10.0 Eligibility Screening* ............................................................................................ 17 
11.0 Recruitment Methods ............................................................................................. 18 
12.0 Procedures Involved*............................................................................................. 20 
13.0 Study Timelines* ................................................................................................... 22 
14.0 Setting .................................................................................................................... 23 
15.0 Community-Based Participatory Research ............................................................ 23 
16.0 Resources and Qualifications ................................................................................. 24 
17.0 Other Approvals ..................................................................................................... 26 
18.0 Provisions to Protect the Privacy Interests of Subjects .......................................... 26 
19.0 Data Management and Analysis* .......................................................................... 27 
20.0 Confidentiality* ..................................................................................................... 28 
A. 
Confidentiality of Study Data ......................................................................... 29 
B. 
Confidentiality of Study Specimens ................................................................ 29 
21.0 Provisions to Monitor the Data to Ensure the Safety of Subjects* ........................ 30 
22.0 Withdrawal of Subjects* ........................................................................................ 32 
23.0 Risks to Subjects* .................................................................................................. 32 
24.0 Potential Benefits to Subjects* .............................................................................. 34 
25.0 Compensation for Research-Related Injury ........................................................... 34 
26.0 Economic Burden to Subjects ................................................................................ 35 
27.0 Compensation for Participation ............................................................................. 35 
28.0 Consent Process ..................................................................................................... 35 
29.0 Waiver or Alteration of Consent Process ............................................................... 40 
30.0 Process to Document Consent ............................................................................... 41 
31.0 Multi-Site Research (Multisite/Multicenter Only)*............................................... 41 
32.0 Banking Data or Specimens for Future Use* ........................................................ 43 
 
 
 

 
Page 2 of 43 
IRB Version: 5/6/19 
Template Instructions 
Sections that do not apply: 
• In several sections, the addition of checkboxes for Not Applicable have been 
added to the template as responses.   
o If an N/A checkbox is present, select the appropriate justification 
from the list.   
o If an N/A checkbox is not present, or if none of the existing 
checkboxes apply to your study, you must write in your own 
justification. 
• In addition: 
o For research where the only study procedures are records/chart 
review:  Sections 6, 21, 22, 24, 25, 26 and 27 do not apply. 
o For exempt research:  Section 6 may not apply. Section 6.1 will 
still apply if there is a study intervention. 
 
Studies with multiple participant groups: 
 
• If this study involves multiple participant groups (e.g. parents and children), 
provide information in applicable sections for each participant group. Clearly 
label responses when they differ.  For example: 
Response Example 
Intervention Group:  
Control Group: 
Formatting: 
• Do not remove template instructions or section headings when they do not apply 
to your study. 
If you are pasting information from other documents using the "Merge Formatting" 
Paste option will maintain the formatting of the response boxes. 
Amendments: 
• When making modifications or revisions to this and other documents, use the 
Track Changes function in Microsoft Word. 
• Update the version date or number on Page 3. 
 
 

 
Page 3 of 43 
IRB Version: 5/6/19 
PROTOCOL TITLE: 
Include the full protocol title. 
Piloting an evidence-based mobile mindfulness practice to support self-
management among Underserved and Racial Minority Adults with Pulmonary 
Hypertension 
 
PRINCIPAL INVESTIGATOR: 
Name 
Department 
Telephone Number 
Email Address 
Response: Tania Von Visger, Ph.D., APRN, CNS, CCNS, PCCN 
SUNY at Buffalo, School of Nursing 
716-829-2201 
Taniavon@buffalo.edu 
 
VERSION NUMBER/DATE: 
Include the version number and date of this protocol. 
Response: Version 6 
 
REVISION HISTORY 
 
Revision 
# 
Version Date 
Summary of Changes 
Consent 
Change? 
1 
8/24/21 
Original 
 
2 
9/13/21 
To provide details about waiver of signature 
consent. Verbal consent as described in Section 
29.1, 29.2, 29.3, and 29.4 
 
3 
3/9/22 
Change health related quality of life 
questionnaire from CAMPHOR to EmPHasis-
10 and change the method of payment to US 
Bank Debit card 
 
4 
4/28/22 
Change to expand inclusion criteria to include 
PH patients throughout the US. 
 
5 
6/13/22 
Change Study inclusion criteria to include PH 
patients of ALL ethnicity, not just PH patients 
who self-identified as an underserved racial 
minority (URM) group. 
 

 
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IRB Version: 5/6/19 
6 
7/17/22 
Change Study exclusion criteria to remove the 
first two exclusions: “Current user of 
mindfulness mobile App” and “Current 
participation in mind-body practice (yoga, Tai 
chi, or Qi Gong).” 
 
7 
9/15/22 
Clarification of research activity participation 
by PH doctors at URMC and Rochester 
Regional Health 
yes 
 
FUNDING: 
Indicate any funding for this proposal. This should match the Funding Sources 
page in Click IRB. 
Response: CTSI Pilot Study Grant, a Seed grant from UB SON 
 
GRANT APPLICABILITY: 
Indicate whether this protocol is funded by a grant (e.g. NIH, foundation grant).  
For a grant with multiple aims, indicate which aims are covered by this research 
proposal. 
NOTE: This question does not apply to studies funded by a sponsor contract. 
Include a copy of the grant proposal with your submission.     
Response: Potential funding from the 2021 CTSI Pilot Study 
 
RESEARCH REPOSITORY: 
Indicate where the research files will be kept, including when the study has been 
closed.  The repository should include, at minimum, copies of IRB 
correspondence (approval, determination letters) as well as signed consent 
documents.  This documentation should be maintained for 3 years after the study 
has been closed.   
Response: Electronic research files will be kept in a dedicated Folder for this 
specific research project in UB Box, password protected according to the UB 
SON guidelines. 
Location: UB BOX Research File 
Address: 3435 Main Street Wende Hall # 201F, Buffalo, NY, 14214 
Department: School of Nursing 
1.0 Study Summary 
 
Study Title 
Piloting an evidence-based mobile mindfulness practice to 
support self-management among Underserved and Racial 
Minority Adults with Pulmonary Hypertension 

 
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Study Design 
two-group comparative study design where waitlisted 
participants will serve as controls. 
Primary Objective 
to determine the feasibility, acceptability, and preliminary 
impacts of the Mindfulness Meditation for PH (MMPH) 
mobile-health program in URM adults with PH in symptom 
management and quality-of-life 
Secondary 
Objective(s) 
None 
Research 
Intervention(s)/ 
Investigational 
Agent(s)  
Mindfulness Meditation for PH (MMPH) mobile-health 
program 
IND/IDE #  
None 
Study Population 
Community-dwelling URM adults diagnosed with PH 
condition 
Sample Size 
20 
Study Duration for 
individual 
participants 
16 weeks (2 months) 18 participation (8 weeks for the 
intervention and eight weeks for follow up) 
Study Specific 
Abbreviations/ 
Definitions  
URM=underserved racial minority; PH=pulmonary 
hypertension; HRQOL=health-related quality of life; 
MMPH=mindfulness meditation for PH; GBM=gentle body 
movement; BAM=body awareness meditation; PAHSS= 
Pulmonary Arterial Hypertension Symptoms Scale; 
EmPHasis-10= Health-related quality of life in pulmonary 
arterial hypertension; PHQ-9=Patient Health 
Questionnaire; CAMS-R= Cognitive and Affective 
Mindfulness Scale-Revised; SUS= System Usability Scale 
2.0 Objectives* 
2.1 Describe the purpose, specific aims, or objectives of this research. 
Aim 1: To determine the feasibility and acceptability of the MMPH in 
community-dwelling URM adults with PH as a symptom self-management 
tool. 
Aim 1a: Feasibility will be assessed by 1) frequency of home 
practice (> 2/week) and 2) retention rate (>70% of participants remaining 
at study completion).  
Aim 1b: Acceptability will be determined by 1) participants' 
evaluation of the MMPH program (composite mean System Usability 
Scale score > 5, scale 1-7), 2) session completion rate (at least 6 of 8 [75% 
attendance] by the participants retained at the study end), and 3) 
qualitative thematic analysis of participants.  
Aim 2: To determine the clinical impacts of an MMPH program in PH-symptom, 
anxiety, and depression reduction among community-dwelling URM adults with 
PH for symptom management. 

 
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2.2 
State the hypotheses to be tested, if applicable. 
NOTE:  A hypothesis is a specific, testable prediction about what you expect to 
happen in your study that corresponds with your above listed objectives. 
Hypothesis 1: MMPH will meet feasibility and acceptability targets for URM 
adults with PH 
Hypothesis 2: Participants will report reductions in symptom severity of pain, 
anxiety, dyspnea, and fatigue at the end of the MMPH modules (short-term 
impacts). Participants will report decreases in the prevalence and intensity of PH-
related symptoms, depression, and improved quality of life at the end of the 
MMPH program (long-term impacts). 
3.0 Scientific Endpoints* 
 
3.1    Describe the scientific endpoint(s), the main result or occurrence under 
study.   
 
NOTE:  Scientific endpoints are outcomes defined before the study begins to determine 
whether the objectives of the study have been met and to draw conclusions from the data.  
Include primary and secondary endpoints.  Some example endpoints are:  reduction of 
symptoms, improvement in quality of life, or survival.  Your response should not be a 
date.   
Response: Symptom Severity Reduction per PAHSS and HRQOL improvement 
per EmPHasis-10. 
 
