Motivational Interviewing to Enhance Adherence of Patients With Psychogenic Non-epileptic Seizures: A Model of Patient Engagement in Functional Neurological Symptom Disorders
Phase: NA
Conditions: Psychogenic Non-epileptic Seizures, Motivational Interviewing
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 
 
  
1 
 
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 
Barbara Dworetzky, MD 
 
PROTOCOL TITLE 
 
Motivational interviewing to enhance adherence of patients with psychogenic 
non-epileptic seizures: a model of patient engagement in functional 
neurological symptom disorders 
 
FUNDING 
Practice Research Training Fellowship (American Academy of Neurology, 
American Brain Foundation) 
 
 
VERSION DATE 
 
July 8th, 2015 
 
SPECIFIC AIMS 
Concisely state the objectives of the study and the hypothesis being tested. 
NB: Specific Aims 1 and 2 pertain to the first part of this project, detailed under BWH IRB protocol 2013P000133. 
Specific Aim 3 pertains to the second part of this project, detailed here. 
 
Aim 1: To identify the baseline characteristics which correlate most closely with non-adherence to treatment in 
patients with PNES. 
Hypothesis 1: Factors including low income, low educational achievement, unmarried status, lack of access to 
transportation, presence of psychiatric comorbidities, high seizure frequency, and long duration since onset of PNES 
will correlate with non-adherence in patients with PNES. 
 
Aim 2: To identify the factors to which non-adherent patients with PNES attribute lack of adherence. 
Hypothesis 2: Patients will most frequently attribute their lack of adherence to external factors including ineffective 
treatment, lack of empathy on the part of their physicians, and difficulty arranging transportation or time away from 
work/childcare. Patients will not attribute non-adherence to internal factors such as ambivalence about treatment, 
avoidance, help-rejection, or psychiatric comorbidities. 
 
Aim 3: To determine whether motivational interviewing improves adherence to treatment (primary 
outcome), seizure frequency, healthcare usage, and quality of life (secondary outcomes). 
Hypothesis 3: A brief in-person interview, using motivational interviewing techniques, will improve 
adherence, seizure frequency, healthcare usage, and quality of life at 4-month follow-up among patients with 
PNES when compared to a control group receiving only informational interviewing. 
 
 
 

Partners Human Subjects Research Application Form  
 
Filename: Protocol Summary 
Version Date:  October 15, 2014 
 
  
2 
BACKGROUND AND SIGNIFICANCE 
Provide a brief paragraph summarizing prior experience important for understanding the 
proposed study and procedures. 
 
Psychogenic non-epileptic seizures (PNES) are common, highly disabling, and can be readily diagnosed via the gold 
standard video-EEG monitoring. Several studies, including two randomized clinical trials have demonstrated the 
efficacy of psychotherapy (and particularly cognitive behavioral therapy) in treating PNES. However the majority of 
patients with PNES do not complete psychotherapy and continue to suffer from seizures, disability, social 
dependence, and increased healthcare resource utilization over the long term. One important barrier to treatment is a 
high rate of non-adherence with psychotherapy among patients with PNES. This study will entail a randomized trial 
of motivational interviewing to improve adherence with psychotherapy among patients with PNES. Motivational 
interviewing is a counseling style that was originally developed to help recovering alcoholics refrain from risky 
alcohol consumption and has subsequently been extensively studied and used in treating substance abuse, promoting 
weight loss in obese patients, and improving adherence with treatment among patients with HIV, schizophrenia, and 
other disorders. 
 
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 population will be screened from all patients diagnosed with PNES in Brigham and Women’s Hospital by 
capture of a definitive event on video EEG without EEG correlate. Patients with a mixed diagnosis of both PNES 
and epileptic seizures will be included. Pediatric patients (under age 18) are not typically evaluated by EEG in our 
hospital and will therefore be excluded. Patients with estimated IQ<70, inability to speak fluently in English or 
Spanish, active substance use disorder, pregnancy, or active medical issues which would preclude participation in 
weekly psychotherapy will be excluded. Patients meeting inclusion criteria will be considered eligible and will be 
approached for this study whether or not they are also enrolled in PHRC IRB protocol 2013P000133 (we anticipate 
that most eligible patients will be enrolled in both protocols). 
 
