Impact of Brain Connectome and Personality on Cognitive Rehabilitation in Multiple Sclerosis
Phase: NA
Conditions: Multiple Sclerosis
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 36 
 
10/02/2017 
 
 
 
 
 
 
 
 
 
 
 
 
Title: Impact of Brain Connectome and Personality on Cognitive Rehabilitation 
in Multiple Sclerosis 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Complete Research Protocol (HRP-503) 
 
Table of Contents 
Template Instructions.......................................................................................................... 3 
1.0 
Objectives ................................................................................................................ 5 
2.0 
Scientific Endpoints ................................................................................................. 6 
3.0 
Background .............................................................................................................. 7 
4.0 
Study Design .......................................................................................................... 10 
5.0 
Local Number of Subjects ..................................................................................... 10 
6.0 
Inclusion and Exclusion Criteria ............................................................................ 11 
7.0 
Vulnerable Populations .......................................................................................... 13 
8.0 
Eligibility Screening .............................................................................................. 14 
9.0 
Recruitment Methods ............................................................................................. 14 
10.0 Procedures Involved............................................................................................... 15 
11.0 Study Timelines ..................................................................................................... 17 
12.0 Setting .................................................................................................................... 18 
13.0 Community-Based Participatory Research ............................................................ 18 
14.0 Resources and Qualifications ................................................................................. 19 
15.0 Other Approvals ..................................................................................................... 20 
16.0 Provisions to Protect the Privacy Interests of Subjects .......................................... 20 
17.0 Data Management and Analysis ............................................................................ 21 
18.0 Confidentiality ....................................................................................................... 22 
A. 
Confidentiality of Study Data ............................................................................ 22 
B. 
Confidentiality of Study Specimens ................................................................... 23 
19.0 Provisions to Monitor the Data to Ensure the Safety of Subjects .......................... 24 
20.0 Withdrawal of Subjects .......................................................................................... 25 
21.0 Risks to Subjects .................................................................................................... 26 
22.0 Potential Benefits to Subjects ................................................................................ 27 
23.0 Compensation for Research-Related Injury ........................................................... 27 
24.0 Economic Burden to Subjects ................................................................................ 28 
25.0 Compensation for Participation ............................................................................. 28 
26.0 Consent Process ..................................................................................................... 28 
27.0 Waiver or Alteration of Consent Process ............................................................... 33 
28.0 Process to Document Consent ............................................................................... 33 
29.0 Multi-Site Research (Multisite/Multicenter Only)................................................. 34 
30.0 Banking Data or Specimens for Future Use .......................................................... 35 
31.0 Drugs or Devices.................................................................................................... 35 
32.0 Humanitarian Use Devices .................................................................................... 36 
 
 
 

 
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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 19, 20, 22, 23, 24, 25, 31, and 32 do not apply. 
o For exempt research:  Sections 31 and 32 do not apply. 
 
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: N/A  
 
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. 
 
 

 
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PROTOCOL TITLE: 
Include the full protocol title. 
Response:  Impact of Brain Connectome and Personality on Cognitive 
Rehabilitation in Multiple Sclerosis 
 
 
PRINCIPAL INVESTIGATOR: 
Name 
Department 
Telephone Number 
Email Address 
Response: Ralph H B Benedict PhD 
      Neurology  
      859-3484,      
                  benedict@buffalo.edu 
 
 
VERSION: 
Include the version date or number. 
Response: Version 1 
 
 
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: The study is not funded by a grant or award. The funding will be 
coming from internal funding of Dr. Benedict’s lab and BNAC. 
 
 

 
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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: Files are maintained in locked cabinets at the academic offices of 
Buffalo General Hospital. 
Location: Buffalo General Hospital 
Address: 100 High Street, Buffalo, NY 
Department: Neurology 
1.0 Objectives 
1.1 Describe the purpose, specific aims, or objectives of this research. 
Response:  The specific aims of this study are:  
[1a] Determine whether low Conscientiousness predicts lesser overall cognitive 
improvement following cognitive rehabilitation in people with MS.  
[1b] Determine whether the impact of Conscientiousness on cognitive 
rehabilitation is moderated by executive function and treatment adherence.   
[2] Identify structural and functional brain connectome characteristics which 
predict successful improvement in sub-domains of cognition following 
rehabilitation. 
This study will also serve to supplement the sample of participants for the current 
IRB approved study ((IRB: 603069, Title: A case-control, 5-year follow-up study 
of cardiovascular, environmental and genetic risk factors for disease progression 
in patients with multiple sclerosis (CEG-MS study).  
 
1.2 
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:  
[1a] We expect that individuals with low baseline Conscientiousness will 
experience a lower magnitude of overall cognitive improvement following 
rehabilitation 
[1b] We expect the impact of Conscientiousness on fidelity of rehabilitation will 
in part be moderated by individual differences in program adherence and 
executive function 

 
Page 6 of 36 
 
[2a] We expect that individual differences in structural and functional connectome 
disturbances will in part explain differences in participant responses to cognitive 
rehabilitation.  
 
