Surveying Patient's Interest in Robotic Rehabilitation Device
Conditions: Stroke, Acute
Sponsor: State University of New York at Buffalo

 
Title  
Surveying stroke patient’s current therapy and interest in robotic 
rehabilitation device 
IRB Institution 
University at Buffalo 
IRB Approval period 
12/8/21-12/7/22 
Note 
Version Date appears as 6.23.2021 because the initial approval date 
was 12/8/2020. There were few modifications in the study team 
members, age is changed from over 21 to over 18 and acute stroke is 
changed to stroke. 

 
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 30 
 
Complete Research Protocol (HRP-503) 
 
Table of Contents 
Template Instructions ...................................................... Error! Bookmark not defined. 
1.0 
Study Summary ........................................................................................................ 3 
2.0 
Objectives* .............................................................................................................. 3 
3.0 
Scientific Endpoints* ............................................................................................... 4 
4.0 
Background* ............................................................................................................ 4 
5.0 
Study Design* .......................................................................................................... 7 
6.0 
Study Intervention/Investigational Agent ............... Error! Bookmark not defined. 
7.0 
Local Number of Subjects ....................................................................................... 8 
8.0 
Inclusion and Exclusion Criteria* ............................................................................ 8 
9.0 
Vulnerable Populations* ........................................................................................ 10 
10.0 Eligibility Screening* ............................................................................................ 11 
11.0 Recruitment Methods ............................................................................................. 11 
12.0 Procedures Involved*............................................................................................. 12 
13.0 Study Timelines* ................................................................................................... 13 
14.0 Setting .................................................................................................................... 14 
15.0 Community-Based Participatory Research ............................................................ 14 
16.0 Resources and Qualifications ................................................................................. 15 
17.0 Other Approvals ..................................................................................................... 16 
18.0 Provisions to Protect the Privacy Interests of Subjects .......................................... 16 
19.0 Data Management and Analysis* .......................................................................... 17 
20.0 Confidentiality* ..................................................................................................... 17 
A. 
Confidentiality of Study Data ......................................................................... 17 
B. 
Confidentiality of Study Specimens ................................................................ 18 
21.0 Provisions to Monitor the Data to Ensure the Safety of Subjects* ........................ 19 
22.0 Withdrawal of Subjects* ........................................................................................ 20 
23.0 Risks to Subjects* .................................................................................................. 21 
24.0 Potential Benefits to Subjects* .............................................................................. 21 
25.0 Compensation for Research-Related Injury ........................................................... 22 
26.0 Economic Burden to Subjects ................................................................................ 22 
27.0 Compensation for Participation ............................................................................. 22 
28.0 Consent Process ..................................................................................................... 23 
29.0 Waiver or Alteration of Consent Process ............................................................... 27 
30.0 Process to Document Consent ............................................................................... 28 
31.0 Multi-Site Research (Multisite/Multicenter Only)*............................................... 28 
32.0 Banking Data or Specimens for Future Use* ........................................................ 30 
 
 
 

 
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PROTOCOL TITLE: 
Include the full protocol title. 
Response: Surveying stroke patient’s current therapy and interest in 
robotic rehabilitation device  
PRINCIPAL INVESTIGATOR: 
Name 
Department 
Telephone Number 
Email Address 
Response:  
Jiyeon Kang, PhD 
Dept. of Mechanical and Aerospace 
Room 1011 Furnas Hall, Buffalo, NY 14260 
Phone: (716) 645 6063 
Fax: (716) 645 2883 
jiyeonk@buffalo.edu 
VERSION NUMBER/DATE: 
Include the version number and date of this protocol. 
v.2 June 23 2021 
REVISION HISTORY 
 
Revision 
# 
Version Date 
Summary of Changes 
Consent 
Change? 
2 
June 23 2021 
Team members, age is changed from over 21 to 
over 18, acute stroke is changed to stroke. 
Date/team 
changed 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
FUNDING: 
Indicate any funding for this proposal. This should match the Funding Sources 
page in Click IRB. 
Response: N/A 
 
GRANT APPLICABILITY: 