4.0 Background* 
4.1 Provide the scientific or scholarly background, rationale, and significance 
of the research based on the existing literature and how it will contribute to 
existing knowledge.  Describe any gaps in current knowledge.  Include 
relevant preliminary findings or prior research by the investigator.  
Patients with pulmonary hypertension (PH) live with a plethora of 
bothersome symptoms,1 of which are consequences of the severe 
cardiopulmonary deterioration of right-sided heart failure. Because PH 
pathophysiology is complicated due to multiple causes, PH diagnosis is 
confirmed with right-sided cardiac catheterization documenting the 
elevation of mean pulmonary arterial pressure > 25 mmHg with 
pulmonary wedge pressure < 15 mmHg.2 There are five etiological 
classifications of PH: idiopathic (Class I), due to left-heart diseases (Class 
II), due to lung diseases (Class III), due to chronic thrombolytic/embolic 
diseases (Class IV), and other causes (Class V).2 Class I PH or pulmonary 
arterial hypertension (PAH) is considered the most severe form of PH and 
comprises approximately 50% of the PH population. Regardless of the 
cause, normalizing pulmonary pressure using PH-specific drugs is the 
main objective of medical management. Little evidence is currently 

 
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available regarding effective self-management strategies to reduce 
symptom burden among under-served racial minority (URM) patients with 
PH. Early diagnosis and prompt initiation of pharmacological treatment 
have shown to improve clinical outcomes, two critical ingredients often 
not available to URM adults. Among patients with a sub-type of PH, PAH 
(pulmonary arterial hypertension), African-Americans (AA) have higher 
mortality rates than Caucasians, and AA women had the highest mortality 
rates across all ages. (3.0, 3.1) Among patients diagnosed with incidental 
PH, AAs were younger with significantly higher right ventricular 
dysfunction and were more frequently covered by Medicare than private 
insurance. (3.2).  Therefore, URM PH patients are disproportionately 
affected by the disease: experiencing a significant burden of healthcare 
needs related to existing health disparity and limited psychological, 
economic, and healthcare resources. (3.3, 3.4). Even though there have 
been tremendous medical and pharmacologic advances in PH treatment in 
the past decades, patients continue to live with unmet psycho-social and 
behavioral health needs that impact their long-term prognoses. Despite 
these advancements, patients living with PH continue to suffer 
psychological distress such as depression, anxiety, and stress,4-10, along 
with a high symptom burden.11,12 Poor physiologic conditions and high 
psychological distress are predictive of poor quality of life among patients 
with PH.13-16 The physiological and psychological distress often leads to 
challenges in successfully managing PH conditions. A culturally tailored, 
innovative complementary health approach to addressing this gap is 
needed to augment symptom self-management, reduce symptom burden, 
promote health and wellness, and health-related quality of life (HRQOL).  
Complementary Health Approach (CHA), defined as non-mainstream 
integrative therapy self-management practice of chronic conditions, has 
been shown to reduce symptom severity and improve quality of life 
(https://nccih.nih.gov/health/integrative-health).17 A mindfulness-based 
stress reduction (MBSR) intervention program, which includes eight 2.5-
hour-weekly sessions, has been shown to reduce depression and anxiety 
symptoms among patients with psychiatric conditions.18 Modified MBSR 
programs have shown effectiveness in symptom burden,19 fatigue,19-22 
and HRQOL22 among persons with cancer. While patients with cancer 
and other chronic conditions use the mind-body intervention (MBI) to a 
greater extent, MBI use among patients with PH is somewhat limited and 
even more so among URM adults with PH. A gentle walking exercise 
program is associated with improvements in six-minute walk distance, 
lung functions, depression, anxiety, and HRQOL.23,24 In a randomized 
controlled trial of 103 PAH patients, a 12-weeks progressive muscle 
relaxation program improved anxiety, depression, and HRQOL.25 Eight-
weeks of slow-paced breathing technique was associated with a reduction 
in depressive symptoms, improved sleep, and HRQOL.26 A pilot, 
randomized controlled trial of MBSR demonstrated some improvement in 
psychological symptoms (depression and anxiety).27 Pilot single-group 

 
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testing of an Urban Zen Integrative Therapy (UZIT) is associated with 
symptom burden reduction and HRQOL improvement.28 In this UZIT 
study, there were pre-post session reductions in pain, anxiety, fatigue, and 
dyspnea, and pre-post UZIT program reductions in PH-related 
symptoms.28 These CHA's show positive effects on the overall 
psychological health; however, practical implementation of CHA is 
limited to the patients' ability to attend in-person sessions, adherence to 
prescribed home practice, and more importantly, availability of culturally 
tailored MBI content. 
Complementary Health Approach (CHA), such as in-person MBI, has 
moderate effects in reducing depression and anxiety across chronic health 
conditions, including PH. However, these benefits were mostly 
demonstrated among participants who had high adherence to the 
intervention practice.27 Technology-assisted MBI (TeleMBI) has shown 
comparable efficacy with in-person MBI among persons with chronic 
conditions; TeleMBI has the added benefits of cost reduction and ease of 
implementation.29-31 TeleMBI for patients with multiple sclerosis via 
skype shows improvement in HRQOL, depression, anxiety, and sleep 
disturbance when delivered at a 5:1 ratio of participants and instructor.29 
TeleMBI for patients with spinal cord injury with depression and chronic 
pain was superior to psychoeducational intervention in reducing 
depressive symptoms, anxiety, pain, and improving HRQOL.30 Online 
TeleMBI reduces depression and anxiety significantly compared to the 
control group among pregnant women with high depressive symptoms.31 
The use of TeleMBI via Mobile-APP among post ICU patients has 
comparable impacts on depression, anxiety, and post-traumatic distress 
symptoms to telephone-based mindfulness delivery.32 This pilot RCT 
study is advancing to a large-scale study to implement TeleMBI Mobile-
APP to treat post ICU symptoms. While mobile- and in-person MBI have 
comparable efficacy, we postulate that the mobile-MBI has the advantages 
of user-activated, "as needed" delivery, consistent dose delivery, and ease 
of use for symptom management for adults with PH. Clearly, given these 
advantages of mobile-MBI and in keeping with the social distancing 
demand of the current COVID-19 pandemic, it is imperative to test 
MMPH mobile MBI for PH in URM communities to address our research 
aims.  
MMPH is a TeleMBI program tailored for URM patients with PH. The 
intervention is modified from an in-person UZIT program that showed clinical 
results in symptom severity reduction and HRQOL improvement among 14 adults 
with PH.28 This 8-weeks program will engage participants, employing both 
instructor-led and self-guided delivery of mindfulness practices (via Zoom and 
APP) to introduce and facilitate the training. Our experience in developing and 
modification of mobile-MBI APP is gleaned from current testing of a mobile-
MBI APP among high-stress college students and URM African-Americans 
participants in Buffalo, NY. Preliminary testing of mobile-MBI among URM 
adults with PH is invaluable from the perspective of addressing health disparity, 

 
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making available a culturally tailored evidence-based intervention of Mindfulness 
for reduction of symptom burden and psychological stress reduction. More 
importantly, the mobile-MBI prototype can be modified and tailored with broader 
applications to other chronic cardiopulmonary conditions, such as chronic 
obstructive pulmonary disease (COPD), Asthma, and COVID-19 long-haul. 
 
4.2 Include complete citations or references.  
 1. Matura LA, McDonough A, Carroll DL. Symptom prevalence, 
symptom severity, and health-related quality of life among young, middle, 
and older adults with pulmonary arterial hypertension. American Journal 
of Hospice & Palliative Medicine. 2016;33(3):214-221. 
2. Galie N, Humbert M, Vachiery JL, et al. 2015 ESC/ERS guidelines for 
the diagnosis and treatment of pulmonary hypertension: The joint task 
force for the diagnosis and treatment of pulmonary hypertension of the 
european society of cardiology (ESC) and the european respiratory society 
(ERS): Endorsed by: Association for european paediatric and congenital 
cardiology (AEPC), international society for heart and lung transplantation 
(ISHLT). Eur Heart J. 2016;37(1):67-119. 
3.0  Davis, K.,K., Lilienfeld, D.,E., Doyle, R.,L., Parikh, K.,S., 
Stackhouse, K.,A., Hart, S.,A., Bashore, T.,M., Krasuski, R.,A., Ryan, 
J.,T., de Jesus Perez, V.,A., Ryan, J.,J., Talwar, ,Arunabh, Garcia, J. G.,N., 
Tsai, ,Halley, Moreno, ,Matthew, Lahm, ,Tim, Zamanian, R.,T., Machado, 
,Roberto, Kawut, S.,M., . . . Mathai, ,Stephen. (2008). Increased mortality 
in african americans with idiopathic pulmonary arterial hypertension; 
health insurance and racial disparities in pulmonary hypertension 
outcomes; health disparities in pulmonary arterial hypertension and the 
impact of the COVID-19 pandemic; health disparities in patients with 
pulmonary arterial hypertension: A blueprint for action. an official 
american thoracic society statement. J Natl Med Association, 100(1), 69-
72. 
3.1 
Ryan, J.,T., de Jesus Perez, V.,A., Ryan, J.,J., Talwar, ,Arunabh, 
Garcia, J. G.,N., Tsai, ,Halley, Moreno, ,Matthew, Lahm, ,Tim, Zamanian, 
R.,T., Machado, ,Roberto, Kawut, S.,M., Selej, ,Mona, & Mathai, 
,Stephen. (2021). Health disparities in pulmonary arterial hypertension and 
the impact of the COVID-19 pandemic; health disparities in patients with 
pulmonary arterial hypertension: A blueprint for action. an official 
american thoracic society statement. Advances in Pulmonary 
Hypertension, 20(1), 6-15. 
3.2 
Parikh, K.,S., Stackhouse, K.,A., Hart, S.,A., Bashore, T.,M., 
Krasuski, R.,A., Ryan, J.,T., de Jesus Perez, V.,A., Ryan, J.,J., Talwar, 
,Arunabh, Garcia, J. G.,N., Tsai, ,Halley, Moreno, ,Matthew, Lahm, ,Tim, 
Zamanian, R.,T., Machado, ,Roberto, Kawut, S.,M., Selej, ,Mona, & 
Mathai, ,Stephen. (2017). Health insurance and racial disparities in 

 
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pulmonary hypertension outcomes; health disparities in pulmonary arterial 
hypertension and the impact of the COVID-19 pandemic; health 
disparities in patients with pulmonary arterial hypertension: A blueprint 
for action. an official american thoracic society statement. Am J Manag 
Care. 2017;23(8):474-480, 23(8), 474-480. 
3.3 
Talwar, ,Arunabh, Garcia, J. G.,N., Tsai, ,Halley, Moreno, 
,Matthew, Lahm, ,Tim, Zamanian, R.,T., Machado, ,Roberto, Kawut, 
S.,M., Selej, ,Mona, & Mathai, ,Stephen. (2017). Health disparities in 
patients with pulmonary arterial hypertension: A blueprint for action. an 
official american thoracic society statement. American Journal of 
Respiratory and Critical Care Medicine, 196(8), e32-e47. 
3.4 
DuBrock, ,H.M., Burger, ,C.D., Bartolome, ,S., Feldman, ,J.P., 
Rosenzweig, ,E.B., Sager, ,J.S., Presberg, ,K.W., Mathai, ,S.C., Lammi, 
,M.R., & Klinger, ,J.R. (2021). Health disparities and treatment patterns in 
portopulmonary hypertension and idiopathic pulmonary arterial 
hypertension: An analysis of the pulmonary hypertension association 
registry. Pulmonary Circulation, 11(3), 1-10. 
4. Halimi L, Marin G, Molinari N, et al. Impact of psychological factors 
on the health-related quality of life of patients treated for pulmonary 
arterial hypertension. Journal of psychosomatic research. 2018;105:45-51. 
5. Harzheim D, Klose H, Pinado FP, et al. Anxiety and depression 
disorders in patients with pulmonary arterial hypertension and chronic 
thromboembolic pulmonary hypertension. Respiratory research. 
2013;14(104):1-10. 
6. J MMV, Delcroix M, Vandevelde E, et al. Emotional symptoms and 
quality of life in patients with pulmonary arterial hypertension. Journal of 
Heart and Lung Transplantation. 2014;33(8):800-8. 
7. McCollister DH, Beutz M, McLaughlin V, et al. Depressive symptoms 
in pulmonary arterial hypertension: Prevalence and association with 
functional status. Psychosomatics: Journal of Consultation and Liaison 
Psychiatry. 2010;51(4):339-339. 
8. Somaini G, Hasler ED, Saxer S, et al. Prevalence of anxiety and 
depression in pulmonary hypertension and changes during therapy. 
Respiration. 2016;91(5):359-66. 
9. Von Visger TT, Kuntz KK, Phillips GS, Yildiz VO, Sood N. Quality of 
life and psychological symptoms in patients with pulmonary hypertension. 
Heart & Lung: The Journal of Acute and Critical Care. 2018;47(2):115-
121. 
10. Aguirre-Camacho A, Moreno-Jimenez B. Depression and anxiety in 
patients with pulmonary hypertension: The role of life satisfaction and 
optimism. Psychosomatics. 2018;59(6):575-583. 

