Virtual Reality-based Rehabilitation for Pediatric TBI (R00 Phase)
Phase: NA
Conditions: TBI (Traumatic Brain Injury)
Sponsor: University of Massachusetts, Lowell

PARTNERS HUMAN RESEARCH COMMITTEE 
PROTOCOL SUMMARY 
Partners Human Subjects Research Application Form  
 
Filename: Protocol Summary 
Version Date:  October 15, 2014 
 
  
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Answer all questions accurately and completely in order to provide the PHRC with the relevant 
information to assess the risk-benefit ratio for the study.  Do not leave sections blank. 
 
PRINCIPAL/OVERALL INVESTIGATOR 
Susan Quinn, MD 
 
PROTOCOL TITLE 
Virtual Reality-based Rehabilitation for Children with Traumatic Brain Injuries 
 
FUNDING 
National Institutes of Health 
 
VERSION DATE 
Version 5.0 3/22/23 
 
SPECIFIC AIMS 
Concisely state the objectives of the study and the hypothesis being tested. 
The overall goal of the project is to assess the preliminary efficacy of a novel VR-based 
interactive cognitive training (VICT) program for cognitive rehabilitation in children with TBI. 
Aim 1. Examine VICT’s efficacy in improving core and daily EF skills among children with 
TBI. 
Hypothesis 1.1: Children in the intervention group will show enhanced improvement over 
controls in trained VR-based EF tasks and untrained NIH Toolbox tasks from baseline to post-
intervention and follow-up visits; 
Hypothesis 1.2: The intervention group will show better reported daily EF than controls at the 
follow-up visit; 
Hypothesis 1.3: Children in the intervention group will show faster improvement than controls in 
daily-reported EF skills between post-intervention and follow-up visits. 
Aim 2. Examine VICT’s efficacy in reducing attentional problems among children with 
TBI. 
Hypothesis 2.1: Children in the intervention group will show a greater reduction in attentional 
problems as measured by testing on the Conners Continuous Performance Test 3rd Edition™ 
(Conners CPT 3TM) from baseline to the post-intervention and follow-up visits than controls; 
Hypothesis 2.2: Children in the intervention group will show fewer everyday attentional 
problems on the Behavior Assessment System for Children 3rd Ed (BASC-3) self- and parent-
ratings of attention at the follow-up visit than controls;  
Hypothesis 2.3: The direct effect of the VICT program in reducing attention problems will be 
mediated by children’s EF behaviors as measured by the Behavior Rating Inventory of Executive 
Function, Second Edition (BRIEF2) at the follow-up visit. 
Aim 3. Examine VICT’s efficacy in improving HRQOL among children with TBI. 
Hypothesis 3.1: The intervention group will show higher levels of reported HRQOL than 
controls at follow-up; 
Hypothesis 3.2: The direct effect of the VICT program on HRQOL at follow-up will be mediated 
by children’s EF skills and ratings of EF behaviors and attention at the post-intervention and 
follow-up visits. 
 

Partners Human Subjects Research Application Form 
  
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Version Date:  October 15, 2014 
 
  
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BACKGROUND AND SIGNIFICANCE 
Provide a brief paragraph summarizing prior experience important for understanding the 
proposed study and procedures. 
Traumatic brain injury (TBI) is a leading cause of acquired disability in U.S. children, with an 
estimated 700,000 cases every year, presenting in 75% of children with trauma and accounting 
for 70% of deaths from childhood trauma. Childhood TBIs often result in significant impairment 
in cognitive functions, particularly in core executive functions (EFs) due to the vulnerability of 
the frontal lobes, especially after a moderate to severe TBI. Core EF is composed of three skills: 
inhibitory control, working memory, and cognitive flexibility.  These skills are associated with 
impaired EF behaviors, increased attention problems, and lower health-related quality-of-life 
(HRQOL). However, evidence-based EF rehabilitation programs are lacking. Although a 
combination of diverse cognitive interventions may improve children’s EF, limited affordability, 
accessibility, adherence, and generalizability hamper clinically adapting and implementing such 
interventions in the rehabilitation setting. Virtual reality (VR) offers an exciting alternative 
strategy for EF rehabilitation of childhood TBI due to its flexibility, accessibility, and immersive 
experiences in three dimensions. These properties may increase adherence to training and foster 
an enhanced transfer of learned EF skills to untrained tasks in everyday life. Thus far, rigorous 
randomized clinical trials (RCTs) have not been conducted to establish the efficacy of VR-based 
EF rehabilitation for childhood TBI. 
 