 
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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: N/A 
 
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: The copies of IRB correspondence or signed consent and HIPPA forms 
will be stored in a locked cabinet located in Furnas Hall Room 809. Only 
personnel related to the project will have access to the document. 
Location: Cabinet with key access 
Address: Room 809 Furnas Hall, Buffalo, NY 14260  
Department: Dept of Mechanical and Aerospace Engineering 
1.0 Study Summary 
 
Study Title 
Surveying patient’s interest in robotic rehabilitation device 
Study Design 
This study is a survey  study targeting stroke patients  
Primary Objective 
Investigating the interest of individuals with stroke in a novel 
robotic device for practicing ADL. 
Secondary 
Objective(s) 
Understanding the need and the current status of stroke 
rehabilitation   
Research 
Intervention(s)/ 
Investigational 
Agent(s)  
This study does not include intervention. 
IND/IDE #  
N/A 
Study Population 
Stroke patients  
Sample Size 
300 
Study Duration for 
individual 
participants 
2 Years 
Study Specific 
Abbreviations/ 
Definitions  
 ADL: activity of daily living 
  
2.0 Objectives* 

 
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2.1 Describe the purpose, specific aims, or objectives of this research. 
Response: (1) To investigate  the interest of individuals with stroke in a novel 
robotic device for enhancing the performance of ADL 
(2) Understanding the need for and satisfaction of current rehabilitative therapy 
targeting ADL training in stroke patients.   
 
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. 
Response:  
(1) We hypothesize that stroke patients will demonstrate interest in robotic 
technologies for practicing ADL. 
(2a) We hypothesize that stroke patients will demonstrate need for rehabilitative 
therapy to enhance ADL post-stroke  
(2b) We hypothesize that stroke patients will demonstrate decreased satisfaction 
with current rehabilitative therapy to enhance ADL. 
(2)  
 
3.0 Scientific Endpoints* 
 
2.1    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:  
 
1) Report of receiving current rehabilitation therapy  
2) Report of decreased satisfaction with current therapy 
3) Frequency and dosage of the therapy  
4) Express the need of robotic therapy 
 
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.  

 
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Response:  
There are approximately 6.6 million stroke survivors in the United States. Every 
year about 800,000 individuals experience new or recurrent strokes (Benjamin 
2017). Patients with stroke often lose function of their upper limbs and have 
difficulty performing activities of daily living (ADLs) post-stroke. Furthermore, 
about 80% of stroke survivors over the age of 65 experience chronic disabilities 
(Barker and Mullooly 1997). After the onset of stroke, first three months are 
considered within the crucial time window when most of the arm recovery happens 
by spontaneous neurologic recovery (Kwakkel 2006). During this acute period, 
motor learning is a necessary condition for recovery. This learning can be promoted 
by rehabilitation which can reduce chronic disabilities (Duncan 2003). 
Occupational therapy (OT) services are often utilized to remediate or restore 
function of the upper limbs. OT services may include optimizing basic self-care, 
interaction with family, recreation, and socialization (Steultjens 2003). However, 
even after completion of standard therapy, up to 75% of individuals experience 
continuous challenges with ADLs (Sturm 2002). Importantly, four years after the 
incident of stroke, only 6% of patients are satisfied with the functionality of their 
impaired arm (Broeks 1999). There is a need to understand whether the therapy is 
not enough for the stroke patients to perform ADLs. Also, needs of alternative 
methods such as robotic therapy to address this issue should be investigated.  
Robotic interventions have been developed in the past to satisfy the high-intensity 
and repeated training. Many robotic interventions have been successful in 
improving upper limb motor scores and strength (Mehrholz 2012, Prange 2009) but 
the consensus in literature demonstrates that these improvements do not always 
transfer to performance of ADLs (Kwakkel 2008). There are three potential reasons 
for the limited transfer of robotic training to ADL performance. First, the current 
robotic therapy has focused more on the individual training of either proximal or 
distal arm joints. However, simultaneous training of proximal and distal joints is 
essential to perform daily living tasks (Oujamaa 2009 , Timmermans 2009). 
Second, many robotic interventions focused on reaching tasks that are different 
from object manipulation. Many ADLs include manipulation tasks that require 
complicated three-dimensional hand posture changes. Third, robotic training 
sessions are often limited to patients in clinical settings because robotic systems are 
bulky and expensive, which makes the home-use challenging.   
We designed a new training strategy using a parallel manipulator, named Spherical 
Parallel Instrument for Daily Living Emulation (SPINDLE). The design is inspired 
by the well-known agile eye structure, which has a 3-RRR structure that enables 
three dimensional rotations (Gosselin 1994,  Gosselin 1996). This device will 
mimic activities of daily living tasks, including complicated object manipulation 
tasks. This device will interact with the user, and provide a compact table-top 
device with high torque and wide range of motion compared to off-the-shelf 
devices. In this study, we will understand if patients has high interest in adopting a 
new robotic therapy at home to improve their activities of daily living. 
 