2.0 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: Our primary end-point are predictive. Our first primary end-point will 
have been met if baseline measures of personality, as measured by the NEO-Five 
Factor Inventory (NEOFFI), will predict overall cognitive improvement following 
rehabilitation. Likewise, our second primary end-point will have been met if 
baseline measures of brain connectivity predict specific improvements in 
cognitive sub-domains, following rehabilitation. Cognitive improvement will be 
measured according to changes from visit 1 to visit 2 for the following 
neuropsychological tests: Symbol Digit Modalities Test (SDMT), California 
Verbal Learning Test 2nd Edition (CVLT), Brief Visuospatial Learning Test 
Revised (BVMT-R), MS Neuropsychological Screening Questionnaire (MSNQ), 
Delis-Kaplan Executive Function System (DKEFS) Sorting Test, Tower of 
London (TOL), Elithorn’s Perceptual Maze Test (EPMT).   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Day  0 
(Visit 1) 
Day 90 
(Visit 2) 
NEO Five Factor Inventory (NEO-FFI) 
X 
X 
Symbol Digit Modalities Test (SDMT) 
X 
X 
California Verbal Learning Test Second Edition (CVLT) 
X 
X 
Brief Visuospatial Memory Test Revised (BVMT) 
X 
X 
MS Neuropsychological Screening Questionnaire (MSNQ) 
X 
X 
Delis Kaplan Executive Function System Tower Test (DKEFS-TT) 
X 
X 
Delis Kaplan Executive Function System Sorting Test (DKEFS-ST) 
X 
X 
Elithorn’s Perceptual Maze Test (EPMT) 
X 
X 
Multiple Sclerosis Quality of Life (MSQoL) 
X 
X 
Beck Depression Inventory Fast Screen (BDI-FS) 
X 
X 
Fatigue Severity Scale (FSS) 
X 
X 

 
Page 7 of 36 
 
3.0 Background 
3.1 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.  
Response: The personality trait Conscientiousness is a behavioral phenotype 
encompassing the proclivity for achievement striving, organization, and deliberation in 
daily activity. Trait Conscientiousness is operationally measured using the NEO Five 
Factor inventory (NEOFFI), a model of personality widely studied in MS and other 
neurological populations.1  Trait Conscientiousness is normally distributed in humans, 
shows substantial cross-observer agreement, and has a similar mean and range across 
different cultures.2,3 
Decreased Conscientiousness relative to healthy controls (HCs) has been observed in 
people with multiple sclerosis (pwMS)4, an autoimmune disease that involves both 
neuroinflammation and neurodegeneration.5 It is important to study Conscientiousness 
decline in pwMS because preliminary findings suggest that Conscientiousness predicts 
poor adaptation and unfavorable disease outcomes in neurological disease.  For 
instance, Conscientiousness predicts CD4 count and viral load over 1-year in HIV 
disease.6  Lower Conscientiousness is associated with increased risk of amnestic mild 
cognitive impairment, and transition to Alzheimer’s dementia over 12 years.7  This trait 
also correlates negatively with mortality risk among older adults following stroke.8  Low 
baseline Conscientiousness is also associated with increased risk of poor disease 
outcomes in non-neurological diseases.  For instance, adults with prediabetes and low 
Conscientiousness are more likely to later develop type II diabetes, and children with 
type I diabetes and low Conscientiousness exhibit worse glycemic control.9,10 Notably, 
low Conscientiousness is also associated with reduced success of behavioral 
interventions on health behaviors and disease outcomes. For example, low 
Conscientiousness is prospectively associated with reduced improvement in medication 
adherence, emotional burden, and physical activity, following a range of behavioral 
interventions in adults with diabetes.11  
Lower trait Conscientiousness may also predict less favorable disease course and 
response to intervention in pwMS.  In cross-sectional studies, lower Conscientiousness 
correlates with impaired processing speed, the hallmark of MS associated cognitive 
impairment.12  Low conscientiousness also predicts transition for employment to 
disability, after controlling for the influence of other factors such as cognitive impairment 
and depression.13,14 
The association between low Conscientiousness and poor functional outcomes in pwMS 
may be due to differences in behavior, such as reduced adherence to disease modifying 
therapies.15  Results from a study in people with Alzheimer’s disease implicates a role of 
executive function, moderating the effect of Conscientiousness of disease outcomes.16 
The impact of low Conscientiousness on successful behavioral intervention in pwMS 
remains unstudied. One investigation of pwMS showed a correlation between reduced 
success of cognitive training and poor adherence.17 Thus, we hypothesize that poor 
adherence and differences in moment-to-moment intention during similar training 
interventions would be a function of low baseline Conscientiousness. One study validates 