 
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11. Matura LA, McDonough A, Carroll DL. Health-related quality of life 
and psychological states in patients with pulmonary arterial hypertension. 
Journal of Cardiovascular Nursing. 2014;29(2):178-184. 
12. Matura LA, McDonough A, Carroll DL. Symptom interference 
severity and health-related quality of life in pulmonary arterial 
hypertension. Journal of pain and symptom management. 2016;51(1):25-
32. 
13. Halank M, Einsle F, Lehman S, et al. Exercise capacity affects quality 
of life in patients with pulmonary hypertension. Lung. 2013;191(4):337-
43. 
14. Talwar A, Sahni S, Kim EJ, Verma S, Kohn N. Dyspnea, depression 
and health related quality of life in pulmonary arterial hypertension 
patients. Journal of exercise and rehabilitation. 2015;11(5):259-65. 
15. Tartavoulle TM. A predictive model of the effects of depression, 
anxiety, stress, 6-minute-walk distance, and social support on health-
related quality of life in an adult pulmonary hypertension population. 
Clinical nurse specialist CNS. 2015;29(1):22-8. 
16. Yorke J, Deaton C, Campbell M, et al. Symptom severity and its effect 
on health-related quality of life over time in patients with pulmonary 
hypertension: A multisite longitudinal cohort study. Nursing & health 
sciences. 2018;5(1):1-8. 
17. NCCIH. Complementary, alternative, or integrative health: What's in a 
name? https://nccih.nih.gov/health/integrative-health#types. Updated June, 
2016. 
18. Hofmann SG, Sawyer AT, Witt AA, Oh D. The effect of mindfulness-
based therapy on anxiety and depression: A meta-analytic review. J 
Consult Clin Psychol. 2010;78(2):169-183. 
19. Kenne Sarenmalm E, Martensson LB, Andersson BA, Karlsson P, 
Bergh I. Mindfulness and its efficacy for psychological and biological 
responses in women with breast cancer. Cancer Med. 2017;6(5):1108-
1122. 
20. Johns SA, Brown LF, Beck-Coon K, et al. Randomized controlled 
pilot trial of mindfulness-based stress reduction compared to 
psychoeducational support for persistently fatigued breast and colorectal 
cancer survivors. Support Care Cancer. 2016;24(10):4085-4096. 
21. Lengacher CA, Reich RR, Paterson CL, et al. Examination of broad 
symptom improvement resulting from mindfulness-based stress reduction 
in breast cancer survivors: A randomized controlled trial. J Clin Oncol. 
2016;34(24):2827-2834. 
22. Reich RR, Lengacher CA, Alinat CB, et al. Mindfulness-based stress 
reduction in post-treatment breast cancer patients: Immediate and 

 
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sustained effects across multiple symptom clusters. J Pain Symptom 
Manage. 2017;53(1):85-95. 
23. Bussotti M, Gremigni P, Pedretti RFE, et al. Effects of an outpatient 
service rehabilitation programme in patients affected by pulmonary 
arterial hypertension: An observational study. Cardiovasc Hematol Disord 
Drug Targets. 2017;17(1):3-10. 
24. Brown MB, Kempf A, Collins CM, et al. A prescribed walking 
regimen plus arginine supplementation improves function and quality of 
life for patients with pulmonary arterial hypertension: A pilot study. 
Pulmonary circulation. 2018;8(1):1-12. 
25. Li Y, Wang R, Tang J, et al. Progressive muscle relaxation improves 
anxiety and depression of pulmonary arterial hypertension patients. 
Evidence-Based Complement and Alternative Medicine. 2015;2015:1-8. 
26. Matura LA, Fargo J, Fritz JS, et al. Slow-paced respiration therapy to 
treat symptoms in pulmonary arterial hypertension. Heart & Lung. 
2017;46(1):7-13. 
27. Tulloh RMR, Garratt V, Tagney J, et al. A pilot randomised controlled 
trial investigating a mindfulness-based stress reduction (MBSR) 
intervention in individuals with pulmonary arterial hypertension (PAH): 
The PATHWAYS study. Pilot Feasibility Study. 2018;4(78):1-11. 
28. Von Visger TT, Thrane SE, Klatt MD, et al. The impact of urban zen 
integrative therapy on symptoms and health-related quality of life for 
patients with pulmonary hypertension. Journal of Palliative Care 
Medicine. 2019;23(5):703-711. 
29. Cavalera,C., Rovaris,M., Mendozzi,L., et al. Online meditation 
training for people with multiple sclerosis: A randomized controlled trial; 
Multiple Sclerosis. 2018;25(4):610-617. 
30. Hearn J,H., Finlay K,A., Yang,E., Schamber,E., Meyer RM,L., Gold 
J,I. Internet-delivered Mindfulness for people with depression and chronic 
pain following spinal cord injury: A randomized, controlled feasibility 
trial. Spinal Cord. 2018;56(8):750-756. 
31. Yang,E., Schamber,E., Meyer RM,L., Gold J,I. Happier healers: 
Randomized controlled trial of mobile Mindfulness for stress 
management. The Journal of Alternative and Complementary Medicine. 
2018;24(5):505-513. 
32. Cox C,E., Hough C,L., Jones D,M., et al. Effects of mindfulness 
training programmes delivered by a self-directed mobile app and by 
telephone compared with an education programme for survivors of critical 
illness: A pilot randomised clinical trial. Thorax. 2018;74(1):33-42. 
33. Elflein J. Percentage of adults in the US with chronic obstructive 
pulmonary disease (COPD) as of 2017, by smoking status and age. 

 
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https://www.statista.com/statistics/1019957/copd-prevalence-among-
adults-us-by-smoking-status-and-age/. Updated 2020. 
34. In,J. Introduction of a pilot study. Korean Journal of Anesthesiology. 
2017;56(8):601-605. 
35. Saldana J. First cycle coding methods & second cycle coding methods. In: 
The coding manual for qualitative researchers. 2nd ed. SAGE Publications Ltd; 
2010:45-182. 
 
5.0 Study Design* 
5.1 Describe and explain the study design (e.g. case-control, cross-sectional, 
ethnographic, experimental, interventional, longitudinal, observational). 
This study will engage community-dwelling URM adults with PH living in the 
United States. We will use a two-group comparative study design where 
waitlisted participants will serve as controls. Considering a 20% attrition rate in a 
behavioral health intervention study, we aim to enroll a total of 20, with at least 
16 participants to address study aims (8-10 in each Group).34 As a pilot study, 
power analysis is not necessary. Statistical analysis will include descriptive 
statistics, mixed-effect modeling for repeated measures, and within-group and 
between-groups comparisons using t-tests or Wilcoxon signed-rank test as 
appropriate and Cohen's d effect size calculation. Multi-time data collection will 
be done via daily mobile-APP use. 
6.0 
Study Intervention/Investigational Agent 
6.1  
Describe the study intervention and/or investigational agent (e.g., 
drug, device) that is being evaluated. 
The MMPH program will include two Zoom-delivered sessions (Weeks #1 & #4), 
six video-recorded sessions (Weeks #2, #3, #5, #6, #7, #8), and daily mindfulness 
meditation practice using a mobile APP during an eight-week study period. 
Similar to the UZIT intervention, each MMPH session will include Gentle Body 
Movement (GBM,10-min), Restorative Pose (Pose,10-min), and Body Awareness 
Meditation (BAM, 20-min). Self-guided audio-video modules of various 
durations will be available according to participants' preference and level of 
comfort (5, 10, 20 minutes). The mobile-APP content will reinforce Zoom content 
such as mindful breathing, GBM of upper extremities, GBM of lower extremities, 
Pose sitting, Pose lying, and BAM practices. The MMPH content will be tailored 
to health management needs specific to PH with cultural consideration of 
mindfulness-related concepts (stress, responding to stress, resiliency). 
 
 
6.2 
Drug/Device Handling: If the research involves drugs or 
device, describe your plans to store, handle, and administer those 

 
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drugs or devices so that they will be used only on subjects and be 
used only by authorized investigators. 
• 
If the control of the drugs or devices used in this protocol will 
be accomplished by following an established, approved 
organizational SOP (e.g., Research Pharmacy SOP for the 
Control of Investigational Drugs, etc.), please reference that 
SOP in this section. 
Response: NOT APPLICABLE 
 
6.3 If the drug is investigational (has an IND) or the device has an IDE 
or a claim of abbreviated IDE (non-significant risk device), include 
the following information: 
• 
Identify the holder of the IND/IDE/Abbreviated IDE. 
• 
Explain procedures followed to comply with sponsor 
requirements for FDA regulated research for the following: 
 
Applicable to: 
FDA Regulation 
IND Studies 
IDE studies 
Abbreviated 
IDE studies 
21 CFR 11 
X 
X 
 
21 CFR 54 
X 
X 
 
21 CFR 210 
X 
 
 
21 CFR 211 
X 
 
 
21 CFR 312 
X 
 
 
21 CFR 812 
 
X 
X 
21 CFR 820 
 
X 
 
Response: NOT APPLICABLE 
 
7.0 Local Number of Subjects 
7.1 Indicate the total number of subjects that will be enrolled or records that 
will be reviewed locally. 
Response: 20 participants 
 
7.2 If applicable, indicate how many subjects you expect to screen to reach your 
target sample (i.e. your screen failure rate).  
Response: Potentially eligible patients from UBMD clinic, URMC, RRH, as well 
as patients across the US from sources such as Research Match and Facebook will  
be screened by research team at UB. Potentially eligible and interested PH 
patients will self-refer and contact us for screening. We will also invited PH 
patients across the US to participate in the study using additional recruitment 
sources such as Research Match, across the US CTSA Hub advertisement, and 

 
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Social media (Facebook) advertisement. With the approved amendment to include 
all ethnicity, we will be able to reach the target enrollment goal as planned.Our 
enrollment goal is 20 patients. 
 
7.3 Justify the feasibility of recruiting the proposed number of eligible subjects 
within the anticipated recruitment period. For example, how many potential 
subjects do you have access to? What percentage of those potential subjects 
do you need to recruit? 
Response: An enrollment rate to a mind-body intervention is approximately 30%, 
yielding about 103 participants. Considering a 15% attrition rate, we will enroll 
20 participants to achieve at least 8 in each Group. We received verbal 
agreements from PH specialists at these locations to assist in referring, of eligible 
participants in the study. 
 