 
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4.2 Include complete citations or references.  
Response:  
[Benjamin, 2017] Benjamin, E. J., Blaha, M. J., Chiuve, S. E., Cushman, M., Das, 
S. R., Deo, R., Floyd, J., Fornage, M., Gillespie, C., Isasi, C., et al. (2017). Heart 
disease and stroke statistics-2017 update: a report from the american heart 
association. Circulation, 135(10):e146–e603. 
 [Broeks 1999] Broeks, J., Lankhorst, G., Rumping, K., and Prevo, A. (1999). The 
long-term outcome of arm function after stroke: results of a follow-up study. 
Disability and rehabilitation, 21(8):357–364. 
[Barker and Mullooly, 1997] Barker, W. H. and Mullooly, J. P. (1997). Stroke in 
a defined elderly population, 1967-1985: a less lethal and disabling but no less 
common disease. Stroke, 28(2):284–290. 
[Duncan, 2003] Duncan, P., Studenski, S., Richards, L., Gollub, S., Lai, S. M., 
Reker, D., Perera, S., Yates, J., Koch, V., Rigler, S., et al. (2003). Randomized 
clinical trial of therapeutic exercise in subacute stroke. Stroke, 34(9):2173–2180. 
[Gosselin 1994] Gosselin,  C.,  Sefrioui,  J.,  and  Richard,  M.  J.,  1994.“On  the  
direct  kinematics  of  spherical  three-degree-of-freedom parallel manipulators 
with a coplanar plat-form”.Journal of Mechanical Design,116(2), pp. 587–593. 
[Gosselin 1996]  Gosselin,  C. M.,  Pierre,  E. S.,  and Gagne,  M.,  1996.“On the 
development of the agile eye”.IEEE Robotics& Automation Magazine,3(4), pp. 
29–37 
[Kwakkel 2006] Kwakkel, G., Kollen, B., and Twisk, J. (2006). Impact of time on 
improvement of outcome after stroke. Stroke, 37(9):2348–2353. 
[Kwakkel, 2008] Kwakkel, G., Kollen, B. J., and Krebs, H. I. (2008). Effects of 
robot-assisted therapy on upper limb recovery after stroke: a systematic review. 
Neurorehabilitation and neural repair, 22(2):111–121. 
[Mehrholz, 2012] Mehrholz, J., Hädrich, A., Platz, T., Kugler, J., and Pohl, M. 
(2012). Electrome chanical and robot-assisted arm training for improving generic 
activities of daily living, arm function, and arm muscle strength after stroke. 
Cochrane database of systematic reviews, (6). 
[Oujamaa, 2009] Oujamaa, L., Relave, I., Froger, J., Mottet, D., and Pelissier, J.-
Y. (2009). Rehabilitation of arm function after stroke. literature review. Annals of 
physical and rehabilitation medicine,52(3):269–293. 
[Prange, 2009] Prange, G., Jannink, M., Groothuis-Oudshoorn, C., Hermens, H., 
and Ijzerman, M. (2009). Systematic review of the effect of robot-aided therapy 
on recovery of the hemiparetic arm after stroke. Journal of rehabilitation research 
and development, 43(2):171–184. 
[Sturm 2002] Sturm, J.W., Dewey, H. M., Donnan, G. A., Macdonell, R. A., 
McNeil, J. J., and Thrift, A. G. (2002). Handicap after stroke: how does it relate to 
disability, perception of recovery, and stroke subtype? the north east melbourne 
stroke incidence study (nemesis). Stroke, 33(3):762–768. 