 
Page 8 of 36 
 
this hypothesis, showing that HCs with low Conscientiousness experience reduced near 
and far transfer effects following a working memory training.18 
In addition to the application of personality measures, studies have also shown that 
baseline patterns of brain connectivity can be applied to predict cognitive improvement 
following training in neurologic disease populations.19 There is growing interest in the 
study and application of structural and functional brain network measures in neurologic 
disease20 and its relationship with cognitive remediation.21  
Our goals for this research are two-fold. First, we aim to demonstrate the value of 
personality assessment as a means of risk-stratification and for directing behavioral 
interventions in pwMS. In order to address our first goal, we will investigate the value of 
personality assessment as a means of predicting successful behavioral interventions. In 
our analysis, we will study whether or not the impact of baseline Conscientiousness on 
successful cognitive intervention is moderated by other behavioral variables, such as 
program adherence and executive function, higher order reasoning.  
In order to address our second goal, we will use a multi-parametric approach in which we 
account for cerebral pathology, such as regional gray matter atrophy, microstructural 
white matter damage, lesion volume and localization, white matter tract integrity and 
structural connectivity, and resting state functional connectivity. We will apply network-
based analysis, where appropriate, in order to account for network-level organization of 
the brain. These methods of analysis are well-suited for elucidating patterns of insult 
which lead to changes in complex emergent phenomenon such as higher level cognition.  
Our results may provide foundation for better directing rehabilitation and 
behavioral treatments. For instance, a short questionnaire could be used to identify 
patients whose personality profile puts them at greater risk for unfavorable disease 
progression. An understanding of this risk could help direct efforts which mitigate against 
these unfavorable outcomes. Similarly, baseline patterns of cerebral pathology could also 
be employed to predict responses the cognitive and other behavioral interventions. There 
is a burgeoning interest in personality trait adaptation and personalized health plans 
among health care agencies22 and we believe our research will contribute meaningfully to 
this growing field of interest.  
 
 
3.2 Include complete citations or references.  
Response:  
1.  
Costa PT, McCrae RR. Professional manual of the revised NEO personality 
inventory and NEO five-factor inventory. Psychol Assess Resour Odessa, FL. 
1992. 
2.  
McCrae RR. Trait psychology and culture: exploring intercultural comparisons. J 
Pers. 2001;69(6):819-846. 
3.  
McCrae RR, Costa PT. Validation of the five-factor model of personality across 
instruments and observers. J Pers Soc Psychol. 1987;52(1):81-90. 
doi:10.1037/0022-3514.52.1.81. 

 
Page 9 of 36 
 
4.  
Benedict RHB, Ph D, Priore RL, et al. Personality Disorder in Multiple Sclerosis 
Correlates with Cognitive Impairment. 2001:70-76. 
5.  
Hauser SL, Oksenberg JR. The neurobiology of multiple sclerosis: genes, 
inflammation, and neurodegeneration. Neuron. 2006;52(1):61-76. 
6.  
O’Cleirigh C, Ironson G, Weiss A, Costa Jr. PT. Conscientiousness predicts 
disease progression (CD4 number and viral load) in people living with HIV. Heal 
Psychol. 2007;26(4):473-480. doi:10.1037/0278-6133.26.4.473. 
7.  
Wilson RS, Schneider JA, Arnold SE, Bienias JL, Bennett DA. Conscientiousness 
and the incidence of Alzheimer disease and mild cognitive impairment. Arch Gen 
Psychiatry. 2007;64(10):1204-1212. 
8.  
Jokela M, Pulkki-Raback L, Elovainio M, Kivimaki M. Personality traits as risk 
factors for stroke and coronary heart disease mortality: pooled analysis of three 
cohort studies. J Behav Med. 2014;37(5):881-889. 
9.  
Jokela M, Elovainio M, Nyberg ST, et al. Personality and risk of diabetes in adults: 
Pooled analysis of 5 cohort studies. Heal Psychol. 2014;33(12):1618-1621. 
doi:10.1037/hea0000003. 
10.  
Vollrath ME, Landolt MA, Gnehm HE, Laimbacher J, Sennhauser FH. Child and 
parental personality are associated with glycaemic control in Type 1 diabetes. 
Diabet Med. 2007;24(9):1028-1033. 
11.  
Fisher L, Hessler D, Masharani U, Strycker L. Research : Educational and 
Psychological Aspects Impact of baseline patient characteristics on interventions 
to reduce diabetes distress : the role of personal conscientiousness and diabetes 
self-efficacy. 2014:739-746. doi:10.1111/dme.12403. 
12.  
Benedict RHB, Schwartz CE, Duberstein P, et al. Influence of personality on the 
relationship between gray matter volume and neuropsychiatric symptoms in 
multiple sclerosis. Psychosom Med. 2013;75(3):253-261. 
doi:10.1097/PSY.0b013e31828837cc. 
13.  
Strober LB, Christodoulou C, Benedict RHB, et al. Unemployment in multiple 
sclerosis : the contribution of personality and disease. 2012. 
doi:10.1177/1352458511426735. 
14.  
Benedict RHB, Wahlig E, Bakshi R, et al. Predicting quality of life in multiple 
sclerosis : accounting for physical disability , fatigue , cognition , mood disorder , 
personality , and behavior change. 2005;231:29-34. doi:10.1016/j.jns.2004.12.009. 
15.  
Bruce JM, Hancock LM, Arnett P, Lynch S. Treatment adherence in multiple 
sclerosis: Association with emotional status, personality, and cognition. J Behav 
Med. 2010;33(3):219-227. doi:10.1007/s10865-010-9247-y. 
16.  
Roy S, Ph D, Ficarro S, et al. Executive Function and Personality Predict 
Instrumental Activities of Daily Living in Alzheimer Disease. Am J Geriatr 
Psychiatry. 2017;24(11):1074-1083. doi:10.1016/j.jagp.2016.06.014. 
17.  
Charvet LE, Yang J, Shaw MT, et al. Cognitive function in multiple sclerosis 
improves with telerehabilitation : Results from a randomized controlled trial. 

