Sleep-SMART for Veterans With MCI and Insomnia: A Pilot Study
Phase: NA
Conditions: Insomnia, Mild Cognitive Impairment
Sponsor: VA Office of Research and Development

Sleep-SMART for Veterans with MCI and 
Insomnia: A Pilot Study
NCT05016960
July 21, 2021

Human Protocol (Version 1.1)
General Information
*Please enter the full title of your protocol:
Sleep-SMART for Veterans with MCI and Insomnia: A Pilot Study
 
 
*Please provide a short name (nickname) to reference this protocol:
Sleep-SMART
* This field allows you to enter an abbreviated version of the Protocol Title to quickly identify 
this protocol.
 
 
Add Site(s)
VA Site (************** DO NOT ADD OR CHANGE, just save and continue **************):
Primary 
Dept?
Department Name
VASDHS - VASDHS
 
Identify protocol staff members
*Please add a Principal Investigator for the study:
 
Erin L. Almklov, PhD
 
3.1 Add all other VA research staff personnel (if name is not in the list, please contact Research 
Staffing to confirm appointment status)
 
A) Additional Investigators
Orff, Henry J., PhD 
 Co-Investigator
Pittman, James O. E., PhD 
 Co-Investigator
Rabin, Adrienn Borsika, PhD 
 Co-Investigator
Twamley, Elizabeth W., PhD 
 Co-Investigator
B) Research Support Staff
Salamat, Jennifer S. 
 Study Coordinator
*Please select the Research Contact(s)
 

Almklov, Erin L., PhD 
Salamat, Jennifer S. 
The Research Contact(s) will receive all important system notifications along with the Principal 
Investigator. (Research Contacts are typically Study Coordinators or the Principal Investigator 
themselves).
 
VASDHS IRB
Human Subjects Protocol
v20190121
Section 1 - Preliminaries
Principal Investigator:
Erin L. Almklov, PhD
Protocol Title:
Sleep-SMART for Veterans with MCI and Insomnia: A Pilot Study
IRB Protocol Number:
H210118
Protocol Nickname:
Sleep-SMART
Form Template Version:
v20150115
Date Prepared:
07/21/2021
Please be advised that this protocol application form has changed as a result of the 2018 Common Rule.  There are new 
questions and sections, and you may be required to provide additional information to previous sections.
1a) Is this study considered human research?
Yes 
No 
I don't know 
1b) Please select:
This is an application for a NEW human subject research protocol 
This is a revision of an existing protocol 
 Section 2 - Research Subjects
2a) What is the total planned number of VA-consented subjects? 
Include the total number of subjects who will prospectively agree to participate in the study (e.g., documented consent, 
oral consent, or other).
31
2b) What is the total number of VA subjects who WILL NOT be consented? 

Include the total number of subjects that will be included without consent (e.g., chart review).  Note: Data about people 
are still considered “human subjects” by the IRB, so even if you do not intend to contact the patients whose charts you 
will review, you still should enter the number of charts as your “planned subjects."
0
 Section 2.1 Consented Subject Groups
2.1) For each of the subject categories listed below, indicate whether or not these subject groups will participate in the study: 
2.1a) Children under the age of 18
Note:   If neonates or children will be involved in this study, certification by the Medical Center Director will be required. 
Only minimal risk research may be performed with children.  Only non-invasive monitoring and/or prospective 
observational and retrospective record review studies that are minimal risk can be conducted in VA involving neonates.
  Yes   
  No
2.1b) Pregnant women
  Yes   
  No
2.1c) Individuals with cognitive/decisional impairment
 Yes   
 No
2.1d) Non-English-speaking individuals
  Yes   
  No
2.1e) Prisoners of War (explicitly targeting this group)
  Yes   
  No
2.1f) Non-Veterans (Note: Justification for inclusion of non-Veterans will be required)
  Yes   
  No
2.1g) Incarcerated individuals (Note: VA CRADO approval will be required)
  Yes   
  No
2.1h) VA employees - including VA paid, IPA, or WOC (Note: Union review and authorization may be required)
  Yes   
  No
2.1i) Students of the institution (e.g., resident trainees) or of the investigator
  Yes   
  No
2.1j) Patients with cancer (or high cancer risk) [explicitly targeting this group]
  Yes   
  No
 Section 3 - Study Features   (these items default to "No" for convenience)
  
3) This section consists of several Yes/No questions addressing protocol characteristics.     Click on 
.
Save and Continue
 Section 3.1 Protocol Basics
Select all that apply
3.1a) The research 
 the participant.
intends to change

 Yes   
 No
3.1b) 
 with living participants to collect data or specimens with no intent to change them.
Interactions
  Yes   
  No
3.1c) This is a study that 
 has any 
 
never
subject contact and does not collect subject identifiers
  Yes   
  No
3.1d) This is a 
study involving retrospective or prospective medical records.
chart review 
  Yes   
  No
3.1e) This is a 
study occurring in-part or in-full at other locations.
multi-site 
  Yes   
  No
3.1f) There is an 
 component to this research. 
international
International research includes sending or receiving human 
derived data or specimens (identifiable, limited data set, coded, or deidentified) to or from an international 
source.  International research does not include studies in which VA is only one of multiple participating sites where the 
overall study-wide PI is not a VA investigator.
  Yes   
  No
3.1g) This study includes 
 (not including VA-leased space or CBOC clinics) conducted under 
off-station activity
VASDHS IRB approval.  Note: this does not include research conducted by a collaborator at their home institution under 
their institutional approval.
  Yes   
  No
3.1h) VA subjects will 
 in part or in full 
 (not including VA-leased space or clinics) under 
participate
at other locations
VASDHS IRB approval.
  Yes   
  No
 Section 3.2 Specimen Use and Data Repository
Indicate whether or not each of the following applies to this protocol
3.2a) Involves specimens that are left over from pathological or diagnostic testing (
)
non-research specimens
  Yes   
  No
3.2b) Involves 
 purposes 
specimens collected for research
only
  Yes   
  No
3.2c) This study includes 
 (specimens are retained for use outside of the purposes of this protocol)
specimen banking
  Yes   
  No
3.2d) The study involves 
genotyping or other 
DNA 
genetic analysis
  Yes   
  No
3.2e) Biological
will be sent outside of the VA.
 specimens/material 
  Yes   
  No
3.2f) A 
 is maintained (data are retained after completion of the protocol for other uses, 
 see 
data repository
IMPORTANT:
? before checking "yes")
  Yes   
  No
3.2g)  
of the VA (identifiable, coded, limited data set, or deidentified)
Data will be shared outside 

 Yes   
 No
 Section 3.3 Treatment and Clinical Trials
Indicate whether or not each of the following applies to this protocol
3.3a) Includes a 
 component (a research treatment)
treatment
 Yes   
 No
3.3b) Study is a 
  
clinical trial. Note:  A clinical trial is a research study in which one or more human subjects are 
 (which may include placebo or other control) to evaluate the effects of 
prospectively assigned to one or more interventions
the interventions on biomedical or behavioral health-related outcomes.
  Yes   
  No
3.3c) Has a data safety monitoring board (
or data safety monitoring committee.
DSMB) 
  Yes   
  No
3.3d) Has a 
 (but not a DSMB) (this is not the data security plan, it is a safety plan).
data safety monitoring plan
  Yes   
  No
 Section 3.4 Drugs and Devices
Indicate whether or not each of the following applies to this protocol
3.4a) 
 that require 
 action such as an Investigational New Drug (IND) approval or exemption or 510(k) 
Drugs
FDA
approval.
  Yes   
  No
3.4b) Other drugs, supplement, etc. that
action for inclusion in the study.
 do not require FDA 
  Yes   
  No
3.4c) Medical 
 IDE approval or waiver
devices requiring FDA
  Yes   
  No
3.4d)
 medical 
 Other
devices
  Yes   
  No
 Section 3.5 Risk and Hazards
Indicate whether or not each of the following applies to this protocol
3.5a) Study places subjects at 
(do not include risks that are due to standard care)
greater than minimal risk 
  Yes   
  No
3.5b) Human subjects are exposed to 
 (do not include standard care).
radioisotopes
  Yes   
  No
3.5c) Subjects have other 
 (e.g., x-rays) (do not include standard clinical use).
radiation exposure
  Yes   
  No
3.5d) Target population has psychiatric diagnosis or behavioral complaint.

 Yes   
 No
 Section 3.6 Clinical Facilities and Standard Care
Indicate whether or not each of the following applies to this protocol
3.6a) Study 
 (e.g., adds required tests run in the VA lab for study purposes; research procedures 
uses VA clinical services
concurrent with clinical care)
  Yes   
  No
3.6b) Includes procedures or drugs that will be considered part of standard care.
  Yes   
  No
3.6c) Involves 
purposes.
lab tests done for research 
  Yes   
  No
 Section 3.7 Subject Expenses and Compensation
Indicate whether or not each of the following applies to this protocol
3.7a) There may be expense or added 
or the subject's insurance.
costs to the subject 
  Yes   
  No
3.7b) This is a 
 and subjects may be billed for study drugs or procedures.
qualifying cancer treatment trial
  Yes   
  No
3.7c) This is a cancer treatment trial but 
 for study drugs or procedures.
subjects will not be billed
  Yes   
  No
3.7d) Subjects will be
(either in cash or other means such as a gift certificate).
 compensated 
 Yes   
 No
 Section 3.8 Subject Activities
Indicate whether or not each of the following applies to this protocol
3.8a) Involves 
 completed by subjects
surveys or questionnaires
 Yes   
 No
3.8b) Includes the use of 
 such as flyers, advertisements, or letters
recruitment materials
 Yes   
 No
3.8c) Involves facial 
 or audio or video 
of 
photographs
recordings 
patients
 Yes   
 No
 Section 3.9 Sponsors and Collaboration
Indicate whether or not each of the following applies to this protocol
3.9a) This research is a funded research project (commercial (industry) sponsor, NIH, VA, other).