 
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[Steultjens, 2003] Steultjens, E. M., Dekker, J., Bouter, L. M., van de Nes, J. C., 
Cup, E. H., van den Ende, C. H., Landi, F., and Bernabei, R. (2003). Occupational 
therapy for stroke patients: When, where, and how? Stroke, 34(3):676–687. 
[Timmermans, 2009] Timmermans, A. A., Seelen, H. A., Willmann, R. D., and 
Kingma, H. (2009). Technology-assisted training of arm-hand skills in stroke: 
concepts on reacquisition of motor control and therapist guidelines for 
rehabilitation technology design. Journal of neuroengineering and rehabilitation, 
6(1):1. 
 
5.0 Study Design* 
5.1 Describe and explain the study design (e.g. case-control, cross-sectional, 
ethnographic, experimental, interventional, longitudinal, observational). 
Response: This is a survey study.  
1.1 Description: Describe the study intervention and/or investigational 
agent (e.g., drug, device) that is being evaluated. 
Response: There will be no specific intervention in this study.  
 
 
5.2 Drug/Device Handling: If the research involves drugs or device, 
describe your plans to store, handle, and administer those 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: N/A 
 
5.3 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: 

 
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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: N/A 
 
6.0 Local Number of Subjects 
6.1 Indicate the total number of subjects that will be enrolled or records that 
will be reviewed locally. 
Response: 300 
 
6.2 If applicable, indicate how many subjects you expect to screen to reach your 
target sample (i.e. your screen failure rate).  
Response: 400 (Screen failure rate will be due to vision/cognitive/auditory 
capability to perform survey or other exclusion criteria) 
 
6.3 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:  
We typically see between 200-300 patients with stroke in a 4 weeks period at 
Buffalo General Medical Center (BGMC) and UBMD Neurology clinic. 
Assuming a conservative 10% of those patients are interested or eligible for the 
study, the expected number of patients recruited over a 2 years period is around 
500.  
 
7.0 Inclusion and Exclusion Criteria* 
7.1 Describe the criteria that define who will be included in your final study 
sample.  
NOTE:  This may be done in bullet point fashion. 
Response:  

 
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1) Episode of single stroke within the past twelve weeks and 2) 
Individuals’ age over 18 years old. 
7.2 Describe the criteria that define who will be excluded from your final study 
sample.   
NOTE:  This may be done in bullet point fashion.  
Response:   
 
Pregnant women , neurological disorders other than stroke (i.e. Parkinson’s), non-
ischemic stroke 
Individuals with severe cognitive impairments (demonstrating difficulty to 
understand, read, and answer the questions in writing)    
Individuals with difficulties to listen the instruction and video of the robotic 
device 
 
7.3  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 
 
7.4 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. 

 
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Response: We will exclude non-English speaking individuals as this is a pilot 
study. All instructions should be equally provided to the user for consistency. 
There will be no benefit or therapeutic effect related to this study. 
 
8.0 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. 
8.1 For research that involves pregnant women, safeguards include: 
NOTE CHECKLIST: Pregnant Women (HRP-412) 
Response: 
  
☒ 
N/A:  This research does not involve pregnant women. 
8.2 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. 
8.3 
For research that involves prisoners, safeguards include: 
NOTE CHECKLIST: Prisoners (HRP-415) 
Response:  
 
☒ 
N/A:  This research does not involve prisoners. 
8.4 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”). 
8.5 For research that involves cognitively impaired adults, safeguards include: 
NOTE CHECKLIST: Cognitively Impaired Adults (HRP-417) 
Response:  

 
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☒ 
N/A:  This research does not involve cognitively impaired adults. 
8.6 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. 
Response: N/A 
 
9.0 Eligibility Screening* 
9.1 
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).  
Response:   
Clinician will evaluate cognitive ability by chart review and then, answering the 
questionnaire of a screening sheet (see modified screening document). 
 