8.0 Inclusion and Exclusion Criteria* 
8.1 Describe the criteria that define who will be included in your final study 
sample.  
NOTE:  This may be done in bullet point fashion. 
1) adults (>18 years), 2) PH confirmed by standard guidelines; 3) willingness to 
participate in the mindfulness practice program for the duration of the study 
period; 4) able to ambulate independently; 5) English-speaking, and 6) have 
access to a mobile phone. 
8.2 Describe the criteria that define who will be excluded from your final study 
sample.   
NOTE:  This may be done in bullet point fashion.  
1) known pregnancy; 2) have psychiatric conditions requiring hospitalization 
within the last year; 3) deaf or hard of hearing.   
 
8.3 Indicate specifically whether you will include any of the following special 
populations in your study using the checkboxes below.   
 
NOTE:  Members of special populations may not be targeted for enrollment in 
your study unless you indicate this in your inclusion criteria. 
Response:   
☐ 
Adults unable to consent 
☐ 
Individuals who are not yet adults (infants, children, teenagers) 
☐ 
Pregnant women 
☐ 
Prisoners 

 
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8.4 Indicate whether you will include non-English speaking individuals in your 
study.  Provide justification if you will exclude non-English speaking 
individuals.  
In order to meet one of the primary ethical principles of equitable selection 
of subjects, non-English speaking individuals may not be routinely excluded 
from research as a matter of convenience. 
In cases where the research is of therapeutic intent or is designed to 
investigate areas that would necessarily require certain populations who 
may not speak English, the researcher is required to make efforts to recruit 
and include non-English speaking individuals.  However, there are studies 
in which it would be reasonable to limit subjects to those who speak 
English.  Some examples include pilot studies, small unfunded studies with 
validated instruments not available in other languages, studies with 
numerous questionnaires, and some non-therapeutic studies which offer no 
direct benefit. 
The study will exclude non-English speaking individuals because the 
questionnaires used to obtain data are available in English format. Furthermore, 
the intervention will be delivered in the English language only. 
 
9.0 Vulnerable Populations* 
If the research involves special populations that are considered vulnerable, 
describe the safeguards included to protect their rights and welfare.   
NOTE: You should refer to the appropriate checklists, referenced below, to ensure you 
have provided adequate detail regarding safeguards and protections. You do not, 
however, need to provide these checklists to the IRB. 
9.1 For research that involves pregnant women, safeguards include: 
NOTE CHECKLIST: Pregnant Women (HRP-412) 
Response: 
  
☒ 
N/A:  This research does not involve pregnant women. 
9.2 For research that involves neonates of uncertain viability or non-viable 
neonates, safeguards include: 
NOTE CHECKLISTS: Non-Viable Neonates (HRP-413), or Neonates of Uncertain 
Viability (HRP-414) 
Response:  
 
☒ 
N/A:  This research does not involve non-viable neonates or neonates of 
uncertain viability. 
9.3 
For research that involves prisoners, safeguards include: 

 
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NOTE CHECKLIST: Prisoners (HRP-415) 
Response:  
 
☒ 
N/A:  This research does not involve prisoners. 
9.4 For research that involves persons who have not attained the legal age for 
consent to treatments or procedures involved in the research ("children"), 
safeguards include:   
NOTE CHECKLIST: Children (HRP-416) 
Response:  
 
☒ 
N/A:  This research does not involve persons who have not attained the 
legal age for consent to treatments or procedures ("children"). 
9.5 For research that involves cognitively impaired adults, safeguards include: 
NOTE CHECKLIST: Cognitively Impaired Adults (HRP-417) 
Response:  
 
☒ 
N/A:  This research does not involve cognitively impaired adults. 
9.6 Consider if other specifically targeted populations such as students, 
employees of a specific firm, or educationally or economically 
disadvantaged persons are vulnerable.  Provide information regarding 
their safeguards and protections, including safeguards to eliminate 
coercion or undue influence. 
Our target population is adults with PH living throughout the United States. There 
is a high likelihood that our study participants may include economically 
disadvantaged persons. The study recruitment and enrollment process will occur 
in collaboration with PH doctors and nurses from these 3 locations and across the 
country who are likely aware of their vulnerability. We will follow the 
standardized and consistent approach in presenting the study material and 
remuneration for their participation. We will provide a sufficient amount of time 
and information to consider their involvement in the study. 
 
10.0 
Eligibility Screening* 
10.1 Describe screening procedures for determining subjects' eligibility.  
Screening refers to determining if prospective participants meet inclusion and 
exclusion criteria.  
Include all relevant screening documents with your submission (e.g. screening 
protocol, script, questionnaire).  
Screening for inclusion criteria includes a YES response to the following 
questions: 
Is the subject have a current diagnosis of pulmonary hypertension? 

 
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Is the subject > 18 years old 
Does the subject have access to an electronic device: iPhone, iPad, 
Android Phone, Laptop? 
Is the subject proficient in English? 
 
Screening for exclusion criteria includes a YES response to the following 
questions: 
Has the subject been hospitalized for a psychiatric reason during the past 
12 months?  
Is the subject hearing-impaired? 
Is the subject pregnant? (for female person) 
1. Via our referring partners and electronic advertisements (using 
Research Match, CTSA Hub advertising and social media [e.g., 
Facebook]), participants will receive an invitation to participate in the 
study. All communications include the contact information to the PI of the 
study, email address and phone number.  
2. Participants may contact the research coordinator by the included phone 
number or email address if they want to learn more about the study. A 
research team member will contact the interested participant and arrange a 
convenient time for a Zoom meeting. 
3. During the Zoom meeting, the research staff member will describe the 
study and review the consent document. If the participants decides to 
participate in the study, the research staff will obtain verbal informed 
consent.  
4. The participant will be provided a link (via email or text) to the 
REDCap database to complete a screening questionnaire. 
 
☐ 
N/A:  There is no screening as part of this protocol. 
11.0 
Recruitment Methods 
☐ 
N/A:  This is a records review only, and subjects will not be 
recruited.  NOTE:  If you select this option, please make sure that 
all records review procedures and inclusion/exclusion screening 
are adequately described in other sections. 
11.1 Describe when, where, and how potential subjects will be recruited.  
NOTE:  Recruitment refers to how you are identifying potential participants and 
introducing them to the study.  Include specific methods you will use (e.g. 
searching charts for specific ICD code numbers, Research Participant Groups, 
posted advertisements, etc.). 

 
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There are two ways we will make the study known to potential eligible 
participants (1) They may hear about the study from their PH doctors during 
routine clinic visits (2) They may see study flyers in recruiting partners’ offices or 
clinics during their routine care.   
Even though we originally proposed that PH doctors send out emails inviting their 
patients to contact us for potential enrollment, none of the doctors used the letter. 
They chose to tell their patients about the study verbally, and we only got one 
referral from RRH. That was the recruitment process we did. As I previously 
indicated, we are no longer enrolling and will not use it. We only want to 
complete the study. 
Electronic recruitment will include direct email sent using the University at 
Buffalo’s Clinical and Translational Science Institute’s (CTSI) Buffalo Research 
Registry and social media (Facebook). The registry includes names of individuals 
who have expressed interest in participating in research studies. Facebook-based 
recruitment will consist of advertisements for the study. 
Flyers will be distributed to our referring partners and will be recruited by PH 
physician referral, self-referral, the use of Buffalo Research Registry, CTSA Hub 
advertisement, Social Media posts (Facebook), and Research Match. Flyers will 
be placed by the Research Coordinator at their locations (our referring partners at 
URMC and RRH). These flyers will be made available in waiting rooms as well 
as in healthcare professionals’ offices. 
In both recruitment methods, interested participants will contact the study team 
directly to initiate the screening as described in section 10.1. None of the referring 
partners will participate in any screening activities, only referrals. 
 
11.2 Describe how you will protect the privacy interests of prospective subjects 
during the recruitment process.   
NOTE:  Privacy refers to an individual's right to control access to him or herself.   
The recruitment email and flyer information offers individuals the freedom to 
participate in the study only if they are interested in doing so.  
Screening interviews will take place by Zoom and will be recorded. Recordings 
will be destroyed after transcripts are created. Participants may take part in the 
interview at a place and time of their choosing. 
Potential research participants will know about the study from PH 
providers, paper brochures, Buffalo Research Registry, or the 
ResearchMatch registry. Researchers will make initial contact with 
potential participants only after a clear indication that they are interested 
to learn more about the study. These indications are referral from their PH 
provider, email or phone contact from the participants, or "yes" response 
through the ResearchMatch registry. 
(Please refer to the Recruitment and Enrollment Protocol) 

 
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After the Introductory meeting, if prospective participants decline to 
participate in the study, the research staff will destroy any personal 
information written down on paper or delete electronic notes. If they 
express interest and want to meet for the Zoom Consent meeting, we will 
keep their information as a reference for that meeting. After the Zoom 
Consent meeting, if prospective participants decline to participate in the 
study, the research staff will destroy any personal information written 
down on paper or delete electronic notes immediately. We will only keep 
the documentation if they agree to participate in the study. 
After enrollment, each subject in all phases of the study will be assigned a 
unique study identification number to be used on all forms. All personally 
identifiable information will be kept strictly confidential. 
Prospective eligible participants will have access to a written version of the 
consent form that the IRB has approved. There will be instruction for the 
participant to read the consent form to gain a further, detailed understanding of 
what the study is about, study participation requirement, and other general 
information about the human research subject. The participant will then contact 
the study coordinator to set a convenient time for a virtual meeting or phone call, 
providing verbal informed consent. 
We will keep all records about the recruitment process in password-protected data 
files according to each institution. Only staff members who are involved in this 
research will have access to this recruitment record. 
 