 
Page 10 of 36 
 
2017:1-13. 
18.  
Studer-luethi B, Jaeggi SM, Buschkuehl M, Perrig WJ. Influence of neuroticism 
and conscientiousness on working memory training outcome. Pers Individ Dif. 
2012;53(1):44-49. doi:10.1016/j.paid.2012.02.012. 
19.  
Arnemann KL, Chen AJ-W, Novakovic-Agopian T, Gratton C, Nomura EM, 
D’Esposito M. Functional brain network modularity predicts response to cognitive 
training after brain injury. Neurology. 2015;84(15):1568-1574. 
doi:10.1212/WNL.0000000000001476. 
20.  
Rubinov M, Sporns O. Complex network measures of brain connectivity: uses and 
interpretations. Neuroimage. 2010;52(3):1059-1069. 
doi:10.1016/j.neuroimage.2009.10.003. 
21.  
Takeuchi H, Sekiguchi A, Taki Y, et al. Training of Working Memory Impacts 
Structural Connectivity. 2010;30(9):3297-3303. doi:10.1523/JNEUROSCI.4611-
09.2010. 
22.  
Chapman BP, Hampson S, Clarkin J. Personality-Informed Interventions for 
Healthy Aging: Conclusions From a National Institute on Aging Workgroup 
Benjamin. 2014;50(5):1426-1441. doi:10.1037/a0034135.Personality-Informed. 
 
 
4.0 Study Design 
4.1 Describe and explain the study design (e.g. case-control, cross-sectional, 
ethnographic, experimental, interventional, longitudinal, observational). 
Response: Interventional 
 
5.0 Local Number of Subjects 
5.1 Indicate the total number of subjects that will be enrolled or records that 
will be reviewed locally. 
Response: We will recruit 50 subjects with multiple sclerosis who are already 
enrolled in CEG-MS study. 
 
5.2 If applicable, indicate how many subjects you expect to screen to reach your 
target sample (i.e. your screen failure rate).  
Response:  
We expect that potential participants to be enrolled through the CEG-MS study 
for suitability for the study. Subjects who agree to participate and pass screening 
requirements will be enrolled in the study.  
 

 
Page 11 of 36 
 
5.3 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:  This research will be conducted through the Buffalo Neuroimaging 
Analysis Center (BNAC) group.  We expect to recruit subjects from the CEG-MS 
study database. Based on our targeted population, we believe there is a sufficient 
number of potential participants to meet participant target of 50 in adherence to 
the protocol. 
 
6.0 Inclusion and Exclusion Criteria 
6.1 Describe the criteria that define who will be included in your final study 
sample.  
NOTE:  This may be done in bullet point fashion. 
Response:  
 
For all subjects: 
- 
males and females above age 18  
- 
fluent in English 
- 
education >9 years 
 
Additional inclusion criteria for MS patients are as follows: 
- 
Clinically definite MS diagnosis 
- 
Expanded Disability Status Scale (EDSS) ≤ 6.5 
- 
MS patients must be relapse-free and stable from the time of their MRI 
acquired for the CEG-MS study 
- 
Willing and able to comply with the study procedures for the duration of the 
trial  
 
6.2 Describe the criteria that define who will be excluded from your final study 
sample.   
NOTE:  This may be done in bullet point fashion.  
Response:   
- 
history of serious medical or psychiatric illness (other than MS in the patient 
group) that may affect cognitive functioning  
- 
color-blindness 

 
Page 12 of 36 
 
- 
history of developmental disability  
- 
past or current alcohol or substance dependence  
- 
History of major depressive disorder, bipolar disorder, or psychotic disorder 
predating the onset of MS 
- 
History of traumatic brain injury as defined by trauma causing loss of 
consciousness or transient post-traumatic or retrograde amnesia exceeding 5 
min 
- 
Other pathology related to MRI abnormalities 
 
6.3 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 
 
6.4 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. 
Response: Non-English speaking individuals will not be able to have a 
neuropsychological assessment battery administered as measures are developed in 
English and no translations are available. Thus non-English speaking individuals 
will not be involved in the research. 

 
Page 13 of 36 
 
 
7.0 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. 
7.1 For research that involves pregnant women, safeguards include: 
NOTE CHECKLIST: Pregnant Women (HRP-412) 
Response: 
  
☒ 
N/A:  This research does not involve pregnant women. 
7.2 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. 
7.3 
For research that involves prisoners, safeguards include: 
NOTE CHECKLIST: Prisoners (HRP-415) 
Response:  
 
☒ 
N/A:  This research does not involve prisoners. 
7.4 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”). 
7.5 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. 

 
Page 14 of 36 
 
7.6 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 
 
8.0 Eligibility Screening  
8.1 
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:  
All subjects will be recruited from the CEG-MS study. Subjects will undergo 
eligibility screening conducted by trained members of the research team using the 
attached phone and in-person script, and screening form to determine whether or 
not they are interested and meet all of the eligibility criteria outlined above.  
 Please see attached.  
 
9.0 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. 
9.1 
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 participants will be identified from the pre-existing list of study 
participants of the CEG-MS study database. Recruitment will be directed towards 
subjects who completed MRI evaluation for the CEG-MS study. These 
individuals will then be further screened based on the inclusion and exclusion 
criteria and contacted in person and via phone. If they are interested, the 
remaining screening questions will be asked. If the individual agrees to participate 
in the study, their appointment for testing will be scheduled based on their 
availability and convenience. 
 