Data will be only collected from screened participants.  
 
 
 
☐ 
N/A:  There is no screening as part of this protocol. 
10.0 
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. 
10.1 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.). 
Response:  Potential subjects will be recruited at Buffalo General Medical Center 
at 100 High Street, Buffalo, NY, 14203, UBMD Neurology clinic at 5851 Main 
Street, Williamsville, NY, 14221, and UBMD Neurology clinic at conventus, 
1001 Main Street, 4th floor. Buffalo, NY, 14203. All patients with stroke get an 

 
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evaluation by the stroke service. Potential participants will be recruited/informed 
about the research opportunity during a routine clinical encounter.  Should the 
subject be interested, a detailed description of the study from the consent 
document will be provided verbally and in writing and consent will be obtain.  
 
10.2 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.   
Response: Before explaining the experiment to the potential participants, the 
examiner will ask the question whether she or he is interested in participating in 
this research and want to hear more about the study details. The researcher will 
emphasize that participation in this survey study is voluntary and participants may 
stop filling the questionnaire at any time with no consequences. 
 
10.3 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. 
 Response: Participants will be recruited by stroke team at BGMC or UBMD 
Neurology clinic. N/A 
 
11.0 
Procedures Involved* 
11.1 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. 
Response: Participants will read the questions on paper and mark on the 
questionnaire to answer. Before starting Part B in the questionnaire, a video 
showing a user training with a robotic device to practice ADLs is shown to the 
participant. We will use an electronic frame to show the video to the participant.     
Participants can spend as much time as they need to finish the questionnaire.  If the 
participant has questions, he/she can answer questions any time regarding the 
questionnaire.  
11.2 Describe what data will be collected.   

 
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NOTE:  For studies with multiple data collection points or long-term follow up, 
consider the addition of a schedule or table in your response. 
Response: The data demonstrating satisfaction, dosage, and frequency of current 
therapy of stroke patients. We will also investigate the interest in robotic therapy 
and the potential to use it for home training.  
 
11.3 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: Please find the attached screening and questionnaire created by PIs. 
11.4 Describe any source records that will be used to collect data about subjects 
(e.g. school records, electronic medical records). 
Response: electronic medical records 
11.5 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. 
Response: N/A 
 
11.6 Indicate whether or not study results will be shared with subjects or others, 
and if so, describe how these will be shared. 
Response: The collected answers of questionnaire will not be shared with subjects 
or others, except disclosure via academic publication.  
 
12.0 
Study Timelines* 
12.1 Describe the anticipated duration needed to enroll all study subjects. 
Response: All data is anticipated to be collected in two years.  
 
12.2 Describe the duration of an individual subject’s participation in the study. 
Include length of study visits, and overall study follow-up time. 
Response: Approximately twenty minutes. 
 
12.3 Describe the estimated duration for the investigators to complete this study 
(i.e. all data is collected and all analyses have been completed). 
Response: We expect to collect and analyze the data within three years. 

 
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13.0 
Setting 
13.1 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.” 
Response: Research procedures will be conducted in a private hospital room at 
Buffalo General Medical Center or UBMD Neurology Clinic. 
.  
 
13.2 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: This study will not be conducted outside of BGH at this time. 
 
☒ 
N/A:  This study is not conducted outside of UB or its affiliates. 
14.0 
Community-Based Participatory Research 
14.1 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 
knowledge with action and achieving social change to improve health outcomes 
and eliminate health disparities. 
Response:  
 
☒ 
N/A:  This study does not utilize CBPR. 

