Computerized Game-based Vestibular Rehabilitation: Assessment of Feasibility and Motor Learning
Conditions: Vestibular Diseases
Sponsor: VA Office of Research and Development

LSCDVAMC 
 
Research Plan 
April 2014 
 
Page 1 of 27 
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Louis Stokes Cleveland Department of Veterans Affairs Medical Center  
Research Plan 
Please contact the IRB office if you have any questions at (216) 791-3800 ext. 64658. 
  Request for Expedited IRB Review Form attached   
Human Subject Research: Human subject research means research involving interaction or intervention with 
living human beings or access to identifiable private information of living human beings. 
Research Plan:  The information requested in the Research Plan is designed to provide the IRB with the necessary 
information such that it can make the federally required determinations codified at 38 CFR Part 16, 21 CFR Parts 
50, 54, & 56, and 45 CFR Part 46  
The Research Plan is to be written so that the non-scientist/non-medical members of the IRB can understand the 
research proposed.  Define all abbreviations and terms that are not part of common language.  
Version Date:  This should be updated subsequently with every modification to any part of the Research Plan.  Any 
modification to this document, no matter how minor, must be reviewed and approved by the IRB prior to 
implementation.  The Research Plan will be stamped with the date of IRB approval 
.   
 
Section 1 – General Information 
1.  Version Date: August 31, 2023 
2.  Title of Project: Computerized game-based vestibular rehabilitation: assessment of feasibility 
and motor learning 
3.  Principal Investigator (PI) (name & degrees): Mark Walker, M.D. 
E-mail: mark.walker5@va.gov 
Pager Number/Cell Phone Number: 440 562 0458 
4.  Research Contact/Research Coordinator (name, degrees): n/a 
 
E-mail:       
Pager Number/Cell Phone Number:       
IRB #: ___________ 
(Assigned by IRB Office) 
 
   
CPA #: ___________ 
(Assigned by IRB Office) 
 
 
 
 
VANEOHS IRB
Effective Date:
October 4, 2023

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Section 2 – Research Sites and Sponsor 
5.  Please list all Research Sites in addition to Louis Stokes Cleveland DVA Medical Center 
(LSCDVAMC); n/a  
International studies when the PI is the Lead Investigator list the countries:   n/a 
a. When study procedures including analysis of identifiable samples or data involving 
LSCDVAMC enrolled subjects will be conducted at any site other than the LSCDVAMC 
please provide the following:  
 Name and contact information for the site:  n/a 
 Describe the plan for communicating protocol amendments, reports of serious 
adverse events, reports of unanticipated problems involving risks to subjects or 
others, interim reports, and DSMB reports to external sites.   n/a 
* When the LSCDVAMC is considered the coordinating center and the PI the lead 
investigator on cooperative research or a multi-center trial contact AO/Research 
Holly.Henry@va.gov. 
6.  Sponsor or other Support (list industry sponsor, government support, etc.):  
VA RRD 
Section 3 – Research Design and Procedures 
7.  Definitions- Provide a list of all abbreviations and specialized terms to be used in this document 
and their definitions: 
Abbreviations / Specialized Terms 
(Use the Enter key in this column to insert additional 
abbreviations and their definitions) 
Definition 
LSCDVAMC  
Louis Stokes Cleveland DVA Medical Center 
VOR 
DVA 
Vestibulo-ocular reflex 
Dynamic visual acuity 
 
8.   Provide a BRIEF SUMMARY of the background for this research. DO NOT CUT and PASTE 
paragraphs that do NOT summarize the background.   
 
Include a critical evaluation of existing knowledge, and specifically identify the information gaps 
that your protocol is intended to fill.   
 
Refer to appropriate citations in the scientific literature and include your references at the end of 
this section.   
 
Include the rationale for conducting the research at the VA. 
The overall goals of our research are to understand how the brain processes visual and 
vestibular signals to drive eye movements and postural reflexes, how these functions are 
disturbed in neurological diseases, how those disturbances cause functional impairments for 
patients, and how these problems can be treated. The goal of this project is to test the 
 
VANEOHS IRB
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efficacy of a custom computer game to induce motor learning in the vestibulo-ocular reflex 
(VOR) and to obtain preliminary data of its feasibility as a tool for clinical vestibular 
rehabilitation. Vestibular disorders occur commonly in the general population, including 
veterans, and they are associated with reduced quality-of-life, disruption of work, and 
limitations of independence [1-4].  
Vestibular rehabilitation is the mainstay of treatment for these conditions [5, 6], but standard 
therapy has key limitations and cannot be easily customized to each patient’s specific level 
of functional impairment. This project builds on our preliminary work to develop an 
interactive computer game for customized vestibular rehabilitation in clinical and home 
settings. 
Traditional vestibular rehabilitation [7] and our new approach are based on research 
regarding vestibular physiology and the plasticity of the VOR[8-12]. The primary function of 
the VOR is to compensate for head movements by rotating the eyes in the opposite 
direction to stabilize the retina on the object being viewed. This permits vision to remain 
clear during movement. When vestibular function is lost due to disease, the VOR no longer 
functions properly and gaze stability during head movement is lost. Vestibular rehabilitation 
aims to retrain the VOR by improving the function of the reflex and facilitating the 
optimization of alternative motor strategies to aid compensation.  
 Recent work suggests that incremental VOR adaptation may be more effective than single-
step adaptation[13]—it may be easier to adapt stepwise to smaller errors than to a large 
error all at once. This approach involves gradually increasing the amount of scene motion 
relative to the head as the VOR adapts, always working closer to the current level of 
function. The ability to adapt the VOR incrementally is a key aspect of our vestibular game, 
and the effectiveness of this approach for short-term adaptation will be directly tested in Aim 
1. 
 
1. Agrawal Y, Carey JP, Della Santina CC, Schubert MC, Minor LB. Disorders of balance 
and vestibular function in US adults: Data from the national health and nutrition examination 
survey, 2001-2004 Arch Intern Med 2009;169:938-944. 
2. Neuhauser HK, Radtke A, von Brevern M, Lezius F, Feldmann M, Lempert T. Burden of 
dizziness and vertigo in the community Arch Intern Med 2008;168:2118. 
3. Agrawal Y, Ward BK, Minor LB. Vestibular dysfunction: Prevalence, impact and need for 
targeted treatment J Vestib Res 2013;23:113-117. 
4. Ward BK, Agrawal Y, Hoffman HJ, Carey JP, Della Santina CC. Prevalence and impact of 
bilateral vestibular hypofunction: Results from the 2008 US national health interview survey 
JAMA Otolaryngol Head Neck Surg 2013;139:803-810. 
5. Cooksey FS. Rehabilitation in vestibular injuries Proc R Soc Med 1946;39:273-278. 
6. Hall CD, Herdman SJ, Whitney SL, et al. Vestibular rehabilitation for peripheral vestibular 
hypofunction: An evidence-based clinical practice guideline. Journal of Neurologic Physical 
Therapy 2016;40:124-155. 
7. Herdman SJ. Role of vestibular adaptation in vestibular rehabilitation Otolaryngol Head 
Neck Surg 1998;119:49-54. 
8. Rambold H, Churchland A, Selig Y, Jasmin L, Lisberger SG. Partial ablations of the 
flocculus and ventral paraflocculus in monkeys cause linked deficits in smooth pursuit eye 
movements and adaptive modification of the VOR. J Neurophysiol 2002;87:912-924. 
 