RESEARCH DESIGN AND METHODS 
Briefly describe study design and anticipated enrollment, i.e., number of subjects to be enrolled 
by researchers study-wide and by Partners researchers.  Provide a brief summary of the 
eligibility criteria (for example, age range, gender, medical condition).  Include any local site 
restrictions, for example, “Enrollment at Partners will be limited to adults although the sponsor’s 
protocol is open to both children and adults.”
The study uses a randomized controlled trial design to investigate the efficacy of a virtual reality-
based executive function training program for cognitive rehabilitation among 32 children between 
6 and 17 years old (inclusive) with TBI. Participants will be recruited from Spaulding 
Rehabilitation Hospital (Boston, MA) and Kennedy Krieger Institute (Baltimore, MD), using the 
following inclusion and exclusion criteria: 
Inclusion criteria: 
• Diagnosed with moderate to severe TBI and 6-17 years at the time of injury;  
• Moderate or severe TBI. Diagnosis is determined by multiple factors, including but not 
limited to: Glasgow Coma Scale score, additional clinical characteristics, and expert opinion 
by physician or therapists.  
• Fluent in English-based communication 
• Physicians note closest to time of enrollment does not include information on agitation, or if 
under observation for agitation, currently score <28 on the Agitated Behavior Scale 
indicating mild to no agitation.  
Exclusion criteria: 
• Severe physical/visual/cognitive impairments secondary to TBI such as inability to follow 
directions, unresponsiveness, and limited motor skills that prevent proper utilization of a VR-
based training and valid administration of the study measures;  
• Premorbid neurological or developmental issues such as autism, developmental delay, severe 
language impairment or neurologic disorder before the injury that might prevent proper 
utilization of a VR-based game and valid administration of the study measures, and that 

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might confound the study findings;  
• More than one post-injury seizure. 
• Patients restricted from using electronic gaming devices 
 
Briefly describe study procedures.  Include any local site restrictions, for example, “Subjects 
enrolled at Partners will not participate in the pharmacokinetic portion of the study.”  Describe 
study endpoints.
The following study procedures will be followed in this study: 
Visit 1:  
Baseline Assessment:  
• On first day of the study, participants will complete a standard cognitive and attention 
assessment using virtual reality, computer, and iPad as well as several questionnaires 
with a researcher. These assessments will take about 60 minutes. 
Intervention Session:  
• Intervention session can take place any time following the baseline assessment. 
Participants will be provided a tutorial to be familiar with the VR equipment, as well as a 
standardized interactive tutorial automatically built into the VR for completing the 
training tasks. 
o The VR game for the intervention group is called “Rescue the Lubdubs”. In this 
game, children will try to rescue an animated creature called “lubdub” by 
defeating the guards (training inhibitory control skills), memorizing the passcode 
to unlock castle gates (training working memory skills), and matching partners 
between the lubdub’s belly and its guards (training cognitive flexibility skills).  
o The VR game for the control group is a relaxing and immersive playground where 
children can throw projectiles (bees, beans, etc.) to different objects in the virtual 
environment (moving boards, water buckets, light bulbs, etc.). This game does not 
require the use of any of the executive functioning skills (i.e., inhibitory control, 
working memory, cognitive flexibility) and therefore serves as a placebo game for 
the control group.  
• Participants will only be randomized to either intervention or control groups after 
completion of the baseline assessment. The randomization scheme is designed blocked 
randomization with random block sizes of 2 and 4 and 1:1 ratio for intervention and 
control treatment.  
o Randomization and the intervention session will be completed by an unblinded 
Research Assistant.  
• Participants will then complete at least one (1) 30-minute intervention session. The child 
and their family can decide if they would like to play the game for a longer period of time.  
Breaks are permitted upon patient request at any time. AEs and serious AEs will be actively 
monitored throughout the intervention sessions. Anxiety in anticipation of the intervention 
will also be assessed before the intervention, while simulator sickness, perceived exertion, 
and subjective VR experience will be measured after the intervention. 
 