 
Page 15 of 36 
 
9.2 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:  
Contact information from CEG-MS study databases is retained on a secure 
network in Buffalo Neuroimaging Analysis Centre (BNAC).  The network is 
password protected and can only be accessed by PI and trained study members.  
Information is de-identified within the contact information file and only those 
with access to both that file and a separate de-identifying key file called ‘CEG 
Codes’ will be able to link the potential participant’s name to his/her contact 
information.  Once a participant has been recruited, his/her information will be 
removed from the recruitment contact information file. 
 
9.3 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: 
Please see attached phone and in-person script. 
 
10.0 
Procedures Involved 
10.1 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:  
The participant will be asked to make a total of two (2) visits, approximately 90 
days apart. Each visit will involve: neuro-performance testing, and self-report 
questionnaires. Each study visit is expected to take approximately 1-2 hours. 
Between the two visits, the participant will be asked to complete a 12 week, 
computer-based cognitive training program. This includes 1 hour of training each 
day for 5 days each week.  

 
Page 16 of 36 
 
On Visit 1, the participants will undergo a full battery of neuro-performance tasks 
including tests and questionnaires that measure your memory, thinking speed, 
fatigue, and personality. This visit is expected to take approximately 1-2 hours.  
The participants will be also asked to have a close friend or family member to 
complete similar surveys.  A self-addressed envelope containing these 
questionnaires will be provided to take home with them. The participant will need 
to pass it onto a close friend or family member to be completed and mailed back. 
In addition, the participant will be asked to take part in the 12 week computerized 
cognitive training program. This can be done at home, or anywhere the participant 
has access to a computer and internet. This cognitive training has been shown to 
improve cognitive performance in people with multiple sclerosis. The training 
involves a variety of interactive exercises which adapt to your abilities. The 
participants will need complete 1 hour of training each day, for 5 days each week.  
At 90 days, the participant will return for the 1-2 hours’ follow-up visit where 
they will complete the same cognitive testing and questionnaires which they had 
completed during visit 1. 
All study visits will take place at Buffalo General Hospital. All of the procedures 
described above will be performed by a trained member of the research team as 
part of the research study.  
If an individual is ineligible for participation, their screening information will be 
discarded (i.e., shredded).  If participants are deemed eligible (either in person or 
over the phone), they will be scheduled to come in to the hospital for 
neuropsychological testing.  Written consent will be obtained prior to 
administration of tests.  As part of the consent process, participants will be asked 
for permission to use any data collected as part of the screening process as well. 
 
10.2 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. 
Response:  Demographic/social history, health history (as provided by 
participants during screening, review of medical records, etc.), and cognitive test 
data. 
 
10.3 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: Below is a list of neuropsychological tests that will be included. 
Symbol Digit Modalities Test (SDMT), California Verbal Learning Test 2nd 
Edition (CVLT), Brief Visuospatial Learning Test Revised (BVMT-R), Delis-
Kaplan Executive Function System [DKEFS] Sorting Test, Delis-Kaplan 

 
Page 17 of 36 
 
Executive Function System [DKEFS] Tower Test. Self-report/informant-report 
surveys have been uploaded. Self-report measures include the Beck Depression 
Inventory-Fast Screen (BDI-FS), Multiple Sclerosis Neuropsychological 
Questionnaire (MSNQ), Fatigue Severity Scale (FSS), NEO-FFI personality 
inventory, Multiple Sclerosis Quality of Life (MSQoL) and Elithorn’s Perceptual 
Maze Test (EPMT). Informant-report measures include the NEO-FFI.  
 
10.4 Describe any source records that will be used to collect data about subjects 
(e.g. school records, electronic medical records). 
Response: We will be collecting MRI and EDSS information for subjects from the 
database of IRB no. 603069 of CEG- MS study. 
 
10.5 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: In case of any incidental findings, the details will be shared 
with subject’s primary care physician by adhering to the procedures and 
reporting policies as outlined by the UBIRB. Results will not be shared 
with participants or anyone else. Any incidental findings for the patients 
will be relayed to the primary neurologist who can make the determination 
regarding whether to share this information with the participant’s primary 
care physician. 
10.6 Indicate whether or not study results will be shared with subjects or others, 
and if so, describe how these will be shared. 
Response:  Study results will not be shared with subjects. 
 
11.0 
Study Timelines 
11.1 Describe the anticipated duration needed to enroll all study subjects. 
Response: It is anticipated that enrollment of all study subjects will be completed 
in one to one-and-a-half years. 
 
11.2 Describe the duration of an individual subject’s participation in the study. 
Include length of study visits, and overall study follow-up time. 
Response:  
Patients will complete two visits (Day 1 and Day 90). Neuropsychological testing 
will take approximately 1-2 hours during a single visit.   
 

 
Page 18 of 36 
 
11.3 Describe the estimated duration for the investigators to complete this study 
(i.e. all data is collected and all analyses have been completed). 
Response: 
Completion of this study, including primary analyses is expected to be in one to 
two years.  
 
12.0 
Setting 
12.1 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:  Screening and neuropsychological procedures will be conducted in a 
private testing room in the Buffalo Neuroimaging Analysis Center (BNAC) at the 
Buffalo General Hospital. Database entry and data analysis will also occur at the 
academic offices of Buffalo Neuroimaging Analysis Center (BNAC). 
 