11.3 Identify any materials that will be used to recruit subjects.  
NOTE:  Examples include scripts for telephone calls, in person announcements / 
presentations, email invitations.  
For advertisements, include the final copy of printed advertisements with your 
submission. When advertisements are taped for broadcast, attach the final 
audio/video tape.  NOTE:  You may submit the wording of the advertisement prior 
to taping to ensure there will be no IRB-required revisions, provided the IRB also 
reviews and approves the final version. 
1) Screening protocol; 2) Screening sheet; 3) email invitation script; 4) 
Advertisement  
12.0 
Procedures Involved* 
12.1 Provide a description of all research procedures or activities being 
performed and when they are performed once a subject is screened and 
determined to be eligible. Provide as much detail as possible.   
NOTE:  This should serve as a blueprint for your study and include enough detail 
so that another investigator could pick up your protocol and replicate the research.  
For studies that have multiple or complex visits or procedures, consider the 
addition of a schedule of events table in in your response. 
Table 1. Study Procedure 

 
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Procedure 
w0-w1 
MMPH-1 
(Zoom #1) 
 
w1-
w2 
MMPH-2 
(video)  
w2-w3 
MMPH-3 
(video) 
w3-w4 
MMPH-4 
(Zoom #2) 
w4-
w5 
MMPH-5 
(video) 
w5-w6 
MMPH-6 
(video) 
w6-
w7 
MMPH-7 
(video) 
w7-w8 
MMPH-8  
(video) 
Zoom #3 
Instructor-led (min X day) 
60 X 1 
60 X 1 
60 X 1 
60 X 1 
60 X 1 
60 X 1 
60 X 1 
60 X 1 
Self-guided (min X day) 
20 X 6 
20 X 6 
20 X 6 
20 X 6 
20 X 6 
20 X 6 
20 X 6 
20 X 6 
Consent 
X 
 
 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
 
 
PAHSS 
X 
 
 
X 
 
 
 
X 
EmPHasis-10 
X 
 
 
X 
 
 
 
X 
PHQ-9 
X 
 
 
X 
 
 
 
X 
CAMS-R 
X 
 
 
X 
 
 
 
X 
Pain (1-10) 
X* 
X* 
X* 
X* 
X* 
X* 
X* 
X* 
Anxiety (1-10) 
X* 
X* 
X* 
X* 
X* 
X* 
X* 
X* 
Fatigue (1-10) 
X* 
X* 
X* 
X* 
X* 
X* 
X* 
X* 
Dyspnea (1-10) 
X* 
X* 
X* 
X* 
X* 
X* 
X* 
X* 
SUS-modified MMPH  
 
 
 
 
 
 
 
X 
Interview -MMPH 
 
 
 
 
 
 
 
X 
Reminder (via phone or 
App) - MMPH 
X 
X 
X 
X 
X 
X 
X 
X 
Note: X* = symptom assessment before and after daily use of MMPH module; PAHSS, Pulmonary 
Arterial Hypertension Symptoms Scale; EmPHasis-10, Health-related quality of life in pulmonary 
arterial hypertension; PHQ-9, Patient Health Questionnaire; CAMS-R, Cognitive and Affective 
Mindfulness Scale-Revised; SUS, System Usability Scale; MMPH, Mindfulness Meditation for 
Pulmonary Hypertension. 
Table 1 outlines the detail and sequence of study intervention. Enrolled 
participants will receive 60-min-weekly intervention for 8 weeks period; 2 of which 
will include video conference practice and the other 6 will include audio-video 
recording of the sessions. During the study period, they will complete self-guided 
meditation using M-App for 20 min/day. 
12.2 Describe what data will be collected.   
NOTE:  For studies with multiple data collection points or long-term follow up, 
consider the addition of a schedule or table in your response. 
Please refer to Table 1 regarding data that will be collected: symptom presence 
and severity, health-related quality of life, depressive symptoms, mindfulness 
score, clinical and demographic data. 
 
12.3 List any instruments or measurement tools used to collect data 
(e.g. questionnaire, interview guide, validated instrument, data collection 
form).   
 
Include copies of these documents with your submission. 
Response: The following questionnaires will be included in this study: 
• 
Cognitive and Affective Mindfulness Scale-Revised (CAMS-R) 
• 
The Patient Health Questionnaire-9 (PHQ-9) 
• 
Pulmonary Arterial Hypertension Symptom Scale (PAHSS) 

 
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• 
Health-related quality of life in pulmonary arterial hypertension   
(EmPHass-10) 
• 
System Usability Scale – MMPH (SUS) 
• 
Pain Scale, Anxiety, Fatigue, Dyspnea 
• 
 
12.4 Describe any source records that will be used to collect data about subjects 
(e.g. school records, electronic medical records). 
We will not use an additional source of records to collect data about subjects in 
this study. 
12.5 Indicate whether or not individual subject results, such as results of 
investigational diagnostic tests, genetic tests, or incidental findings will be 
shared with subjects or others (e.g., the subject's primary care physician) 
and if so, describe how these will be shared. 
NOT APPLICABLE 
 
12.6 Indicate whether or not study results will be shared with subjects or others, 
and if so, describe how these will be shared. 
NOT APPLICABLE 
 
13.0 
Study Timelines* 
13.1 Describe the anticipated duration needed to enroll all study subjects. 
As previously described, we anticipate enrolling all 20 subjects within three 
months. 
 
13.2 Describe the duration of an individual subject's participation in the study. 
Include the length of study visits and overall study follow-up time. 
The duration of an individual subject's participation in the entire study 
(consent to the completion of focused-group interview) will be three 
months or less. There will be no physical study visits, only virtual study 
visits for Zoom participation and individual interview sessions. 
• 
Enrollment, consenting, baseline data = 30 minutes  
• 
Completion of all 8 sessions (60 min/each) = 480 minutes for the 8 
weeks 
• 
20min/day practice for 8 weeks = 56 days X 20 min = 1,120 min = 
18.7 hours over 8 weeks = 2.3 hours per week. 
• 
Focused interview = 1 hour 
• 
Questionnaires completion = 10 min X 8 weeks = 80 min total 

 
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13.3 Describe the estimated duration for the investigators to complete this study 
(i.e. all data is collected and all analyses have been completed). 
The estimated duration for the investigators to complete this study will be about 
12 months (recruitment, enrollment, intervention, data collection, data analysis). 
14.0 
Setting 
14.1 Describe all facilities/sites where you will be conducting research 
procedures.  Include a description of the security and privacy of the 
facilities (e.g. locked facility, limited access, privacy barriers).  Facility, 
department, and type of room are relevant.  Do not abbreviate facility 
names.   
NOTE:  Examples of acceptable response may be: "A classroom setting in the 
Department of Psychology equipped with a computer with relevant survey 
administration software," "The angiogram suite at Buffalo General Medical 
Center, a fully accredited tertiary care institution within New York State with 
badge access," or, "Community Center meeting hall." 
All research procedures will be conducted from participants' private space (home) 
because we will deliver MMPH intervention via Zoom connection, video-
recording viewing, and Mindfulness App use. Study participants will download 
the mindfulness App to their mobile devices. Research staff and interventionists 
will interact with study participants through Video conference connections from 
the privacy of their own work space. 
 
14.2 For research conducted outside of UB and its affiliates, describe: 
• Site-specific regulations or customs affecting the research 
• Local scientific and ethical review structure 
NOTE:  This question is referring to UB affiliated research taking place outside 
UB, i.e. research conducted in the community, school-based research, 
international research, etc.  It is not referring to multi-site research.  UB affiliated 
institutions include Kaleida Health, ECMC, and Roswell Park Cancer Institute.   
Response: NOT APPLICABLE 
 
☒ 
N/A:  This study is not conducted outside of UB or its affiliates. 
15.0 
Community-Based Participatory Research 
15.1 Describe involvement of the community in the design and conduct of the 
research.  
NOTE:  Community-Based Participatory Research (CBPR) is a collaborative 
approach to research that equitably involves all partners in the research process 
and recognizes the unique strengths that each brings.  CBPR begins with a 
research topic of importance to the community, has the aim of combining 

 
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knowledge with action and achieving social change to improve health outcomes 
and eliminate health disparities. 
Response: NOT APPLICABLE 
 
☒ 
N/A:  This study does not utilize CBPR. 
15.2 
Describe the composition and involvement of a community advisory 
board. 
Response: NOT APPLICABLE 
 
☒ 
N/A:  This study does not have a community advisory board. 
16.0 
Resources and Qualifications 
16.1 Describe the qualifications (e.g., education, training, experience, expertise, 
or certifications) of the Principal Investigator and staff to perform the 
research.  When applicable describe their knowledge of the local study sites, 
culture, and society.  Provide enough information to convince the IRB that 
you have qualified staff for the proposed research.  
NOTE:  If you specify a person by name, a change to that person will require prior 
approval by the IRB.  If you specify a person by role (e.g., coordinator, research 
assistant, co-investigator, or pharmacist), a change to that person will not usually 
require prior approval by the IRB, provided that the person meets the 
qualifications described to fulfill their roles. 
Dr. Tania Von Visger is the PI of this study. She is a tenure track Assistant 
Professor at UB SON with experience conducting a clinical trial with patients 
with PH using Urban Zen Integrative Therapy intervention. In the UZIT study, 
she created the study protocol, trained and maintain the interventionists' 
competency for the duration of the UZIT study. She also has experience 
conducting clinical studies involving multi-disciplinary team members with 
Critical Care and Transplant patients. 
Dr. Yu-Ping Chang is the primary co-Investigator in this study. She is the Senior 
Assistant Dean at UBSON and Director of SON Center of Nursing Research 
(CNR). Dr. Chang leads a PCORI-funded study using a video-conference 
mindfulness program in African American community participants living in 
Buffalo. She is a mental health expert and familiar with systems and processes at 
SUNY UB. 
A qualified and experienced Research Assistant/Research Coordinator from 
the UBSON will coordinate participant activities in this MMPH project. She will 
be responsible for the overall recruitment and enrollment of study participants in 
the study. The RA is trained through the UBSON CNR with familiarity in the 
conduct of various types of research. They also have extensive experience 
working with many research faculty members at the SON. 

 
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MMPH Interventionist who is familiar with the delivery of Mindfulness practice 
via Zoom to URM participants will be an integral member of the research team. 
They will assist the PI in content development and creating the AV recording of 
MMPH presentations and modules. In our current collaborative research projects 
(PI = Chang), we have identified four potential interventionists with these 
experiences that we can tap into based on their interests and availability. 
CSE 611 Independent Project Course. In collaboration with the UB School of 
Engineering Professor, study PI will secure student interest in the MMPH App 
study. A dedicated group of engineering students will design and develop an 
MMPH mindfulness App for course credit during their enrollment in the Fall 
2021 semester. We have full support from the UB SOE. 
 
Describe other resources available to conduct the research.  
16.2 Describe the time and effort that the Principal Investigator and research 
staff will devote to conducting and completing the research. 
NOTE:  Examples include the percentage of Full Time Equivalents (FTE), hours 
per week.  The question will elicit whether there are appropriate resources to 
conduct the research. 
Response: Dr. Von Visger (PI) will dedicate her full-time commitment to this 
project as she is a tenure-track Assistant Professor. She currently has a five credit-
hours teaching commitment. 
Co-I will dedicate 10% of her FTE to this project. 
Per the contract, the UBSON will provide 10 hours per week of RA/ Clinical 
Research Coordinator time in this project. 
MMPH Interventionists will dedicate 0.5 FTE for 26 weeks (6 months), 
including the time to design and review MMPH content, record the audio App and 
deliver the Zoom interventions. Their engagement in this project will also include 
training time to get familiar with the research protocol and time for re-trained if 
the study takes longer than anticipated. 
 
16.3 Describe the availability of medical or psychological resources that subjects 
might need as a result of anticipated consequences of the human research, if 
applicable. 
NOTE:  One example includes: on-call availability of a counselor or psychologist 
for a study that screens subjects for depression. 
Participants will be referred to their primary healthcare providers for further 
assessment if/when the need arises concerning participants' mental health needs. 
We will also provide community-based resources if they need additional support.  
 