Our goal will be to enroll 60 patients diagnosed with PNES, with 30 randomized to the treatment arm 
(motivational interview) and 30 randomized to the control arm (informational interview). 
 
Potential subjects will be asked if they are willing to meet with study staff by a member of the clinical team 
during their inpatient admission. If the patient is willing, they will be approached during their admission by a 
member of the study staff. The recruiter will not be a member of the treatment team, and in all cases the recruiter 
will clearly specify that the patient will receive the same standard-of-care treatment for PNES (initial clinical 
follow-up with neuropsychiatrist and epileptologist and psychotherapy from a licensed therapist) whether or not they 
participate in the study. 
The purpose and structure of the study will be described, and if the individual is interested than the full 
informed consent process will completed, including detailed review of all potential risks and benefits. Because the 
informed consent process will be completed during an inpatient admission, time constraints will be minimized and 
the patient will have ample time to consider his or her consent. If informed consent is obtained, then study 
procedures will begin.  
Baseline demographic data, psychiatric comorbidities, quality of life, and healthcare resource utilization will be 
recorded in the EMU and the patient will be randomized to treatment (standard treatment + motivational 
interviewing) vs. control (standard treatment only). The patient will be scheduled for an initial appointment in the 
“long-term monitoring clinic” with an epileptologist and a neuropsychiatrist (part of standard care for PNES at 
BWH). At the end of this clinic appointment the patient will have either a motivational interview (treatment) or 
informational interview (control) depending on their randomization. They will then be referred for weekly 
psychotherapy either at BWH or with a local provider (again, part of standard care for PNES at BWH). After 4 
months they will be called and have a phone interview regarding their adherence to treatment, their reasons for 
adherence or non-adherence, seizure frequency, quality of life, and healthcare resource utilization over the prior 3 
months. 

Partners Human Subjects Research Application Form  
 
Filename: Protocol Summary 
Version Date:  October 15, 2014 
 
  
3 
 
 
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.
 
Baseline demographic data, psychiatric comorbidities, seizure frequency, quality of life, and healthcare resource 
utilization will be recorded following enrollment during the inpatient stay as part of PHRC IRB protocol 
2013P000133.  If the patient is not enrolled in protocol 2013P000133, baseline demographic data, seizure data, 
psychiatric comorbidities, qualities of life and healthcare resource utilization will be collected during the admission 
at which the patient is diagnosed, as detailed in appendix 1. All enrolled subjects will be scheduled for an initial 
appointment in the joint psychiatry-neurology clinic with a board certified neuropsychiatrist and board certified 
neurologists, which is standard of care for newly diagnosed PNES patients at Brigham and Women’s Hospital. 
All subjects will attend the initial clinic visit with the neuropsychiatrist and epileptologist. At the end of this 
visit, those subjects randomized to motivational interviewing will be questioned using standardized motivational 
interviewing techniques by the study author who is a board certified neurologist and who will have formal training 
and certification in motivational interviewing. Motivational interviews will include the classical 4 steps of MI: 1) 
engagement (in which the patient’s goals and interests are elicited and the therapeutic alliance is established); 2) 
focusing (in which the specific subjects of discussion and intervention are negotiated); 3) strengthening motivation 
(in which the patients’ reasons for healthcare intervention are made explicit, discussed, and reinforced); and 4) 
planning (in which actions for healthcare intervention are planned out based on the patients’ own goals and 
interests). 
The initial clinic visit and subsequent interview will be recorded with the patients’ consent, and blinded 
reviewers hired through the department of psychiatry, trained and certified in motivational interviewing, will score 
the audio recordings using the Motivational Interviewing Treatment Integrity code (MITI) 4.0 to assess fidelity to 
standardized motivational interviewing techniques. Recordings and blinded review of interviews are for the sole 
purpose of ensuring that the interviewer is in fact using proper interviewing techniques (ie motivational interviewing 
techniques for patients in the motivational interviewing arm and abstinence from motivational interviewing 
techniques in the control arm). Such recordings and review are recommended in motivational interviewing research. 
Those subjects randomized to the control group will also undergo an initial clinic visit with a neuropsychiatrist 
and neurologists – again recorded with the subjects’ consent and scored using the MITI 4.0 to assess abstinence 
from motivational interviewing techniques. However they will not undergo any subsequent motivational interview. 
Following the initial clinic visit, all subjects with ongoing seizures will either be scheduled for ongoing 
psychotherapy for treatment of PNES at Brigham and Women’s Hospital or referred to a local psychotherapist 
according to their preference. 
All subjects will be contacted by phone at 4 month follow-up. If necessary they will be called 5 times at various 
times during the day and early evening. If they are not reached, they will receive a letter requesting them to contact 
the study staff to complete the study. Subjects will be questioned about their adherence to treatment. The primary 
outcome will be the number of psychotherapy sessions for the treatment of PNES in which they have participated 
over the past three months. They will also be assessed for secondary outcomes including dichotomous adherence 
(either seizure freedom or active participation in psychotherapy for the treatment of PNES, with more than 5 
sessions over the past 3 months), seizure frequency over the past month, number of hospitalizations and emergency 
department visits over the past 3 months, and quality of life as measured by the brief QOLIE-10 instrument. For 
those patients who give permission, their psychotherapists will be contacted by study staff to confirm the exact 
number of psychotherapy sessions over the past 3 months. A standard Partners clinical records release form with the 
patient’s signature will be sent to the therapist’s office. 
 
Biostatistical Analysis: 
A) Motivational Interviewing Treatment Integrity 
Fidelity to motivational interviewing techniques during motivational interviewing sessions (intervention arm) 
will be assessed by blinded reviewers using the Motivational Interviewing Treatment Integrity code (MITI) 4.0. 
Relational scores and technical scores of ≥4 will be taken as indicating adherence to motivational interviewing 
techniques. Conversely abstinence from motivational interviewing techniques during informational interviews 
(control arm) will also be assessed by blinded reviewers using the MITI 4.0. Relational scores and technical scores 
of ≤2 will be taken as indicating abstinence from motivational interviewing techniques. 
 

Partners Human Subjects Research Application Form  
 
Filename: Protocol Summary 
Version Date:  October 15, 2014 
 
  
4 
B) Outcome data 
Outcome data collected during study, collected at 4 month follow-up, includes seizure frequency over the past 3 
months, number of emergency department visits over the past 3 months, QOLIE-10 score (see attached instrument), 
and participation in psychotherapy for the treatment of PNES (and number of sessions over the past 3 months). The 
primary outcome will be adherence, defined as attending 8 or more psychotherapy sessions over the past 3 months. 
Secondary outcomes will include decrease in PNES frequency, seizure freedom, change in QOLIE-10 score, and 
change in monthly ED visits.  
Intergroup comparisons will be made between the treatment arm (motivational interviewing) and control arm 
(informational interviewing) using the t-test or Wilcoxon rank-sum test depending on normality of distributions. 
 
C) Power analysis: 
Sample size of 30-per-arm was calculated to detect a difference in adherence of 25% vs. 60% with power 
of 0.80 and alpha of 0.05. 
 
 
 
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.
 
All patients enrolled in study will still receive standard of care for patients diagnosed with PNES at Brigham and 
Women’s Hospital: initial clinical follow-up with neuropsychiatrist and epileptologist and psychotherapy from a 
licensed therapist. Study patients will additionally receive either an informational interview (control arm) or a 
motivational interview (treatment arm) following their initial clinic follow-up. 
 
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.
 
Research procedures (motivational interviewing vs. informational interview) are consistent with sound research 
design. Motivational interviewing has been studied and used for years in promoting abstinence from substance abuse 
and adherence with treatment in other disorders (HIV, schizophrenia, etc.), and is thought to be associated with 
minimal risk.  
 
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.
 