12.2 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:  
 
☒ 
N/A:  This study is not conducted outside of UB or its affiliates. 
13.0 
Community-Based Participatory Research 
13.1 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 

 
Page 19 of 36 
 
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. 
13.2 
Describe the composition and involvement of a community advisory 
board. 
Response:  
 
☒ 
N/A:  This study does not have a community advisory board. 
14.0 
Resources and Qualifications 
14.1 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: Ralph Benedict is a board-certified neuropsychologist.  All members of 
the research team will receive extensive training to administer study procedures in 
this research.  They will also undergo required CITI and UBIRB GCP training.  
They will also be closely supervised by Ralph Benedict.    
 
Describe other resources available to conduct the research.  
14.2 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: The PI will be adequately accessible to oversee this project.  In 
addition, members of the research team will be dedicated to conducting the 
project.  
 

 
Page 20 of 36 
 
14.3 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. 
Response: While there are no anticipated consequences, the PI will be adequately 
accessible to address any needs. Any unanticipated medical emergencies or 
incidental findings will be brought to the attention of a neurologist responsible for 
the care of the patient.  
 
14.4 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:  
As described above, all research staff will undergo extensive training in 
administration of neuropsychological tests and they will be closely supervised by 
neuropsychologist, Dr. Ralph Benedict.  They will also be required to undergo all 
necessary research training protocols before engaging in research activities with 
participants.   
 
15.0 
Other Approvals 
15.1 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. 
16.0 
Provisions to Protect the Privacy Interests of Subjects 
 
16.1 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.”   

 
Page 21 of 36 
 
Response:  
Study procedures are performed in private, noise- and temperature-controlled 
rooms and will be conducted in the presence of only one designated, trained 
member of the research team. Study documents are maintained in a locked staff 
office that is only accessed by designated personnel.  Participants are reminded 
that they are free to refuse to answer any questions at any time.  When they 
contact the research team via telephone they are able to determine the privacy of 
the settings in which they participate.   
 
16.2 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. 
Response:  
After the consent process, the participant controls the research team’s access to 
such information because it was directly provided by the participant through an 
interview/survey procedure. 
 
17.0 
Data Management and Analysis 
17.1 Describe the data analysis plan, including any statistical procedures.  This 
section applies to both quantitative and qualitative analysis.  
Response:  
Statistical analyses will be performed using SPSS 22.0 (IBM Inc., Armonk, NY, 
USA) and R 3.4.1 (The R Foundation). 
[1a] Determine whether low Conscientiousness predicts lesser overall cognitive 
improvement following cognitive rehabilitation in people with MS. The question 
of whether Conscientiousness predicts successful intervention will be addressed 
using baseline measures of trait Conscientiousness and cognitive performance 
before and after rehabilitation. We will assess linear relationships between 
baseline trait Conscientiousness and overall magnitude of cognitive improvement 
using linear regression models. Cognitive improvement will be measured 
according to differences in cognitive scores between baseline assessment during 
visit 1 and post-rehabilitation assessment at visit 2. In order to summarize results 
across all cognitive measures, test scores will be converted to normalized z-scores 
and averaged together.  
1b] Determine whether the impact of Conscientiousness on cognitive 
rehabilitation is moderated by executive function and treatment adherence. In 
order to address the question of whether or not adherence and executive function 
moderate the impact of Conscientiousness on intervention success, we intend to 
add interaction parameters to the linear regression analysis described for aim 1a. 

 
Page 22 of 36 
 
For instance, we will calculate the interaction variable between Conscientiousness 
and DKEFS-ST (executive function) and include it in our regression models.  
[2] Identify structural and functional brain connectome characteristics which 
predict successful improvement in sub-domains of cognition following 
rehabilitation. In order to identify brain connectome characteristics which, predict 
specific responses to sub-domains of cognition following rehabilitation, we intend 
to employ linear machine/statistical learning techniques, such as partial least 
squares regression. The correct statistical learning models will be identified at the 
time of analysis in order to produce the most appropriate predictions. Models will 
be selected according to the distribution and dimensionality of our connectome 
variables. Following training of the predictive models, fit of the models will be 
assessed using k-fold cross validation. 
 
17.2 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: Given a 0.38 effect size observed in a previous study of HCs which 
indicated a relationship between Conscientiousness and successful cognitive 
training20, power analysis indicated 41 participants would be sufficient for an 80% 
chance of avoiding type II error. 
 
17.3 Describe any procedures that will be used for quality control of collected 
data. 
Response:  
All MRI data has already been reviewed for quality by expert investigators 
responsible for the CEG-MS study. 
Scoring and data entry will be completed and checked by trained staff members 
under the supervision of the PI.  
 
18.0 
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.   
 
18.1 
A.  Where and how will all data and records be stored?  Include 
information about:  password protection, encryption, physical controls, 

 
Page 23 of 36 
 
authorization of access, and separation of identifiers and data, as applicable.  
Include physical (e.g. paper) and electronic files. 
Response: Neuropsychological testing data and clinical outcome measures 
will be maintained in de-identified participant charts. These charts will be 
stored in a locked cabinet and entered into a password-protected database. 
Appropriate legal guidelines regarding retention of records will be 
followed. Identifiable data will be destroyed at the earliest possible point. 
The subject will not be identified by name in any study reports, and these 
reports will be used for research purposes only.  Every effort will be made 
to keep the subject’s personal medical data confidential. Stored data will 
be accessed only by the PI and/or designated research staff. The use of 
stored, de-identified data is undetermined at this time. 
 