Visit 2:  
Post Intervention Assessment: Post-intervention assessment will be scheduled upon 
completion of the intervention session and should take place within 1 week after the 
intervention session. Research staff blinded to the participants’ group assignment will 
administer the post-training assessment, which consists of the same set of tasks as those in 

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the baseline assessment, as well as VR experience questions such as motion sickness, 
perceived benefits and challenges, and physical exertion. 
 
Between Visit 2 and Visit 3: 
• A brief EMA-EF Survey will be sent to participants to complete daily between the post-
intervention and follow-up visits, which may take about 2 minutes per day for 30 days. 
 
Visit 3: 
Follow-Up Visit  
• Follow-up visits are scheduled 30 days following the post-intervention assessment (up to 
12 months). Staff blinded to the participants’ group assignment will administer the 
following measures: 
o VR and NIH Toolbox tests; 
o Conners CPT 3;  
o Children’s Anxiety Meter; 
o Self-report BRIEF2, BASC-3, and PedsQL Generic Core Scales;  
o TPVT  
o Media Use Survey.  
o A parent will complete the parent-report version of BRIEF2, BASC-3, and PedsQL. 
 
The study endpoint is the preliminary efficacy of the VICT program, defined as the changes in 
VR Assessment Scores, NIH Toolbox Composite Scores, and BRIEF2 Global Scores between 
baseline and post-intervention and between baseline and follow-up assessment. 
 
For studies involving treatment or diagnosis, provide information about standard of care at 
Partners (e.g., BWH, MGH) and indicate how the study procedures differ from standard care.  
Provide information on available alternative treatments, procedures, or methods of diagnosis.
The virtual reality intervention is designed to be supplementary to standard of care at Spaulding 
Rehabilitation Hospital. Therefore, all participants will still receive standard of care as 
determined by their doctors regardless of participation of this study or random assignment to the 
intervention or control group. 
 
 
Describe how risks to subjects are minimized, for example, by using procedures which are 
consistent with sound research design and which do not unnecessarily expose subjects to risk or 
by using procedures already being performed on the subject for diagnostic or treatment purposes.
Based on data collected during the pilot phase as well as a comprehensive assessment conducted 
with our clinical collaborators, we do not anticipate significant risks to the participants beyond the 
usual standard of care for this study. Specifically, the virtual reality equipment will be set up 
ergonomically to minimize the physical risks and burden of the equipment to the patients. Also, 
age-appropriate VR content has be designed to minimize psychological risks. Questionnaires and 
computerized tasks used in this study have all been used repeatedly in previous research (including 
the pilot study) or clinical practice without adverse effects. Because all participants will continue 
to receive standard therapies/care at the hospital, participation in or withdrawal from the study will 
not affect participants’ standard care or treatment.  
 