 
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16.4 Describe your process to ensure that all persons assisting with the research 
are adequately informed about the protocol, the research procedures, and 
their duties and functions. 
We will have at least monthly Research Team meetings to review participant 
recruitment, enrollment, research procedures, research-related issues. Team 
members will receive weekly updates about the overall progress of the study. 
 
17.0 
Other Approvals 
17.1 Describe any approvals that will be obtained prior to commencing the 
research (e.g., school, external site, funding agency, laboratory, radiation 
safety, or biosafety). 
Response:  
 
☒ 
N/A:  This study does not require any other approvals. 
18.0 
Provisions to Protect the Privacy Interests of Subjects 
18.1 Describe how you will protect subjects' privacy interests during the course 
of this research. 
NOTE:  Privacy refers to an individual's right to control access to him or herself.  
Privacy applies to the person.  Confidentiality refers to how data collected about 
individuals for the research will be protected by the researcher from release.  
Confidentiality applies to the data.   
Examples of appropriate responses include: "participant only meets with a study 
coordinator in a classroom setting where no one can overhear", or "the participant 
is reminded that they are free to refuse to answer any questions that they do not 
feel comfortable answering."   
To protect participants' privacy interests and safety during the study, a research 
team member will only contact the participants on the phone in a private office 
where no one can overhear the conversation. Any email communications with 
participants will be kept private and confidential. All data collected during the 
study will be stored on a secure, password-protected cloud that only the research 
team has access to. 
About Zoom communication, participants will meet with a study coordinator from 
the privacy of their home where no one can overhear the discussion about their 
participation in the study. Participants will be reminded not to discuss any 
personal information outside of the group discussion during the Zoom 
intervention. 
The participant will be reminded that they are free to refuse to answer any 
questions that they do not feel comfortable answering.  
18.2 Indicate how the research team is permitted to access any sources of 
information about the subjects.   

 
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NOTE:  Examples of appropriate responses include:  school permission for review 
of records, consent of the subject, HIPAA waiver.  This question does apply to 
records reviews. 
Sources of information about the subjects before enrollment will only be 
accessible to PH doctors. Once enrolled, research data will be stored in Research 
Files at UBSON, and only research team members (PI, co-I, RA) will have 
access. There will be no need for medical record review because the outcome data 
will be participant-reported outcomes (symptom presence, symptom severity, 
quality of life).  
 
19.0 
Data Management and Analysis* 
19.1 Describe the data analysis plan, including any statistical procedures.  This 
section applies to both quantitative and qualitative analysis.  
As a pilot study, power analysis is not necessary. Statistical analysis will include 
descriptive statistics, mixed-effect modeling for repeated measures, and within-
group and between-groups comparisons using t-tests or Wilcoxon signed-rank test 
as appropriate and Cohen's d effect size calculation. Multi-time data collection 
will be done via daily mobile-APP use.  
We will follow the standard procedure in quantitative data analysis that 
includes general data inspection to verify the accuracy, completeness, and 
normality of the dataset using the SPSS23 program. We will compare 
clinical outcomes within-group (pre-post) as well as between groups in the 
post-intervention period. We will follow the recommendation of 
inappropriate statistical analysis and interpretation specific to each survey. 
For continuous variables, we will use a paired student t-test, independent 
t-test analytical approaches. For categorical variables and non-normally 
distributed variables, we will use non-parametric statistical methods (X2). 
Frequency distributions will be produced for all variables, and 
demographic information will be used to describe the sample. The impact 
of the M-App use on outcome variables will be analyzed using paired t-
test and repeated measure ANOVA. 
Qualitative data (focused-group interview data) will be analyzed using the 
standard qualitative thematic analysis procedure. We will transcribe the 
audio-recorded data and upload it into NViVo data management system. 
We will adhere to the thematic analysis method, described as follows:  
1. A researcher will read and re-read the entire text to get a general sense 
of the participants' whole experience of being a student during the 
COVID-19 pandemic. While reading through the transcript, the researcher 
will take initial notes and perform a general review to get familiar with the 
data before analyzing the data.  
2. The researcher will descriptively open code by dividing the significant 
text segments into 'meaningful units', keeping the participants' own words. 
The researcher will re-read all the codes again to eliminate redundancies. 

 
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The comparative discussion of these codes with other research team 
members to achieve a consensus will provide a validation step.  
3. The researcher will use an inductive approach to look over the 
consensus codes, identify patterns among them, and start coming up with 
categories that describe 'critical moments,' significant aspects of the 
experiences.  
4. The researcher will categorize the codes into overarching elements and 
higher-level categories and then cluster similar categories into the related 
themes. To make sure that the themes are useful and accurately represent 
the data, the researcher will return to the original data set and reflectively 
compare the categories against it.  
5. The researcher will discuss with the research team members to refine 
the themes and develop the central theme. The researcher will then define 
and name the central theme by formulating its meanings and figuring out 
how it helps understand participants' experiences.  
6. Finally, the researcher will develop an overall description of the essence of the 
participants' experience by merging the themes into the central theme/s in a 
flowing narration. 
19.2 If applicable, provide a power analysis.   
NOTE:  This may not apply to certain types of studies, including chart/records 
reviews, survey studies, or observational studies.  This question is asked to elicit 
whether the investigator has an adequate sample size to achieve the study 
objectives and justify a conclusion.  
NOT APPLICABLE 
 
19.3 Describe any procedures that will be used for quality control of collected 
data. 
We will set up the required data entry field within the M-App and 
REDCap function to ensure that the data entry is accurate and complete. 
Erroneous (out-of-range) data entry will be less likely, as controlled by the 
proper setup of the data fields. Also, the system will remind participants to 
enter data into the required data field before proceeding to the following 
sections. A dedicated research coordinator will review data entry once a 
week to verify survey completion and confirm no missing data. In the case 
of missing data discovery, the research coordinator will contact and ask 
participants to complete it as soon as possible. 
Before the data analysis process, two researchers will review the dataset for 
accuracy and discuss any possible reliability issues in data collection. 
20.0 
Confidentiality* 
 

 
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A. Confidentiality of Study Data 
 
Describe the local procedures for maintenance of confidentiality of study data 
and any records that will be reviewed for data collection.   
 
20.1 
A.  Where and how will all data and records be stored?  Include 
information about:  password protection, encryption, physical controls, 
authorization of access, and separation of identifiers and data, as applicable.  
Include physical (e.g. paper) and electronic files. 
With the use of M-App and REDCap programs, there will be minimal 
paper documentation of study data. In the rare instances where paper data 
collection is needed, they will be kept in a locked cabinet located in the 
PI's office (Wende 201F). The paper documentation will contain only 
participant study numbers without an identifiable name. Record linking 
study ID numbers with their names will be kept in a separate locked 
cabinet. 
We will upload data from M-App and REDCap into the SPSS and NViVO 
without any identifiable information. We will use only study ID numbers 
during data analysis. 
We will upload audio voice recordings captured from Zoom directly to the 
NiVIVO database, locked and secured with password-protected access. 
20.2 
A.  How long will the data be stored? 
The researchers will keep paper documentation (if any) and de-identified data for 
five years until we complete other associated studies. The expired, signed consent 
forms and materials will be deposited with the UB repository, whose security 
policy has been written according to best practice. All electronic data will be de-
identified and stored on a secure, password-protected cloud. 
20.3 
A.  Who will have access to the data? 
Only the PI and other research team members will have access to both paper 
documentation and the cloud data. 
20.4 
A.  Who is responsible for the receipt or transmission of the data? 
The PI and other research team members are responsible for the receipt and 
transmission of the data. 
20.5 
A.  How will the data be transported? 
We will transport the data since it will be stored on a secure, password-protected 
cloud. 
B. Confidentiality of Study Specimens 
 
Describe the local procedures for maintenance of confidentiality of study 
specimens.   

 
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☒ 
N/A:  No specimens will be collected or analyzed in this research.   
(Skip to Section 21.0) 
 
20.6 
B.  Where and how will all specimens be stored?  Include information 
about:  physical controls, authorization of access, and labeling of specimens, as 
applicable.   
Response: NOT APPLICABLE 
 
20.7 
B.  How long will the specimens be stored? 
Response: NOT APPLICABLE 
 
20.8 
B.  Who will have access to the specimens? 
Response: NOT APPLICABLE 
 
20.9 
B.  Who is responsible for receipt or transmission of the specimens? 
Response: NOT APPLICABLE 
 
20.10 B.  How will the specimens be transported? 
Response: NOT APPLICABLE 
 
 
21.0 
Provisions to Monitor the Data to Ensure the Safety of 
Subjects* 
☐ 
N/A:  This study is not enrolling subjects, or is limited to records review 
procedures only.  This section does not apply. 
 
NOTE:  Minimal risk studies may be required to monitor subject safety if the research 
procedures include procedures that present unique risks to subjects that require 
monitoring.  Some examples include:  exercising to exertion, or instruments that elicit 
suicidality or substance abuse behavior.  In such cases, N/A is not an acceptable 
response. 
 
21.1 Describe the plan to periodically evaluate the data collected regarding both 
harms and benefits to determine whether subjects remain safe. 
The PI will be responsible for safeguarding data integrity and safety 
monitoring for human subjects and communicating any negative outcomes 
or serious events to the IRB and other applicable offices/agencies. 

 
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The research team will meet weekly to review participant data and accrual. If 
participant accrual or retention drop under the requirement to complete the study, 
the PI and research team will discuss and develop strategies to overcome the 
identified issues. Record from the participants enrolled during each will be 
reviewed to ensure that all participants are eligible for the study. The research 
team will also monitor developments in the literature and results of related studies 
that may impact the participants or the ethics of the research. 
21.2 Describe what data are reviewed, including safety data, untoward events, 
and efficacy data. 
To ensure the integrity of the research study, we will review progress relevant to 
study recruitment and enrollment, intervention fidelity, clinical outcomes, and 
safety data. With the minimal to low risk associated with this research, there are 
no anticipated life-threatening adverse events for this proposed research project. 
In the rare occurrence, it will be reported to the PI and research team immediately. 
Researchers will notify the IRB within seven days of the adverse event 
occurrence. A thorough investigation will be initiated, including a review of the 
protocol to ensure no undue exposure to risk occurred. 
21.3 Describe any safety endpoints. 
There is a potential risk of emotional distress to participants when answering 
survey questions about symptoms or feelings. Although unlikely, participants may 
experience sensations of anxiety, depression, and worse physical symptoms. 
Participants will be instructed to rest and re-focus their attention from completing 
the survey in such a scenario. Suppose a participant expresses any distress, or the 
research team suspects the participant is experiencing distress for any reason 
during the research. In that case, the participant may be removed from the study 
and offered a referral to mental health services. The adverse events will be 
reported to the IRB by the PI within the required timeframe. 
21.4 Describe how the safety information will be collected (e.g., with case report 
forms, at study visits, by telephone calls with participants). 
The PI will collect safety data during telephone calls with the participant(s) and 
during data collection from the participant's self-evaluations. 
21.5 Describe the frequency of safety data collection. 
Safety data collection occurs once every two weeks for eight weeks and one hour 
during the focus group interview. 
21.6 Describe who will review the safety data. 
The PI and research team will review the safety data. 
21.7 Describe the frequency or periodicity of review of cumulative safety data. 
The review of cumulative safety data will occur weekly. 
21.8 Describe the statistical tests for analyzing the safety data to determine 
whether harm is occurring. 