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9. Miles FA, Lisberger SG. Plasticity in the vestibulo-ocular reflex: A new hypothesis. Annu 
Rev Neurosci 1981;4:273-299. 
10. Boyden ES, Katoh A, Raymond JL. Cerebellum-dependent learning: The role of multiple 
plasticity mechanisms. Annu Rev Neurosci 2004;27:581-609. 
11. Luebke AE, Robinson DA. Gain changes of the cat's vestibulo-ocular reflex after 
flocculus deactivation. Exp Brain Res 1994;98:379-390. 
12. Luebke AE, Robinson DA. Climbing fiber intervention blocks plasticity of the 
vestibuloocular reflex. Ann N Y Acad Sci 1992;656:428-430. 
13. Schubert MC, Della Santina CC, Shelhamer M. Incremental angular vestibulo-ocular 
reflex adaptation to active head rotation. Exp Brain Res 2008;191:435-446. 
 
9. Provide a BRIEF SUMMARY of the purpose and scientific rationale for this research. DO NOT 
CUT and PASTE paragraphs that do NOT summarize the purpose and scientific rationale.   
 
State clearly, in terms a non-scientist/non-medical person can comprehend, what you expect to 
learn from the study and the specific hypothesis (es) to be tested. 
 
The objectives should be stated in such a way that the reader can determine the appropriateness 
of the study design. 
 
The hypothesis of the study is that computer-game-based incremental adaptation will induce 
robust VOR motor learning and will provide an engaging platform for vestibular 
rehabilitation.  
In the first aim, we will test the ability of the game to induce VOR plasticity (to modify the 
gain of the VOR) in subjects with intact vestibular function. To do this, we will have subjects 
play the game with a visual condition (background movement that is tied to head velocity) 
that requires them to make a larger than normal eye movement when the head rotates. 
Such visual-vestibular mismatch has been shown in the past to lead to an increase in the 
gain of the VOR, even when tested in the dark. Our hypothesis is that incremental 
adaptation (increasing the amount of visual-vestibular mismatch gradually in a series of 
steps) will be more effective in inducing this plasticity, so we will compare the change in gain 
with this paradigm to that induced by imposing the full amount of visual-vestibular mismatch 
all at once. 
In the second aim, we will obtain preliminary data regarding the efficacy and feasibility of the 
game for clinical vestibular rehabilitation. Patients with peripheral vestibular hypofunction will 
play the game with the degree of visual-vestibular mismatch customized for their individual 
level of impairment. They will provide feedback regarding the game and their tolerance of 
the playing experience. Each subject will play once a week for four weeks. This will give us 
preliminary data regarding short-term VOR learning in these patients.  
10. Describe the means of analyzing the data and evaluating the results.   
 
State the anticipated methods to be used for analysis and interpretation of the data. 
 
The methods must compliment the design of the study and the nature of the data which is being 
collected. 
Data Analysis: The primary outcome measures for this experiment are the passive and 
active VOR gains. The VOR gain will be calculated for each subject and condition using an 
 
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optimization procedure in MATLAB that fits eye velocity to delayed head velocity. In addition 
to assessing the slow-phase gain change, we will examine “non-vestibular” components of 
the post-adaptation eye movements; for example, an increase in saccades during the head 
rotation (covert saccades) may also contribute to gaze stability. 
A secondary measure will be the change in DVA with x1.5 viewing, with the prediction that 
DVA with the moving scene will improve after the VOR has adapted to that visual-vestibular 
condition and that the improvement in DVA will correlate with that of the VOR. Pre- and 
post-adaptation VOR gains will be compared using a paired t-test, employing a power 
transformation if the assumption of normality is not satisfied. Most of the software that will be 
required for data analysis has already been written by the PI or other members of the 
laboratory. 
Vestibular patients will complete questionnaires (Dizziness Handicap Inventory, Activity-
based Balance Confidence) to assess the extent and functional impact of their symptoms, 
but these will not be outcome measures for the study. 
Subjects will rate their feelings of motion sickness on a 0-10 scale following each playing 
session. 
11. Provide a BRIEF DESCRIPTION of how the estimated number of study subjects needed for 
this research was determined  
 
If this is a quantitative study provide the method of determining sample size estimates. 
 
If multiple studies are planned provide a power analysis or justification for each one. 
This is an unpowered pilot study that is funded under the SPiRE mechanism. The number of 
subjects was chosen to provide adequate preliminary data to support a funding application 
for a larger clinical trial.  
12.  The research involves the following procedures conducted by and for what purpose: 
PROCEDURE 
PERFORMED BY:          
PROCEDURE IS: 
Research 
Staff 
 
LSCDVAMC 
Clinical or 
Support Staff 
Standard 
of Care* 
For 
Research 
Purposes 
Only** 
Audiotaping / Videotaping 
 Attach VA Form 10-3203  REQUIRED 
ONLY FOR IN-PATIENT AND OUT-
PATIENT SUBJECTS 
 
 
 
 
Biopsy 
 
 
 
 
Blood collection 
 
 
 
 
Chart review – prospective 
 
 
 
 
Chart review – retrospective 
 
 
 
 
Review of existing data ( ex: registry, 
Database , etc.) 
 
 
 
 
 
VANEOHS IRB
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PROCEDURE 
PERFORMED BY:          
PROCEDURE IS: 
Research 
Staff 
 
LSCDVAMC 
Clinical or 
Support Staff 
Standard 
of Care* 
For 
Research 
Purposes 
Only** 
 X-ray or Ionizing radiation exposure 
 
 
 
 
Clinical Tests 
 
 
 
 
Device implantation 
 
 
 
 
Drug administration 
 
 
 
 
EEG,  EKG , ECG…etc 
 
 
 
 
Gene therapy, Genetic analysis 
 
 
 
 
Pregnancy/Breastfeeding Screening 
 
 
 
 
Interview, Questionnaire, Diary, Survey 
(please attach) 
 
 
 
 
Stool collection, Urine collection, or any 
Non-surgical Specimen collection 
 
 
 
 
Surgical procedure or Specimen removal 
during surgery 
 
 
 
 
Tissue banking (complete Section 12) 
 
 
 
 
Use of pre-existing tissues/specimens 
 
 
 
 
Other (list):  measurement of head and 
eye movements; measurement of visual 
acuity; exposure to visual stimuli during 
passive and/or active head movement, 
including while playing a video game. 
 
 
 
 
 
*Standard of care procedures are procedures performed in the course of normal medical care. 
 
**Research Procedures are performed for the purposes of this research alone. 
13. Please describe the research design and all study related procedures.  
 
Describe ALL PROCEDURES ASSOCIATED WITH THIS RESEARCH.  This includes 
standard of care and research procedures.   
 
For complex studies please include diagrams and tables.  Be sure to describe when each 
procedure will be performed.  Be sure to provide information for each cohort, including normal 
controls).  
 