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Describe explicitly the methods for ensuring the safety of subjects.  Provide objective criteria for 
removing a subject from the study, for example, objective criteria for worsening disease/lack of 
improvement and/or unacceptable adverse events.  The inclusion of objective drop criteria is 
especially important in studies designed with placebo control groups.
To ensure safety of subjects, the virtual reality video-game training program used in this study was 
designed with developmental and clinical appropriateness in mind and has been refined based on 
feedback from pilot participants to protect children from further potential physical or 
psychological risks. Specifically, the training system consists of an individual mechanism support 
arm used to suspend the VR goggle in front of a participant’s eyes with easy-to-adjust 
height/direction and stereo headphones to avoid the physical burden of a traditional VR headset 
on the patients’ injured head. The VR system, which is securely fixed on a wheeled mobile 
workstation, allows a patient to operate the program either reclining on a hospital bed or in a 
wheelchair in his/her patient room, depending on the patient’s clinical needs and personal 
preference. Furthermore, to ensure the hygiene of the equipment, the equipment is sanitized with 
germicidal wipes after each use.  
Trained study staff will approach patients and their families in a sensitive and caring fashion to 
minimize any potential psychological uneasiness in participating in this study. The study staff will 
receive over the entire study period, extensive training in identifying any significant physical or 
mental discomfort. Breaks during both the VR training sessions and various outcome measures 
will be available to participants upon request. Participants who feel uncomfortable either 
physically or psychologically using the VR or any of the study measures will have options to 
withdraw from the study at any time without affecting their access to standard care. Should adverse 
events occur with the participants, the study staff will immediately terminate the VR game and 
contact attending doctors/nurses for assessment. Adverse events will be monitored in real-time and 
reported to the corresponding institutional IRB. 
FORESEEABLE RISKS AND DISCOMFORTS 
Provide a brief description of any foreseeable risks and discomforts to subjects.  Include those 
related to drugs/devices/procedures being studied and/or administered/performed solely for 
research purposes.  In addition, include psychosocial risks, and risks related to privacy and 
confidentiality.  When applicable, describe risks to a developing fetus or nursing infant.
A small number of participants, depending mainly on their previous experience with electronic 
gaming in general and VR gaming in particular, might experience symptoms related to motion 
sickness, such as headaches, nausea, blurred vision, and physical/mental fatigue while 
completing the training/tasks in the virtual environment. However, based on the data collected 
from the pilot study, we anticipate a minimal occurrence of these symptoms. For those who did 
experience such symptoms, the side effects were found (in our pilot study) to be low in strength, 
short-lived, and disappeared after regular breaks that we offered any time during the game per 
participants’ preferences. Additionally, some participants might experience mental tiredness or 
psychological discomfort while completing questionnaires and/or other outcome measures. Such 
discomfort is likely to be minimal, infrequent, and short-lived. Participants have the option to 
refuse answering any of the questions they are not comfortable with, or completely withdrawn 
from any measurement instrument or the entire study should they feel so, any time during the 
study without affecting their standard care. 
 
EXPECTED BENEFITS 
Describe both the expected benefits to individual subjects participating in the research and the 
importance of the knowledge that may reasonably be expected to result from the study.  Provide 

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a brief, realistic summary of potential benefits to subjects, for example, “It is hoped that the 
treatment will result in a partial reduction in tumor size in at least 25% of the enrolled subjects.”  
Indicate how the results of the study will benefit future patients with the disease/condition being 
studied and/or society, e.g., through increased knowledge of human physiology or behavior, 
improved safety, or technological advances. 
Children who participate in this study may not directly benefit as the purpose of the study is to 
assess the preliminary efficacy of this virtual reality-based executive function training system for 
childhood TBI rehabilitation. However, because both the intervention group and the control group 
will have access to state-of-the-art virtual reality-based gaming, participants might enjoy varying 
levels of fun and pleasure playing with the VR games while receiving standard care at the hospital. 
Furthermore, standardized outcome assessments for executive functions, attention problems, and 
health-related quality of life might also indirectly help participants and their families gain a better 
understanding of their child’s recovery processes. Finally, the results gained from data collected 
from this study might inform future refinement and development of the VR system for maximizing 
the potential benefits of the intervention for other children with TBI. Although the potential 
benefits of direct participation in this study are limited, they are reasonable in relation to the 
minimal risk incurred.  
 