 
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14.2 
Describe the composition and involvement of a community advisory 
board. 
Response:  
 
☒ 
N/A:  This study does not have a community advisory board. 
15.0 
Resources and Qualifications 
15.1 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. 
Response:  
 Jiyeon Kang (PI) has background on rehabilitation robotics and collected 
biomechanical data of healthy individuals, Parkinson disease, cerebral palsy, and 
cerebellar ataxia patients. Amit Kandel MD. has practice on various stroke 
patients and works in Buffalo General Medical Center. Ghazala Saleem has 
background on occupational therapy and worked with stroke, traumatic injury, 
and pediatric disorder patients. Student researchers will be get involved this study. 
Student researchers who are working in this project finished CITI program 
training to establish a basic knowledge of human subjects research. Amit Kandel 
MD. will be involved in recruitment, consent, and administration of the survey. 
 
Describe other resources available to conduct the research.  
15.2 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: We estimate that the PI (Jiyeon Kang) and Co-PIs (Amit Kandel MD 
and Ghazala Saleem) will devote 10% of their time to the study.  The research 
assistance will devote 30% of their time to the study. 
 
15.3 Describe the availability of medical or psychological resources that subjects 
might need as a result of anticipated consequences of the human research, if 
applicable. 

 
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NOTE:  One example includes: on-call availability of a counselor or psychologist 
for a study that screens subjects for depression. 
Response: This research only collects answer of questionnaires. The minimal risk 
is to invoke frustration by reading and understanding the questionnaires. Some 
participants may feel boredom by answering the questionnaires.   
 
15.4 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. 
Response: All personnel who will conduct human subject studies will be trained. 
Their role will be assigned, and they will be informed about the protocol, 
procedures, and duties. Before starting this study, all staff members will 
participate a dry-run test to practice their knowledge.  
 
16.0 
Other Approvals 
16.1 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. 
17.0 
Provisions to Protect the Privacy Interests of Subjects 
17.1 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.”   
Response: Participants will be assigned an unidentifiable code when analyzing the 
data. During the study, the participant can ask questions anytime or stop 
answering the questionnaire anytime.  
17.2 Indicate how the research team is permitted to access any sources of 
information about the subjects.   
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. 

 
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Response: Subjects private clinical information will be review by the attending 
neurologist as part of routine stroke care. The use of this information for the 
present study will only be done once the subject has consented to be a part of the 
study.   
The consent and HIPAA forms will be signed by the participant before the study. 
Amit Kandel will have access to the clinical chart to access information needed 
for this study.   
 
18.0 
Data Management and Analysis* 
18.1 Describe the data analysis plan, including any statistical procedures.  This 
section applies to both quantitative and qualitative analysis.  
Response: Descriptive statistics will be computed to examine the demographic of 
the sample. Frequency statistics will be carried out to assess percentages of 
responses in each category. We will use Chi-square statistics to examine the 
relationship between satisfaction with current therapy and the interest in robotic 
therapy. If a relationship exists between the two variables, we will compute 
logistic regression to examine if decreased satisfaction in current therapy predicts 
high interest in the robotic device.  
 
18.2 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.  
Response:  
 
18.3 Describe any procedures that will be used for quality control of collected 
data. 
Response: The post-processed data will be visually investigated whether all the 
procedures were properly proceeded. Outliers will be also detected during this 
investigation.  
 
19.0 
Confidentiality* 
 
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.   
 

 
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19.1 
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. 
Response: The file linking subjects’ name to ID will be in paper form and will be 
stored in a locked file cabinet inside PI’s laboratory along with signed consent 
forms. The rest of the data will be stored in a password protected computer in 
Furnas 809 which does not have internet connection. Password will be disclosed 
only to individuals who are related to this project.  After the mandatory 3 years of 
data retention, the questionnaire will be shredded. Only coded data will be 
reported in research papers, conference presentations and participating research 
lab meetings.  
 
19.2 
A.  How long will the data be stored? 
Response: The file linking subjects’ name to ID will be retained until the end o f 
the stujdy. It will be destroyed afterwards. All data will be stored at least 3 years 
in a password protected folder regarding this project. After the mandatory 3 years 
of data retention, the data can be deleted from the password protected computer in 
Furnas 809 which does not have internet connection. 
19.3 
A.  Who will have access to the data? 
Response: Only researchers directly involved in the study will have access to this 
data. Access will only be available to those working on the project through 
password protection. 
 