 
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We will use descriptive statistics (counts of the event) to determine the events of 
distress. 
21.9 Describe any conditions that trigger an immediate suspension of the 
research. 
We do not anticipate any situation that would trigger an immediate suspension of 
the study. 
22.0 
Withdrawal of Subjects* 
☐ 
N/A:  This study is not enrolling subjects.  This section does not apply. 
 
22.1 Describe anticipated circumstances under which subjects may be withdrawn 
from the research without their consent. 
Participants may be withdrawn from the research without their consent if the PI or 
research team member discovers a participant is in severe psychological distress 
or is admitted into the hospital for a psychiatric condition. 
22.2 Describe any procedures for orderly termination.   
NOTE:  Examples may include return of study drug, exit interview with clinician.  
Include whether additional follow up is recommended for safety reasons for 
physical or emotional health. 
NOT APPLICABLE 
 
22.3 Describe procedures that will be followed when subjects withdraw from the 
research, including retention of already collected data, and partial 
withdrawal from procedures with continued data collection, as applicable. 
We will attempt to use all the available data obtained from all participants 
(intention to treat). Pre and post comparison of the experimental Group 
will be conducted as aggregate means using all available data collected. 
When participants decide to leave the study, we will ask them if they would allow 
us to use the data we have collected before their decision to withdraw. If the 
subjects agree to use the data, the collected data will be handled and analyzed the 
same as research data. If the participants do not allow the use of the data, we will 
make every attempt to destroy the data. 
23.0 
Risks to Subjects* 
23.1 List the reasonably foreseeable risks, discomforts, hazards, or 
inconveniences to the subjects related to their participation in the research. 
Consider physical, psychological, social, legal, and economic risks.  Include 
a description of the probability, magnitude, duration, and reversibility of the 
risks.  
NOTE:  Breach of confidentiality is always a risk for identifiable subject data. 

 
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There are no foreseeable physical risks, discomfort, hazard, or 
inconveniences to the subjects related to their participation in this 
research. However, there is potential physical harm if participants use the 
M-App in circumstances that require total attention, such as driving or 
operating heavy machinery. There is an inherent risk of participants 
becoming so relaxed and drift off into a sleep state, which may put them in 
danger during these activities. Therefore, we will instruct participants in 
the proper use of the M-App and the environment/conditions they need to 
avoid practicing with the M-App. 
For a Zoom intervention group, there is always the chance that someone 
will share something someone else said (confidentiality breach). At the 
beginning of the interview, we will remind participants not to share this 
information with anyone. (This information will be a part of the consent 
document, indicating no guarantee that this may not occur).  
 
There is a potential risk of emotional discomfort to participants when answering 
survey questions about symptoms or feelings. Although unlikely, participants may 
experience sensations of anxiety, depression, and worse physical symptoms. 
Participants will be instructed to rest and re-focus their attention from completing 
the survey in such a scenario. If needed, participants will be given the contact 
information in their local areas (according to their primary care doctors). 
Questionnaires included in this research study are standardized tools used widely 
with no reported adverse harm. Fatigue is possible when answering questions 
from a battery of questionnaires. However, most surveys used in this study are 
shortened versions that generally require less than 10 minutes to complete. 
23.2 Describe procedures performed to lessen the probability or magnitude of 
risks, including procedures being performed to monitor subjects for safety. 
To address potential physical harm (mentioned above), we will provide 
specific instructions on how to complete the M-App modules at home. 
To monitor subjects for safety risk, we will conduct weekly research 
meetings to review the progress of the research activity and any 
participants' safety concerns. We will create action plans to mitigate any 
issues that may arise.  
We will employ all reasonable efforts to protect the confidentiality of the 
participants' protected health information. Identifiable data is immediately 
de-identified, and de-identified data is stored separately from identifiable 
data. We will keep participants' names and other identifying information 
confidential when the data is prepared or oral or written publications.  
Specific to participants' interviews, there is a potential risk of emotional distress 
due to the sensitive nature of the topics. We will provide all interviewed 
participants with information on mental health resources and support groups at the 
time of enrollment. 

 
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23.3 If applicable, indicate which procedures may have risks to the subjects that 
are currently unforeseeable. 
None other than the potentiality of "falling asleep" during the practice. 
23.4 If applicable, indicate which research procedures may have risks to an 
embryo or fetus should the subject be or become pregnant. 
Response:  
NONE 
 
23.5 If applicable, describe risks to others who are not subjects. 
Response:  
NONE 
 
24.0 
Potential Benefits to Subjects* 
24.1 Describe the potential benefits that individual subjects may experience by 
taking part in the research.  Include the probability, magnitude, and 
duration of the potential benefits.  Indicate if there is no direct benefit.   
NOTE:  Compensation cannot be stated as a benefit. 
There are potential benefits that individual subjects may experience by taking part 
in the research. Based on existing literature reporting on the use of M-App, 
mindfulness practice can increase one's level of Mindfulness that may help with 
focus and attention beneficial to their mental health and well-being. Participation 
in this study may benefit from stress and anxiety reduction, which can be helpful 
to their academic learning and social interaction. 
25.0 
Compensation for Research-Related Injury 
☒ 
N/A:  The research procedures for this study do not present risk of 
research related injury (e.g. survey studies, records review studies).  This 
section does not apply.   
25.1 
If the research procedures carry a risk of research related injury, 
describe the available compensation to subjects in the event that such 
injury should occur.   
NOT APPLICABLE 
 
25.2 
Provide a copy of contract language, if any, relevant to compensation for 
research related injury. 
NOTE:  If the contract is not yet approved at the time of this submission, submit the 
current version here.  If the contract is later approved with different language 
regarding research related injury, you must modify your response here and 
submit an amendment to the IRB for review and approval. 

 
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NOT APPLICABLE 
 
26.0 
Economic Burden to Subjects 
26.1 
Describe any costs that subjects may be responsible for because of 
participation in the research.   
NOTE:  Some examples include transportation or parking. 
The only anticipated cost to participants relevant to the study includes data 
charges from their phone carrier if they are not using a Wi-Fi service or go over 
the allotted data usage with their phone carrier. 
☐ 
N/A:  This study is not enrolling subjects, or is limited to records review 
procedures only.  This section does not apply. 
27.0 
Compensation for Participation 
27.1 
Describe the amount and timing of any compensation to subjects, 
including monetary, course credit, or gift card compensation. 
Participants will be compensated at four timepoints with US Bank Prepaid 
Cards, in a total value up to $90.00 after completing the study. 
☐ 
N/A:  This study is not enrolling subjects, or is limited to records 
review procedures only.  This section does not apply. 
☐ 
N/A:  There is no compensation for participation.  This section 
does not apply. 
28.0 
Consent Process 
28.1 Indicate whether you will be obtaining consent.   
NOTE:  This does not refer to consent documentation, but rather whether you will 
be obtaining permission from subjects to participate in a research study.   
Consent documentation is addressed in Section 29.0. 
☒ 
Yes 
(If yes, Provide responses to each question in this Section) 
☐ 
No 
(If no, Skip to Section 29.0) 
 
28.2 Describe where the consent process will take place.  Include steps to 
maximize subjects' privacy. 
Once it is determined a participant is qualified, they will have access to a written 
version of the consent form that the IRB has approved. We will email a copy of 
the consent form to review at least two days before providing consent. They will 
gain a further, detailed understanding of the study, participation requirement, and 
other general information about the human research subject in the privacy of their 
homes. The consent process will take place during a virtual meeting between a 
member of the research team and the interested, eligible participant to review the 
content of the consent form. The research coordinator will put the consent form 

 
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up on the screen and go through it and then ask the participant to either orally 
agree or not. If they don't consent, they may leave by logging out. If they stay, 
they are verbally demonstrating their consent. During this meeting, we will 
provide the participant with plenty of opportunities to ask additional questions 
about the study.  If it is agreeable with the participant, the researcher will obtain 
verbal consent. 
28.3 Describe how you will ensure that subjects are provided with a sufficient 
period of time to consider taking part in the research study.   
NOTE:  It is always a requirement that a prospective subject is given sufficient 
time to have their questions answered and consider their participation.  See "SOP: 
Informed Consent Process for Research (HRP-090)" Sections 5.5 and 5.6. 
The participant will receive a written consent form at least two days before the 
virtual meeting between the eligible participant and the research coordinator. The 
participant will have sufficient time to ask further questions about the study 
during the meeting. If they are unsure whether to participate at that time, they will 
be given an additional day to decide their participation.  In such a case, the 
research coordinator can schedule another virtual meeting convenient for the 
participant. 
28.4 Describe any process to ensure ongoing consent, defined as a subject's 
willingness to continue participation for the duration of the research study.   
Emails will be sent to the participants each week by the research team to remind 
participants of their volunteer status and ability to withdraw from participation at 
any time. 
28.5 Indicate whether you will be following "SOP: Informed Consent Process for 
Research (HRP-090)." Pay particular attention to Sections 5.4-5.9. If not, or 
if there are any exceptions or additional details to what is covered in the 
SOP, describe: 
• 
The role of the individuals listed in the application who are involved in 
the consent process 
• 
The time that will be devoted to the consent discussion 
• 
Steps that will be taken to minimize the possibility of coercion or 
undue influence 
• 
Steps that will be taken to ensure the subjects' understanding 
We will be following HRP-900 with the exception that consent provisions will not 
be made to conduct consent in languages other than English even if this is 
preferred by the participant because we expect that the participants will speak 
English sufficiently to understand the consent form. 
☒ 
We have reviewed and will be following "SOP: Informed Consent Process 
for Research (HRP-090)." 
 
Non-English Speaking Subjects  

 
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☒ 
N/A:  This study will not enroll Non-English speaking subjects.   
(Skip to Section 28.8) 
28.6 Indicate which language(s) other than English are likely to be 
spoken/understood by your prospective study population or their legally 
authorized representatives. 
 
NOTE: The response to this Section should correspond with your response to 
Section 8.4 of this protocol. 
Response:  
NOT APPLICABLE 
 
28.7 If subjects who do not speak English will be enrolled, describe the process 
to ensure that the oral and written information provided to those subjects 
will be in that language, how you will ensure that subjects are provided with 
a sufficient period of time to consider taking part in the research study, and 
any process to ensure ongoing consent. Indicate the language that will be 
used by those obtaining consent.  
NOTE:  Guidance is provided on "SOP:  Informed Consent Process for Research 
(HRP-090)." 
Response:  
NOT APPLICABLE 
 
 
Cognitively Impaired Adults 
☒ 
N/A:  This study will not enroll cognitively impaired adults.   
(Skip to Section 28.9) 
28.8   Describe the process to determine whether an individual is capable of 
consent.  
Response: NOT APPLICABLE 
 
 
Adults Unable to Consent 
☒ 
N/A:  This study will not enroll adults unable to consent.  
(Skip to Section 28.13) 
When a person is not capable of consent due to cognitive impairment, a legally 
authorized representative should be used to provide consent (Sections 28.9 and 
28.10) and, where possible, assent of the individual should also be solicited 
(Sections 28.11 and 28.12). 