This study will also significantly improve our understanding of the efficacy of a novel VR-based 
training system designed explicitly for childhood TBI rehabilitation of executive functions. The 
findings from this project will not only inform future development of the VR-based intervention 
program but also provide the foundational expertise and empirical data necessary to develop and 
implement a more comprehensive multi-module VR training system that targets skills beyond 
executive functions, such as emotional and social skills for children with TBI. In the long term, 
results of this study are also likely to inform VR-based psychological rehabilitation for individuals 
at different developmental stages with other types of acquired brain injuries. We believe the 
importance of the knowledge to be gained in this study outweighs the minimal risks associated 
with participation in the study. 
EQUITABLE SELECTION OF SUBJECTS 
The risks and benefits of the research must be fairly distributed among the populations that stand 
to benefit from it.  No group of persons, for example, men, women, pregnant women, children, 
and minorities, should be categorically excluded from the research without a good scientific or 
ethical reason to do so.  Please provide the basis for concluding that the study population is 
representative of the population that stands to potentially benefit from this research.
Under the NIH definition of children as those under 18 years, the present study will include ‘children.’ 
Because this is a study evaluating the efficacy of a virtual reality-based executive function training 
program specifically designed for childhood TBI rehabilitation, this study will not include participants 
above 18 years old.  
The present study will include both sexes. We expect that males will be overrepresented in the sample of 
children with traumatic brain injuries (TBIs) since the ratio in the pilot data collected was approximately 
60% male:40% female. This overrepresentation may be due to the higher incidence of pediatric TBIs in 
males in the broader population. We also anticipate that mothers are more likely to complete the parent-
report measures for the study based on the participation rates of fathers versus mothers in previous 
behavioral studies. However, the decision regarding which parent participates in the study will be left to 
the discretion of individual families to promote flexibility and convenience. 
Recruitment to the present study will be representative of the minority distribution at Spaulding 
Rehabilitation Hospital and the greater Boston, MA area, and with respect to any racial influences that 
affect pediatric diagnoses. We expect that approximately 10% of participants to self-identify as Hispanic 

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or Latino, 20% as African American, 5% as Asian/Pacific Islander, and 7% as multiracial. Because 
traumatic brain injuries do not occur randomly in the local population, these numbers are estimated based 
on the relative difference in incidence rates of childhood TBI from a five-year review of records at the 
Spaulding Rehabilitation Hospital. These percentages reflect a slightly larger population of minorities than 
those reported by local sociodemographic data reported by the State of Massachusetts.  
 
When people who do not speak English are excluded from participation in the research, provide 
the scientific rationale for doing so.  Individuals who do not speak English should not be denied 
participation in research simply because it is inconvenient to translate the consent form in 
different languages and to have an interpreter present.
The present study will only include participants who are able to communicate in English, 
because this prototype virtual reality video games developed for this study has instructions both 
in written and spoken English, but not available in other languages so far. As with any 
standardized psychological assessment and training instruments, availability in a different 
language require strict validation of psychometric properties specific to that language as well as 
cultures using that language. As a first step in our line of research, we plan to evaluate the 
efficacy of this virtual reality game in English for this study, as it is the most common language 
used by pediatric patients with traumatic brain injuries in the greater Boston area. And if 
successfully, we will incorporate other languages in future validation studies specific to the 
culture and population using those languages.  
 
For guidance, refer to the following Partners policy: 
          Obtaining and Documenting Informed Consent of Subjects who do not Speak English
          https://www.partners.org/Assets/Documents/Medical-Research/Clinical-
Research/Non-English-Speaking-Subjects.pdf 
 
 
 
RECRUITMENT PROCEDURES 
Explain in detail the specific methodology that will be used to recruit subjects.  Specifically 
address how, when, where and by whom subjects will be identified and approached about 
participation.  Include any specific recruitment methods used to enhance recruitment of women 
and minorities.
The study will recruit from Spaulding Rehabilitation Hospital (SRH) and Kennedy Krieger 
Institute (KKI). We expect most patients will be recruited by site-PI Dr. Susan Quinn from the 
Pediatric Inpatient Rehabilitation Unit at SRH (Medical Director of the Unit; Site PI), and we 
expect KKI to enroll 8-12 subjects. Possible methods to recruit potential participants include 
reviewing medical records, referral by Dr. Quinn or her colleagues at SRH, self-referral by 
patients themselves via Clinicaltrials.gov. Flyers will also be posted within SRH facility to 
supplement patient recruitment. Targeted Research Announcements via Patient Gateway will 
also be used to increase recruitments from other MGB sites; patient information will be obtained 
through RPDR. 
 