19.4 
A.  Who is responsible for receipt or transmission of the data? 
Response: Only the PI (Dr. Jiyeon Kang) will be responsible or receipt or 
transmission of the data. 
 
19.5 
A.  How will the data be transported? 
Response: There is a very low chance to transport the data. But if there is a certain 
need, a password protected hard drive will be used.  
 
B. Confidentiality of Study Specimens 
 
Describe the local procedures for maintenance of confidentiality of study 
specimens.   
 
☒ 
N/A:  No specimens will be collected or analyzed in this research.   
(Skip to Section 19.0) 
 

 
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19.6 
B.  Where and how will all specimens be stored?  Include information 
about:  physical controls, authorization of access, and labeling of specimens, as 
applicable.   
Response:  
 
19.7 
B.  How long will the specimens be stored? 
Response:  
 
19.8 
B.  Who will have access to the specimens? 
Response:  
 
19.9 
B.  Who is responsible for receipt or transmission of the specimens? 
Response:  
 
19.10 B.  How will the specimens be transported? 
Response: 
 
 
20.0 
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. 
 
20.1 Describe the plan to periodically evaluate the data collected regarding both 
harms and benefits to determine whether subjects remain safe. 
Response: N/A for questionnaire study 
 
20.2 Describe what data are reviewed, including safety data, untoward events, 
and efficacy data. 
Response: N/A 
 

 
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20.3 Describe any safety endpoints. 
Response: N/A 
 
20.4 Describe how the safety information will be collected (e.g., with case report 
forms, at study visits, by telephone calls with participants). 
Response: N/A 
 
20.5 Describe the frequency of safety data collection. 
Response: N/A 
 
20.6 Describe who will review the safety data. 
Response: N/A 
 
20.7 Describe the frequency or periodicity of review of cumulative safety data. 
Response: N/A 
 
20.8 Describe the statistical tests for analyzing the safety data to determine 
whether harm is occurring. 
Response: N/A 
 
20.9 Describe any conditions that trigger an immediate suspension of the 
research. 
Response: N/A 
 
21.0 
Withdrawal of Subjects* 
☐ 
N/A:  This study is not enrolling subjects.  This section does not apply. 
 
21.1 Describe anticipated circumstances under which subjects may be withdrawn 
from the research without their consent. 
Response: Though highly unlikely due to the short questionnaire , the participant 
may get tired by reading the questionnaire.  He or she may be withdrawn from the 
study. 
 
21.2 Describe any procedures for orderly termination.   

 
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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. 
Response: This study does not include any drug or clinical intervention. 
 
21.3 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. 
Response: There will be no retention from this study as this study does not 
include any drug or clinical intervention. 
 
22.0 
Risks to Subjects* 
22.1 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. 
Response: We do not expect any risk in this questionnaire study. 
 
22.2 Describe procedures performed to lessen the probability or magnitude of 
risks, including procedures being performed to monitor subjects for safety. 
Response:  
 
22.3 If applicable, indicate which procedures may have risks to the subjects that 
are currently unforeseeable. 
Response: We do not expect any risk in this questionnaire study. 
 
22.4 If applicable, indicate which research procedures may have risks to an 
embryo or fetus should the subject be or become pregnant. 
Response: We do not expect any risk in this questionnaire study. 
 
22.5 If applicable, describe risks to others who are not subjects. 
Response: We do not expect any risk in this questionnaire study. 
 
23.0 
Potential Benefits to Subjects* 

 
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23.1 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. 
Response: No direct benefits are expected for subjects in this study. The 
information obtained from this study will provide a better understanding of how 
stroke patients perceive the current therapy. 
 
24.0 
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.   
24.1 
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.   
Response: 
 
24.2 
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. 
Response:  
 
25.0 
Economic Burden to Subjects 
25.1 
Describe any costs that subjects may be responsible for because of 
participation in the research.   
NOTE:  Some examples include transportation or parking. 
Response: There will be no cost that subjects will be responsible for because of 
participation in the research. 
 