 
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28.9  Describe how you will identify a Legally Authorized Representative (LAR).  
Indicate that you have reviewed the "SOP: Legally Authorized 
Representatives, Children, and Guardians (HRP-013)" for research in New 
York State.  
NOTE:  Examples of acceptable response includes: verifying the electronic 
medical record to determine if an LAR is recorded. 
Response: NOT APPLICABLE 
 
☐ 
We have reviewed and will be following "SOP: Legally Authorized 
Representatives, Children, and Guardians (HRP-013)."  
28.10 For research conducted outside of New York State, provide information 
that describes which individuals are authorized under applicable law to 
consent on behalf of a prospective subject to their participation in the 
research. One method of obtaining this information is to have a legal 
counsel or authority review your protocol along with the definition of 
"legally authorized representative" in "SOP: Legally Authorized 
Representatives, Children, and Guardians (HRP-013)." 
Response: NOT APPLICABLE 
 
28.11 Describe the process for assent of the adults: 
• 
Indicate whether assent will be obtained from all, some, or none of the 
subjects.  If some, indicate which adults will be required to assent 
and which will not. 
Response: NOT APPLICABLE 
 
• 
If assent will not be obtained from some or all subjects, provide an 
explanation of why not. 
Response: NOT APPLICABLE 
 
28.12 Describe whether assent of the adult subjects will be documented and the 
process to document assent.   
NOTE:  The IRB allows the person obtaining assent to document assent on the 
consent document using the "Template Consent Document (HRP-502)" Signature 
Block for Assent of Adults who are Legally Unable to Consent. 
Response: NOT APPLICABLE 
 
 
Subjects who are not yet Adults (Infants, Children, and Teenagers) 

 
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☒ 
N/A:  This study will not enroll subjects who are not yet adults.   
(Skip to Section 29.0) 
28.13 Describe the criteria that will be used to determine whether a prospective 
subject has not attained the legal age for consent to treatments or 
procedures involved in the research under the applicable law of the 
jurisdiction in which the research will be conducted (e.g., individuals under 
the age of 18 years).  For research conducted in NYS, review "SOP: Legally 
Authorized Representatives, Children, and Guardians (HRP-013)" to be 
aware of which individuals in the state meet the definition of "children."  
NOTE:  Examples of acceptable responses include: verification via electronic 
medical record, driver's license or state-issued ID, screening questionnaire. 
Response:  
NOT APPLICABLE 
 
28.14For research conducted outside of New York State, provide information 
that describes which persons have not attained the legal age for consent to 
treatments or procedures involved the research, under the applicable law of 
the jurisdiction in which research will be conducted.  One method of 
obtaining this information is to have a legal counsel or authority review 
your protocol along the definition of "children" in "SOP: Legally 
Authorized Representatives, Children, and Guardians (HRP-013)." 
Response:  NOT APPLICABLE 
 
28.15 Describe whether parental permission will be obtained from: 
Response:  
☐  One parent even if the other parent is alive, known, competent, reasonably 
available, and shares legal responsibility for the care and custody of the 
child. 
☐ 
Both parents unless one parent is deceased, unknown, incompetent, or not 
reasonably available, or when only one parent has legal responsibility for 
the care and custody of the child. 
☐ 
Parent permission will not be obtained.  A waiver of parent permission is 
being requested. 
NOTE:  The requirement for parent permission is a protocol-specific determination 
made by the IRB based on the risk level of the research.  For guidance, review the 
"CHECKLIST: Children (HRP-416)."  
28.16Describe whether permission will be obtained from individuals other than 
parents, and if so, who will be allowed to provide permission.  Describe 
your procedure for determining an individual's authority to consent to the 
child's general medical care. 

 
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Response: NOT APPLICABLE 
 
28.17 Indicate whether assent will be obtained from all, some, or none of the 
children.  If assent will be obtained from some children, indicate which 
children will be required to assent. 
Response: NOT APPLICABLE 
 
28.18 When assent of children is obtained, describe how it will be documented. 
Response: NOT APPLICABLE 
 
29.0 
Waiver or Alteration of Consent Process 
Consent will not be obtained, required information will not be disclosed, or the 
research involves deception. 
☐ 
N/A:  A waiver or alteration of consent is not being requested. 
29.1 If the research involves a waiver or alteration of the consent process, please 
review the "CHECKLIST: Waiver or Alteration of Consent Process (HRP-
410)" to ensure that you have provided sufficient information for the IRB to 
make the determination that a waiver or alteration can be granted.   
NOTE:  For records review studies, the first set of criteria on the "CHECKLIST: 
Waiver or Alteration of Consent Process (HRP-410)" applies.  
Response:  
Enrolled participants will receive 60-min-weekly intervention for 8 weeks period; 2 
of which will include video conference practice and the other 6 will include audio-
video recording of the sessions. During the study period, they will complete self-
guided meditation using M-App for 20 min/day. These procedures are not beyond 
the risks presented by everyday life. 
 
 
29.2 If the research involves a waiver of the consent process for planned 
emergency research, please review the "CHECKLIST: Waiver of Consent 
for Emergency Research (HRP-419)" to ensure you have provided sufficient 
information for the IRB to make these determinations.  Provide any 
additional information necessary here: 
Response:  
We will email a copy of the consent form to review at least two days before 
providing consent. They will gain a further, detailed understanding of the study, 
participation requirement, and other general information about the human 
research subject in the privacy of their homes. Doing this via Zoom is more 

 
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practicable than in-person and follows UB guides for COVID safety of research 
volunteers. 
9.3/ The waiver or alteration will NOT adversely affect the rights and welfare of 
the subjects: The consent process will take place during a virtual meeting between 
a member of the research team and the interested, eligible participant to review 
the content of the consent form. The research coordinator will put the consent 
form up on the screen and go through it and then ask the participant to either 
orally agree or not. 
9.4/ Whenever appropriate, the subjects will be provided with additional pertinent 
information after participation: It is not necessary in a low risk study such as this.  
 
30.0 
Process to Document Consent 
☐ 
N/A:  A Waiver of Consent is being requested.   
(Skip to Section 31.0) 
30.1 Indicate whether you will be following "SOP: Written Documentation of 
Consent (HRP-091)." If not or if there are any exceptions, describe whether 
and how consent of the subject will be obtained including whether or not it 
will be documented in writing.   
NOTE:  If your research presents no more than minimal risk of harm to subjects 
and involves no procedures for which written documentation of consent is normally 
required outside of the research context, the IRB will generally waive the 
requirement to obtain written documentation of consent.  This is sometimes 
referred to as 'verbal consent.' Review "CHECKLIST: Waiver of Written 
Documentation of Consent (HRP-411)" to ensure that you have provided sufficient 
information.  
If you will document consent in writing, attach a consent document with your 
submission.  You may use "TEMPLATE CONSENT DOCUMENT (HRP-502)".  
If you will obtain consent, but not document consent in writing, attach the script of 
the information to be provided orally or in writing (i.e. consent script or 
Information Sheet).   
Response:  
 
☒ 
We will be following "SOP:  Written Documentation of Consent" 
(HRP-091). 
31.0 
Multi-Site Research (Multisite/Multicenter Only)* 
☒ 
N/A:  This study is not an investigator-initiated multi-site study.  This 
section does not apply. 
 
31.1 
Indicate the total number of subjects that will be enrolled or records that 
will be reviewed across all sites. 
Not Applicable 

 
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31.2 If this is a multi-site study where you are the lead investigator, describe the 
processes to ensure communication among sites, such as the following. See 
"WORKSHEET: Communication and Responsibilities (HRP-830).": 
• 
All sites have the most current version of the IRB documents, including 
the protocol, consent document, and HIPAA authorization. 
• 
All required approvals have been obtained at each site (including 
approval by the site's IRB of record). 
• 
All modifications have been communicated to sites, and approved 
(including approval by the site's IRB of record) before the 
modification is implemented. 
• 
All engaged participating sites will safeguard data as required by 
local information security policies. 
• 
All local site investigators conduct the study appropriately in 
accordance with applicable federal regulations and local laws. 
• 
All non-compliance with the study protocol or applicable requirements 
will be reported in accordance with local policy. 
 
Not Applicable 
 
31.3 Describe the method for communicating to engaged participating sites (see 
"WORKSHEET: Communication and Responsibilities (HRP-830)" ): 
• 
Problems (inclusive of reportable events) 
• 
Interim results 
• 
Study closure 
Not Applicable 
31.4 
If this is a multicenter study where you are a participating 
site/investigator, describe the local procedures for maintenance of 
confidentiality. (See "WORKSHEET: Communication and 
Responsibilities (HRP-830).") 
• 
Where and how data or specimens will be stored locally? 
• 
How long the data or specimens will be stored locally? 
• 
Who will have access to the data or specimens locally? 
• 
Who is responsible for receipt or transmission of the data or 
specimens locally? 
• 
How data and specimens will be transported locally? 
Response: NOT APPLICABLE 
 
31.5 
If this is a multicenter study and subjects will be recruited by methods not 
under the control of the local site (e.g., call centers, national 

 
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advertisements) describe those methods.  Local recruitment methods are 
described elsewhere in the protocol. 
• 
Describe when, where, and how potential subjects will be 
recruited. 
• 
Describe the methods that will be used to identify potential 
subjects. 
• 
Describe materials that will be used to recruit subjects. (Attach 
copies of these documents with the application. For 
advertisements, attach the final copy of printed advertisements. 
When advertisements are taped for broadcast, attach the final 
audio/video tape. You may submit the wording of the 
advertisement prior to taping to preclude re-taping because of 
inappropriate wording, provided the IRB reviews the final 
audio/video tape.) 
Response: NOT APPLICABLE 
 
32.0 
Banking Data or Specimens for Future Use* 
☒ 
N/A:  This study is not banking data or specimens for future use or 
research outside the scope of the present protocol.  This section does not 
apply. 
32.1 If data or specimens will be banked (stored) for future use, that is, use or 
research outside of the scope of the present protocol, describe where the 
data/specimens will be stored, how long they will be stored, how the 
data/specimens will be accessed, and who will have access to the 
data/specimens.  
NOTE:  Your response here must be consistent with your response at the "What 
happens if I say yes, I want to be in this research?" Section of the Template 
Consent Document (HRP-502). 
Response: NOT APPLICABLE 
 
32.2 List the data to be stored or associated with each specimen. 
Response: NOT APPLICABLE 
 
32.3 Describe the procedures to release banked data or specimens for future 
uses, including: the process to request a release, approvals required for 
release, who can obtain data or specimens, and the data to be provided with 
specimens. 
Response: NOT APPLICABLE