The hypothesis of the study is that computer-game-based incremental adaptation will induce 
robust VOR motor learning and will provide an engaging platform for vestibular 
rehabilitation. The hypothesis will be tested with two specific aims: 
Aim 1 (Healthy volunteers) will test the efficacy of our game to elicit VOR motor learning in 
18 healthy volunteers with no history of vestibular disease. Each subject will play the game 
 
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twice for sessions of 300 trials each (about 30 minutes of game playing). In one of these 
sessions, the game will be structured to increase VOR gain in a single step and in the other 
session, the gain increase will be advanced incrementally to the same final target. The 
hypothesis predicts that the latter paradigm will lead to more efficient learning. The specific 
procedures for Aim 1 will be as follows: 
Each subject will participate in two separate sessions on different days. In one session, the 
full visual-vestibular mismatch (x1.5) will be introduced at the start of the game (paradigm A) 
and in the other session scene motion will be gradually adjusted to adapt the VOR 
incrementally (paradigm B). Each session will consist of 300 trials. To eliminate an order 
effect, the paradigm order will be randomized across the group of subjects: half will do 
paradigm A first, and the other half will begin with paradigm B. 
Aim 2 (Vestibular Patients) will test the playing experience of 12 subjects with peripheral 
vestibular disorders and will obtain preliminary data regarding efficacy and feasibility of the 
game for clinical vestibular therapy. The experimental protocol will be similar to that of Aim 1 
(see above), with recording of both eye and head positions during VOR testing and game 
playing. The active and passive VOR, as well as DVA, will be recorded before and after the 
game. For each subject, we will begin by determining the baseline VOR gain. The game will 
then be played with a scene motion that corresponds to a VOR gain that is 20% higher than 
the baseline value for active rotation, separately set for each direction of head rotation. For 
example, if a patient with left vestibular hypofunction has a baseline VOR gain of 0.5 for 
active turns to the left, then scene motion will be set to x0.6 viewing (20% higher than 0.5). 
The subject will play the entire game with this condition, rather than advancing the difficulty 
as in Aim 1, because in clinical rehabilitation the difficulty is advanced more slowly, in a 
series of sessions over weeks of therapy. 
 
Data Acquisition: We will record head position using our 3-D magnetic-field coil system, long 
considered the gold standard for measuring eye and head rotations, due to its accuracy and 
high signal-to-noise ratio. Our system has large field coils (6 ft cube), which provides an 
adequate area of homogeneity at the center of the field for head-free recordings. Eye 
movements will be recorded simultaneously using a lightweight head-mounted video-
oculography (VOG) system (IScan) that records 2-D eye position at 240 Hz. Analog VOG 
pupil-tracking data are saved together with the head coil signals in the same file for reliable 
synchronization of eye and head.  Finally, calibrated head positions will be calculated in real 
time (via Simulink Real Time) and sent over UDP to the gaming computer to drive scene 
motion at the specified visual-vestibular mismatch. A computer-generated log file will record 
data from each trial: instructed direction of head movement; optotype size, orientation, and 
on-time; the subject’s key-press response; and a time-stamp for synchronization with the 
recorded head and eye position data.  
Data Analysis: Data are analyzed using custom programs that are written by the PI and 
study staff. In some cases. electronic data from head and eye movement recordings will be 
transported offsite for data analysis using specialized software. The data files to be analyzed 
will be coded so that they can be reconnected with the correct subject when the data are 
returned to the LSCDVAMC, but they will not contain other subject identifiers. The code will 
be stored only at the LSCDVAMC (as per Q56), so there will not be a way to connect data to 
a specific subject when the data are offsite.   
14. Will the research involve the following? 
       
 N/A     Chart/Data Review               
 
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Placebo Group 
 No 
 Yes (describe):       
Other Control Group 
 No 
 Yes (describe): Note that although healthy individuals 
without vestibular disease will participate in the study, 
they will be the subjects of Aim 1, not controls for the 
vestibular patients of Aim 2 (the two Aims have 
different objectives). 
Randomization 
 No 
 Yes (describe): The only randomization will be the 
order of the two playing sessions in Aim 1. 
Deception 
 No 
 Yes (describe):       
15.  Does the research involve the use and/or disclosure of Individually Identifiable Health 
Information in any form or medium? 
 No      
 Yes 
If yes, complete the required HIPAA Waiver/Authorization forms. 
16. Does the study include the administration of a study agent that does not require FDA approval 
and does not require an IND (e.g. vitamins, food supplements, isotope tracers, alternative 
medicines, etc.)? 
 No 
 Yes -provide a detailed description of the procedures used to assure patient safety: 
      
17. Will radioactive material be administered or will subjects be exposed to ionizing radiation?  
 
Ex.  Radiographic equipment, fluoroscopic equipment, and CT scanners, etc. 
 No  
 Yes  
18. In your judgment, could the objectives of the research be met in a way that presents less risk to 
subjects?  
 No      
 Yes please explain:       
Section 4 – Subject Selection, Recruitment, and Vulnerable Populations 
19.  Anticipated duration of entire study reported in years: The study as proposed is expected to 
last for 6 years (a one-year extension was approved by VA RRD, an additional no-cost 
extension will be requested to complete enrollment and study procedures, follow-on years 
for additional data analysis, including preparation of the next funding proposal).   
20.  Estimated number of subjects to be studied at the LSCDVAMC or charts/records to be 
reviewed.   
 
Provide answers for each cohort including normal controls; (patients, family members, treating 
physicians,): 
AIM 1: Healthy volunteers: 30 (per the funded protocol, enrollment will be stopped when 
completed data are obtained for 18 subjects) 
AIM 2: Vestibular Patients: 20: (per the funded protocol, enrollment will be stopped when 
completed data are obtained for 6 subjects with unilateral hypofunction and 6 subjects with 
bilateral hypofunction) 
 
 
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Note that it may be necessary to enroll more than the targeted number of subjects in order 
to reach the goals, if some subjects drop out before completing the full study. 
21.  Estimated number of subjects to be studied or charts/records to be reviewed at all sites  
 
Provide answers for each cohort including normal controls; (patients, family members, treating 
physicians,) 
      
 
N/A SINGLE SITE 
 
22.  Duration of individual subject participation  
Provide answers for each cohort including normal controls; (patients, family members, treating 
physicians,).  Each experimental session is expected to last approximately one hour. Healthy 
volunteers who are the subjects of Aim 1 will each participate for two recording sessions. 
Vestibular patients who are the subjects of Aim 2 will each participate for four sessions. 
Analysis of subjects' data will continue for the duration of the study. 
 
Chart/record review   
 N/A 
23. Age range of subjects  
 
provide answers for each cohort, including normal controls: 
 
 Adults 18 years or greater  
        Specific age range (list age range): 18-75  
       
 Children –waiver from VACO:  
 attached   
 pending- provide submission date:       
**Contact AO/Research holly.henry@va.gov for guidance.. 
24. Which of the following will be recruited or reviewed for this study (check all that apply)? 
 Veteran Inpatients 
 Men 
 Veteran Outpatients 
 Women 
 Veteran Families                                                   
 *Normal volunteers 
 *Non-Veterans;    Provide justification For Aim 1, there may be few healthy veterans 
available who are eligible and willing to participate. 
*According to VHA Handbook 1605.04 Notice of Privacy Practices VHA must provide a copy of its 
VHA Notice of Privacy Practices to all non-Veteran patients (e.g., active duty personnel or those 
seeking care in humanitarian circumstances) receiving care or treatment at a VHA health care facility 
or non-Veteran research subjects enrolled in an approved VHA research study with clinical trials. VA 
Form 10-0483 Acknowledgement of the Notice of Privacy Practices should be signed by the non-
Veteran research subject at the time of consent and given a copy of the Notice of Privacy Practices. 
Once the Acknowledgement Form is signed please send a copy to the Privacy Officer.  If additional 
information is needed please contact your Facility Privacy Officers Joseph Picklo or Tomica Jefferson 
joseph.picklo@va.gov / phone 8214102 tomica.jefferson@va.gov / phone 8214101. 
 
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25.  Which vulnerable population(s) will be TARGETED  for recruitment in this study:  
 
Indicate only those populations that are specifically targeted for the research described 
in this document.  
 
It is not necessary to check any box if, for example, your study will include a full range 
of subjects, some of whom may be elderly or subjects who might incidentally be 
employees.  
  N/A Chart Review (proceed to Item 30) 
 NONE (proceed to Item 26) 
 Medical students, house staff, or Employees of the VAMC or Case 
 Pregnant Women OR Women who are Breastfeeding, Human Fetuses, or Neonates 
 Children – Complete Section 14 “Children as Research Subjects” 
 Prisoners   (The LSCDVAMC does not conduct research involving prisoners) 
 Targeting Persons over Age 65 
 Persons with Acute/Severe Mental/Physical Disabilities (describe):       
 Persons with Cognitive, Social, Economic, or Educational Disadvantages (describe):       
 Others (describe):        
 
a. Provide the Scientific and Ethical reasons for Targeting these vulnerable populations in the 
research:   
      
b. What additional safeguards or provisions will be used to protect the rights and welfare of the 
identified targeted vulnerable subjects? 
 
 Surrogate consent 
 
 Subject assent 
 
 Use of a consent or Medical monitor 
 
 Use of a waiting period 
 
 A patient advocate will participate in the informed consent process 
 
 Key elements of informed consent will be presented orally 
             
 No supervisor or rater will be involved in obtaining consent 
 Other - Describe Additional safeguards you plan to use:         
c. Describe the procedures used to ensure that the subject’s legally authorized representative is 
well informed regarding his/her role and obligation to protect persons with impaired 
decision making capacity:   
      
26.  Procedures for Recruiting Subjects -check all that apply and attach all recruitment materials: 
 Not Applicable 
 
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 Materials;  Recruitment Letter, Posting on Bulletin Board, Brochure, Flyer, Post card, etc. 
 Media; Internet Ads, Press Releases, Newspaper, Radio 
 Investigator’s Patient Population 
 Physician Referral 
 Letters to Physicians/Clinicians 
 
 Other (describe): Referrals from physical therapy, audiology; CPRS chart review (see #27 
below)   
 
27.  Will VA computer systems be used to identify potential subjects?  
 
e.g. VISTA, CPRS, Pharmacy Databases, other clinical databases, etc, 
       
 No    
 Yes- Describe how the computer will be used to identify patients.  List all systems             
used and all information to be collected: Potential subjects for Aim 2 (patients with vestibular 
hypofunction) will be recruited from the population of patients in the VANEOHS clinics 
that treat vestibular disorders. In addition to direct referrals, the P.I. will review the 
medical records of patients that have been seen in these clinics (CLE NEURO 
VESTIBULAR WALKER, CLE NEURO VESTIBULAR STAHL, CLE ENT clinics, CLE 
AUDIOLOGY BALANCE, CLE PT VESTIBULAR BALANCE) to identify veterans who 
may be eligible to participate. These veterans will be sent a recruitment letter describing 
the study and offering them the opportunity to be considered for participation. A number 
will be provided for the veteran to call to express interest or to decline to participate. It 
will also explain that if no response is received within 2 weeks from the mailing of the 
letter, the veteran may receive a follow-up call by study staff.   
In some cases, even for patients recruited by direct referral, it may be necessary for the PI to 
review a potential subject's medical record in CPRS to confirm eligibility, before the subject is 
consented and enrolled in the study. Identifiers that will potentially be accessed include: Name, 
Date of Birth, Social Security Number, Medical History, Imaging 
28. Will subjects be identified and/or recruited in clinics and/or inpatient wards at the 
LSDCVAMC? 
 No 
 Yes- explicitly describe your process for identifying and/or recruiting these 
patients: (address all cohorts):  Patients will be recruited by Dr. Walker from the 
VANEOHS neurology clinic or will be referred by other providers. As above, patients will 
also be identified by review of CPRS records of patients seen in those clinics. 
29.  In addition to the consent form will any other materials be given to the subject? 
            
 N/A Chart/data review 
     
 No 
 Yes- check all that apply and submit for IRB review: 
                          
 Letter 
 
 
 
             
 Information Sheets  
                          
Questionnaire, Survey, Diary 
              
 Other (flyer, brochure, describe):  The recruitment flyer and recruitment letter 
with study information will be used to advertise the study to potential subjects. 
30.  Please list by bullet point inclusion/exclusion criteria for the study.   
 
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 
Entry criteria should be as detailed as necessary to define the subject population(s) under study 
and reduce confounding design.  Include precise criteria for age, gender, and other relevant 
factors.  
 
 List specific exclusion criteria which could interfere with the study design or place a subject at 
risk during the study.  
 
 Provide answers for each cohort, including normal controls. 
AIM 1: Healthy Volunteers 
• Adults age 18-75 
• No history of vestibular disease 
• Equivalent visual acuity at testing distance of 20/30 or better without or with spectacles 
 
AIM 2: Vestibular Patients 
• Adults age 18-75 
• Peripheral vestibular hypofunction (unilateral n=6, bilateral n=6) 
• No central vestibular disorder 
• Equivalent visual acuity at testing distance of 20/30 or better without or with spectacles 
 
  N/A Chart/data review  
31.  By role, (PI, Coordinator, etc.) who will assess for eligibility and how will this be accomplished? 
The PI will assess all potential subjects for eligibility by personal interview and a brief 
clinical examination. Veterans who are potential subjects for Aim 2 will be further assessed 
for eligibility by a review of their medical record pertaining to the diagnosis of peripheral 
vestibular disease. 
32.  Are any subjects excluded on the basis of race, ethnic group, understanding of English, 
socioeconomic status, education, gender, or pregnancy? 
 
Note: It is appropriate to indicate that you do not anticipate encountering potential subjects who 
do not speak English based on the population to be studied  
 No      
 Yes - (provide justification): All subjects will need to understand English 
sufficiently to follow instructions during the experimental session. 
      
  N/A Chart/data review  
33. Will subjects be reimbursed or paid an incentive for participating? 
 No (skip to item #35)      
 Yes  
  N/A Chart/data review (skip to item #38)      
34. How and when will they be paid? 
 
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 Cash 
 Check 
 Other -please explain: They will receive a voucher from the PI 
that they will take to the Agent Cashier to be paid.  
 Prorated -provide schedule: $30 for each session completed 
 Fixed -provide schedule 
      
35. Will subjects be responsible for any of the costs related to the research? 
 No      
 Yes- please explain:       
36.  Will treating physicians, clinicians, or researchers be compensated or paid an incentive for 
referring or enrolling subjects? 
 No      
 Yes -please explain:       
37.  Please describe steps you will take to ensure that subject selection is fair and equitable: 
We will accept all adult subjects regardless of gender or ethnicity, who are interested and 
eligible for the study.   
Section 5 – Risks and Benefits 
38.  Please list by bullet and describe the reasonably foreseeable physical, psychological, social, 
economic, and privacy risks, side effects, or discomforts associated with the research and their 
expected frequency and severity. 
 
If this study is a retrospective chart review, or involves only the analysis of data, risk may still be 
present in the form of data security concerns.  
• There may be mild motion sickness or disorientation when the subject's head is turned or 
from the visual motion on the screen. 
• Research data could be inadvertently disclosed. 
*Certificate of Confidentiality:   
 
Certificates of Confidentiality are issued by the National Institutes of Health (NIH) to protect identifiable 
research information from forced disclosure.  
 
They allow the investigator and others who have access to research records to refuse to disclose identifying 
information on research subjects in any civil, criminal, administrative, legislative, or other proceeding, 
whether at the federal, state, or local level.  
 
Certificates of Confidentiality may be granted for studies collecting information that, if disclosed, could 
have adverse consequences for subjects or damage their financial standing, employability, insurability, or 
reputation.  
 
By protecting researchers and institutions from being compelled to disclose information that would 
identify research subjects, Certificates of Confidentiality help achieve the research objectives and promote 
participation in studies by assuring confidentiality and privacy to subjects. 
 
 For more information, see http://grants1.nih.gov/grants/policy/coc/index.htm.  
 
39.  Is this project principally concerned with the collection of sensitive information such as sexual 
attitudes, use of drugs or addictive products, and illegal conduct that would need to be 
protected against subpoena or forced disclosure in order to protect subjects?  
 
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 No    
       
 Yes- will an application for a *Certificate of Confidentiality be submitted to the National Institute 
of Health upon IRB approval (or approval contingent on the issuance of such a certificate)? 
       
 Yes 
 No provide a justification as to why a Certificate of Confidentiality will not be 
obtained:  
 
          
 
40.  Describe all procedures that minimize risks, please include study and standard of care 
procedures: 
• If the subject becomes too motion sick, he/she may stop the experiment at any time. Both 
the head movements and the visual stimulation that are a part of this study are comparable 
to what is experienced in everyday life and in routine clinical examinations. 
• Research data will be secured in several ways. First, all paper forms, including consent 
forms, will be kept in a locked cabinet in the PI's locked office, within the Daroff-Dell'Osso 
Ocular Motility Laboratory. Second, electronic data will be stored on encrypted drives (non-
networked encrypted drive in the Daroff-Dell'Osso Ocular Motility Laboratory and encrypted 
VA networked drive [Ocular Motility Research Drive]). Moreover, the only identifiers 
associated with these binary data files are the subject code and the timestamp indicating 
when the files were created and the data was collected. No more explicit subject indentifiers, 
such as name, birthdate, SSN, or any clinical diagnosis information, are contained in these 
coded files.  
41.  Describe alternative procedures or course of treatment, if any, which might be advantageous to 
the subject.  State if no alternatives exist or if this is not a treatment study. 
This is not a treatment study. 
Minimal Risk: Minimal risk means that the risks of harm anticipated in the proposed research are not greater, 
considering probability and magnitude, than those ordinarily encountered in daily life or during the performance of 
routine physical or psychological examinations or tests.   
42.  Please give your overall risk classification for the research: 
 Minimal Risk 
 Greater than Minimal Risk 
 
43. Will subjects receive any direct benefit from this research? 
 No 
 Yes -describe the direct benefits:       
44.  Please explain briefly why you consider the risks associated with the study to be reasonable in 
relation to its benefits?  
The risk is minimal and is comparable to that experienced in normal everyday life and in 
clinical examinations. This risk is small compared to the potential long-term benefit of more 
effective treatment for these functionally disabling disorders.  
Section 6 – Informed Consent 
45. Type and number of Consent- 
 
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 
When more than one consent form is being used  a descriptor MUST  be  in the header section 
describing the population and/or phase of the study:  
 Written Informed Consent –number used in this study  1 
 *Oral Script/Letter/Information Sheet- number used in this study         *Submit Request 
for Consent Waiver Form-waiver of documentation of informed consent 
 No informed consent at all in this study- Submit a Request for Consent Waiver Form- 
waiver of informed consent and proceed to item 53  
46.  Will all adult subjects have the capacity to give informed consent? 
 Yes  
 No- Describe range of impairment.  
 
Research involving more than minimal risk, capacity should be determined by a psychiatrist, 
clinical psychologist, or other qualified professional not otherwise involved in the research.  
 
 Individuals who lack the capacity to consent may participate in research only if a legally 
authorized representative gives consent on their behalf. 
 n/a 
47.  Will anyone other than the subject be authorized to provide consent or permission for the 
subject’s involvement in the research?  
 
e.g., parents, court ordered guardian, spouse, etc. 
 No 
 Yes -please explain:       
48.  Describe how and where informed consent will be obtained:  
If a potential subject calls to inquire about the study, the details of the experiment will be 
explained, and he or she will be offered a consent form to review at home, if desired. 
The actual consent process will take place in the Daroff-Dell'Osso Ocular Motility 
Laboratory when a potential subject comes for the experiment. At that time, the study will 
again be explained in detail by the PI or co-I, the potential subject's understanding of the 
procedure will be confirmed, and the subject will be given the opportunity to sign the 
consent form or to decline to participate. 
49.  Will there be an opportunity for potential subject to take the consent form home to discuss 
participation and options with family members?  
             
 Yes    
 No - please explain:       
50.  List by role who will be obtaining informed consent from subjects or their legally authorized 
representatives: 
 
ex. study coordinator, co-investigator, research nurse, research assistant, PI 
PI, co-investigator 
51.  Please describe how informed consent will be obtained from subjects who do not read or 
understand English;  
 
identify any languages likely to be encountered, and attach a copy of a translated and 
authenticated informed consent document  
 
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 
It is appropriate to indicate that you do not anticipate encountering potential subjects who do not 
speak English based on the population to be studied 
We do not plan to enroll subjects who do not understand English. It is necessary that all 
subjects understand English, so that will be able to follow the instructions during testing 
sessions. 
52.  Describe who (by Role ex. PI, Coordinator, etc.) and how it will be determined that subjects 
and/or legally authorized representative understand the research and their rights.  
 
ex. question and answer, repeat back parts of the research, describe a procedure…etc 
The PI or co-investigator will confirm understanding by asking potential subjects to repeat 
back the expectations and potential risks. 
Section 7 – Privacy and Confidentiality 
Privacy - refers to a person’s desire to control the access of others to themselves.  For example, persons 
may not want to be seen entering a place that might stigmatize them, such as a pregnancy counseling center 
that is clearly identified as such by signs on the front of the building.  Privacy concerns people, whereas 
confidentiality concerns data.  The research proposal should outline strategies to protect privacy including 
how the investigator will access information about potential subjects. 
In developing strategies for the protection of subjects’ privacy, consideration should be given to: 
 
Methods used to identify and contact potential subjects 
 
Settings in which an individual will be interacting with an investigator 
 
Appropriateness of all personnel present for research activities 
 
Methods used to obtain information about subjects and the nature of the requested information 
 
Information that is obtained about individuals other than the “target subjects,” and whether 
such individuals meet the regulatory definition of “human subject” (e.g., a subject provides 
information about a family member for a survey) 
 
How to access the minimum amount of information necessary to complete the study 
 
Confidentiality - methods used to ensure that information obtained by researchers about their subjects is 
not improperly divulged.  Confidentiality refers to the researcher’s agreement with the subject about how the 
subject’s identifiable private information will be handled, managed, and disseminated. The research proposal 
should outline strategies to maintain confidentiality of identifiable data, including controls on storage, 
handling, and sharing of data. When appropriate, certificates of confidentiality could be used to maintain the 
confidentiality of identifiable data  
 
When the IRB evaluates research proposals for strategies for maintaining confidentiality, where appropriate, 
consideration will be given as to whether:  
 
Methods to shield subjects' identity adequately protect subject privacy 
 
There is a long-range plan for protecting the confidentiality of research data, including a schedule 
for destruction of identifiers associated with the data 
 
The consent form and other information presented to potential research subjects adequately and 
clearly describe confidentiality risks.  
 
The informed consent process and the informed consent document, and if applicable the 
Authorization Form, clearly delineates who will have access to the subject’s information and under 
what circumstances data may be shared (i.e., government agencies, sponsors).
 
 
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53. Describe when and where subjects will provide their information. Include the nature of the 
information and who will receive and use the information. Document the provisions used to 
protect privacy interests of those subjects when gathering their information and data.  
For subjects with vestibular disorders (Aim 2), basic clinical information will most often have 
been obtained at the time of clinical evaluation or may be provided by the referring medical 
provider. Additional information, such as completion of questionnaires, will be obtained in 
the private conference room of the Daroff Dell’Osso Ocular Motility Laboratory. The 
information collected will include the neurological history, vestibular symptoms reported, the 
clinical neurological examination, and the symptom questionnaires. This information will be 
important for interpreting the results of the study. The primary data for experiments in this 
study will be in electronic form and will consist of recordings of eye movements and game 
playing. Data will be secured, and only research study staff will have access to them. 
Results will be shared and published publicly only in de-identified form.    
54. Will researchers have access to identifiable private information about potential subjects outside 
of this research project?  Ex. PI is provider who has access to medical records for clinical care 
 No 
 Yes- please explain: The PI is a VA staff physician who has access to 
medical records as part of patient care. 
55. Will Researchers collect identifiable private information on anyone other than the subject? 
 
Ex. family members, friends, colleagues, classmates…etc. 
 No 
 Yes -please explain:       
56. At the time data are transcribed or recorded for this study they are?   
 
 Fully identifiable- list identifiers to be collected:        
 Coded with a unique identifier- describe the code:  sequential code 
           a. Who will have access to the key?  The PI 
           b. Where is the key maintained? Two locking barriers must be in place between the 
coded data and the key. A paper copy of the key will be kept in a locked file cabinet in 
the PIs locked office. An electronic version will be kept on the PI's encrypted VA 
network drive  
       
 De-identified-by Privacy Officer or Statistician. 
 Other (describe):        
57. How will electronic research data be secured while the study is active? 
 
 No electronic data will be stored 
 
 VA encrypted laptop 
 
 Encrypted VA device/media- describe: stored on encrypted drive in Ocular Motility 
Laboratory (BC300F) with password protection 
 
 VA network drive; 
                            
 M: drive; whose?       
                            
 S: drive   
 
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Folder access password protected 
                            
Other drive location (for example P: drive): Ocular_motility on 
\\vhaclehsm01\Research 
                                      
Folder access password protected 
58. How will hardcopy research data be secured while the study is active?  Two locking barriers 
must be in place. 
 No hardcopy data will be stored 
 Locked office and locked file cabinet 
 Data coded by PI or study staff with a master list secured and kept separately 
 Data de-identified by Privacy Officer or Statistician- (VA does not consider coded data to be 
de-identified) 
 Other -specify:        
 
59. Provide the physical location including room number (and address if outside of this VA) where 
all electronic and hardcopy data will be stored:  Wade Park: BC300R, BC300F, BE 215. 
60. Is identifiable information physically or electronically sent TO the LSCDVAMC from other 
institutions or locations? 
 No  
 Yes - contact Privacy Officer Joseph Picklo or Tomica Jefferson joseph.picklo@va.gov / 
phone 8214102 tomica.jefferson@va.gov / 8214101 or Information Security 
Officer Bruce Frankford   bruce.frankford@va.gov / phone 821 1604 – prior to 
submitting to the Research Service. 
**If yes complete the following: 
a. LSCDVAMC investigator will receive: 
 Hardcopy information or specimens 
 Electronic information   
b. What are the procedures for transporting and/or transmitting identifiable information 
securely? 
      
c. What will be the final disposition of the identifiable data transferred to the LSCDVAMC? 
 
Records will be retained in accordance with RCS 10-1. 
61.  Is identifiable information physically or electronically sent FROM the LSCDVAMC to other 
institutions or locations? 
 No  
 Yes contact Privacy Officer Joseph Picklo or Tomica Jefferson joseph.picklo@va.gov / 
phone 8214102 tomica.jefferson@va.gov / 8214101 or Information Security 
Officer Bruce Frankford   bruce.frankford@va.gov / phone 821 1604 – prior to 
submitting to the Research Service 
    **If yes complete the following: 
  a. The LSCDVAMC investigator will send: 
 
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 Hardcopy information or specimens  
 
 Electronic information     
  b. What are the procedures for transporting and/or transmitting identifiable information 
securely? 
      
 c. What will be the final disposition of the identifiable data transferred offsite? 
Records will be retained in accordance with RCS 10-1.     
Files containing the results of the data analysis will be returned to the LSCDVAMC and stored 
electronically along with the original data files from the same subject, as per Q57. 
 
62. Record Control Schedule 10-1 indicates all research records must be retained indefinitely.  Please 
indicate where this information will be stored and the safe guards to protect it: 
 
a. Electronic Safeguards: 
 
 No electronic data will be stored 
 
 VA encrypted laptop 
 
 Encrypted VA device/media- describe: stored on encrypted drive in Ocular Motility 
Laboratory (BC300F) with password protection 
 
 VA network drive; 
                            
 M: drive; whose?       
                            
 S: drive   
                                      
Folder access password protected 
                            
Other drive location (for example P: drive): Ocular_motility on 
\\vhaclehsm01\Research 
                                      
Folder access password protected 
 
  b. Hardcopy safeguards.  Two locking barriers must be in place.  
   
  No hardcopy data will be stored 
   
  Locked Office and Locked File Cabinet 
   
  Coded by Study Staff  
   
  De-identified by Privacy Officer or Statistician 
   
  Other- Describe:       
 
Facility name, address, and room number where hardcopy or electronic data will be stored:  
      
Section 8 – Data and Safety Monitoring –Greater than Minimal Risk Study 
 
For all research that is greater than minimal risk a Data and Safety Monitoring Plan must be developed.  
 
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 
This is a plan to assure the research includes a system of appropriate oversight and monitoring of the 
conduct of the study to ensure the safety of subjects and the validity and integrity of the data. 
*CHECK BOX IF THIS IS A MINIMAL RISK STUDY  
 SKIP TO #65 
63. Safety monitoring for this greater than minimal risk project will include:  
 Data Safety Monitoring Board:   
 Data Monitoring Committee  
 Other 
 
Attach the plan or provide details including whether committee is independent from the study 
sponsor, how often it meets, whether written reports are available, etc  
      
64.  Describe the plan for on-site data monitoring by the sponsor, contract research organization 
(CRO), or other independent body:          
 
*Research Office must be notified of all on-site monitoring visits. 
65.  Conditions that may result in removal of subjects from the research (check all that apply):   
 Medical condition unchanged 
 Medical condition worsened 
 
 Serious adverse event 
 Intolerable complications 
 Pregnancy 
  
 Investigator’s clinical judgment 
 Subject withdrawal  
 Subject uncooperative or noncompliant 
 Study closure by sponsor or FDA 
 Refusal to suspend breast-feeding 
 Other-describe:       
 Not Applicable 
66.  If a subject withdraws or is removed from the study, describe the potential risks of early 
withdrawal and the procedures in place to minimize these risks: 
 
      
Section 9 – FDA-Regulated Drugs/Biologics 
NOTE: If this research involves the use of any drugs or biologics, the study is 
subject to the Food and Drug Administration (FDA) regulations.   
 
Documentation of FDA approval for the experimental use of these agents must be provided for 
review (industry sponsored protocol listing the IND number, letter from the FDA, letter from 
industry sponsor, or other document and/or communication verifying the IND for this study). 
 
All drug/biologic products must be dispensed and tracked through the LSCDVAMC Research 
Pharmacy.   
 
An M.D. must be part of the Research Team for all studies that involve the use of a device or drugs. 
 
The LSCDVAMC Pharmacy and Therapeutics (P&T) Committee must approve:  (1) Studies of 
investigational drugs (2) research involving an FDA-approved drug used in a non-approved manner, 
and (3) an FDA-approved drug, used as approved, when its use is part of a research protocol.   
 
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 
VA Form 10-9012 Investigational Drug Information Record –must be completed for each drug 
being evaluated in a research study, regardless of IND status.  In addition, the VA Form 10-9012 
provides a listing of all authorized prescribers for the study drug(s). 
67.  Type of Product- check all that apply: 
 Not Applicable -No FDA-regulated drugs/biologics involved – Proceed to Section 10 
 Drug 
 Biologic or Other:        
68.  Type of Trial (check as applicable): 
 Phase I 
 Phase II 
 Phase III 
 Phase IV 
NA 
 
Phase I Trials: Initial studies to determine the metabolism and pharmacologic actions of drugs in humans, 
the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include 
healthy subjects and/or patients.  
Phase II Trials: Controlled clinical studies conducted to evaluate the effectiveness of the drug for a 
particular indication or indications in patients with the disease or condition under study and to determine the 
common short-term side effects and risks.  
Phase III Trials: Expanded controlled and uncontrolled trials after preliminary evidence suggesting 
effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the 
overall benefit-risk relationship of the drug and provide adequate basis for physician labeling.  
Phase IV Trials: Post-marketing studies to delineate additional information including the drug's risks, 
benefits, and optimal use.
69.  FDA Status of Drugs/Biologics – 
* For drugs, an IND may not be necessary if ALL seven of the following 
conditions are met: 
1. The drug being used in the research is lawfully marketed in the United States; 
2. The research is not intended to be reported to FDA in support of a new indication for use or to support any other 
significant change in the labeling for the drug; 
3. The research is not intended to support a significant change in the advertising for the product; 
4. The research does not involve a route of administration or dosage level, use in a subject population, or other 
factor that significantly increases the risks (or decreases the acceptability of the risks) associated with the use of 
the drug product; 
5. The research is conducted in compliance with the requirements for IRB review and informed consent (21 CFR 
parts 56 and 50, respectively); 
6. The research is conducted in compliance with the requirements concerning the promotion and sale of drugs (21 
CFR 312.7); 
7. The research does not intend to invoke 21 CFR 50.24 (Exception from informed consent requirements for 
emergency research). 
 
Provide the following information for each drug/biologic used in this study: 
Trade and 
Generic Name 
Manufacturer 
FDA 
Approved
Product use 
consistent with 
product labeling 
IND 
Required*
IND Number 
IND Sponsor or 
Holder** 
      
        
      
      
     
      
      
 
 
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70. **When the PI holds the IND, complete the following: 
i. The PI has reviewed the Guidance on Requirements of the Sponsor and the Investigator 
as Sponsor 
 Yes 
ii. As the PI, you will comply with the regulatory responsibilities of a sponsor 
 Yes 
71.  Drug Information for each drug listed in the protocol -check as applicable  
 Approved Drugs 
 Not Approved   
 
Attach VA Form 10-9012 Investigational Drug Information Record for each drug used 
in the protocol 
 
Attach Package Insert or PDR monograph – copy ready, 8.5 x 11 for each drug listed in 
the protocol 
 
Attach Investigator’s Brochure 
72.  Provide a detailed description of how FDA-regulated drugs/biologics will be stored, secured, 
dispensed, administered, tracked, and returned. 
 
      
Section 10 – FDA-Regulated Devices 
This section should be completed for a medical device that is the subject of a 
clinical study designed to evaluate the effectiveness and/or safety of the device.   
 
An investigational device may be an FDA approved device that is being studied for an unapproved use or 
efficacy.  This also includes an approved device that is being studied for an unapproved or approved use in 
a controlled, randomized, or blinded clinical trial.   
 
Documentation of FDA approval for the experimental use of the device must be provided for review 
(industry sponsored protocol listing the IDE number, letter from the FDA, letter from industry sponsor, or 
other document and/or communication verifying the IDE for this study). 
Device Risk Determination: 
Significant Risk (SR) Device is an investigational device that:  (1) is intended as an implant and presents a 
potential for serious risk to the health, safety, or welfare of a subject, or (2) is purported or represented to be for a 
use in supporting or sustaining human life and presents a potential for serious risk to the health, safety, or welfare of 
a subject; or (3) is for a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or 
otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or 
welfare of a subject; or (4) otherwise presents a potential for serious risk to the health, safety, or welfare of a subject. 
Non significant Risk (NSR) Device is a device other than a significant risk device. 
The IRB is required to document the basis for risk determination based on the proposed use of a device in the 
research by considering the nature of the harm that may result from the use of the device.  FDA has the ultimate 
decision in determining SR and NSR.   
An M.D. must be part of the Research Team for all studies that involve the use of a device. 
 
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The Environment of Care Committee (EOC) must approve all research that involves electrically line-operated 
devices, which have leads or electrodes and will come in contact with human subjects. 
73. Type of Product-check all that apply: 
 Not Applicable -No FDA-regulated devices involved – Proceed to Section 11) 
 An FDA regulated device will be used BUT not with intent of studying safety or efficacy 
(Proceed to Section 11) 
 Device 
74. List the device-include name and manufacturer:       
75.  FDA Regulatory Status of the Device: 
 FDA Approved Device  
 
A device approved by the FDA for distribution, marketing, sale to, and use by, the 
public for the study’s indication. 
  New Indication of an FDA Approved Device 
 
A device NOT approved by the FDA for distribution, marketing, sale to, and use by, 
the public for the indication used in the study.   
  
  Investigational - Investigational Device Exemption (IDE)  
 
An FDA designation that permits a manufacturer to lawfully ship an unapproved 
device for use in a research study.  
   Provide the following: 
a.  IDE Number:        
b.  IDE Sponsor or Holder:        
     If the PI holds the IDE, complete the following: 
i. The PI reviewed the Guidance on Requirements of the Sponsor and the 
Investigator as Sponsor  
      
 Yes 
ii. As the PI, you will comply with the regulatory responsibilities of a sponsor 
 
      
 Yes 
c. FDA or Sponsor Device Risk Determination 
  Non-Significant Risk 
  Significant Risk 
d. Attach documentation of FDA approval for the experimental use of the device 
(industry sponsored protocol listing the IDE number, letter from the FDA, letter 
from industry sponsor, or other document and/or communication verifying the IDE 
for this study). 
 Humanitarian Use Device (HUD) 
 
An FDA designation for a medical device intended to benefit patients in the 
treatment or diagnosis of a disease or condition that affects or is manifested in fewer 
 
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than 4,000 individuals in the United States per year. For more information about 
Humanitarian Use Devices see the HRPP SOP manual on the R&D website. 
 Provide the following: 
a. HUD Number:        
b. HUD Sponsor or Holder:        
c. Include a copy of the FDA letter granting Humanitarian Use Device (HUD) status. 
 