Provide details of remuneration, when applicable.  Even when subjects may derive medical 
benefit from participation, it is often the case that extra hospital visits, meals at the hospital, 
parking fees or other inconveniences will result in additional out-of-pocket expenses related to 

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study participation.  Investigators may wish to consider providing reimbursement for such 
expenses when funding is available
We will provide the participating patient in the form of check with $40.00 for completing the 
baseline assessment, an additional $50.00 for completing the designated training (or comparable 
VR game for the control group) and post-intervention assessment, an additional $60 for 
completing the entire 30-day EMA-EF daily survey (pro-rated if completed fewer than 30 
surveys), and finally an additional $80.00 for completing the follow-up assessment. In addition 
to the above honorarium provided to the patient, we will provide the parent with a one-time 
$80.00 honorarium also in the form of a check for completing the parent questionnaires at the 
follow-up visit.  
For guidance, refer to the following Partners policies: 
          Recruitment of Research Subjects 
          https://www.partners.org/Assets/Documents/Medical-Research/Clinical-
Research/Recruitment-Of-Research-Subjects.pdf
 
          Guidelines for Advertisements for Recruiting Subjects
          https://www.partners.org/Assets/Documents/Medical-Research/Clinical-
Research/Guidelines-for-Advertisements.pdf 
 
          Remuneration for Research Subjects
          https://www.partners.org/Assets/Documents/Medical-Research/Clinical-Research/Remuneration-for-
Research-Subjects.pdf 
 
 
CONSENT PROCEDURES 
Explain in detail how, when, where, and by whom consent is obtained, and the timing of consent 
(i.e., how long subjects will be given to consider participation).  For most studies involving more 
than minimal risk and all studies involving investigational drugs/devices, a licensed physician 
investigator must obtain informed consent.  When subjects are to be enrolled from among the 
investigators’ own patients, describe how the potential for coercion will be avoided.
The researchers will ensure that they understand study participation is voluntary and will not 
affect any treatment in current or future visits. Informed consent and assent will be obtained by 
the study PI or trained research staff per institution policy.  Informed consent process will allow 
for all questions from participants and family are addressed satisfactorily. No study procedures 
will be implemented until after informed consent and assent (if applicable) are obtained.  
 
Potentially eligible patients and family will be screened according to the inclusion and exclusion 
criteria. Children and legal guardians will be approached only if they are awake, alert, and 
interested in the study after the initial introduction. Patients may also contact the PI or research 
staff via contact methods provided on distributed flyers or study protocol on clinicaltrials.gov or 
by referral from other departments or institutions to the PI.  
 
 
NOTE: When subjects are unable to give consent due to age (minors) or impaired decision-
making capacity, complete the forms for Research Involving Children as Subjects of Research 

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and/or Research Involving Individuals with Impaired Decision-making Capacity, available on 
the New Submissions page on the PHRC website: 
      https://partnershealthcare.sharepoint.com/sites/phrmApply/aieipa/irb 
 
For guidance, refer to the following Partners policy: 
     Informed Consent of Research Subjects:
     https://www.partners.org/Assets/Documents/Medical-Research/Clinical-
Research/Informed-Consent-of-Research-Subjects.pdf
 
 
 
DATA AND SAFETY MONITORING 
Describe the plan for monitoring the data to ensure the safety of subjects.  The plan should 
include a brief description of (1) the safety and/or efficacy data that will be reviewed; (2) the 
planned frequency of review; and (3) who will be responsible for this review and for determining 
whether the research should be altered or stopped.  Include a brief description of any stopping 
rules for the study, when appropriate.  Depending upon the risk, size and complexity of the 
study, the investigator, an expert group, an independent Data and Safety Monitoring Board 
(DSMB) or others might be assigned primary responsibility for this monitoring activity.        
 
NOTE: Regardless of data and safety monitoring plans by the sponsor or others, the principal 
investigator is ultimately responsible for protecting the rights, safety, and welfare of subjects 
under his/her care. 
Because this study involves only the use of electronic video games as the sole interventional 
strategy, the risk of this study is minimal. Furthermore, the site PI assures that informed 
consent/assent will be obtained before enrolling any child, that all participants meet eligibility 
criteria, and that the study is conducted according to the IRB-approved research plan. Study data 
will be accessible at all times for the site PI to review. The site PI will review study conduct 
(e.g., accrual, drop-outs, protocol deviations). The data review will also include self-reported data 
from participants regarding their virtual reality experiences as measured in designated instruments 
attached to this protocol, including physical exertion, motion sickness symptoms, and levels of 
fun, pleasure, motivation playing the virtual reality games. If there are more than five participants 
experiencing the same symptoms (such as motion sickness) as measured above, the PI will stop 
the study, review the study protocol, revise as necessary, and submit the modified/refined protocol 
for IRB approval before the study resumes.   
Describe the plan to be followed by the Principal Investigator/study staff for review of adverse 
events experienced by subjects under his/her care, and when applicable, for review of sponsor 
safety reports and DSMB reports.  Describe the plan for reporting adverse events to the sponsor 
and the Partners’ IRB and, when applicable, for submitting sponsor safety reports and DSMB 
reports to the Partners’ IRBs.  When the investigator is also the sponsor of the IND/IDE, include 
the plan for reporting of adverse events to the FDA and, when applicable, to investigators at 
other sites.   
 
NOTE: In addition to the adverse event reporting requirements of the sponsor, the principal 
investigator must follow the Partners Human Research Committee guidelines for Adverse Event 
Reporting

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The site PI will review adverse events (AEs) and serious adverse events (SAEs), as well as 
participants’ discomfort, including fatigue and simulator sickness in real-time and in aggregate 
weekly. The site PI ensures all protocol deviations, AEs, and SAEs are reported to the NICHD and 
IRB according to the applicable regulatory requirements. 
 
MONITORING AND QUALITY ASSURANCE 
Describe the plan to be followed by the principal investigator/study staff to monitor and assure 
the validity and integrity of the data and adherence to the IRB-approved protocol.  Specify who 
will be responsible for monitoring, and the planned frequency of monitoring.  For example, 
specify who will review the accuracy and completeness of case report form entries, source 
documents, and informed consent.   
 
NOTE: Regardless of monitoring plans by the sponsor or others, the principal investigator is 
ultimately responsible for ensuring that the study is conducted at his/her investigative site in 
accordance with the IRB-approved protocol, and applicable regulations and requirements of the 
IRB.
The site-PI and research assistants will review and monitor the validity and integrity of the data 
collected, source documents, informed consent, and protocol implemented according to the IRB-
approved protocol, on a regular basis through project meetings with all study staff. The PI will be 
responsible for overseeing the study protocol implementation as approved by the IRB. 
 
For guidance, refer to the following Partners policies: 
          Data and Safety Monitoring Plans and Quality Assurance
         https://www.partners.org/Assets/Documents/Medical-Research/Clinical-Research/DSMP-in-
Human-Subjects-Research.pdf 
 
          Reporting Unanticipated Problems (including Adverse Events)
          https://www.partners.org/Assets/Documents/Medical-Research/Clinical-
Research/Reporting-Unanticipated-Problems-including-Adverse-Events.pdf
 
 
 
PRIVACY AND CONFIDENTIALITY 
Describe methods used to protect the privacy of subjects and maintain confidentiality of data 
collected.  This typically includes such practices as substituting codes for names and/or medical 
record numbers; removing face sheets or other identifiers from completed 
surveys/questionnaires; proper disposal of printed computer data; limited access to study data; 
use of password-protected computer databases; training for research staff on the importance of 
confidentiality of data, and storing research records in a secure location.   
 