 Yes   
 No
3.9b) Other 
is provided (e.g., drugs or supplies).
commercial (industry) non-financial support 
  Yes   
  No
3.9d) The protocol has 
 involvement (e.g., subjects or funding).
Department of Defense
  Yes   
  No
3.9c) The PI or other study staff member has a financial interest or other
related to this study.
 real or potential conflict 
  Yes   
  No
3.9e) This study involves 
research activities (research conducted at other institutions under the authorities or 
c llaborative 
o
approvals of the other institution/s). Note: this may include other VA and/or non-VA institutions, but does not include off-
site VA research.
  Yes   
  No
 Section 4 - Estimated Duration
4) What is the estimated duration of the entire study?  (From IRB approval to IRB closure)
2 years
 Section 5 - Lay Language Summary
5) Provide a summary or synopsis of the proposed study using non-technical language (not more than 1 paragraph)
Cognitive Behavioral Therapy for Insomnia (CBT-I) is the first-line treatment for chronic insomnia. 
However, cognitive impairments may limit progress in CBT-I for older Veterans with Mild Cognitive 
Impairment (MCI). This study will develop and pilot test Sleep-SMART (Sleep Symptom Management and 
Rehabilitation Therapy), an adapted CBT-I treatment that incorporates Cognitive Symptom Management 
and Rehabilitation Therapy (CogSMART) principles with a goal of improving sleep treatment and 
rehabilitation outcomes for Veterans with co-occurring MCI and insomnia. The innovation of this study 
centers on enhancing CBT-I by providing supportive cognitive strategies designed to improve treatment 
adherence, learning, and acceptability. We anticipate that by improving sleep we can concurrently 
improve daily functioning, increase quality of life, prevent or reduce late-life disability, and mitigate long-
term cognitive decline in this Veteran population.
 Section 6 - Specific Aims
6) Provide a statement of specific aims and 
 that serve as the basis for this protocol.  Emphasize those aspects that 
hypotheses
justify the use of human subjects.
Aim 1: Develop the Sleep-SMART intervention and treatment manual using a participatory research 
approach during a 6-month development phase.
Aim 2: Assess the feasibility and acceptability of Sleep-SMART in 26 Veterans aged 60 or older with MCI 
and insomnia. 
H1: Feasibility. 26 Veterans will be enrolled. At least 20 Veterans will complete the treatment. Feasibility 
will also be assessed by collecting data on recruitment; refusal rate; reasons for treatment 
discontinuation; treatment fidelity; and tracking contextual barriers and facilitators for implementation. 
H2: Acceptability. Veterans will find Sleep-SMART acceptable as measured by the Client Satisfaction 
Questionnaire (CSQ); Acceptability of Intervention Measure (AIM) and Intervention Appropriateness 
Measure (IAM); qualitative interview data; percent of sessions attended; and treatment adherence 
(percent homework completion, basic skills assessment of treatment material, and discrepancy scores 
between prescribed sleep time and objectively recorded sleep).
Aim 3: We will explore the effects of Sleep-SMART on rehabilitation outcomes (WHODAS 2.0, ILSS), 
quality of life (QOLI), sleep (PSQI, ISI, sleep efficiency), and cognitive functioning (subjective: Neuro-QOL 
and ECog; objective: neuropsychological assessment). 

 Section 7 - Background and Significance
7) Provide a succinct discussion of relevant background information to justify performing the proposed study.
The population of older Veterans is growing rapidly, with approximately 13 million Veterans age 55 or 
older, representing over two-thirds of all Veterans. Given the exponential increase in aging Veterans, 
cognitive decline and dementia are a significant public health issue. Mild Cognitive Impairment (MCI) is a 
transitional state between normal aging and dementia characterized by deficits in memory or other 
cognitive domains with intact everyday functioning. The prevalence of MCI is 15-20% in people over 60. 
However, aging veterans are at an elevated risk for developing MCI and dementia. Sleep disturbance is 
one of the core non-cognitive symptoms of MCI, with over half of MCI patients experiencing insomnia 
symptoms. Chronic insomnia is associated with greater risk of cognitive decline, and recent research has 
shown that sleep disturbances are associated with the pathogenesis of dementia.
In addition to increased risk of cognitive decline, a growing number of studies demonstrate associations 
between insomnia symptoms and disability among older adults. Insomnia has been linked to limitations in 
activities of daily living, greater difficulty with household tasks, and restricted participation in community 
events. Insomnia is associated with a decline in physical functioning and greater fall risk, which can lead to 
injuries and increased disability. Veterans are particularly vulnerable to insomnia, with rates double and 
even triple those of civilian populations. Thus, older Veterans with MCI and comorbid insomnia represent a 
high-risk population for future development of more severe cognitive and functional decline.
Cognitive Behavioral Therapy for Insomnia (CBT-I) is the first-line treatment for chronic insomnia and is 
effective in older adults and Veterans. Compared to pharmacologic treatment, CBT-I is as effective in the 
short-term and more effective in the long term for treatment of insomnia. However, cognitive impairments 
may limit the rate of progress in CBT-I for older Veterans with MCI. For example, memory impairment is 
associated with worse treatment adherence and poorer clinical outcomes. Incorporating supportive 
cognitive strategies from Cognitive Symptom Management and Rehabilitation Therapy (CogSMART) into a 
CBT-I protocol has the potential to improve treatment learning, adherence, and outcomes for this Veteran 
population. CogSMART is an evidence-based manualized intervention that provides compensatory 
strategies to improve attention, learning, memory, and executive functioning. It has been shown to 
improve cognition, functional capacity, neurobehavioral symptom severity, and quality of life in Veterans 
with psychiatric illness, TBI, and MCI.
The proposed study aims to develop and pilot test Sleep-SMART (Sleep Symptom Management and 
Rehabilitation Therapy) - a modified CBT-I treatment that incorporates select CogSMART strategies to 
enhance CBT-I learning and adherence for Veterans with co-occurring insomnia and MCI. CBT-I has been 
adapted for various populations, including older adult civilians with MCI. However, Veterans face unique 
barriers and challenges. Therefore, Sleep-SMART will be developed for and with Veterans. Specifically, we 
will develop the Sleep-SMART intervention and manual using a systematic user-centered process that will 
allow for maintaining fidelity to core CBT-I components while improving the fit for Veterans with MCI by 
incorporating purposely selected CogSMART strategies - the goal of which is to assist Veterans with 
cognitive impairments in maintaining adherence to the CBT-I regimen, thereby leading to faster and more 
complete sleep treatment benefits. Sleep-SMART will consist of six 50-minute individual sessions and will 
be delivered via telehealth (video-conferencing), creating the potential for wide dissemination and broader 
reach to Veterans who may face barriers to accessing care or safety concerns related in-person treatment. 
By attending to and addressing the cognitive barriers to successful sleep treatment, we can alter the 
course of the Veterans’ trajectories and help prevent the negative consequences of chronic insomnia in this 
vulnerable Veteran population.
 Section 9 - Design and Methods
9) Describe the research design and the procedures to be used to accomplish the specific aims of the project.  Provide a precise 
description of the planned data collection (include what systems or databases will be used/accessed to gather data), analysis and 
interpretation.  For chart review studies, include the timeframe of collection.  Address sample size, inclusion of women and 
minorities.  Define in clear terms exactly what will be done to the human subjects. 
Phase I – Sleep-SMART Treatment Development (6 months)
Overview: We propose to develop the Sleep-SMART intervention and manual over the first 6 months of the 
project. The standard CBT-I approach is based on the VA Evidence-Based CBT-I Treatment Roll-out 
manual, and involves six 50-minute sessions, addressing several important concepts including the 
underlying causes of insomnia, sleep restriction and stimulus control techniques, sleep hygiene, stress 

management, and relapse prevention. CogSMART is a manualized intervention providing training in 
strategies to improve prospective memory, attention, learning/memory, and executive functioning. 
CogSMART is based on theories of cognitive compensation and habit learning. Sleep-SMART is intended to 
be a treatment for insomnia that will follow the standard 6 session 50-minute CBT-I format and will deliver 
CBT-I treatment along with training in select CogSMART strategies to enhance intervention learning and 
adherence. 
 The study team, whose members have expertise working with the target 
Development Approach:
population and in developing manualized treatments currently used at the VASDHS, will develop the Sleep-
SMART treatment and manual using a multistep, participatory, and systematic approach (IM Adapt) with 
input from diverse stakeholders. 
 5 Veterans from the target population will be recruited to participate in a 
Development Process:
confidential focus group in which they will answer semi-structured questions about their interest in a 
cognitively enhanced insomnia treatment; their perspectives on the adequacy of current treatment-as-
usual; personal reservations about behavioral treatment for sleep; current challenges with sleep, 
cognition, and daily living; perceptions about CBT-I and CogSMART strategies; opinions on telehealth and 
technology for the delivery of health services; etc. The focus group will be audio-recorded and transcribed 
for qualitative analysis. The investigators will make revisions to the existing VA Evidence-Based CBT-I 
Treatment Roll-out manual based on professional expertise and stakeholder feedback while ensuring 
protection of key CBT-I ingredients. Subsequently, 2-4 VHA providers (who work with the populations of 
interest) will individually review the manual and will be asked to make notes of their perceptions, including 
ease of use, content, structure, length, exercises, and components that may not resonate with the Veteran 
population or would not be feasible. This information will be used to guide additional revisions and 
adaptations. All focus group and expert feedback will be reviewed and discussed by the full study team 
using decision making rules outlined in Goldstein et al. (2012) before finalizing adaptations and pilot 
testing the intervention. We will use the expanded Framework for Reporting Adaptations and Modifications 
(FRAME) model as a guide for tracking and organizing adaptations. Deliverables from the development 
phase will include the Sleep-SMART treatment manual.
hase II – Pilot Testing the Sleep-SMART Intervention
P
For Phase II, we will enroll 26 participants ages 60 and older.
Pre-Treatment Assessment (2 hours in person):  Following informed consent, insomnia diagnosis will be 
confirmed based on a structured clinical sleep disorder interview and ISI score >7. Participants will also be 
administered a battery of self-report questionnaires selected to assess quality of life, daily functioning, 
disability, sleep, and subjective cognitive functioning, as well as a brief (45 min) standardized 
neuropsychological battery to pilot procedures for a larger trial. To reduce fatigue, participants will be 
offered and encouraged to take breaks as often as needed when appropriate. Participants will then 
complete a sleep diary for 14-days to prospectively record sleep and will be given an actigraph (a wearable 
activity/sleep monitor) to wear continuously for the 14-day baseline evaluation. 
Sleep-SMART Treatment Phase (6 sessions virtual):
 A licensed clinical psychologist with experience 
delivering CBT-I will deliver the 50-minute 6-session Sleep-SMART intervention via secure home-based 
video teleconferencing (e.g., Veteran Video Connect or Webex). Throughout the treatment phase, Veterans 
will be asked to keep a sleep diary as part of treatment. Missed and rescheduled appointments will be 
allowed, however we will limit total treatment completion time to 8 weeks from the first treatment session.
Post-treatment Assessment (2 hours in person ): After completing the treatment, all Veterans will fill out a 
sleep diary and wear an actigraph for the 14-day post-treatment evaluation. Veterans will also be 
scheduled for a post-treatment assessment that will include completion of a) self-report questionnaires, b) 
neuropsychological testing, and c) a brief semi-structured interview. 
Measures
Self-report measures of quality of life, daily functioning, disability, sleep, and cognition
: WHO Disability 
Assessment Schedule 2.0 (WHODAS 2.0); Independent Living Skills Survey (ILSS); Quality of Life 
Inventory (QOLI); Neuro-QOL scales: Applied Cognition Executive Functions Scale and Applied Cognition 
General Concerns Scale
Everyday Cognition Scale (ECog); Sleep Diaries; Actigraphy; Insomnia Severity 
; 
Index (ISI); Pittsburgh Sleep Quality Index (PSQI); Hopkins Verbal learning Test Revised (HVLT-R); Brief 
Visuospatial Memory Test-Rev (BVMT-R); Wechsler Adult Intelligence ScaleIV (WAIS-IV) Digit Span
DKEFS
; 
Trails (Number and Letter Sequencing & Number-Letter Switching); D-KEFS Verbal Fluency.
Feasibility: Feasibility in this investigation will be measured by: 1) 
 absolute number, 
Recruitment:
proportion, and representativeness of individuals willing to participate, documenting the utility of 
recruitment strategies, recording reasons for not participating, and noting challenges in meeting inclusion
/exclusion criteria; 2) 
l: estimated as the number of patients accrued divided by the number of 
Accrua
months of accrual; 3) 
estimated as the number of patients who refuse to participate 
Refusal Rate: 
divided by the number eligible; 4) 
 defined as the percentage of Veterans who complete the 6-
Retention:
session treatment; 5) Participants who drop out will be contacted via telephone to document Reasons for 

6)
Therapist Checklist; 7) Feasibility of Intervention 
Treatment Discontinuation; 
 Treatment Fidelity: 
Measure (FIM) completed by study therapists at post-intervention; and 8) Periodic Reflections in which 
the research team will engage in guided monthly discussions, using the template provided by Finley et al. 
2018, to ensure consistent documentation of key activities and other phenomena, e.g., barriers and 
facilitators.
Acceptability: Acceptability in this investigation will be measured by collecting the following data from 
Veteran participants: 1) client Satisfaction Questionnaire (post-treatment);
2)
 
 Percent of sessions 
 3)
: percent 
 
attended;
 Treatment adherence
homework completion,
basic skills assessment of 
discrepancy scores between prescribed sleep time and objectively recorded sleep; 
treatment material, and 
4) 
 (TUQ); and 5) 
in which a trained 
Telehealth Usability Questionnaire
Semi-Structured Interview 
clinical research staff member will conduct a 20-minute audio-recorded, post-intervention semi-structured 
qualitative interview which will involve administration of the Acceptability of Intervention Measure (AIM) 
and Intervention Appropriateness Measure (IAM) followed by the collection of qualitative data for each of 
these scales as well as additional information regarding barriers, facilitators, etc., to inform refinements to 
the intervention and to inform future delivery and scale up of Sleep-SMART via telehealth.
Data Analytic Plan
Qualitative data:  Interview and focus group data will be independently coded by two project team 
members using a rapid qualitative analytic approach described by Hamilton and colleagues. A third team 
member will assess coding quality and resolve conflicts. Using a mixed-methods convergent design 
approach, the qualitative data will be used to explain and support/refute the quantitative data and to 
inform treatment refinement as well as future implementation efforts.
Quantitative data : Descriptive statistics will be obtained for all quantitative variables, including 
distributions, means, medians, variances, standard deviations, skewness, kurtosis, ranges, and quartiles. 
SPSS Version 27 will be used for all quantitative analyses.
 
 Section 9.8 Questionnaires & Surveys
9.8) Provide the name and a reference for questionnaires/surveys that are standard or identify them here and attach a copy of 
the questionnaire/survey.  Questionnaires or surveys that are not clinical standard references must be uploaded.  Reference the help 
link for additional information related to surveys administered to VA personnel and approved platforms for web-based surveys. 
WHO Disability Assessment Schedule 2.0 (WHODAS 2.0): Üstün TB. Measuring Health and Disability: 
Manual for WHO Disability Assessment Schedule WHODAS 2.0. World Heal Organ. 2010. 
Independent Living Skills Survey (ILSS): Wallace CJ, Liberman RP, Tauber R, Wallace J. The Independent 
Living Skills Survey: A comprehensive measure of the community functioning of severely and persistently 
mentally ill individuals. Schizophr Bull. 2000. doi:10.1093/oxfordjournals.schbul.a033483
Quality of Life Inventory (QOLI): Frisch MB, Cornell J, Villanueva M, Retzlaff PJ. Clinical Validation of the 
Quality of Life Inventory: A Measure of Life Satisfaction for Use in Treatment Planning and Outcome 
Assessment. Psychol Assess. 1992. doi:10.1037/1040-3590.4.1.92
Neuro-QOL scales- Applied Cognition Executive Functions Scale and Applied Cognition General Concerns 
Scale: Cella D, Nowinski C, Peterman A, et al. The neurology quality-of-life measurement initiative. Arch 
Phys Med Rehabil. 2011. doi:10.1016/j.apmr.2011.01.025
Everyday Cognition Scale (ECog): Farias ST, Mungas D, Reed BR, et al. The Measurement of Everyday 
Cognition (ECog): Scale Development and Psychometric Properties. Neuropsychology. 2008. doi:10.1037
/0894-4105.22.4.531
Insomnia Severity Index (ISI): Bastien CH, Vallières A, Morin CM. Validation of the insomnia severity 
index as an outcome measure for insomnia research. Sleep Med. 2001. doi:10.1016/S1389-9457(00)
00065-4
Pittsburgh Sleep Quality Index (PSQI): Buysse DJ, Reynolds CF, Monk TH, Berman SR, Kupfer DJ. The 
Pittsburgh sleep quality index: A new instrument for psychiatric practice and research. Psychiatry Res. 
1989. doi:10.1016/0165-1781(89)90047-4
Feasibility of Intervention Measure (FIM);Acceptability of Intervention Measure (AIM) and Intervention 
Appropriateness Measure (IAM): Weiner BJ, Lewis CC, Stanick C, et al. Psychometric assessment of three 
newly developed implementation outcome measures. Implement Sci. 2017. doi:10.1186/s13012-017-

0635-3 
Client Satisfaction Questionnaire (CSQ): Attkisson CC, Zwick R. The client satisfaction questionnaire. Eval 
Program Plann. 1982. 
Telehealth Usability Questionnaire (TUQ): Parmanto B, Lewis, Jr. AN, Graham KM, Bertolet MH. 
Development of the Telehealth Usability Questionnaire (TUQ). Int J Telerehabilitation. 2016. doi:10.5195
/ijt.2016.6196 
Columbia-Suicide Severity Rating Scale (CSSRS): Posner, K., Brown, G. K., Stanley, B., Brent, D. A., 
Yershova, K. V., Oquendo, M. A., Currier, G. W., Melvin, G. A., Greenhill, L., Shen, S., & Mann, J. J. 
(2011). The Columbia-Suicide Severity Rating Scale: Initial validity and internal consistency findings from 
three multisite studies with adolescents and adults. The American Journal of Psychiatry, 168(12), 1266–
1277. https://doi.org/10.1176/appi.ajp.2011.10111704
 Section 9.11 Pictures and Audio/Video Recordings of Patients
9.11) Describe the purpose of photographs (facial), or audio, or video recordings of patients.  Describe whether the recordings 
will contain, or potentially contain, identifiers.  Note: use of photographs or recordings must be covered in the informed consent 
process and documented consent documents (e.g., consent form, information sheets, telephone screen scripts).
The focus group and qualitative interviews will generate digital voice files, which are considered 
identifiers. To minimize risk, during recorded interviews participants will only be identified using their 
project ID number, and there will be no mention of their name or other identifiers. All digitally recorded 
interviews will be transcribed by research staff for verbatim transcription. The transcription will not 
include any identifying information accidentally disclosed in interviews. In addition, Webex treatment 
sessions will be video recorded for training and fidelity purposes.
 Section 10 - Human Subjects
10) Describe the characteristics of the proposed subject population. Include age, gender, ethnicity, and health status as 
appropriate.  Note: Data about people are still considered “human subjects” by the IRB, so even if you do not intend to contact the 
patients whose charts you will review, you still describe the characteristics related to the subjects whose charts you will review.   
Provide inclusion and exclusion criteria as appropriate.  Provide a statement how non pregnancy is confirmed if 
pregnancy is an exclusion criteria.
For multisite studies, provide the total number of subjects from all sites and include description of the local site's role as 
a coordinating center if applicable.
Indicate the number of VA participants to be studied.
Indicate the estimated number of 
 subjects that will fail the screening process, if any.
consented
The proposed study will consist of two phases: development of the Sleep-SMART intervention and 
treatment manual (Phase I) and pilot testing to assess feasibility and acceptability of the intervention 
(Phase II). 
In Phase I, we will recruit 5 Veterans ages 60 and older with co-occurring MCI and insomnia to participate 
in a onetime 45-minute focus group. 
For Phase II, we will enroll 26 participants ages 60 and older with co-occurring MCI and insomnia. 
We will make every effort to recruit women for this study. To ensure adequate ethnic/racial diversity in 
our sample we will also attempt to recruit a sample composed of at least 25% of individuals from ethnic
/racial minority groups, including Hispanic/Latino and African American, consistent with the 2013 US 
Census. We will not include children in the study.
Inclusion criteria for this study include:
1.Veteran ages 60 or older who are competent to provide informed consent.
2.Chart diagnosis of MCI based on previously published criteria, as assessed by the VASDHS 
Neuropsychological Assessment Unit.
3.A DSM-5 diagnosis of insomnia corroborated by an Insomnia Severity Index score >7 at intake.
4.Must be able to understand, speak, and read English with acceptable visual and auditory acuity.

Exclusion criteria for this study include:
1.Sleep disorders other than insomnia as determined by medical chart review and clinical interview. 
2.History of a neurological disorder, dementia, and moderate or severe TBI.
3.Auditory, visual, or other impairments that would prevent ability to use the computer device or 
participate in assessments.
4.Schizophrenia, psychotic disorder, bipolar disorder, and/or current substance use disorder.
5.Evidence of suicidality more than “low risk” as assessed by the Columbia Suicide Severity Rating Scale 
(CSSRS)at intake (pre-treatment assessment)
 Section 10.5 Individuals with Cognitive/Decisional Impairment
10.5) Provide the rationale and additional study procedures that will be required for including individuals with known cognitive 
impairment or institutionalized individuals.  Address Decisional Capacity Assessment and Surrogate Consent Sections 12.6 and 
12.7.
Informed consent will be obtained at the time of the first study visit (i.e., focus group or pre-treatment 
evaluation). When the subject arrives for the appointment, a verbal explanation of the protocol will be 
given by the Principal Investigator or a member of the research team. A post-consent quiz will also be 
administered to ensure adequate understanding of the key elements of the study. If the subject performs 
adequately on the post-consent questionnaire, they will be asked to sign the consent form. If the subject 
is unable to demonstrate capacity to sign the consent form, they will be thanked for being a possible 
subject in the study and excused from the rest of testing. Given that we will be recruiting patients with 
mild cognitive impairment, as opposed to demented individuals, it is not anticipated that any patients will 
be unable to consent.
 Section 11 - Recruitment
11) Describe, step-by-step, the plans for recruitment of subjects (or selection of subjects as in record review). This description 
must include how, when, and where potential subjects are approached as well as procedures for identifying potential 
participants (through medical records, physician referral, third-party sources, etc.).  Include how selection is equitable.  Indicate 
if vulnerability to coercion may be present and if so plans to ensure voluntary participation.
Eligible Veterans be recruited from relevant VASDHS clinics, though primarily from colleagues in the 
Neuropsychological Assessment Unit, which receives an average of 55 to 60 new consults per month. MCI 
is among the most common diagnosis and roughly 75-100% of Veterans screened through the 
neuropsychology unit report symptoms consistent with insomnia.
Recruitment will be accomplished through: 
1. A flyer (Recruitment Brochure) describing study participation posted in VASDHS clinics. 
2. Dr. Bondi will also directly refer patients from the Neuropsychological Assessment Unit (using the 
Research Candidate form). 
3. Potential participants may be recruited from co-investigators' research studies previously completed (e.
g., Dr. Twamley's research studies). If a research participant who is potentially eligible for our study 
indicated in the previously completed research study that they would like to be contacted for future 
research opportunities, he or she will be informed of our research opportunities via phone call by a 
research assistant. If the patient indicates that they are not interested, the research assistant will thank 
them for their time and will not contact them again regarding the study. 
4. Potential participants may also be recruited by a search of ICD codes for MCI and insomnia in CPRS. 
Any patients not previously referred to our study from VASDHS clinics and sources aforementioned, who 
may be eligible for
the study, will be notified via the uploaded Recruitment Letter (Recruitment Contact Form) that a research 
assistant on this protocol will be contacting them approximately 2 weeks from the day the letter is sent. A 
research assistant will then call the patient to explain the study and gauge interest in participating. If the 
patient indicates that they are not interested, the research assistant will thank them for their time and will 
not contact them again regarding the study. 
All potential participants will meet via telephone or in-person with a member of the research team who 
will explain the study’s purpose and answer any initial questions. If the individual expresses interest in the 
study, they will be administered an pre-consent screen, which will inquire about the inclusion/exclusion 
criteria to determine eligibility.

Participants will be recruited from both genders and each ethnic group in proportions representative of 
those in VASDHS. 
 Section 11.1 Recruitment Materials
11.1) Identify all recruitment materials (flyers, advertisements, letters, etc.) that will be used; include the web address for any 
web-based advertisements. The text of all communications with prospective participants must be reviewed and approved by the 
IRB before it can be used.  You will be reminded to attach copies of recruitment materials to the initial submission packet.  
Note:  Posting of flyers with pull tabs is not permitted within VASDHS (including the VMRF building).
Recruitment will take place at the VA San Diego. Recruitment methods include:
1. Obtaining referrals through VA San Diego’s Neuropsychology Clinic via the Research Candidate Form. 
2. Recruitment brochures will be posted in relevant VASDHS clinics. 
3. Recruitment Contact Form will be sent to potential participants based on a search of ICD codes for MCI 
and insomnia in CPRS.
Participants will also be recruited from other studies completed if they had indicated they would like to be 
contacted for future research opportunities.
 Section 12 - Informed Consent
12) Indicate whether or not each category of consent is involved in this study:
12a) Will the study team obtain information or biospecimens for the purpose of screening, recruiting, or determining the 
eligibility of prospective subjects without (or prior to) obtaining informed consent of the prospective subject or the 
prospective subject’s LAR?
 Yes   
 No
Check one or both of the below boxes if they apply to this study:
Information will be obtained through oral or written communication with the prospective subject or the subject’s Legally 
Authorized Representative (LAR) and this is not a FDA regulated study.
 Yes   
 No
Identifiable information or biospecimens will be obtained by accessing records or stored identifiable biospecimens and this 
is not an FDA regulated study.
 Yes   
 No
If either or both of the above boxes is checked "yes", an informed consent waiver does not have to be requested for this 
 if the protocol is initially approved after 01/01/2019 or if it has been converted to the 2018 Common Rule 
activity
requirements. However, a request for a HIPAA waiver will still need to be requested and informed consent obtained for 
any research interventions after eligibility is established.  Otherwise, waivers of consent and authorization must be 
requested for this activity.  Waivers of consent and authorization are required for screening purposes for FDA regulated 
research. 
12b) 
 informed consent
Signed
 Yes   
 No
12c) Waiver of documented consent (e.g., 
consent) for all or part of the study.
oral 
  Yes   
  No
12d) Request for a 
 of consent for all or some study activities.
waiver

  Yes   
  No
12e) Alteration of 
 of consent.
other required elements
  Yes   
  No
12f) 
assent to participate (Director approval will be required)
Child 
  Yes   
  No
12g) Will any language 
 be used by those obtaining consent and understood by the prospective 
other than English
participant or the legally authorized representative?
  Yes   
  No
12h) 
 to determine if participants have the capacity to consent for themselves.
Decisional Capacity Assessment
 Yes   
 No
12i) 
 consent (legally authorized representative)
Surrogate
  Yes   
  No
 Section 12.1 Informed Consent Process
12.1a) Will consent be obtained before any study procedures are performed (including screening procedures except screening 
procedures with Consent/HIPAA waiver approval)?
 Yes   
 No
12.1b) Will the information being communicated to the participant or legally authorized representative during the consent 
process include exculpatory language through which the participant or legally authorized representative is made to waive or 
appear to waive any of the participant’s legal rights or release or appear to release the Researcher, Sponsor, the VA or its agents 
from liability for negligence.
  Yes   
  No
12.1c) A master list of all VA subjects consented (written or not) under this protocol will be maintained.
 Agree 
 Disagree
12.1d) Identify the circumstances under which consent will be obtained including where the process will take place; any waiting 
period between describing the research and obtaining consent including sufficient time for the prospective participant to 
consider participation, and any steps taken to minimize the possibility of coercion or undue influence.
Informed consent will be obtained at the time of the baseline (pre-intervention) assessment visit or prior 
to participating in the focus group. All potential interested participants will have previously spoken or met 
with a member of the research team who explained the study’s purpose, answered any questions, and 
conducted a prescreening interview to determine eligibility. 
During consenting, the research study personnel will read the informed consent to the participants while 
they follow along with their own copy. Participants will receive a thorough explanation of the nature of the 
intervention, their study involvement duration, compensation for their participation, possible risks and 
benefits, and potential alternative treatments. Study personnel will answer participant questions as they 
arise. Additionally, participants will be administered a decisional capacity assessment to ensure that they 
understand all parts of the study. 
All participants will be provided with a copy of the consent document and a copy of the Experimental 
Subject’ s Bill of Rights. Informed consent will be documented with the VA IRB-approved written consent 
form that each participant will sign in-person prior to participation. Signed and witnessed consent forms 

will be kept on file in a specially secured cabinet. To avoid coercion, potential participants will be informed 
verbally, and in the consent form, that they may withdraw at any time, skip any questions they choose 
not to answer, and that the information they provide will not affect their care at VASDHS.
 Section 12.6 Decisional Capacity Assessment
12.6a) Describe the method(s) for determination of decisional capacity: (see ? for guidance)  Please note that documentation of 
the assessement is required. 
Capacity to consent for this study will be evaluated with a consent quiz, which will include questions about 
the purpose of the study, length of the study, potential risks and benefits, and the ability to withdraw at 
any time without penalty. Potential participants will be given three chances to answer each question 
correctly, with the correct information provided in the event the individual answers incorrectly. The 
Veteran will be given ample time to ask questions about the study and will also be given time to make a 
decision and discuss with other appropriate parties his or her participation in the study prior to giving 
informed consent. If the investigator determines that the participant does not meet the criteria to provide 
informed consent, he/she will not be enrolled in the study.
12.6b) If subjects with limited decisional capacity will be enrolled, describe methods for obtaining subject assent or why they are 
not indicated:
Participants with limited decisional capacity will not be enrolled.
12.6c) If subjects with limited decisional capacity will be enrolled, describe procedures for respecting subject dissent and any 
additional safeguards or why these features are not needed:
Participants with limited decisional capacity will not be enrolled.
12.6d) If subjects with limited decisional capacity will be enrolled, describe the risk and, if greater than minimal, the relation to 
potential benefits:
Participants with limited decisional capacity will not be enrolled.
12.6e) If subjects with limited decisional capacity will be enrolled, describe the justification for the inclusion of any incompetent 
persons or persons with impaired decision-making capacity:
Participants with limited decisional capacity will not be enrolled.
 Section 12.9 HIPAA Authorization
For each category below, indicate whether or not this study involves the indicated process:
12.9a) 
 HIPAA Authorization.  
Signed
**New Template is available in the  Help section**
? 
 Yes   
 No
12.9b) HIPAA waiver to cover the entire study
  Yes   
  No
12.9c) HIPAA waiver for recruitment, screening, and/or for a portion of the study.
 Yes   
 No
12.9d) HIPAA Authorization or waiver is 
 for some or all of the study subjects (e.g. no health data).
not required
  Yes   
  No

 Section 12.10 HIPAA Waivers and Alterations
12.10a) Describe the purpose/nature of the HIPAA waiver or alteration and list specifically, what identifiers and health 
information are being requested under the waiver/alteration and identify whether the waiver is for access, use, and/or collection 
.
of this information
1) The waiver will be used to conduct a brief phone screen used to determine eligibility for the study so 
that potential participants do not waste time and unnecessary hardship traveling to the VASDHS. The 
study could not be practically conducted without the waiver and without access to and use of PHI.
The subjects will be screened via phone call to determine eligibility to participate. Contact information will 
also be collected to provide potential participants information on the study and follow-up with eligibility. 
The data that will be collected under the waiver will include:
-Name
-Mailing address
-Phone number(s)
-Neurological and psychiatric diagnoses
-Age
-Last 4 of SSN
Immediate inclusion/exclusion questions include questions about sleep, insomnia, other sleep disorders, 
cognitive functioning, major medical conditions, and other general health-related questions (See attached 
Phone Screen).
2) The waiver will also be used to recruit potential study participants through the Neuropsychology 
Assessment Unit and other relevant clinics at VASDHS. Veterans who may be interested will be asked to 
sign a Research Candidate Form while at clinic, and a research assistant will contact them if they indicate 
on the form that they agree to be contacted. Additionally, the provider may inform the research team of a 
potential study participant. At that point, a research assistant will either go speak to the patient in person 
about the study if the patient expresses interest in meeting with study staff, or will send the patient a 
letter stating that we will be calling them about a research opportunity.
The Research Candidate form asks for the patient's name, provider name, appointment day/time, and 
telephone number (if they indicate they would like to be contacted). Calling the subject will require 
patient's name and telephone number to later be contacted.
3) The waiver will also be used to reach potential study participants through CPRS (using the ICD codes 
for MCI and insomnia) as well as to confirm diagnoses of MCI and insomnia for eligibility determinations. 
Recruiting by ICD code search requires knowing the patient's medical diagnoses (MCI and insomnia). 
Verifying eligibility requires Veteran's last name and last 4 of SSN. 
4) Finally, the waiver will also be used to reach potential study participants through previously completed 
research studies, if they had agreed to be contacted for future research opportunities. Any patients who
may be eligible will be called to inform them of our new research opportunities. This will This will require 
the patient's name, mailing address, and telephone number to be contacted in the future.
12.10b) The proposed access, use, and/or disclosure of PHI involves no more than a minimal risk to the privacy of individuals.
 Agree 
 Disagree
12.10c) The plan to protect the identifiers from improper use and disclosure is adequate.
 Agree 
 Disagree
Describe the plan
Participant identity will be coded immediately upon entry into the study, and neither the participants’ 
names nor any identifying information will be present in the data set. Study records entered into a 
computer system will be assigned code numbers and will not be individually identifiable. Hardcopy data 
will be stored in a locked cabinet that is maintained in the PI's locked office (building 1 room 2253) within 
the VA. All electronic data will be stored within the VA secure network in the PI's VASDHS R: drive folder 
(R:\PIfolders\Almklov) and will be accessed only by approved study personnel using VA secured 
workstations.

All SI related to this study will be destroyed in accordance with RCS-10 and under the direction of the VA 
Records Control Manager. In the event of a real or suspected breach of security, the VA Police, the VA 
Information Security Officer, and the VA Privacy Officer will be notified.
12.10d) An adequate plan to destroy the identifiers at the earliest opportunity consistent with conduct of the research, unless 
there is a health or research justification for retaining the identifiers or such retention is otherwise required by law.
 Agree 
 Disagree
12.10d2) Describe the plan:
SI, such as subject's medical diagnosis, will be used for the purpose of enrollment and subject's personal 
information, such as age, gender, and education, will be used to characterize the subject pool utilized in
this study. Addresses and telephone numbers will also be collected as a means to contact the subjects for 
follow-up when indicated. All data used in this study will be de-identified and linked to SI by a subject 
number. Hard copy SI will also be stored for backup purposes in the PI's office, within Building #1 room 
2253.
Data will be destroyed according to RCS-10 under Records Control Manager guidance.
12.10e) By signing this protocol for submission, the PI is providing written assurance that the PHI will not be reused or disclosed 
to any other person or entity, except as required by law, for authorized oversight of the research project, or for other research 
 
for which the use or disclosure of protected health information would be permitted by the Privacy Rule. 38 U.S.C. 7332 
:  If the waiver of HIPAA authorization is for the use of 38 USC 7332 information (applicable to drug abuse, alcohol 
Information
abuse, HIV infection, and sickle cell anemia records), by signing this protocol for submission the PI is providing written 
assurance that the purpose of the data is to conduct scientific research and that no personnel involved may identify, directly or 
indirectly, any individual patient or subject in any report of such research or otherwise disclose patient or subject identities in 
any manner. (Ref:  38 U.S.C. 7332(b)(2)(B))
 Agree 
 Disagree
12.10f) The research could not practicably be conducted without the waiver or alteration.
 Agree 
 Disagree
12.10f2) Describe how the waiver/alteration enables the research to be conducted
Without the phone screen for contact information and brief exclusionary criteria there would be no feasible 
way for us to send participants directions and appointment confirmation. There would also be potential for
many participants to travel to VASDHS to participate in the study, sign a consent form only to find out 
they are ineligible for the study and be excused. This would waste the time of the participant as well the
VASDHS.
The ability to contact VA patients directly will allow us to recruit more veterans to be enrolled in the 
study. 
Finally, the ability to access medical diagnoses consistent with study inclusion criteria in CPRS will reduce 
burden on potential study participants as research staff will be able to verify diagnostic eligibility. 
12.10g) The research could not practicably be conducted without access to and use of the PHI.
 Agree 
 Disagree
12.10g2) Describe why it would be impracticable to conduct this research without the PHI described 12.10a. (v3/8/18)
The data collected by phone screen is necessary to assess study eligibility.
The research candidate form allows research staff on this protocol to call the Veteran and recruit them for 
the study, if interested and eligible. This form provides the means to contact the potential participant.
The Veteran's name and contact information will be required for calling individuals who were not 
presented the opportunity to sign the form (this includes subjects previously enrolled in other studies). 
The patient's phone number will be required to contact the patient.
Accessing medical diagnoses in CPRS allows the research team to focus recruiting attention on those who 

are likely eligible. Additionally, Veteran last name and last 4 of SSN are required to verify diagnostic 
information in CPRS. Having access to this information will reduce participant burden.
 Section 13 - Alternatives to Participation
13) Describe the alternatives to participation in this research study (see ? for guidance)
The alternative to participating is to not participate.
 Section 14 - Potential Risks
14) Describe any potential or known risks or discomforts and assess their likelihood and seriousness (see ? for guidance)
Risks to confidentiality (research risk): participation may result in loss of confidentiality due to unforeseen 
circumstances (fire or flood that may compromise locked data) or in the context of regulatory audits and 
mandated reporting. Every effort will be made to protect the confidentiality of participant records. 
However, a risk for potential loss of a participant’s confidentiality exists. This is highly unlikely given the 
precautions taken in the data management plan, but the possibility is not zero. 
Risks associated with data collection (research risk and therapeutic risk) include feeling frustrated, bored 
and/or fatigue during the assessments; and feeling discomfort during focus group or interviews due to 
talking about emotional topics or symptoms. 
Risks associated with sleep treatment (research and therapeutic risk) include feeling discomfort during the 
therapy process due to talking about emotional topics or symptoms; and initial exacerbation of nighttime 
sleep difficulties and/or an increase in daytime sleepiness due to sleep restriction component of CBT-I.
Risks associated with video-based treatments (research and therapeutic risk) include the use of video-
conferencing to deliver the Sleep-SMART intervention which could potentially result in technical challenges 
as well as loss of privacy. 
 Section 15 - Risk Management
15) Describe the procedures for protecting against or minimizing any potential risks/discomforts, and the adequacy of resources 
for conducting the study and resources participants may need as a consequence of the research.  When applicable, include detail 
of the following safety measures:   
(a) The type of safety information to be collected, including AEs; 
(b) 
Frequency of safety data collection; 
(c) Frequency or periodicity of review of cumulative safety data; 
(d) Statistical tests for analyzing the safety data to determine if harm is occurring; and 
(e) 
Conditions that trigger an immediate suspension of the research.  See ? for further 
requirements.
Protection from Risks Associated with Confidentiality: The following steps are taken to minimize the risk to 
confidentiality. Electronic data will be stored on a secure research drive on our VA network, accessible 
only to VA research personnel associated with the proposed study. Electronic records will include a 
password-protected key linking participant numbers with subject names. Paper records will be coded by 
participant number only and will not include names. All paper records will be kept in locked cabinets in a 
locked room. A special custom-tailored database system will be developed for this project to ensure the 
highest possible data reliability. Data entry programs will include double data entry, item prompts, skip 
patterns, range checks, and logical validity routines. Copies of audio files from staff qualitative interviews 
will be stored on the VA secure server. The focus group and qualitative interviews will generate digital 
voice files, which are considered identifiers. To minimize risk, during recorded interviews participants will 
only be identified using their project ID number, and there will be no mention of their name or other 
identifiers. All digitally recorded interviews will be transcribed by research staff for verbatim transcription. 
The transcription will not include any identifying information accidentally disclosed in interviews. 
Participants will be instructed not to state any names or other identifying information in their interviews. 
Any identifying information found in voice files from the qualitative interviews would be accidental and 
rare; no identifying information will be found in transcripts. The transcription files will be stored on a VA 
server behind the VA firewall. Members of the investigative team will be well educated regarding the 
protection of patients’ rights to confidentiality. Identities of participants will not be revealed in the 
publication or presentation of any results from this project. Procedures specified in the consent forms are 
consistent with HIPAA regulations. All investigators and research staff will complete the VA human subject’

s certification requirements, as well as certification in HIPAA regulations.
Protection from Risks Associated with Data Collection: To minimize the risk of patient discomfort, 
Veterans will be informed that they have the right to refuse to answer questions or to terminate their 
participation in the study at any time without prejudice. In cases where Veterans are frustrated, bored, 
and/or fatigued during assessments they will be given the opportunity to take breaks prior to resuming 
work on these tasks. Clinical staff will be available if immediate in-person evaluation is required for 
medical or mental health issues.
Protection from Risks Associated with Sleep Treatment: Patients will be given adequate time during 
therapy sessions to address significant concerns that may arise in session and between sessions. The CBT-
I treatment utilizes sleep restriction in early sessions, which may lead initially to poorer nighttime sleep 
and/or greater levels of daytime sleepiness. Therefore, during treatment Veterans will be carefully and 
repeatedly advised of this potential side-effect. At the session prior to initiation of sleep restriction 
treatment, adequate safety measures will be planned and discussed with each Veteran. Adverse events, 
including those unlikely to be the result of participation in the research will be monitored at every study 
contact, including therapy as well as assessment sessions.
Protection from Risks Associated with Video-Based Treatments: The home-based video-conferencing 
delivery of care will be accomplished using one of participant’s own devices or a loaner device (e.g., 
tablet) provided by the study team. Participants who do not have access to high-speed internet will be 
provided with a device that has been preconfigured for cellular data. Participants will be instructed to 
complete treatment sessions from a private, quiet setting of their choosing. Research team staff will be 
available for home-based equipment set-up and training if necessary. To assure patient confidentiality and 
HIPAA compliance, we will use VA-approved software, such as the VA Video Connect platform currently in 
use within the VA. Final selection of software will be performed at the time of study launch to avoid issues 
related to changes in policy, access, or availability. These software packages allow standard computers 
with standard connections to teleconference (video and audio) in real time, using federal government 
tested and approved encryption. Importantly, these software encryption packages meet Federal 
Government Standards for encryption at a level that does not require a virtual private network (VPN; 
however, the software is VPN compatible) and this encryption is already Federal Information Processing 
Standard (FIPS) 140-2 certified and can be installed on Federal government and VA computers. The most 
recent Home-Based Telemental Health Standard Operating Procedures Manual (VHA Office of Connected 
Care, 2017) will be used in order to best implement the intervention. Data on the type and amount of 
assistance required for successful home-based delivery will also be tracked. 
 Section 17 - Potential Benefits
17) Discuss benefits that may be gained by the subject as well as potential benefits to society in general  (see ? for guidance)
Veterans will receive free evaluations of their sleep and neuropsychiatric functioning. If any previously 
unknown medical conditions or sleep disorders are discovered as a result of these exams, we will discuss 
the results with the participant and make an appropriate referral for treatment. We will also provide the 
Veteran or his/her doctor, with appropriate written release, any of the medical information gathered as 
part of this study. Veterans will also receive free individual therapy for their sleep problems, and they will 
be paid for participation in the assessments. Other than these items, participants will not personally 
benefit from their participation. Benefits to society at large include testing and evaluating evidence-based 
treatments for co-occurring MCI and Insomnia.
 Section 18 - Risk/Benefit Analysis
18) Discuss why the risks to subjects are reasonable in relation to the anticipated benefits to subjects and in relation to the 
importance of the knowledge that may reasonably be expected to result.
The primary risks of participating in this study are things like fatigue, emotional discomfort, and potential 
brief exacerbation of nighttime sleep difficulties and /or daytime sleepiness. As noted above, there are 
specific plans in place to lessen the likelihood of any of these potential risks.
To the best of our knowledge, the risk/benefit ratio appears to be reasonable in relation to the anticipated 
benefits to be gained by the participants and others. The study involves minimal risk and most 
participants are eager to contribute to furthering sleep treatment research.

 Section 20 - Compensation for Participation
20) Provide all details and justifications of the compensation plan.  See ? for detailed requirements.
Year 1 focus group participants (N= 5) will receive a $20 gift card for a total of $100. Phase II participants 
(N=26) will be compensated for their baseline and post-treatment assessment points ($100 total per 
participant; $50 per assessment). The total over 2 years will be $2,700. 
 Section 21 - Responsibilities and Qualifications
Here are the identified study staff members
Erin L. Almklov, PhD
Adrienn Borsika Rabin, PhD, Elizabeth W. Twamley, PhD, Henry J. Orff, PhD, James O. E. Pittman, PhD, 
Jennifer S. Salamat
21) For each staff member listed above, describe their role and qualifications.  Also indicate which of the study staff are 
authorized to obtain consent, when applicable to the study. 
Erin Almklov, Ph.D., study PI, is a licensed clinical psychologist at VA san Diego Healthcare System 
(VASDHS) and is a member of the Education and Dissemination unit in the VASDHS Center for Stress and 
Mental Health (CESAMH). She is a formally trained neuropsychologist. Clinically, she has worked 
extensively with older adults with Mild Cognitive Impairment and dementia. She is experienced in treating 
Veterans including providing Cognitive Behavior Therapy for Insomnia (CBT-I). Her research focus has 
been on issues related to sleep, aging, and the use of health technology to improve care; and she is well 
published in these areas. On the proposed project, Dr. Almklov will work with the Co-Is and other key 
stakeholders to develop the Sleep-SMART intervention and manual. She will oversee the coordination of 
the activities of co-investigators and other personnel in implementing the study protocol and testing 
hypotheses. She will supervise project staff daily; monitor adherence to study protocol and procedures; 
oversee regulatory activities; supervise data collection and entry; collaborate on planning and conducting 
data analyses; prepare articles for publication; and develop future proposals arising from this project. 
Elizabeth Twamley, Ph.D., Co-Investigator, is the Director of the Clinical Research Unit of the Center of 
Excellence for Stress and Mental Health (CESAMH) at the VASDHS; Professor of Psychiatry at the 
University of California San Diego (UCSD); and RR&D Research Career Scientist. She is a 
neuropsychologist with expertise in MCI, dementia, TBI, PTSD, neuropsychological assessment, 
measurement of functional outcomes, cognitive rehabilitation interventions, and randomized controlled 
trial methodology and data analysis. She is the developer of Cognitive Symptom Management and 
Rehabilitation Therapy (CogSMART) and Compensatory Cognitive Training (CCT) interventions and has 
served as PI in multiple randomized controlled trials involving these interventions, funded by VA, NIMH, 
the Department of Defense, and NARSAD. She will participate in the development of the Sleep-SMART 
treatment and manual. She will also be responsible for providing therapist training and oversight related 
to the delivery of CogSMART cognitive strategies, attend regular research team meetings, collaborate on 
data analyses and interpretation, help prepare articles for publication, and assist in the development of 
future proposals arising from this project. 
Henry Orff, Ph.D. Co-Investigator, is an expert in Behavioral Sleep Medicine whose research focuses on 
the impact of sleep disturbance (particularly insomnia) on mental/physical health and quality-of-life 
functioning. His work also addresses a variety of issues that include neuropsychological performance, 
neurophysiological outcomes, and evaluation of treatment approaches for insomnia in specific clinical 
populations (e.g., Veterans with history of mild traumatic brain injury). On the current project, he will 
participate in the development of the Sleep-SMART intervention and provide training and oversight related 
to the delivery of the CBT-I treatment components. He will also attend regular research team meetings, 
and play an active role in recruitment, data analyses/interpretation, manuscript writing, and grant 
development.
James Pittman, Ph.D., Co-Investigator, is Section Chief of La Jolla Outpatient Mental Health Programs; 
Lead Mental Health Social Work; Associate Director of Education and Dissemination in the Center for 
Stress and Mental Health (CESAMH); Director of the CESAMH eScreening Core; and co-developer of the 
VA eScreening program. He has expertise in the use of technology to aid in health-related screening, 
triaging, and monitoring of clinical outcomes. Furthermore, he is experienced in user centered design, 
participatory research, mixed methods, and implementation science methodology. On the proposed 

project, Dr. Pittman will participate in the development of the Sleep-SMART intervention, supervise the 
use of technology of collect data and provide care, and assist with the collection and analysis of 
qualitative data. He will also participate in data interpretation, research team meetings, and the 
development of scientific publications and future proposals arising from this project.
Borsika Rabin, Ph.D., is an Assistant Professor in the Department of Family Medicine at UCSD; Co-Director 
of the UC San Diego Dissemination and Implementation Science Center; Co-Lead of the Implementation 
Science Triple Aim QUERI at the Eastern Colorado VA Healthcare System; and Implementation Scientist 
for CESAMH at the VASDHS. She will provide guidance and consultation during the Sleep-SMART 
development phase, including use of the IM-adapt framework. She will also help guide modifications to 
the intervention based on stakeholder feedback. In addition, Dr. Rabin will be available to provide 
consultation pertaining to developing, analyzing, and interpreting qualitative interview data, feasibility and 
acceptability measures, and other implementation-related outcomes.
Ms. Jennifer Salamat, will function as the research coordinator. She will assist with day-to-day research 
coordination including participant recruitment, screening, consenting, scheduling, and retention activities. 
She will administer assessments and self-report measures; transcribe interview data; and will be 
responsible for data scoring and entry. She will also assist with administrative and regulatory tasks.
 Section 22 - Bibliography
22) List relevant articles that the IRB can use to provide necessary background for the protocol. Do not include an extensive 
NIH-grant-style bibliography.  (Up to 5 recommended, but use more if needed to support the protocol or citations above.)
Roberts R, Knopman DS. Classification and epidemiology of MCI. Clin Geriatr Med. 2013. doi:10.1016/j.
cger.2013.07.003
da Silva RAPC. Sleep disturbances and mild cognitive impairment: A review. Sleep Sci. 2015. doi:10.1016
/j.slsci.2015.02.001
Matthews EE, Arnedt JT, McCarthy MS, Cuddihy LJ, Aloia MS. Adherence to cognitive behavioral therapy 
for insomnia: A systematic review. Sleep Med Rev. 2013. doi:10.1016/j.smrv.2013.01.001
Twamley EW, Jak AJ, Delis DC, Bondi MW, Lohr JB. Cognitive symptom management and rehabilitation 
therapy (CogSMART) for veterans with traumatic brain injury: Pilot randomized controlled trial. J Rehabil 
Res Dev. 2014. doi:10.1682/JRRD.2013.01.0020
Twamley EW, Vella L, Burton CZ, Heaton RK, Jeste D V. Compensatory cognitive training for psychosis: 
Effects in a randomized controlled trial. J Clin Psychiatry. 2012. doi:10.4088/JCP.12m07686
Twamley EW, Thomas KR, Gregory AM, et al. CogSMART compensatory cognitive training for traumatic 
brain injury: Effects over 1 year. J Head Trauma Rehabil. 2015. doi:10.1097/HTR.0000000000000076
 Section 23 - Sponsors and Collaborators
23) Clarify any industry financial or other support (e.g., NIH funds the study or Company X provides the assay kits).    Identify 
non-VA Research collaborators and their role in this protocol, including whether or not they have access to subjects or identified 
 
data.
Sponsor: VA Rehabilitation Research & Development Small Projects in Rehabilitation Research (SPiRE) 
Grant 1 I21 RX003721-01A1. 
Michael Thomas, Ph.D. (non-VA Research Consultant/Statistician) is an Assistant Professor in the 
Department of Psychology at Colorado State University and Assistant Adjunct Professor in the Department 
of Psychiatry at the University of California, San Diego. As the statistical consultant on this project, he will 
work closely with the principle investigator and the study team to provide statistical support for the study. 
He will only have access to aggregate de-identified quantitative data to provide statistical support. Data 
will be transferred via encrypted VA email.
In the submission form, upload a copy of the grant, subaward, CRADA, etc. as appliable to the 
study.
 

Section 27 - Privacy, Confidentiality, and Information Security
27a) Provide a brief description of how participant privacy and confidentiality will be protected in this study. Describe the 
circumstance under which it may be possible for a research team member to identify subjects and any related protections or 
assurances to prohibit or avoid identification. Describe how the number of people with access to identifiers for research 
purposes is limited in order to protect a participant’s privacy.
All electronic data will be stored within the VA secure network in the PI's VASDHS R: drive folder (R: 
\PIfolders\Almklov) and will be accessed only by approved study personnel using VA secured 
workstations. All paper records will be kept in locked cabinets in a locked room. In the event of a real or 
suspected breach of security, the VA Police, the VA Information Security Officer, and the VA Privacy 
Officer will be notified.
27.b) Entry of a CPRS 
is required when 
 
Research Informed Consent Note
subjects will be admitted as inpatients or treated as 
for research 
t
an outpatients 
 
and he study involves research medical care or may affect medical care.
If a Research consent Note is required, then a 
 should also be entered for each procedure or 
Research Progress Note
intervention.
Scanning the Consent and HIPAA Authorization into CPRS is 
.  Linking the Consent to the Research Informed 
not required
Consent Note may be permitted and can be useful for trials involving the Research Pharmacy or when research will be 
performed in conjunction with clinical procedures.
For Non-Veterans, if Research Informed Consent Notes are entered, then the 
 must be scanned into 
NOPP Acknowledgment
the record.  Otherwise a copy of the signed NOPP must be retained with the Investigator's research records and a copy sent 
to the Privacy Officer; see the
 Help for more information.
  ?
27.b1) Is entry of CPRS notes required based on the above criteria?
CPRS notes are needed for ALL subjects 
CPRS notes are needed for SOME subjects 
CPRS notes are NOT needed for any subjects 
Identify for which group or groups CPRS records will be entered and to which groups this requirement does not 
apply.
CPRS will be entered for subjects who pass eligibility screening, are enrolled, and attend at least one 
treatment session. CPRS records will not be entered for those who fail eligibility screening after signing 
informed consent or who drop out prior to treatment.
27c) Select the VA Sensitive Information (VASI) use category
This study does not collect or use any VASI 
This study uses but does not save, collect, copy, or record VASI 
This study does collect or record VASI 
 Section 27.1  VA Sensitive Information (VASI)
27.1a) For each type of VASI, indicate all that apply:
Indicate which of the following will be collected/recorded:
Protected Health Information (PHI)
Names
Device identifiers and serial numbers
E-mail addresses

Medical record numbers
URLs (Universal Resource Locator)
All elements of dates (except year) or any age over 89
Health plan beneficiary numbers
IP Addresses (Internet Protocol)
Telephone numbers
Account numbers
Biometric Identifiers including finger and voice print
Fax numbers
Certificate or license numbers
Full face photographic images and comparable images
All geographic subdivisions smaller than a state
Vehicle ID and serial numbers including license plate numbers
Social security numbers or scrambled SSNs (describe below)
Other unique identifying number, characteristic, or code (describe below)
27.1a1)  Describe why SSN are needed for this study
SSN are needed for subject payment and last 4 are needed to verify medical diagnoses for eligibility 
determinations.
27.1b) Consent Forms and/or HIPAA Authorization
 Yes   
 No
27.1c) Images with personal identifiers are used for this study (x-rays, MRI images with patient names, record numbers, dates, 
etc.)?
  Yes   
  No
27.1d) Photos with faces or audio video recordings are used for this study.
 Yes   
 No
27.1d1) Identify the device or devices that will be used to take/make the photographs or recordings. 
Audio recording device - the Pocket Memo Voice Recorder DPM8000 or Olympus 7000 Voice Recorder.
For those who complete the remote treatment intervention, we will use the video recording option 
available in VA WebX.
27.1d2) Identify where images will be stored (e.g., in the medical record, with study hardcopy records, with study 
electronic VASI records
The digital audio recordings will be uploaded to a folder in the PI's VASDHS R: drive folder (R:\PI 
folders\Almklov) immediately following the session for secure storage and the information will be deleted 
from the recorder. The recordings will not be individually identifiable. The key relating group numbers to 
the individuals will be stored separately and accessible only by approved study personnel. The audio 
recordings will be transcribed by a trained member of the research team. Any named individual or location 
discussed will be struck from the text record to avoid a potential breach in confidentiality.
Video recordings from the VA WebX system are automatically saved to the WebX’s host account, which 

will then be downloaded/saved to the secure R-drive (in R:\Almklov) and will only be accessible to the 
approved study staff through PIV log in.
27.1e) Biological specimens with identifiers are used for this study.
  Yes   
  No
 Section 27.2  Data Collection, Tools, and Resources
27.2a)  Will any specially obtained software be used?
 Yes   
 No
27.2a1) Describe the software, and identify license requirements and the ownership of the software or license.  Identify on 
what computer/network the software will be used (e.g., VA, VA Research/VMRF, local hard drive) and any data that will 
be stored in temporary files on the computer’s hard drive
Software provided with the Actiwatch Spectrum by Philips Respironics will be used to analyze actiwatch 
data. We will also use VA approved software to (e.g., ATLAS.ti) analyze qualitative data. Finally, we will 
use SPSS 26.0 or newer to analyze quantitative data. All programs and data will be stored on the VA 
network.
27.2b) Will any mobile devices (laptop, tablet, portable hard-drive, etc.) be used in support of this study?
 Yes   
 No
27.2b1) Provide details of the device/s.  Indicate whether the device is FIPS 140-2 encryption validated and confirm that 
the device is listed in the VA EIL.  Provide details regarding the nature of the data that will be stored or transmitted on the 
device and confirm whether a copy of all data will be stored on the VA network. 
Participants without access to a smartphone, tablet, or computer with webcam will be given a loaner 
tablet for the 6-session treatment phase, which are available through Co-I Pittman’s lab, purchased 
through VA mobile. The tablets are FIPS 140-2 encryption validated and listed in the VA EIL. The tablets 
will be used for the video-based Sleep-SMART sessions. No data will be stored on the tablets, but a video 
recording of each session will be stored on the VA network.
Those who participate in the Sleep-SMART treatment will be given an Actiwatch Spectrum (Philips 
Respironics, Bend, OR) to wear for 2 week prior to treatment and for two weeks after completing the 
treatment. The Actiwatch is a wrist-watch styled device designed to objectively measure levels of activity, 
sleep, and illumination exposure. The actiwatches are FIPS 140-2 encryption validated and listed in the VA 
EIL. Data (i.e., sleep, activity, and light exposure information) collected from the actiwatches will be 
transferred from the watches and stored on the VA network.
27.2c) Does the study require use of an electronic data capture system? 
 Yes   
 No
27.2c1) Provide the web address, details regarding their security features, the nature of the data involved, and the research 
purpose.  Also include a description of how VA retains a copy of the data entered into the system.
The secure VA eScreening program may be used to collect some self-report questionnaire data.

VA approved software (e.g., ATLAS.ti) may used to analyze qualitative data. 
SPSS 26.0 will be used to analyze quantitative data.
We will use the Actiwatch Spectrum (Philips Respironics, Bend, OR): a wrist-watch styled device designed 
to objectively measure levels of activity, sleep, and illumination exposure. Use of the Actiwatch will allow 
us to objectively measure sleep and wake activity during the baseline and post-treatment assessment 
weeks.
The data entered into these systems will be exported by research staff and stored within the VA secure 
network in the PI's folder in the R drive.
27.2d) Will any other web-based applications be used (e.g., for recruitment, completing online questionnaires, or processing 
data)?
  Yes   
  No
27.2e)  Will coded data that excludes personal identifiers be used?   Coded data excludes 
HIPAA identifiers (per VHA 
all 
Handbook 1605.1 Appendix B), including dates
 Yes   
 No
27.2e1) Identify where the code key is stored and in what format (electronic, paper).
The code key will be in an electronic and hardcopy format but separate from the coded data
 Section 27.3  Data Sharing and Transportation
27.3a) Does this study involve collecting, sharing or transporting any type of data outside of the local VA?
 Yes   
 No
27.3b) This study collects VASI outside of VA (i.e., at a non-VA location).
  Yes   
  No
27.3c) VASI is transported outside of VA for any purpose other than sharing.
  Yes   
  No
27.3d) PHI may be disclosed to monitoring/auditing agencies by HIPAA Authorization.  Note:  The Research Office must be 
notified when monitors come to audit
 Yes   
 No

27.3e) Data may be shared with collaborators or others in the conduct of this protocol.
 Yes   
 No
27.3e1)  Describe the data to be shared or disclosed, the entities to which the data are to be disclosed, how the data are to 
be transmitted, and how the transmitted data will be stored, retained, destroyed, and/or further disclosed and to whom. 
This includes data from individual subjects as well as other data developed during the research such as the analytic data 
and the aggregate data.  For PHI and VASI, indicate the authority/ies permitting the sharing or disclosure of data (HIPAA 
Authorization, Limited Data Set, Data Use Agreement, VA Form 10-5345-Request for and Authorization to Release 
Health Information., etc.).
Michael Thomas, Ph.D. (non-VA Research Consultant/Statistician) is an Assistant Professor in the 
Department of Psychology at Colorado State University and Assistant Adjunct Professor in the Department 
of Psychiatry at the University of California, San Diego. As the senior statistician on this project, he will 
work closely with the principle investigator and the study team to provide statistical support for the study. 
He will only have access to aggregate de-identified quantitative data to provide statistical support. 
This data will contain no identifiers and will be sent via secure VA encrypted email; and while being 
analyzed, will be stored on a password-protected computer
by the collaborator. 
 
Section 27.4  Research Record Storage and Retention
For each type of record, indicate whether it is collected for this study
27.4a) Hardcopy records/data (includes paper, pictures, film, etc.)
 Yes   
 No
27.4a1) Identify precisely where hardcopy data will be stored to include physical site, building, and room number, etc.  For 
each location identify whether VASI or non-sensitive information is stored at that location.  For VASI, identify how the 
data is secured. 
Neuropsychological tests, administered in a pencil-and-paper format, will be administered and recorded 
answers, VASI, and non-sensitive information will be stored in the PI's lab space (building 1 room 2253) 
in locked cabinets.
27.4a2) Are all of the above locations at VA?
 Yes   
 No
27.4b) Electronic study records (includes computer files, removable disk files, digital files, etc.).
 Yes   
 No
27.4b1) Identify precisely where 
electronic records/data will be stored to include the full map drive, network 
 
non-sensitive
location/server name, etc., and a brief description of what data/information is stored at each location.

Location of Electronic non-sensitive records/data: \\R01SDCHSM02.R01.MED.VA.GOV\Research\Almklov
The data stored on the R-Drive can only be accessed through a VA computer and study staff who are on 
the protocol will have specific access to the PI's research folder. Non-sensitive electronic data include the 
following: questionnaires, assessment data, and audio recordings. 
Questionnaire and assessment data will have a participate code and will not contain any identifying 
information. 
Audio recordings of interviews and focus groups will be transferred to the VA computer R drive for 
transcription and qualitative analysis, and all audio files will be destroyed at the end of the study. 
Participants will be instructed to refrain from stating their name and any other identifying information.
27.4b2) Identify precisely where 
electronic records/data will be stored to include the full map drive, network location
 
VASI
/server name, etc., and a brief description of what data/information is stored at each location.
If no VASI is collected or recorded for this study, simply indicate that the “Study does not collect or record VASI”.
Location of Electronic VASI: \\R01SDCHSM02.R01.MED.VA.GOV\Research\Almklov
VASI will be stored on the secure VA computer R:\ drive (local network storage behind VA firewall) which 
requires PIV access. The folders will be backed-up by VASDHS IT service. Only study staff who are on the 
protocol will have access to the PI's research folder.
VASI including name, contact information, code key, appointment dates, and last four of SSN will be 
stored. Video recordings of the treatment sessions will also be stored for training and fidelity purposes.
27.4b3) Are any of the locations described in 27.4b outside of the VA Secure Network? Note: this includes storage on a 
computer local hard drive.
  Yes   
  No
27.4c)  Record Retention - VHA requires compliance with Records Control Schedule (RCS-10) for retention 
of electronic and hard copy records.  Following study closure, these temporary records must be retained for six 
years and then destroyed.  Longer retention may be permitted if requred by other Federal regulations or 
requirements.  Will RCS-10 requirements be followed (i.e., 6-year retention)?
I will adhere to VHA Records Control Schedule-10 requirements 
I request an exception to RCS-10 requirements 
 Section 27.5  Additional Privacy or Information Security Details
Provide any other privacy or information security details here.
None
 Section 27.6  Attestations
In the event of real or suspected breach of security, the Information Security Officer, Privacy Officer, VA Police (if 
appropriate), and the individual’s supervisor will be notified within one hour of learning of the event.
 Agree 
 Disagree
Study staff will be up to date on any required VHA Privacy Policy and Information Security training or they will not be allowed 
access to VA Sensitive Information.

 Agree 
 Disagree
Access to research sensitive information, if any, will be removed when study personnel are no longer part of the research team.
 Agree 
 Disagree
At least one copy of all study records (whether sensitive or non-sensitive) will be retained under VA control and only destroyed 
in compliance with the approved Records Control Schedule
 Agree 
 Disagree
The VA retains ownership of the research data.  Should the investigator leave the VA, custody of the research records will be 
assigned to another investigator and the Research Service notified in writing, or custody of the research records will be 
transferred to the Research Service.
 Agree 
 Disagree
 Section 28 - Protocol Association to New or Existing Project
  
28) Is this a new R&D Project?  Before you go on to complete the 
 (which is used for 
Initial Review Submission Form
attachments), please address the association of this Protocol to an R&D Committee Project.  This Protocol may represent a new 
R&D Project, or it may be an additional Protocol under an existing R&D Project (such as when a single grant supports multiple 
  
Protocols).  Will this Protocol be submitted to the R&D Committee as a new Project?
 Yes   
 No
 The Protocol Application is now complete for a Protocol that will also be a new 
R&D Committee Project.
 
Next you will go on to the Initial Review Submission Form which is used to package up the 
Protocol Application and any needed attachments and submit them to the IRB.
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