☐ 
N/A:  This study is not enrolling subjects, or is limited to records review 
procedures only.  This section does not apply. 
26.0 
Compensation for Participation 
27.1 
Describe the amount and timing of any compensation to subjects, 
including monetary, course credit, or gift card compensation. 

 
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Response:  
 
☐ 
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. 
27.0 
Consent Process 
27.1 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 27.0. 
☒ 
Yes 
(If yes, Provide responses to each question in this Section) 
☐ 
No 
(If no, Skip to Section 27.0) 
 
27.2 Describe where the consent process will take place.  Include steps to 
maximize subjects’ privacy. 
Response: Consent is obtained in a private hospital room at Buffalo General 
Medical Center.  
27.3 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. 
Response: The participant will be informed before the consent that he or she can 
use as much as time as he/she needs. Participants will be also informed to be 
allowed to ask questions or withdraw the study when she or he felt discomfort 
during the study.  
 
27.4 Describe any process to ensure ongoing consent, defined as a subject’s 
willingness to continue participation for the duration of the research study.   
Response: This is a onetime questionnaire study. 
 
27.5 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 

 
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• 
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 
Response:  
 
☒ 
We have reviewed and will be following “SOP: Informed Consent Process 
for Research (HRP-090).” 
 
Non-English Speaking Subjects  
☒ 
N/A:  This study will not enroll Non-English speaking subjects.   
(Skip to Section 26.8) 
27.6 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 6.4 of this protocol. 
Response:  
 
27.7 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:  
 
 
Cognitively Impaired Adults 
☒ 
N/A:  This study will not enroll cognitively impaired adults.   
(Skip to Section 26.9) 
27.8   Describe the process to determine whether an individual is capable of 
consent.  

 
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Response: Clinician will evaluate cognitive ability by chart review and then,  
answering the questionnaire using of a screening sheet (see modified screening 
document ) 
 
Adults Unable to Consent 
☒ 
N/A:  This study will not enroll adults unable to consent.  
(Skip to Section 26.13) 
When a person is not capable of consent due to cognitive impairment, a legally 
authorized representative should be used to provide consent (Sections 26.9 and 
26.10) and, where possible, assent of the individual should also be solicited 
(Sections 26.11 and 26.12). 
27.9  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:  
 
☐ 
We have reviewed and will be following “SOP: Legally Authorized 
Representatives, Children, and Guardians (HRP-013).”  
27.10 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:  
 
27.11 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:  
 
• 
If assent will not be obtained from some or all subjects, provide an 
explanation of why not. 

 
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Response:  
 
27.12 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:  
 
 
Subjects who are not yet Adults (Infants, Children, and Teenagers) 
☒ 
N/A:  This study will not enroll subjects who are not yet adults.   
(Skip to Section 27.0) 
27.13 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:  
 
27.14For 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:  
 
27.15 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. 

 
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☐ 
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).”  
27.16Describe 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. 
Response:  
 
27.17 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:  
 
27.18 When assent of children is obtained, describe how it will be documented. 
Response:  
 
28.0 
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. 
28.1 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:  
 
28.2 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 

 
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information for the IRB to make these determinations.  Provide any 
additional information necessary here: 
Response:  
 
29.0 
Process to Document Consent 
☐ 
N/A:  A Waiver of Consent is being requested.   
(Skip to Section 29.0) 
29.1 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). 
30.0 
Multi-Site Research (Multisite/Multicenter Only)* 
☒ 
N/A:  This study is not an investigator-initiated multi-site study.  This 
section does not apply. 
 
30.1 
Indicate the total number of subjects that will be enrolled or records that 
will be reviewed across all sites. 
Response:  
 
30.2 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).”: 

 
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• 
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. 
Response:  
 
30.3 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 
Response:  
 
30.4 
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:  
 
30.5 
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 
advertisements) describe those methods.  Local recruitment methods are 
described elsewheres in the protocol. 
• 
Describe when, where, and how potential subjects will be 
recruited. 

 
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• 
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:  
 
31.0 
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. 
31.1 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:  
 
31.2 List the data to be stored or associated with each specimen. 
Response:  
 
31.3 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: