Feasibility of a Yoga- and Mindfulness-Based Intervention for Resident Physicians
Phase: NA
Conditions: Burnout, Professional, Anxiety, Depression, Stress
Sponsor: Brigham and Women's Hospital

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 
 
Sat Bir S. Khalsa 
 
PROTOCOL TITLE 
 
An Evaluation of Changes in Psychological Health to a Yoga Program for 
Medical Residents 
 
NCT03687450 
 
FUNDING 
 
Partners Centers of Expertise 
BWH Osher Center 
 
VERSION DATE 
 
5/4/19 
 
SPECIFIC AIMS 
Concisely state the objectives of the study and the hypothesis being tested. 
 
We aim to initiate and complete the first investigation of the effect of yoga 
on resident physicians’ psychological health using a randomized controlled 
trial to measure outcomes across several domains. To meet the goals of the 
proposed project we have identified three specific aims: 
 
Specific Aim 1: Assess the acceptability and feasibility of the yoga program 
through measuring participation and conducting standardized interviews with 
a subset of yoga participants. 
 
Specific Aim 2: Evaluate the effect of the yoga program on resident 
physicians’ stress, burnout, resilience, mindfulness, mood, depression, 
anxiety, and sleep quality using quantitative self-report measures. 
 
Specific Aim 3. Examine whether outcome measures were perceived as 
relevant to the participants’ work environment and were not burdensome as 
to the length and content of the program. 
 
 

Partners Human Subjects Research Application Form 
  
Filename: Protocol Summary 
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. 
 
Resident physicians experience high levels of acute and unmanaged chronic 
stress and burnout, which impairs performance and increases risk for 
developing psychological and physical health problems. Medical institutions 
have addressed this problem with limited success with organizational 
changes, such as schedule reform, and educational wellness curricula. Yoga 
is a comprehensive system of mind-body practices including physical 
postures and exercises, breath regulation, deep relaxation, and 
meditation/mindfulness techniques. Yoga has been demonstrated to reduce 
stress and burnout across a wide range of populations including frontline 
medical professionals such as nurses and medical students.  
 
The Kripalu Center for Yoga & Health has developed the standardized RISE 
(resilience, integration, self-awareness, engagement) yoga program that has 
been evaluated to improve stress, mood, sleep quality, resilience and 
mindfulness in workplace populations including medical professionals. 
Furthermore, previous research from members of our team indicates that 
yoga-related practices promote beneficial changes in gene expression 
including up regulation of genes related to energy metabolism and immune 
function and down regulation of genes related to inflammation and stress. 
 
The proposed study would be the first investigation of a yoga program for 
medical residents. This is particularly important considering the high level of 
stress and burnout in this population, and the demonstrated ability of yoga 
to attenuate both. Also, this proposed project would be the first to 
investigate the mediating factors of resilience and mindfulness on changes in 
stress, mood, and burnout in a medical workplace setting. 
 
 
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 project will implement a mixed-methods randomized controlled trial to 
investigate the impact of the 6-week RISE program on psychological health 
in Longwood medical area residents. The RISE program is an existing 
standardized yoga program at Kripalu that will be adapted for residents in a 
60-90-minute, once-weekly class for six weeks. Participants will be 
randomized to either the RISE yoga program or a no treatment control 

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group. Participants randomized to the RISE program will also be instructed 
to maintain a short 10-15-minute daily home yoga practice. Sessions will be 
lead by experienced instructors from Kripalu and will be held in the 
Longwood medical area. Prior to randomization, all subjects will complete a 
questionnaire including information on prior yoga experience and 
demographic data such as gender, age, year in residency, residency 
program, race, and ethnicity. Additional questions assessing participants’ 
yoga practice after the study will be asked at 2 and 6 months post-program. 
Participants will complete questionnaires to study the self-report outcomes 
as described below in “Quantitative Self-Report Measures.” These will be 
assessed at baseline, at program completion (post-program), at 2-month 
follow-up, and at 6-month follow-up.  
 
Participants will include resident physicians at Longwood medical area 
hospitals. The only exclusion criterion is having practiced yoga, meditation, 
tai chi, qigong, or another mind-body practice at least 25 hours or more in 
the past 6 months. Participants must be willing not to practice mind-body 
programs other than the treatment protocol during the intervention. 
Participants must be able to commit to attend at least 4 out of 6 sessions.  
We plan to enroll up to 200 participants with a goal of at least 60 
participants with a 2:1 ratio of participants randomized to yoga to 
participants randomized to control. The control group will receive a one 
session of RISE after their participation in the trial is complete. 
 
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 RISE program will be delivered as a 6-week yoga-based program on-site 
at Brigham and Women’s Hospital in Boston. The program will consist of six 
60-90-minute weekly yoga-based RISE classes. A pre-assessment survey 
among residents will be conducted to determine the most beneficial location 
and time. RISE classes will include sitting meditation, mindfulness, breathing 
techniques, yoga postures, as well as exercises and instruction in mindful 
communication, mindful sleep preparation, and mindful eating. The program 
time allocation will be approximately 1/3 yoga instruction and/or practice, 
1/3 didactic, and 1/3 experiential. Participants will be provided with tools, 
skills, and practices that they can use throughout their day. 
 
A member of the study staff will take attendance at each RISE session. 
Participants will log their home practice via smart phone login, REDcap 
survey, voicemail line, or paper log to monitor frequency and duration. 
 
Outcome Measures 
Primary Outcome Measure:  

Partners Human Subjects Research Application Form 
  
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Feasibility. We will measure the percentage of participants in the 
intervention group that are able to complete four or more of the six RISE 
classes. 
 
Secondary Outcome Measures:  
Quantitative Self-Report Measures 
Some or all of the following measures will be used: 
Resilience. The 14-item Resilience Scale (RS-14; Wagnild & Young, 1993) 
aims to evaluate whether individuals in the face of adversity are able to 
adapt and restore equilibrium. Resilience is considered a positive 4 
personality characteristic that enhances individual adaptation. The RS 
displays high levels of reliability and validity (Wagnild 2009). 
Mindfulness. The Five Facet Mindfulness Questionnaire (FFMQ) is a well-
established 39-item scale for the assessment of mindfulness (Baer et al., 
2006). The 15-item FFMQ is a validated short-form of the 39-item FFMQ 
(Baer et al., 2006; Baer et al., 2012; Gu et al., 2016). The FFMQ measures 
five aspects of mindfulness: observing, describing, awareness, non-
judgment of experience, and non-reactivity to inner experience (Baer et al., 
2006; 2012). 
Stress. The 10-item Perceived Stress Scale (PSS) is the most widely used 
psychological instrument for measuring the perception of stress. Items are 
designed to tap how unpredictable, uncontrollable, and overloaded 
respondents find their lives (Cohen et al., 1983). 
Burnout and Professional Fulfillment. The Maslach Burnout Inventory (MBI) 
is a 22-item instrument that has been widely used to evaluate three domains 
of burnout, including emotional exhaustion, depersonalization, and sense of 
personal accomplishment, in health care professionals and trainees. The 
scale is rated on a 7-point Likert scale. A two-question screen based on the 
MBI developed to evaluate emotional exhaustion and depersonalization has 
shown strong, consistent associations with the full MBI evaluation for EE and 
DP and has been validated in internal medicine resident physicians (West CP, 
et al., 2009; 2012). The 16-item Professional Fulfillment Index (PFI) 
measures physician professional fulfillment and burnout across three scales; 
professional fulfillment, interpersonal disengagement, and work exhaustion 
(Trockel et al., 2018). The PFI has been validated in practicing and resident 
physicians (Trockel et al., 2018). 
Depression and Anxiety. The Depression Anxiety and Stress Scale (DASS; 
Henry & Crawford, 2005) is a set of three self-report scales that are 
designed to measure the negative emotional states of depression, anxiety, 
and stress. The shorter 21-item scale will be used to limit the number of 
questions for busy trainees. The Patient Reported Outcomes Measurement 
Information System (PROMIS) Depression and Anxiety 8-item short-form 
(Pilkonis et al., 2014) measures symptoms of depression (negative mood, 
views of self, and social cognition, as well as decreased positive affect and 
engagement) and anxiety (fear, anxious misery, hyperarousal, and somatic 
symptoms related to arousal).  

Partners Human Subjects Research Application Form 
  
Filename: Protocol Summary 
Version Date:  October 15, 2014 
 
  
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Affect. The Positive and Negative Affect Schedule (PANAS; Watson et al., 
1988) is a commonly used, well validated, reliable measure of positive and 
negative mood, and is composed of 10 positive mood terms (i.e. interested, 
enthusiastic, proud), and 10 negative mood terms (i.e. distressed, guilty, 
hostile). 
Sleep Quality. The Patient-Reported Outcomes Measurement Information 
System (PROMIS) Sleep Disturbance item bank assesses qualitative aspects 
of sleep and wake function. Short forms containing 4 and 8 items has been 
developed from the original 27-item question bank and correlates strongly 
with the longer form (Yu et al., 2011; 2012). Questions regarding sleep 
quality, latency, and other sleep qualities are rated on a 5-point Likert scale 
ranging from “not at all” to “very much.”  
Well-Being: The 7-item Resident Physician Well-Being Index has been used 
in resident physicians to evaluate overall well-being (Dyrbye et al., 2014). 
This has been studied in resident physicians previously and residents with 
scores greater than or equal to 5 were at a greater risk of adverse events 
including burnout, suicidal ideation, and reporting a recent medical error. 
 
Exploratory outcome measures: 
Relevance Questionnaire. We have developed and will administer a relevance 
questionnaire as a means to understand the participants’ perception of the 
outcome measures employed in the study, including whether the measures 
were relevant to the participants’ work environment, level of burden if any, 
the length and content of the battery. 
 
Qualitative Interviews. A block-randomized sample of 35% of the resident 
physicians in the RISE group will participate in 20-30 minute interviews after 
the RISE intervention is complete and the end program quantitative 
measures have been taken. We will use standard qualitative research 
methods in the form of structured interviews to gather information about 
each participant’s experience of the yoga program with regard to feasibility, 
any barriers to practice that were encountered, intention to continue using 
the yoga-based skills and practices learned in the program, and any changes 
in their psychosocial and physical health and wellbeing as a result of the 
program. 
 
References: 
1. Wagnild G, Young H. Development and psychometric. J Nurs Measure, 
1993;1(2):165-178. 
2. Wagnild GM. (2009). The resilience scale user's guide. Worden, MT: 
The Resilience Centre. 
3. Baer RA, Smith GT, Hopkins J, Krietemeyer J, Toney L. Using self-
report assessment methods to explore facets of mindfulness. 
Assessment, 2006;13(1):27-45. 

Partners Human Subjects Research Application Form 
  
Filename: Protocol Summary 
Version Date:  October 15, 2014 
 
  
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4. Baer RA, Carmody J, Hunsinger M. Weekly change in mindfulness and 
perceived stress in a mindfulness-based stress reduction program. J 
Clil Psychol. 2012;68(7):755-65. 
5. Gu J, Strauss C, Crane C, Barnhofer T, Karl A, Cavanagh K, Kuyken W. 
Examining the factor structure of the 39-item and 15-item versions of 
the Five Facet Mindfulness Questionnaire before and after mindfulness-
based cognitive therapy for people with recurrent depression. 
Psychological Assessment, 2016;28(7):791. 
6. Cohen S, Kamarck T, Mermelstein R. A global measure of perceived 
stress. J Health Soc Behav, 1983, 385-396. 
7. West CP, Dyrbye LN, Sloan, JA, Shanafelt TD. Single item measures of 
emotional exhaustion and depersonalization are useful for assessing 
burnout in medical professionals. J Gen Intern Med, 
2009;24(12):1318-1321. 
8. West CP, Dyrbye LN, Satele D, Sloan J, Shanafelt TD. Concurrent 
validity of single-item measures of emotional exhaustion and 
depersonalization in burnout assessment. J Gen Intern Med 
2012;27:1445-52. 
9. Trockel M, Bohman B, Lesure E, Hamidi MS, Welle D, Roberts L, 
Shanafelt T. A brief instrument to assess both burnout and 
professional fulfillment in physicians: reliability and validity, including 
correlation with self-reported medical errors, in a sample of resident 
and practicing physicians. Acad Psychiatry, 2018;42(1):11-24.  
10. 
Henry JD, Crawford JR. The short-form version of the Depression 
Anxiety Stress Scales (DASS-21): Construct validity and normative 
data in a large non-clinical sample. Brit J Clin Psychol, 
2005;44(2):227-239. 
11. Pilkonis PA, Yu L, Dodds NE, Johnston KL, Maihoefer CC, Lawrence SM. 
Validation of the depression item bank from the Patient-Reported 
Outcomes Measurement Information System (PROMIS®) in a three-
month observational study. J Psychiat Res, 2014;56:112-9. 
12. Watson D, Clark LA, Tellegen A. Development and validation of brief 
measures of positive and negative affect: the PANAS scales. Journal of 
personality and social psychology, 1988;54(6):1063. 
13. 
Yu L, Buysse DJ, Germain A, Moul DE, Stover A, Dodds NE, 
Johnston KL, Pilkonis PA. Development of short forms from the 
PROMIS™ sleep disturbance and sleep-related impairment item banks. 
Behavioral Sleep Medicine, 2012;10(1):6-24. 
14. 
Dyrbye, LN, Satele, D, Sloan, J, Shanafelt, TD (2014). "Ability of 
the Physician Well-Being Index to identify residents in distress." J Grad 
Med Educ 6(1): 78-84. 
 
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.
 

Partners Human Subjects Research Application Form 
  
Filename: Protocol Summary 
Version Date:  October 15, 2014 
 
  
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Not applicable 
 
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.
 
There are minimal risks of injury during yoga. The practice of the physical 
exercises and postures, breathing exercises, relaxation techniques, and 
meditation in the yoga treatment involve little risk, although at times 
subjects may find them challenging and difficult to complete. Overexertion 
on the physical exercises may lead to temporary muscle soreness for up to a 
week.  However, subjects will be instructed to gradually increase their effort 
on any physical exercises or breathing exercises so as not to overexert 
themselves, and to stop if they experience unexpected unpleasant 
symptoms.  The control of mental activity aims at controlling the 
participant’s thinking process.  There are no known risks for controlling 
thought processes.  There may be risks and side effects that are currently 
unknown and/or unanticipated. 
 
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.
 
Not applicable  
 
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.
 
There is a minimal risk of loss of privacy with respect to the data collected 
although confidentiality will be maintained according to standard procedures. 
The study staff will take all appropriate precautions and keep this 
information fully controlled. 
 
Emotional distress may be experienced when subjects complete the outcome 
measures. For example, rumination on the existence and severity of 
negative psychological characteristics may pose limited risks to subjects 
during or following questionnaire administration.  
 
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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Version Date:  October 15, 2014 
 
  
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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. 
 
It is hoped that those in the RISE yoga program will show improvements in 
psychological health outcomes. 
 
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.
 
The study is restricted to individuals enrolled in residency programs in the 
Longwood medical area. Though residents in other programs may also 
benefit, the study excludes these programs to impose a size limit on yoga 
classes and offer a convenient location for residents. 
 
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.
 
Physicians practicing in the United States must be proficient in English. 
Therefore, no subjects will be excluded on the basis of language. 
 
 
For guidance, refer to the following Partners policy: 
          Obtaining and Documenting Informed Consent of Subjects who do not Speak English
          https://partnershealthcare-public.sharepoint.com/ClinicalResearch/Non-
English_Speaking_Subjects.1.10.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.
 
An e-mail containing study information will be distributed to all BWH Internal 
Medicine residents. If the recruitment goal of at least 60 participants is not 

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met, an e-mail containing study information will be distributed to all BWH 
residents. Recruitment flyers will also be posted in common areas and 
workspaces used by residents. If more subjects are necessary, recruitment 
will be extended to other Longwood medical area hospitals. E-mails will be 
sent to residents via institutional e-mails. 
 
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 
study participation.  Investigators may wish to consider providing reimbursement for such 
expenses when funding is available
 
As described above, participants will receive a $25.00 gift card for the 
purchase of a yoga mat as incentive for enrolling in the study.  
 
For guidance, refer to the following Partners policies: 
          Recruitment of Research Subjects 
          https://partnershealthcare-
public.sharepoint.com/ClinicalResearch/Recruitment_Of_Research_Subjects.pdf
 
          Guidelines for Advertisements for Recruiting Subjects
          https://partnershealthcare-
public.sharepoint.com/ClinicalResearch/Guidelines_For_Advertisements.1.11.pdf
 
          Remuneration for Research Subjects
          https://partnershealthcare-
public.sharepoint.com/ClinicalResearch/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.
 
Potential subjects who respond to recruitment e-mails and/or fliers will be 
provided with information about the study along with a link to the consent 
form via their unique Partners e-mail address. Informed consent will be 
performed electronically via REDCap survey software. Participants will have 
an opportunity to review the consent form and indicate via REDCap that they 
would like more information about the study. A member of the study staff 
will then contact the potential subject. If the potential subject elects to 
proceed, they will provide informed consent with an electronic signature via 
REDCap survey. This consent must be signed prior to completion of the pre-
intervention questionnaires. The consent form is included separately for IRB 
review. The REDCap consent process was discussed with Lynn Simpson. 

Partners Human Subjects Research Application Form 
  
Filename: Protocol Summary 
Version Date:  October 15, 2014 
 
  
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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 
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://partnershealthcare-
public.sharepoint.com/ClinicalResearch/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. 
 
The Principal Investigator, Dr. Sat Bir Khalsa, will be responsible for the 
oversight of data and safety issues, and will be ultimately responsible for 
determining whether the research should be altered or stopped. The efficacy 
data to be reviewed will include subject’s responses to self-report 
questionnaires and interviews. As data from each planned assessment 
becomes available, analyses will be conducted to screen for adverse effects 
on subjects’ mental health (only non-clinical indicators are assessed) and 
behavioral outcomes from the questionnaires or interviews. 
Research staff conducting interim analyses of efficacy data will immediately 
inform Dr. Khalsa if any evidence of adverse events, including data 
breaches, is found. All project staff and yoga instructors will be fully 
instructed in the maintenance of confidentiality required for this study, will 
be trained to observe for potential adverse events and report to the PI if one 
occurs as soon as an event is observed (staff are instructed that the PI and 
post-doctoral fellow/project leader are available by cell phone at all times), 
and will meet on a regular basis for ongoing training, supervision, and 
problem solving. See the section on “Privacy and Confidentiality” below for a 
description of procedures that will be followed to prevent potential data 
breaches.

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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
 
Adverse events (AEs) will be reported by Dr. Khalsa to the IRB at least once 
per year and will be reported as part of the annual progress report. 
Specifically, the PI compiles an annual report to the IRB as part of the 
recertification process. This report includes a summary of data collection 
activities, certifications on human subjects training and conflict of interest 
issues, and a report of AEs if any. AEs will be described in this annual report. 
Serious adverse events (SAEs) will be reported to the IRB within 24 hours of 
the event by email, including a brief explanation of the SAE and when it 
occurred. A written follow-up will be submitted within 72 hours of the event 
and will include information on the date of the event, what occurred, actions 
taken by the project staff, planned follow up (if any), whether the event 
appears to be related to completing the outcome measures, and whether the 
affected participant will continue in the study. Following any AEs or SAEs, 
Dr. Khalsa will consult with study staff to determine a course of corrective 
action, and will report these corrective actions to the IRB. Study staff will 
immediately report any breaches of data security directly to Dr. Khalsa who 
will report these incidents to the IRB as described above. (See the section on 
“Privacy and Confidentiality” below for a description of procedures that will 
be followed to prevent potential data breaches.) 
 
 
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.

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Procedures will be used at several points to ensure the integrity of the data. 
The measures used in the study were selected on the basis of previous 
research which indicates that the scales have good reliability and strong 
evidence of construct validity. In addition, data transferred from paper 
questionnaires will be double-checked by blinded staff members to ensure 
integrity of the data entry. Questionnaires are edited before data entry by 
research assistants who are trained to code any ambiguous responses (e.g., 
subject circles two numbers on a single response scale) and to flag protocols 
that show evidence of obvious invalidity using standardized criteria (e.g., zig-
zag patterns). 
 
 
For guidance, refer to the following Partners policies: 
          Data and Safety Monitoring Plans and Quality Assurance
            https://partnershealthcare-
public.sharepoint.com/ClinicalResearch/DSMP_in_Human_Subjects_Research.pdf  
          
          Reporting Unanticipated Problems (including Adverse Events)
          https://partnershealthcare-
public.sharepoint.com/ClinicalResearch/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 majority of data will be collected via REDcap, which is consistent with 
privacy and confidentiality requirements for research protocols. If there are 
paper forms, they will be stored in a locked file cabinet. All electronic data 
files will be stored in a password-protected computerized database. The only 
people with access to these files will be IRB approved study staff. Subjects 
will be assigned a study ID number that will be used to identify data sets. No 
identifiable information, such as name or date of birth, will be on any 
primary source data documents. A master enrollment log will be maintained, 
and will be used to match subject’s names and study ID numbers. This 
enrollment log will be encrypted with a password and will only be accessible 
by approved study staff.  

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Version Date:  October 15, 2014 
 
  
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No identifiable data will be shared or published outside of the study staff.  
Once all of the data from the study have been fully verified and baseline 
data matched with end-program data, all paper data information will be 
entered into electronic data files in which only subject codes are associated 
with the data; no identifiable information will be associated with these files.  
All personal identifiers such as name and birth date will not appear in the 
electronic data.  All research staff will be trained on the importance of 
confidentiality of data. 
 
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.
 
N/A 
 
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.
 
N/A 
 
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 
approval and a copy of the IRB-approved consent form from the institution where the 
specimens/data were collected.
 
N/A