18.2 
A.  How long will the data be stored? 
Response: Data will be stored for the duration of the study and according 
to federal regulations. 
 
18.3 
A.  Who will have access to the data? 
Response: The principal investigator and delegated research staff. 
 
18.4 
A.  Who is responsible for receipt or transmission of the data? 
Response: The principal investigator and delegated research staff. 
 
18.5 
A.  How will the data be transported? 
Response: Data will not be transported locally.  
 
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) 
 
18.6 
B.  Where and how will all specimens be stored?  Include information 
about:  physical controls, authorization of access, and labeling of specimens, as 
applicable.   
Response:  

 
Page 24 of 36 
 
 
18.7 
B.  How long will the specimens be stored? 
Response:  
 
18.8 
B.  Who will have access to the specimens? 
Response:  
 
18.9 
B.  Who is responsible for receipt or transmission of the specimens? 
Response:  
 
18.10 B.  How will the specimens be transported? 
Response: 
 
 
19.0 
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. 
 
19.1 Describe the plan to periodically evaluate the data collected regarding both 
harms and benefits to determine whether subjects remain safe. 
Response: Data will be reviewed periodically to confirm the safety of all 
subjects.  
 
19.2 Describe what data are reviewed, including safety data, untoward events, 
and efficacy data. 
Response: All data will be reviewed. 
 
19.3 Describe any safety endpoints. 
Response: There are no safety endpoints in this study.  There is no active medical 
intervention and the assessments pose no known risk to the subjects. 

 
Page 25 of 36 
 
 
19.4 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 
 
19.5 Describe the frequency of safety data collection. 
Response: N/A 
 
19.6 Describe who will review the safety data. 
Response: N/A 
 
19.7 Describe the frequency or periodicity of review of cumulative safety data. 
Response: N/A 
 
19.8 Describe the statistical tests for analyzing the safety data to determine 
whether harm is occurring. 
Response: N/A 
 
19.9 Describe any conditions that trigger an immediate suspension of the 
research. 
Response: N/A 
 
20.0 
Withdrawal of Subjects 
☐ 
N/A:  This study is not enrolling subjects.  This section does not apply. 
 
20.1 Describe anticipated circumstances under which subjects may be withdrawn 
from the research without their consent. 
Response: Participation in this study is voluntary. Patients are explicitly informed 
that that they may withdraw from the study at any time and for any reason. 
Additionally, if, in the opinion of the site PI that a subject is no longer able to 
provide informed consent, or if a subject is non-compliant with study visits he/she 
may be withdrawn from the study. For example, if more than three attempts to 
contact the patient to schedule any study-related procedure are unsuccessful, the 
patient may be withdrawn 
 
20.2 Describe any procedures for orderly termination.   

 
Page 26 of 36 
 
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: In the event of early termination/withdrawal from the study, an 
exit interview will be conducted by the PI, treating clinician or trained 
members of the research team.  
 
20.3 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: Participation in this study is voluntary.  Referred patients may 
refuse to participate without penalty and such refusal will not prejudice 
future treatment or benefits at the Jacobs Neurological Institute (JNI) or 
Buffalo Neuroimaging Analysis Center (BNAC).  Patients will be free to 
discontinue participation in the study at any time without fear of penalty or 
loss of medical care or loss of any benefits to which you may otherwise be 
entitled. If a subject chooses to withdraw from the study, the data collected 
up to the time of withdrawal will continue to be used, but the subject will 
no longer be contacted and no further data will be collected. 
 
21.0 
Risks to Subjects 
21.1 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: The only foreseeable risk is breach of confidentiality, although 
this is unlikely to occur. Since subjects are being asked to perform 
cognitive and manual tasks as part of this study, however, they may 
experience some stress or anxiety or fatigue associated with mental and 
physical exertion. There are no social, legal, or economic risks. 
 
21.2 Describe procedures performed to lessen the probability or magnitude of 
risks, including procedures being performed to monitor subjects for safety. 
Response: N/A 
 
21.3 If applicable, indicate which procedures may have risks to the subjects that 
are currently unforeseeable. 

 
Page 27 of 36 
 
Response: Subjects are being asked to perform cognitive and manual tasks 
and some may experience psychological stress/pressure/anxiety or mental 
fatigue with such exertion. 
 
21.4 If applicable, indicate which research procedures may have risks to an 
embryo or fetus should the subject be or become pregnant. 
Response: N/A 
 
21.5 If applicable, describe risks to others who are not subjects. 
Response: There are no anticipated risks to others who are not subjects.  
 
22.0 
Potential Benefits to Subjects 
22.1 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: Participants who successfully adhere to the study protocols are 
expected to experience improved cognitive performance and perceived cognition.  
 
23.0 
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.   
23.1 
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: The University at Buffalo has no program to pay for medical 
care for research-related injury. No injuries are expected.  
 
23.2 
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: N/A 
 

 
Page 28 of 36 
 
24.0 
Economic Burden to Subjects 
24.1 Describe any costs that subjects may be responsible for because of 
participation in the research.   
NOTE:  Some examples include transportation or parking. 
Response:  
The subject is not responsible for any costs of the procedures involved in the 
study. 
 