  510(k) Status –  
 
A device determined by the FDA to be “substantially equivalent” to an existing 
device that is legally marketed in the U.S. Until a 510(k) device is approved, it is still 
considered investigational.  
 
a. Provide the name of an equivalent device and sufficient documentation to justify 
510(k)       
 
76. Attach device information (i.e., brochure, device label) 
77.  Provide a detailed description of how FDA-regulated devices will be stored, secured, dispensed, 
administered, tracked, and returned. 
      
Section 11 – Genetic Testing and Discovery of Genetic Information (DNA) 
78.  Does the research involve genetic testing or DNA/RNA extraction? 
 No genetic testing (Proceed to Section 12) 
 Yes- complete the following: 
a. Describe the purpose of the genetic testing component of the study 
 
  Is it to establish risks, associations, or prevalence? 
 
      
b. Describe whether the test is a standard test already in clinical use or a new or experimental 
laboratory study 
 
      
c. Describe the accuracy of the test 
 
Sensitivity, specificity, reliability, validity, and variability 
 
      
79.  Does an abnormal test result indicate that the subject: 
 
 
 Has a specific condition 
 Is at risk for a specific condition 
 May be at risk for a specific condition 
 Has, is, or may be at risk for some other outcome 
 
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 Other (describe):       
80.  Does a normal test result indicate that the subject 
 Is not at risk for a specific condition 
 Is at a lower risk for a specific condition 
 Is at a population risk for a specific condition 
81.  Is there a risk of discovery of other results such as non-parentage or other genetic conditions? 
 No  
 Yes- please explain:       
82.  Will test results produce information on anyone (e.g. a first-degree relative) besides the 
subject? 
 No 
 Yes- please explain:       
 
83.  To whom and in what manner will genetic information be reported? 
      
84. Will genetic counseling be made available to subjects? 
            
 No   
 Yes- indicate who will conduct the counseling and whether there are any         
additional charges:        
 
85.  Will DNA samples be stored? 
 
 No 
 Yes--describe where, how, and for how long the samples will be stored: 
      
86.  Who will own the DNA samples?        
87.  Will there be any subsequent analysis of the DNA samples? 
 
 No  
 Yes- describe the purpose of the subsequent analysis and whether there will be 
dissemination of any new information: 
      
88.  Describe how samples will be handled if the subject withdraws consent for further 
participation: 
      
89.  Will the samples be distributed to other investigators? 
 
 No 
 Yes- please explain:       
 
90. Describe the provisions to maintain the confidentiality of research data, especially in cases 
where data can be linked to individual subjects: 
      
Section 12 – Tissue Collection/Storage/Banking* 
 
VANEOHS IRB
Effective Date:
October 4, 2023

LSCDVAMC                                                                                                                                              Research Plan 
 April 2014                                                                                                                                                  Page 26 of 27 
 
 
                                                                                                                                 
It is VA policy to ensure that human biological specimens, as well as the linked data collected as 
part of research projects conducted by VA investigators in VA facilities or approved off-site 
locations, are maintained at *VA approved tissue banks or VA-sponsored tissue banks.  
 
 See VHA Directive 2000-043 “Banking of Human Research Subjects’ Specimens” for more 
information and also visit   http://www.research.va.gov/programs/tissue_banking/default.cfm 
 
Human biological specimens (specimens). 
 
Human biological specimens are materials, such as blood, urine, tissue, organs, hair, nail 
clippings, buccal swabs or any other materials that are derived from human subjects and are 
either collected specifically for research purposes or as residual specimens from diagnostic, 
therapeutic or surgical procedures. 
91. *Does the research involve storage or banking of human specimens or identifiable private 
information for use in future studies? (check all that apply) 
 No (proceed to Section 13) 
 Yes-describe status of VA approved or VA sponsored 
facility:       
 Storing or banking identifiable private information  
 Storing or banking human specimens  
Please provide the following information: 
a. What identifying information will be required?  
      
b. What are the foreseeable uses of the specimens (e.g., research, pharmaceutical products, 
production of cellular lines for various uses, etc.)?  
      
c. What is the VA approved or VA sponsored location/institution where the information 
and/or specimens will be stored?        
d. How long will the information and/or specimens be stored?   
      
e. Is the storage facility an on-site or off-site location?  
      
f. Will subjects be able to request that their specimen and/or information be withdrawn 
from the bank or repository?  (explain) 
      
Section 13 – Children as Research Subjects 
Research involving children must not be conducted by VA investigators while on official duty or at VA or VA-
approved offsite facilities unless a waiver has been granted by the CRADO (See VHA Directive 2001-028 
“Research Involving Children” for more information. 
92.   Do you plan to enroll children as research subjects? 
 No (Proceed to Section 14) 
 
VANEOHS IRB
Effective Date:
October 4, 2023

LSCDVAMC                                                                                                                                              Research Plan 
 April 2014                                                                                                                                                  Page 27 of 27 
 
 
                                                                                                                                 
 Yes- Age range of subjects:        
93.  Category of Research (Check the box next to the category of research you believe your research 
falls under. The IRB will make a final category determination during review.): 
 Research involving minimal risk (the probability & magnitude of harm or 
discomfort anticipated are not greater than those ordinarily encountered in daily 
life or during routine physical or psychological tests.) (46.404) 
 Research involving greater than minimal risk but of potentially direct benefit to the 
subject. (46.405) 
 Research involving greater than minimal risk and no prospect of direct benefit to 
the subject but likely to yield generalizable knowledge about the subject’s disorder 
or condition. (46.406) 
 Research not otherwise approvable which presents an opportunity to understand, 
prevent or alleviate a serious problem affecting children/decisionally impaired 
adults. (46.407) 
94. Do you anticipate enrolling minors who are wards of the state?  
 
 No     
 Yes 
95. Permission of parents or guardian (check one only):  
 The permission of each child’s parents or guardian will be sought 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 (required for 
categories 46.406 and 46.407 above in item 104). 
 The permission of only one parent will be sought (acceptable for categories 46.404 
or 46.405).  If marked, provide justification:        
96. Assent of Children (check one only): 
 The assent of each child who is capable of providing assent based on age, maturity, 
and psychological state will be sought. 
 The assent of each child will not be sought because the capability of all of the 
children in this study population is so limited that they cannot reasonably be 
consulted.  Explain why the capacity is so limited, e.g., age, maturity and/or 
psychological state:         
  The assent of each child will not be sought because the intervention or procedure 
involved in the research holds out a prospect of direct benefit that is important to 
the health or well-being of the children and is available only in the context of the 
research.  Explain what the direct benefit may be and why it is only available in the 
context of the research:        
Section 14 – Other 
97.  Please describe any other study procedures not referenced in the previous sections: 
 Not applicable 
      
 
VANEOHS IRB
Effective Date:
October 4, 2023