We will also continuously review any adverse reactions to motivational interviews or informational interviews, 
and will stop the study if there is any indication of repeated adverse reactions. The study author and principal 
investigator will be responsible for continuous review of adverse reactions.  
Individuals will be dropped from the study in cases where PNES is significantly worsening (>100% increase in 
frequency) or where psychiatric symptoms are otherwise significantly worsening, and where the principal 
investigator and/or the treating psychiatrist feels that study participation is contributing to psychiatric 
decompensation. 
 
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 

Partners Human Subjects Research Application Form  
 
Filename: Protocol Summary 
Version Date:  October 15, 2014 
 
  
5 
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.
 
 
Psychosocial risks include potential embarrassment or sense of stigmatization due to motivational interviewing or 
informational interviewing, or to the 6 month follow-up phone calls. Additionally there is a potential loss of privacy 
associated with audio recording of the motivational interviewing and informational interviewing sessions. 
 
 
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 
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. 
 
Individual subjects in both the treatment arm and control arm of this study may benefit from additional time 
with a board certified neurologist, and the opportunity to ask questions about their diagnosis and treatment, which 
are often points of confusion following a new diagnosis of PNES. If our intervention of motivational interviewing is 
successful in improving adherence and outcomes in patients with PNES, then subjects randomized to the treatment 
arm may experience these benefits. 
 
Potential social benefits include the test of a promising intervention to improve adherence with psychotherapy 
among a large, significantly disabled, and difficult to treat patient population (see background and significance). 
Evidence based treatments (such as cognitive behavioral therapy) exist for PNES, but are currently rarely completed, 
in part because adherence rates are ~50% under the best circumstances. It is hoped that motivational interviewing 
will provide an improvement in adherence with psychotherapy of at least 25%. If motivational interviewing is 
successful in improving adherence and seizure control among patients with PNES, this may benefit not only those 
patients, but also the healthcare system and society as a whole. Untreated or incompletely treated patients with 
PNES are economically and socially dependent, have frequent emergency department visits and hospital admissions, 
and incur high medical care costs. 
 
 
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.
 
Patients will not be excluded from study participation on the basis of gender, pregnancy, or ethnicity. Pediatric 
patients (<18 years of age) will not be included because such patients are not typically evaluated with video EEG at 
Brigham and Women’s Hospital. Otherwise, patients will not be excluded on the basis of age. 
 
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.

Partners Human Subjects Research Application Form  
 
Filename: Protocol Summary 
Version Date:  October 15, 2014 
 
  
6 
 
Patients will not be excluded from study participation 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.
 
Potential subjects will be asked if they are willing to meet with study staff by a member of the clinical team 
during their inpatient admission. If the patient is willing, they will be approached during their admission by a 
member of the study staff. The recruiter will not be a member of the treatment team, and in all cases the recruiter 
will clearly specify that the patient will receive the same standard-of-care treatment for PNES (initial clinical 
follow-up with neuropsychiatrist and epileptologist and psychotherapy from a licensed therapist) whether or not they 
participate in the study. 
 
The purpose and structure of the study will be described, and if the patient is interested then the full informed 
consent process will be completed by a physician investigator once the diagnosis of PNES is made. The informed 
consent process will include detailed review of the consent form and all potential risks and benefits. The patient will 
be encouraged to ask questions. If the patient is unsure about participation, they will be encouraged to take the 
consent form and review it further during the course of the admission. In that case the physician investigator will 
return at a later time during the admission, and will again review the consent form and answer any questions. 
Because the informed consent process will be completed during an inpatient admission, time constraints will be 
minimized and the patient will have ample time (>12 hours) to consider his or her consent.  
At that time the patient will be randomized to treatment (motivational interviewing) vs. control (informational 
interviewing). 
 
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
 
There are no extra hospital or clinic visits necessitated by this study, beyond the usual standard of care at 
Brigham and Women’s Hospital. Therefore it is expected that there will be no additional expenses for study 
participants and no travel or other significant inconveniences.   
 
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

Partners Human Subjects Research Application Form  
 
Filename: Protocol Summary 
Version Date:  October 15, 2014 
 
  
7 
          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.
 
Study staff will initially discuss the study with patients during the inpatient admission. If 
the patient is interested, informed consent will then be obtained by a licensed physician 
investigator. The consent process will begin with a review of the consent form. The patient 
will be encouraged to ask questions. If the patient is still unsure if he wants to participate, 
he will be encouraged to take the consent form and review it further during the course of 
the admission. In that case the physician investigator will return at a later time during the 
admission, and will again review the consent form and answer any questions. If the patient 
agrees to participation and signs the consent, then the new subject will be randomized and 
study procedures will be performed. 
 
 
 
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.        
 

Partners Human Subjects Research Application Form  
 
Filename: Protocol Summary 
Version Date:  October 15, 2014 
 
  
8 
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. 
 
No serious safety issues are anticipated in this study. Nonetheless, study staff will continuously review any 
adverse reactions to motivational interviews or informational interviews. Any unanticipated problems, including 
adverse events involving risks to subjects or others will be reported to the principal investigator weekly. Any serious 
adverse events will be reported within 24 hours. Any unanticipated problems, including adverse events involving 
risks to subjects or others that are serious, unexpected, and related or possibly related to the research study will be 
reported to the IRB within 5 working days/ 7 calendar days of the date the investigator first becomes aware of the 
event.  
The principal investigator will stop the study if there is any indication of repeated adverse reactions. The 
principal investigator will be responsible for review of adverse reactions and for overseeing the safety of study 
subjects.  
Individuals will be dropped from the study in cases where PNES is significantly worsening (>100% increase in 
frequency) or where psychiatric symptoms are otherwise significantly worsening, and where the principal 
investigator and/or the treating psychiatrist feels that study participation is contributing to psychiatric 
decompensation. Subjects may also choose to leave the study at any time. In the event that a subject is dropped from 
the study or chooses to leave, the study staff will document the reason for their leaving the study and the principal 
investigator will ensure that they withdraw in the safest manner possible, in coordination with their treating 
psychiatrist. In the event that the subject does not have a treating psychiatrist or psychotherapist at the time of their 
withdrawal, a study physician investigator will provide a referral. The principal investigator will be responsible for 
the safe withdrawal of patients from the trial. 
 
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
 
No serious safety issues are anticipated in this study. Nonetheless, study staff will continuously review any 
adverse reactions to motivational interviews or informational interviews. Any unanticipated problems, including 
adverse events involving risks to subjects or others will be reported to the principal investigator weekly. Any serious 
adverse events will be reported within 24 hours. Any unanticipated problems, including adverse events involving 
risks to subjects or others that are serious, unexpected, and related or possibly related to the research study will be 
reported to the IRB within 5 working days/ 7 calendar days of the date the investigator first becomes aware of the 
event.  
 
 
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.   

Partners Human Subjects Research Application Form  
 
Filename: Protocol Summary 
Version Date:  October 15, 2014 
 
  
9 
 
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 study staff will be responsible for accurate entry of all data into a password protected electronic database on 
the Partners network. The principal investigator will be ultimately responsible for data integrity and quality 
assurance and will review entered data at least once monthly. 
 
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.
 
Subjects will immediately be given a unique code after signing the consent 
form. There will be one form with contact information that will contain the subject’s 
name and medical record number, but all other data forms will only contain the 
subject id. The data collection forms and signed informed consent will be stored in 
binders in locked cabinets in the locked offices of the epilepsy division. Audio 
recordings will be stored in the same locked cabinets. Only IRB-approved study 
staff will have access to keys. The electronic database will be housed in a limited-
access server on the Partners network and will be password protected. Only the 
IRB-approved study staff will know the password. All study staff will be trained in 
the critical importance of data confidentiality. 
 
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, 

Partners Human Subjects Research Application Form  
 
Filename: Protocol Summary 
Version Date:  October 15, 2014 
 
  
10 
and whether the specimens/data will contain identifiers that could be used by the outside 
collaborators to link the specimens/data to individual subjects.
 
There are no outside research collaborators. 
 
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.
 
There are no collaborating sites. 
 
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.
 
There are no outside research collaborators.