NOTE: Additional measures, such as obtaining a Certificate of Confidentiality, should be 
considered and are strongly encouraged when the research involves the collection of sensitive 
data, such as sexual, criminal or illegal behaviors.
The privacy and confidentiality of study participants will be maintained by assigning each 
participant a unique study ID number. IRB-approved study personnel will maintain a master file 
that links the participants’ names and their study ID numbers in a password-protected electronic 

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database at Spaulding Rehabilitation Hospital. All other study materials, randomization 
procedures, and databases will only use the study ID number for identification purposes without 
participants’ names or any other Protected Health Information attached. All de-identified paper 
documents will be stored in locked cabinets in PI (Dr. Jiabin Shen)’s office/lab space at University 
of Massachusetts Lowell. All de-identified electronic data will be stored on a secured electronic 
database locally hosted by University of Massachusetts Medical School and managed by the PI 
Dr. Jiabin Shen and IRB-approved personnel.  
Study results from the data analysis will be reported only in an aggregated format without any 
identifying information. The PI (Dr. Shen) and Co-I (Dr. Quinn) will ensure that all study staff 
observe these safeguarded measures to maintain data confidentiality and minimize any potential 
risks of participating in this study. 
 
SENDING SPECIMENS/DATA TO RESEARCH COLLABORATORS OUTSIDE 
PARTNERS 
Specimens or data collected by Partners investigators will be sent to research collaborators 
outside Partners, indicate to whom specimens/data will be sent, what information will be sent, 
and whether the specimens/data will contain identifiers that could be used by the outside 
collaborators to link the specimens/data to individual subjects.
 
Only de-identified data and source documents (e.g., original questionnaires responded by 
participants/parents), as well as original consenting documents will be sent to PI (Jiabin Shen)’s 
institution, University of Massachusetts Lowell.   
 
Specifically address whether specimens/data will be stored at collaborating sites outside 
Partners for future use not described in the protocol.  Include whether subjects can withdraw 
their specimens/data, and how they would do so.  When appropriate, submit documentation of 
IRB approval from the recipient institution.
The above mentioned de-identified data will be stored and managed by PI (Jiabin Shen) at his lab 
at University of Massachusetts Lowell. His lab uses REDCap (hosted by UMass Medical School 
for all five UMass campus users) to manage electronic databases. UMass Lowell also uses 
Microsoft OneDrive Business edition for all faculty members to store research data, which will 
be securely protected by passwords and firewalls. De-identified paper documents/data will be 
stored in locked cabinets in locked lab/office space of the PI. Only PI and IRB-approved study 
personnel will access to these de-identified databases and documents. Participants will not be 
able to withdraw their data stored at UMass Lowell/REDCap because all those data will be de-
identified and therefore we will be unable to trace back the data to an individual participant for 
deletion. 
 
A reliance agreement will be established between Partners and UMass Lowell IRB. 
 
RECEIVING SPECIMENS/DATA FROM RESEARCH COLLABORATORS OUTSIDE 
PARTNERS 
When specimens or data collected by research collaborators outside Partners will be sent to 
Partners investigators, indicate from where the specimens/data will be obtained and whether the 
specimens/data will contain identifiers that could be used by Partners investigators to link the 
specimens/data to individual subjects.  When appropriate, submit documentation of IRB 

Partners Human Subjects Research Application Form 
  
Filename: Protocol Summary 
Version Date:  October 15, 2014 
 
  
12 
 
approval and a copy of the IRB-approved consent form from the institution where the 
specimens/data were collected.
 
Spaulding Rehabilitation Hospital will not receive any data collected from outside of Spaulding. 
The study team at SRH will only have REDCap access to data collected at Spaulding.