☐ 
N/A:  This study is not enrolling subjects, or is limited to records review 
procedures only.  This section does not apply. 
25.0 
Compensation for Participation 
25.1 
Describe the amount and timing of any compensation to subjects, 
including monetary, course credit, or gift card compensation. 
Response: Subjects will receive $50 compensation for completion of each study 
visit. Checks will be mailed to subjects.  
 
☐ 
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. 
26.0 
Consent Process 
26.1 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) 
 
26.2 Describe where the consent process will take place.  Include steps to 
maximize subjects’ privacy. 
Response: The consent process will take place in a private, temperature 
and noise controlled testing room in BNAC, Department of Neurology, 
Buffalo General Hospital. 
 
26.3 Describe how you will ensure that subjects are provided with a sufficient 
period of time to consider taking part in the research study.   

 
Page 29 of 36 
 
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: Consent will be provided in-person prior to neuropsychological 
assessment at a point where the PI or his representative is available to 
answer any questions about the study.   
 
26.4 Describe any process to ensure ongoing consent, defined as a subject’s 
willingness to continue participation for the duration of the research study.   
Response: Prior to all study-related procedures participants will reminded that 
participation is voluntary. 
 
26.5 Indicate whether you will be following “SOP: Informed Consent Process for 
Research (HRP-090).” 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 
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) 
26.6 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: N/A 
 

 
Page 30 of 36 
 
26.7 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.  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: N/A 
 
 
Cognitively Impaired Adults 
☒ 
N/A:  This study will not enroll cognitively impaired adults.   
(Skip to Section 26.9) 
26.8   Describe the process to determine whether an individual is capable of 
consent.  
Response: Individuals are deemed capable when they express an understanding of 
the study objectives, procedures, etc. Understanding of the study procedures, 
objectives, etc will be determined if the subject is able to coherently relay relevant 
information when asked by the research staff. 
 
 
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). 
26.9  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).”  

 
Page 31 of 36 
 
26.10 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: N/A 
 
26.11 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. 
Response:  
 
26.12 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) 
26.13 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.”  

 
Page 32 of 36 
 
NOTE:  Examples of acceptable responses include: verification via electronic 
medical record, driver’s license or state-issued ID, screening questionnaire. 
Response:  
 
26.14For 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:  
 
26.15 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).”  
26.16Describe 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:  
 
26.17 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:  
 
26.18 When assent of children is obtained, describe how it will be documented. 

 
Page 33 of 36 
 
Response:  
 
27.0 
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. 
27.1 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:  
 
27.2 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:  
 
28.0 
Process to Document Consent 
☐ 
N/A:  A Waiver of Consent is being requested.   
(Skip to Section 29.0) 
28.1 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).   

 
Page 34 of 36 
 
Response: Consent form is included in the application packet 
 
☒ 
We will be following “SOP:  Written Documentation of Consent” 
(HRP-091). 
29.0 
Multi-Site Research (Multisite/Multicenter Only) 
☒ 
N/A:  This study is not an investigator-initiated multi-site study.  This 
section does not apply. 
 
29.1 If this is a multi-site study where you are the lead investigator, describe the 
processes to ensure communication among sites, such as: 
 
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. 
 
All non-compliance with the study protocol or applicable requirements 
will be reported in accordance with local policy. 
Response:  
 
29.2 Describe the method for communicating to engaged participating sites: 
 
Problems 
 
Interim results 
 
Study closure 
Response:  
 
29.3 
Indicate the total number of subjects that will be enrolled or records that 
will be reviewed across all sites. 
Response:  
 
29.4 
If this is a multicenter study for which UB will serve as the IRB of record, 
and subjects will be recruited by methods not under the control of the local site 
(e.g., call centers, national advertisements) describe those methods.  
Response:  

 
Page 35 of 36 
 
 
30.0 
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. 
30.1 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: The data will be maintained indefinitely. 
 
30.2 List the data to be stored or associated with each specimen. 
Response: Data collected from the research-related procedures described above 
will be stored.  
 
30.3 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: Data will not be released to those outside the clinical treatment 
or research team. 
 
31.0 
Drugs or Devices 
☒ 
N/A:  This study does not involve drugs or devices.  This section does not 
apply. 
31.1 If the research involves drugs or devices, list and describe all drugs and 
devices used in the research, the purpose of their use, and their regulatory 
approval status.  
Response:  
 
31.2 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. 
Response: 

 
Page 36 of 36 
 
 
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: 
31.3 Identify the holder of the IND/IDE/Abbreviated IDE. 
Response:  
 
31.4 Explain procedures followed to comply with FDA sponsor requirements 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:  
 
32.0 
Humanitarian Use Devices 
☒ 
N/A:  This study does not involve humanitarian use devices.  This does 
not apply. 
32.1 
For Humanitarian Use Device (HUD) uses provide a description of the 
device, a summary of how you propose to use the device, including a description 
of any screening procedures, the HUD procedure, and any patient follow-up 
visits, tests or procedures. 
Response:  
 
32.2 
 For HUD uses provide a description of how the patient will be informed 
of the potential risks and benefits of the HUD and any procedures associated with 
its use. 
Response: