Efficacy of Nurse-Delivered Brief Behavioral Treatment to Self-Manage Insomnia in Cancer Survivors
Phase: NA
Conditions: Chronic Insomnia
Sponsor: State University of New York at Buffalo

Cover Page for Protocol and Statistical Plan 
Official Title: 
Efficacy of Nurse-Delivered Brief Behavioral Treatment to 
Self-Manage Insomnia in Cancer Survivors 
NCT number: 
NCT03810365 
Document Type: 
Study Protocol and Statistical Plan 
Date of the 
Document: 
9-26-2023

 
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 42 
 
 
Complete Research Protocol (HRP-503) 
 
Table of Contents 
Template Instructions.......................................................................................................... 2 
1.0 
Objectives ................................................................................................................ 4 
2.0 
Scientific Endpoints ................................................................................................. 4 
3.0 
Background ............................................................................................................ 54 
4.0 
Study Design .......................................................................................................... 94 
5.0 
Local Number of Subjects ................................................................................... 105 
6.0 
Inclusion and Exclusion Criteria .......................................................................... 105 
7.0 
Vulnerable Populations ........................................................................................ 126 
8.0 
Eligibility Screening ............................................................................................ 137 
9.0 
Recruitment Methods ........................................................................................... 147 
10.0 Procedures Involved............................................................................................. 168 
11.0 Study Timelines ................................................................................................... 209 
12.0 Setting .................................................................................................................. 209 
13.0 Community-Based Participatory Research ........................................................ 2110 
14.0 Resources and Qualifications ............................................................................. 2210 
15.0 Other Approvals ................................................................................................. 2311 
16.0 Provisions to Protect the Privacy Interests of Subjects ...................................... 2311 
17.0 Data Management and Analysis ........................................................................ 2412 
18.0 Confidentiality ................................................................................................... 2612 
A. 
Confidentiality of Study Data ........................................................................ 2613 
B. 
Confidentiality of Study Specimens ............................................................... 2713 
19.0 Provisions to Monitor the Data to Ensure the Safety of Subjects ...................... 2814 
20.0 Withdrawal of Subjects ...................................................................................... 3015 
21.0 Risks to Subjects ................................................................................................ 3116 
22.0 Potential Benefits to Subjects ............................................................................ 3216 
23.0 Compensation for Research-Related Injury ....................................................... 3216 
24.0 Economic Burden to Subjects ............................................................................ 3317 
25.0 Compensation for Participation ......................................................................... 3317 
26.0 Consent Process ................................................................................................. 3317 
27.0 Waiver or Alteration of Consent Process ........................................................... 3821 
28.0 Process to Document Consent ........................................................................... 3922 
29.0 Multi-Site Research (Multisite/Multicenter Only)............................................. 3923 
30.0 Banking Data or Specimens for Future Use ...................................................... 4024 
31.0 Drugs or Devices................................................................................................ 4124 
32.0 Humanitarian Use Devices ................................................................................ 4225 
 
 
 

 
Page 2 of 42 
IRB Version: JAN2016 
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:  
This is not a study involving multiple participant groups. 
 
Formatting: 
• Do not remove template instructions or section headings when they do not apply 
to your study. 
If you are pasting information from other documents using the “Merge Formatting” 
Paste option will maintain the formatting of the response boxes. 
Amendments: 
• When making modifications or revisions to this and other documents, use the 
Track Changes function in Microsoft Word. 
• Update the version date or number on Page 3. 
 
 

 
Page 3 of 42 
IRB Version: JAN2016 
PROTOCOL TITLE: 
Include the full protocol title. 
Response:  
Efficacy of Nurse-Delivered Brief Behavioral Treatment to Self-Manage 
Insomnia in Cancer Survivors. 
  
 
PRINCIPAL INVESTIGATOR: 
Name 
Department 
Telephone Number 
Email Address 
Response:  
Grace Dean, PhD, RNSuzanne Dickerson, PhD, RN 
School of Nursing 
716-829-32353254 
gdeansdickers@buffalo.edu 
 
VERSION: 
Include the version date or number. 
Response:  
     April 14, 2022 September 15, 20221/18/23 
 
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:  
1 R01 NR018215-01 all aims of the study are covered by this research proposal.  
 

 
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IRB Version: JAN2016 
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:  
All paper documentations will be kept in a locked cabinet in the PI’s office. All 
electronic documentations will be kept on a password-protected drive within the 
School of Nursing 
Location: 321D 301E Wende Hall 
Address: 3435 Main Street 
               Buffalo, NY, 14214 
Department: School of Nursing 
1.0 Objectives 
1.1 Describe the purpose, specific aims, or objectives of this research. 
Response:  
Specific Aim 1: To determine the efficacy of Brief Behavioral Treatment for 
Insomnia (BBTI), experimental condition, compared to Healthy Eating Program 
(HEP), attention control, on insomnia severity in cancer survivors with insomnia.  
Specific Aim 2: To determine predictors for efficacy of BBTI.  
Specific Aim 3: To evaluate BBTI implementation with a focus on 
characterization of the patient- and provider-level facilitators and barriers.  
 
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:  
Hypothesis 1: Participants receiving BBTI will exhibit significant and durable 
improvement in insomnia severity index (key variable), sleep quality, mood, and 
functional status and quality of life measures over HEP.  
Hypothesis 2: Selective demographics (older age), disease stage (stage I), 
treatment-related (surgery only), mood (nondepressed) and positive beliefs about 
sleep (needing less than 8-hours of sleep) will predict BBTI efficacy.  
 
2.0 Scientific Endpoints 
 

 
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IRB Version: JAN2016 
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: 
The scientific endpoints for this study are improvements in sleep, mood, 
functional status and quality of life. 
  
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: Insomnia has devastating effects on health, function and well-being 
(1). Insomnia symptoms occur in one-third of the general population and 10-15% 
meet criteria for insomnia disorder, marked by chronic sleep disturbances that 
causes distress and impair their daytime functioning (2). Symptoms and side 
effects of cancer and cancer treatments render cancer survivors at increased risk 
for insomnia disorder (3-5). An estimated 40% of cancer survivors report sleep 
disturbances years after completing treatment (6). Consequently, interventions to 
address insomnia in cancer survivors are essential. Treatments for insomnia 
include pharmacologic and non-pharmacologic therapies that are equally 
efficacious; however, hypnotic medications such as benzodiazepine receptor 
agonists have potentially serious adverse effects including tolerance, drowsiness 
and cognitive impairment (7). Non-pharmacologic interventions, preferred by both 
patients and clinicians, include Cognitive Behavioral Therapy for Insomnia (CBTI), 
considered the “gold standard,” which requires expert training to deliver and 
multiple individual sessions (8, 9). Research in non-cancer populations revealed that 
CBTI is safe, efficacious, and durable (10, 11). However, CBTI is not widely 
available due to a lack of trained professionals and the high cost of treatment (12). 
Thus, a major gap in the field of oncology is an alternative to CBTI that is nurse-
delivered, rigorously tested, low cost, durable, and having high treatment fidelity. 
Our preliminary data using Brief Behavioral Treatment for Insomnia (BBTI), a 
multicomponent intervention that integrates circadian science and behavioral 
principles of conditioned learning, revealed clinically significant improvements in 
insomnia severity, total sleep time, and sleep quality without the negative effects 
commonly reported with hypnotic medications in lung cancer survivors (13). 
Additionally, BBTI has been tested in several other pilot studies including older 
adults with chronic insomnia (14),  treatment-resistant insomnia (15), and 
veterans with PTSD and insomnia (16). However, before BBTI is ready for 
translation into cancer nursing clinical practice, additional research on efficacy 

 
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and durability of BBTI is required. We hypothesize that exposing cancer 
survivors with insomnia to BBTI can help them self-manage their behavior to 
improve their sleep and quality of life. 
Preliminary Studies The multidisciplinary team assembled for the current project 
has conducted four studies that involved a homogeneous sample of lung cancer 
survivors and patients receiving chemotherapy for advanced lung cancer(43-46). 
These studies established that lung cancer survivors (n=76) experienced middle 
insomnia (i.e., difficulty maintaining sleep) while patients receiving 
chemotherapy for lung cancer (n=50) had early (i.e., difficulty falling asleep) and 
middle (difficulty staying asleep) insomnia(43, 46). Additionally, these studies 
revealed that lung cancer patients with poor sleep scored significantly lower on 
measures of quality of life than lung cancer patients with good sleep(47). Eighty-
five percent of patients with non-small cell lung cancer (NSCLC) in a longitudinal 
mixed method study had pre-existing insomnia related to anxiety, cancer- and 
treatment-related symptoms, and poor sleep hygiene practices(45).  
The NIH-funded (1R15NR013779) pilot RCT involved lung cancer survivors 
who were more than 6 weeks post-surgery for stage I or II NSCLC and > 1-year 
since any other cancer treatment. Recruitment occurred during a routine 
survivorship clinic visit. Participants (n=44) were screened for sleep disorders 
with the Sleep Disorders Symptom Checklist(48), ApneaLink plus (AHI<15) and 
Insomnia Severity Index >8. BBTI was manualized and content about the impact 
of melatonin, cortisol and nicotine on sleep for lung cancer survivors was added 
and the attention control intervention, Healthy Eating Program (HEP), was 
developed(13). No significant differences in baseline ISI were noted between 
groups (p=0.11). Posttreatment ISI mean score was 15.07 +/- 4.42 for the control 
group and 6.94 +/-5.27 for the BBTI group (p<0.001; ES=1.61). Quality of life, 
using the Functional Assessment of Cancer Therapy-Lung (FACT-L), revealed 
nonsignificant baseline scores (p=0.52), but control group mean scores decreased 
(74.67 +/- 26.40) while BBTI group mean scores increased (90.73 +/-21.35) 
which revealed a significant between group difference (p<0.046). Patients 
receiving BBTI improved FACT-L by 6.6 points and patients receiving the 
attention control declined by 14.5 points.      
Taken together these previous studies confirm that insomnia was common in this 
homogeneous sample of cancer survivors. BBTI significantly reduced insomnia 
and improved quality and QOL at the post treatment measure. However, 
durability in the efficacy of BBTI was not assessed at 3-months or 12-months 
post-treatment. Additionally, current sleep literature does not include studies 
using BBTI in heterogeneous samples of cancer survivors with insomnia. This 
research team has the knowledge and experience to conduct and deliver the 
proposed RCT. In fact, this team includes researchers with expertise in the areas 
of nursing, medical oncology, pulmonary/sleep medicine and biostatistics. The 
NIH-funded PI is an advanced practice nurse with more than 20 years of clinical 
experience and 15 years of cancer-related fatigue, sleep and circadian rhythms 
and QOL research. The PI is collaborating with Suzanne Dickerson, DNS, RN, 
Professor and Chair of Biobehavioral Health and Clinical Sciences, University at 

 
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Buffalo, School of Nursing, a qualitative researcher, Alan Aquilina, MD, a 
pulmonologist, sleep clinician and Co-Director of the University at Buffalo Sleep 
Fellowship Program; Mary Reid, PhD, Professor of Oncology, Roswell Park 
Comprehensive Care Center (RPCCC) and Gregory Wilding, PhD, Professor and 
Chair, Department of Biostatistics, University at Buffalo. The PI has an 
established record of collaboration with clinicians and researchers from RPCCC 
and the University at Buffalo, NY. 
   
3.2 Include complete citations or references.  
Response:  
1. 
Institute of Medicine CoSMaR, Board on Health Sciences, Policy. 
Sleep disorders and sleep deprivation: an unmet public health problem. 
Washington, DC: National Academy of Sciences; 2006. 
2. 
Ohayon MM. Epidemiology of insomnia: what we know and what 
we still need to learn. Sleep Med Rev. 2002;6(2):97-111. PubMed PMID: 
12531146. 
3. 
Davidson JR, MacLean AW, Brundage MD, Schulze K. Sleep 
disturbance in cancer patients. Soc Sci Med. 2002;54(9):1309-21. 
PubMed PMID: 12058848. 
4. 
Irwin MR, Olmstead RE, Ganz PA, Haque R. Sleep disturbance, 
inflammation and depression risk in cancer survivors. Brain Behav 
Immun. 2013;30 Suppl:S58-67. doi: 10.1016/j.bbi.2012.05.002. PubMed 
PMID: 22634367; PubMed Central PMCID: PMC3435451. 
5. 
Stepanski EJ, Walker MS, Schwartzberg LS, Blakely LJ, Ong JC, 
Houts AC. The relation of trouble sleeping, depressed mood, pain, and 
fatigue in patients with cancer. J Clin Sleep Med. 2009;5(2):132-6. 
PubMed PMID: 19968046; PubMed Central PMCID: PMC2670332. 
6. 
Palesh OG, Roscoe JA, Mustian KM, Roth T, Savard J, Ancoli-
Israel S, Heckler C, Purnell JQ, Janelsins MC, Morrow GR. Prevalence, 
demographics, and psychological associations of sleep disruption in 
patients with cancer: University of Rochester Cancer Center-Community 
Clinical Oncology Program. J Clin Oncol. 2010;28(2):292-8. Epub 
2009/11/26. doi: JCO.2009.22.5011 [pii] 
10.1200/JCO.2009.22.5011. PubMed PMID: 19933917; PubMed Central 
PMCID: PMC2815717. 
7. 
Edinger JD, Means MK. Cognitive-behavioral therapy for primary 
insomnia. Clin Psychol Rev. 2005;25(5):539-58. Epub 2005/06/14. doi: 
10.1016/j.cpr.2005.04.003. PubMed PMID: 15951083. 
8. 
Morin CM, Bootzin RR, Buysse DJ, Edinger JD, Espie CA, 
Lichstein KL. Psychological and behavioral treatment of insomnia:update 

 
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of the recent evidence (1998-2004). Sleep. 2006;29(11):1398-414. Epub 
2006/12/14. PubMed PMID: 17162986. 
9. 
Morin CM, Bootzin RR, Buysse DJ, Edinger JD, Espie CA, 
Lichstein KL. Psychological and behavioral treatment of insomnia:update 
of the recent evidence (1998-2004). Sleep. 2006;29(11):1398-414. Epub 
2006/12/14. PubMed PMID: 17162986. 
10. 
Edinger JD, Sampson WS. A primary care "friendly" cognitive 
behavioral insomnia therapy. Sleep. 2003;26(2):177-82. Epub 
2003/04/10. PubMed PMID: 12683477. 
11. 
Edinger JD, Wohlgemuth WK, Radtke RA, Coffman CJ, Carney 
CE. Dose-response effects of cognitive-behavioral insomnia therapy: a 
randomized clinical trial. Sleep. 2007;30(2):203-12. Epub 2007/03/01. 
PubMed PMID: 17326546. 
12. 
Morin CM, Belanger L, LeBlanc M, Ivers H, Savard J, Espie CA, 
Merette C, Baillargeon L, Gregoire JP. The natural history of insomnia: a 
population-based 3-year longitudinal study. Arch Intern Med. 
2009;169(5):447-53. doi: 10.1001/archinternmed.2008.610. PubMed 
PMID: 19273774. 
13. 
Dean GE, Weiss C, Klimpf M, Alameri R, Ziegler P, Steinbrenner 
LM, Dexter E, Dillon S, Jungquist CR, Dickerson SS. Nurse-delivered 
brief behavioral treatment for insomnia in lung cancer survivors. 
Behavioral Sleep Medicine. in review. 
14. 
Buysse DJ, Germain A, Moul DE, Franzen PL, Brar LK, Fletcher 
ME, Begley A, Houck PR, Mazumdar S, Reynolds CF, 3rd, Monk TH. 
Efficacy of brief behavioral treatment for chronic insomnia in older 
adults. Arch Intern Med. 2011;171(10):887-95. doi: 
10.1001/archinternmed.2010.535. PubMed PMID: 21263078; PubMed 
Central PMCID: PMC3101289. 
15. 
Wang J, Wei Q, Wu X, Zhong Z, Li G. Brief behavioral treatment 
for patients with treatment-resistant insomnia. Neuropsychiatric disease 
and treatment. 2016;12:1967-75. doi: 10.2147/NDT.S110571. PubMed 
PMID: 27536119; PubMed Central PMCID: PMC4977084. 
16. 
Germain A, Shear MK, Hall M, Buysse DJ. Effects of a brief 
behavioral treatment for PTSD-related sleep disturbances: a pilot study. 
Behaviour research and therapy. 2007;45(3):627-32. Epub 2006/06/17. 
doi: 10.1016/j.brat.2006.04.009. PubMed PMID: 16777060. 
43. 
Dean GE, Finnell DS, Scribner M, Wang YJ, Steinbrenner LM, 
Gooneratne NS. Sleep in Lung Cancer: The Role of Anxiety, Alcohol and 
Tobacco. Journal of Addictions Nursing. 2010;21:130-8. doi: 
10.3109/10884601003777620. 

 
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44. 
Dean GE, Redeker NS, Wang YJ, Rogers AE, Gooneratne NS. 
Sleep, mood and quality of life in patients receiving treatment for lung 
cancer. Oncology Nursing Forum.(2013);40(5):441-451. 
45. 
Dickerson SS, Sabbah EA, Ziegler P, Chen H, Steinbrenner LM, 
Dean GE. Sleep is not a priority when living my life after a diagnosis of 
lung cancer. Oncology Nursing Forum. (2012);39(5):492-499. 
46. 
Gooneratne NS, Dean GE, Rogers AE, Nkwuo JE, Coyne JC, 
Kaiser LR. Sleep and quality of life in long-term lung cancer survivors. 
Lung Cancer. 2007. PubMed PMID: 17765353. 
47. 
Gooneratne NS, Dean GE, Rogers AE, Nkwuo JE, Coyne JC, 
Kaiser LR. Sleep and quality of life in long-term lung cancer survivors. 
Lung Cancer. 2007;58(3):403-10. doi: 10.1016/j.lungcan.2007.07.011. 
PubMed PMID: 17765353; PubMed Central PMCID: PMC2206246. 
48. 
Klingman KJ, Jungquist CR, Perlis ML. Introducing the Sleep 
Disorders Symptom Checklist-25: A Primary Care Friendly and 
Comprehensive Screener for Sleep Disorders. Sleep Medicine Research. 
2017;8(1):17-25. doi: https://doi.org/10.17241/smr.2017.00010. 
 
 
 
4.0 Study Design 
4.1 Describe and explain the study design (e.g. case-control, cross-sectional, 
ethnographic, experimental, interventional, longitudinal, observational). 
Response:  
This is a longitudinal, randomized, efficacy trial. The experimental intervention, 
BBTI (attached), is being used to help participants with insomnia to sleep better. 
To receive this treatment, participants need to be enrolled in the study. The 
attention control intervention, HEP (attached), is not expected to improve sleep.   
Baseline measures will be obtained prior to the intervention.  
All of the multi-components of BBTI will be delivered individually in the clinic 
setting or online during a 45-minute session.  
Outcome measures will be completed 1-month and again at 3-months and 
12-months post-intervention. Each participant will complete one-week of: 
1) Sleep diaries; 2) wrist actigraphy; and 3) a study packet with 
questionnaires on insomnia severity, sleep quality, insomnia symptoms, 
and beliefs about sleep, functional performance and quality of life. 
Additionally, two REDCap emails at 6-months and 9-months from the 
intervention will be sent to ensure patient safety and encourage participant 
retention. The emails will ask the participants to answer a safety question 
we currently ask at each previous data collection with a "Yes" or "No" 

 
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answer: Do you find that your sleepiness is bad enough that you are at risk 
of falling asleep while driving or doing something hazardous or harmful? 
Additionally, we will ask 2 questions from the Sleep Diary about their 
sleep: Please rate over the past week: Restful sleep 0-4 (4=excellent) and 
Sleep quality 0-4 (4=excellent). 
 
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:  
The total number of subjects enrolled in the study will be 158, with 79 subjects 
from each group (intervention and attention-control group) 
5.2 If applicable, indicate how many subjects you expect to screen to reach your target 
sample (i.e. your screen failure rate).  
Response:  
As the local study intends to enroll 158 participants, it is expected that 316 people 
will need to be screened. 
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:  
There are approximately 4,000 cancer survivors scheduled for care in the 
RPCCC’ survivorship clinic annually. Half of these survivors will not be eligible 
for the study. That leaves approximately 2000 potentially eligible participants to 
recruit. As only 158 participants are needed over a 3-year recruitment period, the 
pool of survivors appears feasible.  
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:  
1. Age ≥ 18 years of age 
2. ≥ 1-month from surgery and ≥ 1-month from any other treatment (except for 
hormone treatment or maintenance targeted therapies) for stages I through III: 
breast, colorectal, and prostate cancers and stages I through IV: lung cancer. 
3. Meet published criteria for chronic insomnia: sleep latency > 30 minutes or 
wake after sleep onset of > 30 mins for ≥ 3 nights/week for at least 1-month 
4. ApneaLink Screening Apnea Hyponea Index < 15 

 
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5. Ability to complete data collection instruments  
 
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:   
1. Other pre-existing sleep disorders except insomnia or obstructive sleep apnea 
who are CPAP-compliant => 4-hours/night use 
2. Unstable medical or psychiatric illness, fibromyalgia, history of seizures, 
current substance abuse 
3. Engaged in night or rotating shift work 
4. Travel across two or more time zones within 1 month prior to study 
participation  
5. Inability to complete data collection measures independently 
6. Individuals with conditions affecting the non-dominant arm (use of wrist 
actigraph) 
 
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:   
Not applicable: None of the following special populations will be recruited in the 
current study. 
☐ 
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 

 
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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:  
Persons who do not speak English are currently excluded from this research based 
on numerous questionnaires in this RCT.  
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: 
There is no possible harm on the pregnancy due to assessing daytime sleepiness 
before and after the intervention, and using paper survey/interview procedures so 
no additional procedures are needed for their protection. 
☐ 
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:  
Not applicable: This research does not involve non-viable neonates or neonates of 
uncertain viability.  
☒ 
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:  
Not applicable: This research does not involve prisoners. 
☒ 
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:  

 
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Not applicable: This research does not involve persons who have not attained the 
legal age for consent. 
☒ 
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:  
Not applicable: This research does not involve cognitively impaired adults. 
☒ 
N/A:  This research does not involve cognitively impaired adults. 
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:  
Not applicable: This research does not involve these populations.  
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: Screening for inclusion criteria includes a YES response to the 
following questions:  
Are at least 18 years of age? 
Insomnia Severity Index>7 and/or Holland Sleep Disorders Screening 
Questionnaire>4.0  
Do you have a diagnosis of breast, colorectal, or prostate cancer stage I, II 
or III; or lung cancer stage I-IV?  
Have you had your cancer surgically removed at least 1-month ago? 
Has it been more than one month since you completed cancer treatment 
(except for hormone treatment or maintenance targeted therapies)? 
Screening for exclusion criteria includes a NO response to the following 
questions: 
Do you have sleep disorders other than insomnia or obstructive sleep 
apnea who are CPAP-compliant => 4-hours/night use? 
Do you have any poorly managed medical/psychiatric illnesses, 
fibromyalgia, or a history of seizures? 
Are you currently exceeding alcohol or abusing drugs? 
Do you engage in shift work of traveled >1 time zone past month? 

 
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Are you able to wear an actigraph on your non-dominant wrist? 
1. The PI or Study Coordinator will use the Recruitment Script and 
Participant Eligibility Screening Form (instruments attached) to screen all 
eligible participants and the Holland Sleep Disorders Questionnaire 
(HSDQ), a valid, reliable and accurate diagnostic measure based on the 
International Classification of Sleep Disorder (ICSD-2) to determine the 
presence of insomnia, sleep apnea or any other sleep disorder. Depending 
on the scores, participants will be enrolled, require additional screening 
(sleep apnea) or referred to their provider for additional sleep disorders 
diagnoses.  
2. Individuals who screen positive for sleep apnea and insomnia will be invited to 
wear the small portable ApneaLink Plus device overnight for one night in their 
home to screen for sleep apnea before continuing in the study. All results of the 
ApneaLink Plus overnight studies will be reviewed by Drs. Aquilina (consultant) 
and Dean (PI) after electronic scoring. Participants with moderate-severe sleep 
apnea (≥ 15 episodes/hour) will be referred for further evaluation and possible 
positive airway pressure treatment. Patients with moderate-severe sleep apnea will 
not be recruited in the proposed study.  
3. If a participant’s result to the screening indicate that they are not eligible, they 
will be thanked for their interest and provided 2 copies of the ApneaLink Plus 
report: one for themselves and a copy for their provider.  
In addition, Buffalo Research Registry, Research Match, and i2b2 have been 
added to screen for eligible participants. For i2b2, the Institute of Healthcare 
Informatics team will provide contact information for the eligible participants. 
The provider will be contacted for approval using the Physician Permission Letter 
(draft letter attached). If the provider does not object, patients will be contacted by 
mail (draft letter attached) and then by telephone. As a result of HRP-611 Partial 
HIPAA Waiver, we will prescreen clinic patients at Roswell Park Comprehensive 
Cancer Center. 
☐ 
N/A:  There is no screening as part of this protocol. 
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:  

 
Page 15 of 42 
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Recruitment flyers (attached) will be distributed to institutions/organizations in 
WNY where participants are likely to be encountered like Cancer centers, 
community centers, Senior centers, VFW posts, etc. Study recruiters will review 
clinic schedules and prescreen medical records for cancer diagnosis, stage of 
disease and last treatment date to highlight potentially eligible participants for 
clinic staff. Clinicians involved in medical management of cancer survivors and 
their staff, will identify potential eligible participants, briefly explain the study, 
and obtain agreement from potential participants to be contacted. The PI or Study 
Coordinator will then contact the eligible participant to obtain their affirmative 
response of their interest in participating and then arrange to meet each potential 
participant in the clinic or at their home, if preferred. Additionally, given the 
shelter-in-place situation and some previous patients had difficulty returning to 
the clinic for the face-to face intervention, we will now offer the option of verbal 
consent and online teaching.  
The following Research Participants Groups will be added: Buffalo Research 
Registry, Research Match, and i2b2. For i2b2, following IRB approval, the 
Institute of Healthcare Informatics team will provide contact information for the 
eligible participants. The provider will be contacted for approval using the 
Physician Permission Letter (draft letter attached). If the provider does not object, 
patients will be contacted by mail (draft letter attached) and then by telephone.  
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:  
Prospective eligible participants will only be approached by clinic staff regarding 
their interest in study participation. Only after eligible participants give consent to 
clinic staff will the PI or Study Coordinator screen the individual. Interested 
participants will be contacted in person or by telephone for the initial screening 
with study personnel (PI or Study Coordinator). If approached in person, eligible 
participants will be screened in a private clinic room with or without family 
members. Each subject in all phases of the study will be assigned a unique study 
identification number to be used on all data forms. All personally identifiable 
information will be kept strictly confidential. The HRP-611 Partial HIPAA 
Waiver has been added to document how privacy will be protected during the 
recruitment process for the new recruitment methods.  
  
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 

 
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IRB Version: JAN2016 
to taping to ensure there will be no IRB-required revisions, provided the IRB also 
reviews and approves the final version. 
 Response:  
Insomnia Recruitment flyer attached. Eligibility Recruitment Script attached. 
Letter to eligible patients in i2b2 database attached. Research Match-Contact 
Message will be a recruitment flyer. 
 
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:  
Following informed consent, in order to rule-out sleep apnea as a 
confounder, all eligible participants will be offered screening for sleep 
apnea with the ApneaLink Plus for one night. Following a negative screen 
for sleep apnea, demographics, diagnoses, treatments, comorbidities, etc. 
will be extracted from the Electronic Health Record (EHR) using the 
Medical Record Review Questionnaire (to verify certain self-report data); 
beliefs about sleep will be determined by Dysfunctional Beliefs and 
Attitudes about Sleep; mood, anxiety and depression will be measured 
with Hospital Anxiety and Depression Scale; pain and quality of life will 
be determined by Functional Assessment of Cancer Therapy-G; sleep 
quality will be measured with Pittsburgh Sleep Quality Index; daily sleep 
will be assessed with 7-day sleep diary; objective sleep will be evaluated 
with 7-day actigraph; fatigue will be assessed with Profile of Mood States; 
and daytime sleepiness will be determined by the Epworth Sleepiness 
Scale (Johns 1991).  
One week, after baseline assessments, each participant will be randomized 
by the biostatistician. Participants will then be scheduled for either the 
brief behavioral therapy for insomnia (BBTI) session (experiment) or the 
healthy eating program (HEP) session (control). Each intervention is 
approximately 45-minutes and will be delivered in the clinical setting, 
online teaching or home.   
At the end of the interventions, each participant will be provided weekly 
sleep diaries to complete for 2-weeks and arrange for 2-follow up 
telephone calls using the Telephone Follow Up Script (attached). Each 
telephone contact will begin by reminding participants that their 
participation is voluntary and they may skip items they wish. Telephone 

 
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contacts are not recorded, but the research assistant will orally ask the 
participant to respond to the questions in the Telephone Follow Up Script 
and record responses as described in 10.2. Study packets with 
questionnaires will be repeated approximately one-month, 3-months and 
12-months after the intervention. Patient Evaluation Questionnaire will be 
administered 1-month and at end of study. Following the one-month data 
collection, the interventionist will contact participants to provide feedback 
on sleep diary data. In addition, two REDCap emails at 6-months and 9-
months from the intervention will be sent to ensure patient safety and 
encourage participant retention. The emails will ask the participants to 
answer a safety question we currently ask at each previous data collection 
with a "Yes" or "No" answer: Do you find that your sleepiness is bad 
enough that you are at risk of falling asleep while driving or doing 
something hazardous or harmful? Additionally, we will ask 2 questions 
from the Sleep Diary about their sleep: Please rate over the past week: 
Restful sleep 0-4 (4=excellent) and Sleep quality 0-4 (4=excellent). 
     
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:  
Data include apnea/hypopnea index, movement (i.e. actigraphs), self-report sleep 
diaries and sleep, mood and quality of life questionnaires. Two-semi-structured 
telephone interviews will be conducted. For each interview, the data will be the 
participant’s oral responses to the questions of the interview instruments as 
recorded in the research assistant’s handwritten notes. 
 
Table 3. Study Variables, Measures, and Time Frames 
Variable 
Measure 
Pr
e 
1- 
 
Mon
th 
3-
Mont
hs 
6-
Mont
hs 
9-
Mont
hs 
12-
Mont
hs 
Predisposing 
factors 
Sleep history 
 
Age, sex, 
race/ethnicity 
 
Holland 
Sleep 
Disorders 
Questionnai
re 
/ApneaLink 
Plus 
Medical 
Record 
Review 
Questionnai
re 
 
X 
 
X 
 
 
 
 
 
Precipitating 
factors 
Cancer 
stage/treatment 
Medical 
Record 
Review 
Questionnai
re 
X 
 
 
 
 
 
 
 

 
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Alcohol/nicotine/caff
eine 
Comorbidities 
Medications 
 
Perpetuating 
factors 
Beliefs about sleep  
 
Dysfunction
al Beliefs 
and 
Attitudes 
about Sleep  
 
X 
 
X 
 
X 
 
 
 
X 
Neurocognitive 
factors 
Symptoms: 
depression, anxiety 
and pain  
 
Hospital 
Anxiety and 
Depression 
Scale 
(anxiety 
and 
depression)
, Functional 
Assessmen
t of Cancer 
Therapy 
(pain)    
X 
 
X 
X 
 
X 
X 
 
X 
 
 
X 
 
X 
Insomnia 
characteristics 
Subjective sleep 
(insomnia severity, 
sleep quality) 
Objective sleep 
(sleep efficiency) 
Insomnia 
Severity 
Index, 
Pittsburgh 
Sleep 
Quality 
Index, 
Sleep diary 
(daily) 
Actigraphy-
Actiwatch 
Spectrum 
Safety 
emails 
X 
X 
 
X 
X 
X 
 
X 
X 
X 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
X 
X 
 
X 
Vulnerability for 
physical-
psychiatric 
problems 
Fatigue 
Sleepiness 
Disrupted mood 
Functional status 
Quality of life 
 
Profile of 
Mood 
States 
Fatigue 
Subscale 
Epworth 
Sleepiness 
Scale 
Hospital 
Anxiety and 
Depression 
Scale 
Functional 
Assessmen
t of Cancer 
Therapy-G 
Functional 
Assessmen
t of Cancer 
Therapy-G 
 
X 
 
X 
X 
 
X 
 
X 
 
X 
 
X 
X 
 
X 
 
X 
 
X 
 
X 
X 
 
X 
 
X 
 
 
 
X 
 
X 
X 
 
X 
 
X 
Telephone Follow 
Up 
Script 
 
X 
 
 
 
 
Patient Evaluation 
Questionnaire 
Perceptions 
of study 
 
X 
 
 
 
X 

 
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effectivenes
s 
 
 
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:  
Attachment  – Participant Eligibility Screening Form 
Attachment  – Eligibility Recruitment Script 
Attachment  – Holland Sleep Disorders Questionnaire 
Attachment  – ApneaLink Plus 
Attachment  – Medical Record Review Questionnaire 
Attachment  – Dysfunctional Beliefs and Attitudes about Sleep Scale 
Attachment  – Hospital Anxiety and Depression Scale 
Attachment  – Functional Assessment of Cancer Therapy – General 
Attachment  – Insomnia Severity Index (ISI) 
Attachment  – Sleep Diary  
Attachment – Actigraphy=Actiwatch Spectrum 
Attachment  – Pittsburgh Sleep Quality Index (PSQI)  
Attachment  – Profile Mood States Fatigue Subscale (POMS-F) 
Attachment  – Epworth Sleepiness Scale (ESS) 
Attachment -Presentation: Brief Behavioral Treatment Insomnia (BBTI) and 
Healthy Eating Program (HEP) 
Attachment -Phone Follow Up Scripts 
Attachment -Patient Evaluation Questionnaire 
 
10.4 Describe any source records that will be used to collect data about subjects (e.g. 
school records, electronic medical records). 
Response:  
Electronic health record at Roswell Park Comprehensive Cancer Center 
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. 

 
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Response:  
If the results of ApneaLink Plus reveals AHI >15, the participant will be provided 
2 copies of the ApneaLink Plus report: one for themselves and a copy for their 
provider. 
 
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:  
Results of the study will be published via abstract, poster and manuscript to 
journals. All results will be aggregated and de-identified.  
 
11.0 
Study Timelines 
11.1 Describe the anticipated duration needed to enroll all study subjects. 
Response:  
The enrollment period is planned for 3 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:  
One week of data collection at home by the participant. Randomization to 
an intervention involving one 45-minute individual session with two 30-
minute telephone calls delivered 1- and 2-weeks after the intervention 
concluding with a 1-month, 3-month and 12-month follow up in person or 
by mail. Following the one-month data collection, the interventionist will 
contact participants to provide feedback on BBTI and PASS programs. 
Participation will involve approximately 11-12 hours over a 13-month time 
period. 
 
 
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:  
The estimated duration for the investigators to complete this study is 5 years. 
 
12.0 
Setting 

 
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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:  
The location will be a private conference room at either RPCI,  other cancer 
provider in WNY, or internet-delivered. 
  
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:  
While the study occurs outside of UB, there are no site specific regulations or 
customs and no local review structures. 
☐ 
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 
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:  
Not Applicable” This study does not utilize CBPR. 
☒ 
N/A:  This study does not utilize CBPR. 
13.2 
Describe the composition and involvement of a community advisory 
board. 

 
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Response:  
Not Applicable: This study does not have a community advisory board. 
☒ 
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:  
The NIH-funded PI is an advanced practice nurse with more than 20 years of 
clinical experience and 15 years of cancer-related fatigue, sleep and circadian 
rhythms and QOL research.  
The Co-I, Professor of Oncology and Director of the Survivorship Clinic, Roswell 
Park Comprehensive Care Center  
The Co-I, Dr. Suzanne Dickerson, DNS, RN, Professor and Chair of 
Biobehavioral Health and Clinical Sciences, University at Buffalo, School of 
Nursing, a sleep scientist and qualitative researcher 
The clinical collaborator, pulmonologist, sleep clinician, University at Buffalo 
Sleep Fellowship Program 
The Co-I, PhD, Biostatistician, University at Buffalo.  
 
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 has 230% effort, Co-Is each have 5-7% effort, a study coordinator is 100% 
effort, and Research Assistant is 50% effort. 
 
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. 

 
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NOTE:  One example includes: on-call availability of a counselor or psychologist 
for a study that screens subjects for depression. 
Response:  
If the results of ApneaLink Plus reveals AHI >15, the participant will be provided 
2 copies of the ApneaLink Plus report: one for themselves and a copy for their 
provider. 
This proposal poses minimal risks. Anxiety and depression will be assessed at 
baseline, one-, three- and 12-months post-intervention. Scores greater than seven 
on either scale will be communicated to participants who will be encouraged to 
contact their health care provider for follow up care. Any participant who exhibits 
distress will be asked permission by the study team member they are with to refer 
them for care as appropriate.  
 
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:  
Once this study has IRB approval, the PI will provide the protocol to each 
member of the research team and then meet with each member of the research 
team individually to tell the PI what their role on the study will be. Participant 
safety and data safety and monitoring will also be reviewed. 
  
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:  
Roswell Park Comprehensive Cancer Center (RPCCC): Human Subject Research 
Committees 
☐ 
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 

 
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participant is reminded that they are free to refuse to answer any questions that 
they do not feel comfortable answering.”   
Response:  
To protect participants’ privacy interests during the course of this research, study 
team members will only meet with the participants in a private clinic room or 
privately via the internet where no one can overhear the conversation. 
Additionally, participants will routinely be reminded that they are free to refuse to 
answer any questions that they feel uncomfortable answering at each data 
collection period. 
 
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:  
Each participant who signs an informed consent will be asked permission by the 
PI or Study Coordinator to verify diagnostic and treatment information in their 
electronic medical record. For clinic list prescreening, we have completed a 
Request for Limited Waiver of the Authorization for the Use of Individually 
Identifiable Health Information for Subject Recruitment Authorization. 
 
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:  
Specific Aim 1. The primary analyses involve the statistical assessment of 
Insomnia Severity Index (ISI) at 1 month and will be based on an analysis of 
covariance (ANCOVA) model. In taking this approach, we fit the dependent 
variable as a linear function of independent variables randomized treatment 
assignment, patient cancer type, the interaction between treatment assignment and 
cancer type, and baseline ISI level. Rather than utilizing the null distribution 
associated with the classic F-test for overall treatment differences within the 
ANCOVA framework, which is dependent on the validity of distributional 
assumptions, an exact permutation testing approach will be utilized. The 
randomization mechanism at work is a crucial component in this study in that it 
will be used to create the randomization distribution by which statistical 
significance will be determined.  For more on this approach see Gail, Tan, and 
Piantadosi (1988)(120). Reported p-values will be obtained from the permutation 
distributions of the test statistics based on 10,000 Monte Carlo simulations. As 
additional analyses, subject covariates will be included as independent variables. 

 
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The interaction of treatment group and subject covariates may also be examined 
in a secondary fashion in order to identify possible differential effects of 
treatment. The analysis of secondary outcomes will proceed in a similar fashion. 
All statistical tests will be two-sided and tested at a 0.05 nominal significance 
level. 
Specific Aim 2. Standard multiple regression will be used to determine predictors 
of efficacious response to BBTI. Standard diagnostic plots will be used to assess 
model fit and transformations of variables may be considered in order to meet 
statistical assumptions.  
Specific Aim 3. Evaluation of BBTI implementation focused on (a) 
characterization of the patient- and provider-level facilitators and barriers; and (b) 
knowledge/skills transfer among staff nurses using focus groups with each of the 
implementation facilitator groups. Transcript-based analysis, the most rigorous 
and accurate type of qualitative analysis, will be performed on focus group data. 
Audio recordings of each focus group meeting will be professionally transcribed 
verbatim and this text will provide the data for analysis. Prior to analysis, 
accuracy of the transcripts will be verified by Dr. Dickerson. The research team 
(Drs. Dean and Dickerson) will read all data repeatedly to achieve immersion and 
obtain a sense of the whole(121). Then data will be read by highlighting exact 
words that capture key thoughts or concepts. Next, the researchers will record first 
impressions, thoughts and initial analysis from the data. Labels for codes will 
emerge as the process continues. Codes may come directly from the text and 
become the preliminary coding scheme. Codes will be sorted into categories, 
which will be used to organize and group codes into meaningful clusters. Final 
codes will be organized into a hierarchical structure, if possible. Findings will be 
used to plan for dissemination and sustainability of this intervention. The 
software, Nvivo, will be used to assist in data management. During years 3 and 5, 
we will engage implementation facilitators and submit an IRB amendment before 
implementing aim 3.  
 
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:  
The estimate of the variability used for sample size calculations was based on 
previous results, which showed the standard deviation to be approximately 4.8. 
Calculations show a sample size of 55 per group (110 total) will allow us to detect 
differences as small as 3 with 90% power. Since the actual analysis to be 
performed is based on a model, which incorporates baseline ISI and cancer type, 
which will account for some of the unexplained variability in the dependent 
variable, these calculations may be viewed as conservative. Based on our 

 
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experience, we expect a 30% drop out rate, thus a total of 158 patients will be 
enrolled into this study. 
 
17.3 Describe any procedures that will be used for quality control of collected data. 
Response:  
Participants will receive detailed verbal and written instructions from the PI and 
study coordinator on how to wear the actiwatch, complete the sleep diaries and 
self-report questionnaires. Also provided will be how to contact the PI and study 
coordinator with questions. Reminders and prompts will be provided to 
participants to avoid unintentional missing data.  
 
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, 
authorization of access, and separation of identifiers and data, as applicable.  
Include physical (e.g. paper) and electronic files. 
Response:  
Research materials will be stored in a locked office in either a locked file cabinet 
or a password-protected computer system. Consent forms with participant 
identifiers are stored in separate files from de-identified paper data. An excel 
spreadsheet with screened positive individuals will be kept on a password 
protected computer file on Roswell Park Cancer Center’s Sharepoint Server. 
18.2 
A.  How long will the data be stored? 
Response:  
Records will be stored for a period of at least 5 years following study completion. 
At the end of data collection excel screening excel spreadsheet will be deleted by 
Roswell’s IT.  
18.3 
A.  Who will have access to the data? 
Response:  
Only the PI and members of the research team will have access to the data and 
excel screening spreadsheet. 
  

 
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18.4 
A.  Who is responsible for receipt or transmission of the data? 
Response:  
The PI and members of the research team are responsible for the receipt and 
transmission of the data.  
 
18.5 
A.  How will the data be transported? 
Response: 
The investigator performing the visit will transport the data securely in a 
briefcase. 
  
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:  
Not Applicable: No Specimens will be collected or analyzed in this research. 
18.7 
B.  How long will the specimens be stored? 
Response:  
Not Applicable: No Specimens will be collected or analyzed in this research. 
18.8 
B.  Who will have access to the specimens? 
Response:  
Not Applicable: No Specimens will be collected or analyzed in this research. 
18.9 
B.  Who is responsible for receipt or transmission of the specimens? 
Response:  
Not Applicable: No Specimens will be collected or analyzed in this research. 
18.10 B.  How will the specimens be transported? 
Response: 
Not Applicable: No Specimens will be collected or analyzed in this research. 
 

 
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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:  
The PI will be responsible for ensuring data integrity and safety monitoring 
for human subjects and communicating any negative outcomes or any 
serious events to the IRBs and other offices/agencies. Because of the 
minimal to low risk associated with this protocol, the data safety and 
monitoring plan (DSMP) for this project involves a Safety Monitoring 
Committee (SMC). The SMC will ensure participant safety, ensure the 
validity and integrity of the data, monitor study progress, and make 
recommendations regarding appropriate protocol and operational changes 
which may have substantial effects upon the ultimate interpretation of the 
study. They will also be responsible for promptly report any serious 
adverse events to the Institutional Review Boards (IRB) at Roswell Park 
Cancer Institute and the University at Buffalo. 
Weekly reviews of participant accrual will be conducted by the PI during 
weekly research meetings. If participant accrual and/or retention drop 
below what is required for successful completion of this study, the PI will 
alert the statistician and strategies will be developed to overcome the 
identified problems. Records from subjects recruited during that week will 
also be scrutinized to insure that all participants are eligible for 
participation in the study. The PI and members of the research team will be 
monitoring developments in the literature and results of related studies that 
may have an impact on the safety of participants or on the ethics for the 
research study. 
 
19.2 Describe what data are reviewed, including safety data, untoward events, and efficacy 
data. 
Response:  
Data review includes eligibility, referral for sleep apnea, referral for low oxygen 
during sleep, completion of data collection instruments, adherence to intervention, 
number of follow up phone calls accepted, and outcome measures of efficacy:  

 
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sleep, mood, functional status and quality of life. Daytime sleepiness will also be 
evaluated daily, but monitored weekly. Additionally, as previously mentioned, we 
are adding a 6 and 9 month follow up email to check on participants’ safety. If 
participants report that they are excessively sleepy, we will provide 
recommendations to reduce sleepiness by telephone or email.   
Because of the minimal to low risk associated with this protocol there are no life-
threatening anticipated adverse events for this proposed research project. In the 
event of an unanticipated adverse event, such as disease-related patient death, it 
will be reported to and reviewed by the PI, SMC, and referring physician within 
seven days. Next, the IRBs at Roswell Park Comprehensive Cancer Center and 
the University at Buffalo as well as sponsoring agencies (NINR) will be notified 
within 15 days. A thorough investigation will be initiated, including review of the 
protocol to insure no undue exposure to risk occurred. 
19.3 Describe any safety endpoints. 
Response:  
This low risk intervention may lead to emotional distress in participants who may 
become frustrated if insomnia does not improve. Anxiety and depression will be 
assessed at baseline, one, three and 12-months post-intervention. Scores greater 
than seven on either scale will be communicated to participants who will be 
encouraged to contact their health care provider for follow up care. 
 
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:  
The safety information will be collected with self-report surveys, during study 
visits and by telephone calls with participants.  
 
19.5 Describe the frequency of safety data collection. 
Response:  
Safety data collection occurs at baseline, weekly then at 1-month, 3-months and 
12 months post-intervention.  
 
19.6 Describe who will review the safety data. 
Response:  
The PI, study coordinator, research assistant and members of the Safety 
Monitoring Committee. 
 
19.7 Describe the frequency or periodicity of review of cumulative safety data. 

 
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Response:  
Reviews of cumulative safety data will initially occur weekly, then biweekly and 
eventually monthly.  
   
19.8 Describe the statistical tests for analyzing the safety data to determine whether harm 
is occurring. 
Response:  
Hospital Anxiety and Depression Scale scores will be summarized. 
 
19.9 Describe any conditions that trigger an immediate suspension of the research. 
Response:  
We do not anticipate any condition that would trigger an immediate suspension of 
the research. 
 
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:  
Participants will be withdrawn from the research without their consent if they are 
unable to complete their responsibilities listed on the consent form or if they 
falsify responses. 
  
20.2 Describe any procedures for orderly termination.   
NOTE:  Examples may include return of study drug, exit interview with clinician.  
Include whether additional follow up is recommended for safety reasons for 
physical or emotional health. 
Response:  
The participants that require early termination from the study will receive 
a telephone call alerting them to the termination and thanking them for 
their participation. If participants are not available via telephone, a letter 
notifying them of their termination will be mailed to their home address.  
  
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. 

 
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Response:  
It is conceivable that some participants may decide not to fully participate, for 
example, not participate in the intervention, but complete survey and actigraph 
data. Their data is still valuable. Data collection would continue and participants 
would receive appropriate compensation. 
 
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:  
A reasonable foreseeable risk is excessive daytime sleepiness early in the study 
from having night-time sleep curtailed as part of the intervention. Daily sleep 
diaries provide daily daytime sleepiness measures and the PI and Study 
Coordinator will monitor for this risk. The known discomforts associated with this 
study include the possibility that participants may become upset thinking about 
some of the questions or topics in this study. If this occurs, the participant should 
notify the research assistant and will then be provided with an appropriate referral 
for assistance. The skin on the participant’s wrist may become irritated by 
wearing the actigraph. If this occurs, the participant will be advised to remove the 
actigraph, apply a thin layer of Eurcerin lotion to the affected area and wear the 
actigraph on the opposite wrist. 
All reasonable efforts will be used to protect the confidentiality of the 
participants’ protected health information. Identifiable data is immediately de-
identified and de-identified data is stored separately from identifiable data. The 
results of this research will be published. However, we will keep participants’ 
names and other identifying information confidential.  
 
21.2 Describe procedures performed to lessen the probability or magnitude of risks, 
including procedures being performed to monitor subjects for safety. 
Response:  
NA 
 
21.3 If applicable, indicate which procedures may have risks to the subjects that are 
currently unforeseeable. 
Response:  
NA 

 
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21.4 If applicable, indicate which research procedures may have risks to an embryo or 
fetus should the subject be or become pregnant. 
Response:  
NA 
 
21.5 If applicable, describe risks to others who are not subjects. 
Response:  
NA 
 
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 in the experimental group will have a high probability of 
improvement in sleep and quality of life, but magnitude and duration of these 
improvements are under investigation. Participants in the control are unlikely to 
receive direct benefit.  
 
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: 
 
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: NA 

 
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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:  
There are no reasonably anticipated costs to subjects. 
☐ 
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:  
Each participant will receive $75 to cover travel and time commitments. 
Participants will receive $25 at the conclusion of baseline testing, $25 at 1-month 
follow up and $25 at the conclusion of data collection.  
☐ 
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 conference room at either Roswell 
Park Comprehensive Cancer Center,  other cancer provider in WNY, or via 
telephone and/or the internet.  
 
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.   

 
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NOTE:  It is always a requirement that a prospective subject is given sufficient 
time to have their questions answered and consider their participation.  See “SOP: 
Informed Consent Process for Research (HRP-090)” Sections 5.5 and 5.6. 
Response:  
The consent will be administered after a detailed study explanation by the PI or 
study coordinator. Eligible participants will then be given a minimum of 30 
minutes to read over the consent form, at which time the PI or study coordinator 
will ask if they have any further questions. The final component of the consent 
process will involve reviewing a brief checklist that outlines the major aspects of 
the study to confirm that the participant fully understands 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:  
At each contact with participants, the PI or study coordinator will routinely 
remind participants of their volunteer status and ability to withdraw from 
participation at any time.  
 
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:  
This research will follow SOP: Informed Consent Process for Research.  
☒ 
We have reviewed and will be following “SOP: Informed Consent Process 
for Research (HRP-090)” with the exception that consent provisions will 
not be made to conduct consent in languages other than English even if 
this is preferred by the participant. Eligible participants all must be able to 
complete data collection instruments which are written in English. 
  
 
Non-English Speaking Subjects  
☐ 
N/A:  This study will not enroll Non-English speaking subjects.   
(Skip to Section 26.8) 

 
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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:  
Not Applicable. 
 
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:  
Not Applicable. 
 
 
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:  
Not Applicable.  
 
 
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. 

 
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Response:  
Not Applicable. 
☐ 
We have reviewed and will be following “SOP: Legally Authorized 
Representatives, Children, and Guardians (HRP-013).”  
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:  
Not Applicable. 
 
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:  
Not Applicable.  
 
• 
If assent will not be obtained from some or all subjects, provide an 
explanation of why not. 
Response:  
Not Applicable.  
 
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:  
Not Applicable.  
 
 
Subjects who are not yet Adults (Infants, Children, and Teenagers) 

 
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☐ 
N/A:  This study will not enroll subjects who are not yet adults.   
(Skip to Section 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.”  
NOTE:  Examples of acceptable responses include: verification via electronic 
medical record, driver’s license or state-issued ID, screening questionnaire. 
Response:  
Not Applicable. 
  
26.14 For research conducted outside of New York State, provide information that 
describes which persons have not attained the legal age for consent to treatments or 
procedures involved the research, under the applicable law of the jurisdiction in which 
research will be conducted.  One method of obtaining this information is to have a 
legal counsel or authority review your protocol along the definition of “children” in 
“SOP: Legally Authorized Representatives, Children, and Guardians (HRP-013).” 
Response:  
Not Applicable.  
 
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).”  

 
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26.16 Describe 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:  
Not Applicable.  
 
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:  
Not Applicable. 
 
26.18 When assent of children is obtained, describe how it will be documented. 
Response:  
Not Applicable.  
 
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:  
 
This study involves web-based data collection triggered via email, a 45-minute 
educational session about sleep and two follow up telephone calls from a nurse in 
graduate student. We want to offer verbal consent to participate because some of 
our participants are unable to return to the clinic for consent. The identifiable 
private information collected electronically in this study is secured via password 
protection. The participants will be provided information about the study from the 
PI/study coordinator, an opportunity to ask questions about the study and if they 
need time to think about their participation or discuss with others before 
consenting to participate in the study. Each participant contact will include a 
reminder of the participant’s “voluntary participation.” 

 
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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:  
Not Applicable.  
 
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).   
Response: This research presents no more than minimal harm to subjects and 
involves no procedures for which written documentation of consent is normally 
required outside of the research context. Reasons for verbal consent include the 
current shelter-in-place situation and potential participants’ inability to return to 
the clinic for consent. 
We will be following SOP: Written Documentation of Consent (HRP-091). 
☐ 
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: 

 
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• 
All sites have the most current version of the IRB documents, including 
the protocol, consent document, and HIPAA authorization. 
• 
All required approvals have been obtained at each site (including 
approval by the site’s IRB of record). 
• 
All modifications have been communicated to sites, and approved 
(including approval by the site’s IRB of record) before the 
modification is implemented. 
• 
All engaged participating sites will safeguard data as required by 
local information security policies. 
• 
All local site investigators conduct the study appropriately. 
• 
All non-compliance with the study protocol or applicable requirements 
will be reported in accordance with local policy. 
Response:  
Not Applicable.  
 
29.2 Describe the method for communicating to engaged participating sites: 
• 
Problems 
• 
Interim results 
• 
Study closure 
Response:  
Not Applicable.  
 
29.3 
Indicate the total number of subjects that will be enrolled or records that 
will be reviewed across all sites. 
Response:  
Not Applicable.  
 
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:  
Not Applicable.  
 
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. 

 
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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:  
Not Applicable. 
 
30.2 List the data to be stored or associated with each specimen. 
Response:  
Not Applicable.  
 
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:  
Not Applicable.  
 
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:  
Not Applicable.  
 
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: 
Not Applicable.  
 
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: 

 
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31.3 Identify the holder of the IND/IDE/Abbreviated IDE. 
Response:  
Not Applicable.  
 
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:  
Not Applicable.  
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:  
Not Applicable.  
 
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:  
Not Applicable.