Enhancing Social Functioning in Schizophrenia Through Scalable Mobile Technology
Phase: NA
Conditions: Schizophrenia, Schizoaffective Disorder
Sponsor: Boston University Charles River Campus

Enhancing Social Functioning in Schizophrenia Through Scalable Mobile Technology
NCT03404219
Unique Protocol ID: 1 R21 MH111501-01
Version date 4.8.2020

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Version:  November, 2017 
 
 
 
BU Charles River IRB 
Application Form (Full Board and Expedited Review) 
 
SECTION A:  PROTOCOL AND CONTACT INFORMATION 
Protocol Number (To be 
assigned by IRB Office): 
4921 
Protocol Title:   
Motivation and Skills Support (MASS) 
Principal Investigator 
(Name, degrees, licenses, 
etc.): 
 Mr. 
 Ms. 
Daniel Fulford, PhD 
 
             Department/School: Occupational Therapy, Sargent College 
BU Mailing Address: 
635 Commonwealth Ave, SAR-512 
             Email: 
dfulford@bu.edu 
             Telephone: 
617-358-2614 
Additional Contact Person: 
Lab coordinator 
              Email: 
buamplab@gmail.com 
              Telephone: 
 
 YES 
(REQUIRED) 
I confirm that I qualify to serve as the Principal Investigator of this study 
and am in compliance with the following policies: 
• http://www.bu.edu/researchsupport/compliance/human-subjects/  
 
SECTION B:  FUNDING 
 
Provide information regarding ALL funding sources in this section.  This includes ANY 
EXISTING FUNDING, PENDING FUNDING, OR FUNDING THAT HAS BEEN 
APPLIED FOR TO SUPPORT THIS RESEARCH.   
Please check all that apply: 
 
This research is funded 
 
Have you received Just In Time (JIT) Notification?    Yes            No 
 
 
Funding has been requested  
Have you received Just In Time (JIT) Notification?    Yes            No 
 
IRB Office use only 
Date submitted________ 
 
FB_____   Exp. ____ 
 

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Version:  November, 2017 
NOTE:  Once the funding has been awarded, submit an amendment to the IRB 
to add the funding source 
 
Research is not funded 
 
If the research is funded or funding has been requested, it is REQUIRED that you 
complete the box below.  The Sponsor Award # must be included in the box below.  If you 
don’t have an award #, please state that in the box below.  If you have multiple funding 
sources, add additional boxes as necessary. 
 
Sponsor Name 
 
National Institute of Mental Health (NIMH) 
Title of 
Grant/Proposal 
 
Enhancing Social Functioning in Schizophrenia through 
Scalable Mobile Technology 
Sponsor Award # 
(REQUIRED)* 
*If Award # is 
pending, put 
pending.  Once 
the funding has 
been awarded, 
submit an 
amendment to 
the IRB to add 
the funding 
source 
 
R21MH111501-01 
 
 
 
YES 
NO 
 
 
 
 
 
Is Boston University the Prime Awardee of the grant? 
 
 
 
Is Boston University receiving a sub-award? 
Name of Prime Recipient: 
 
*NOTE:  Provide a copy of the grant application, funding proposal, scope of work, or sub-award 
agreement.  The University is required to verify that all funding proposals and grants have been 
reviewed by the IRB before funds are awarded. 
 
If this research study is for your dissertation, provide a copy of your prospectus (if available). 
 
 
 
 
 
 

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Version:  November, 2017 
SECTION C:  CONFLICT OF INTEREST 
 YES 
(REQUIRED) 
I confirm that ALL those responsible for the design, conduct, or reporting 
of the proposed program, including at minimum, all Senior/key personnel 
in the grant application, have completed the financial interest disclosure 
forms, submitted them to the COI office, and completed training as 
dictated at: http://www.bu.edu/researchsupport/compliance/conflicts-of-
interest/,  and as provided under the Boston University Investigator 
Conflicts of Interest Policy for Research.     
 
NOTE:  You must attach a copy of the PI’s COI submission 
confirmation email.  COI submission confirmation emails for all 
other study staff should be maintained at the research site.     
Of the financial interest disclosure forms submitted, did you check “yes” to any of the 
questions on either the FIND1 or NONFIND1 form? 
 Yes*            No 
 
 
 
*If  you checked “yes” to any of the questions on either the FIND1 or NONFIND1 form, the 
IRB Director will contact the COI office to obtain the disclosure information. 
 
 
SECTION D:  TYPE OF REVIEW 
 
For Guidance regarding Type of Review please refer to the following website: 
http://www.bu.edu/researchsupport/compliance/human-subjects/submitting-an-irb-protocol/  
 
I. 
FULL BOARD 
 
Please refer to the IRB website for Full Board submission deadlines and meeting dates:  
http://www.bu.edu/researchsupport/compliance/human-subjects/dates-and-timing-of-the-irb-
committee/  
II. 
EXPEDITED  
 
In order to qualify for expedited review, the study must be no more than minimal risk* AND 
must fall into one of the categories below.  Check all that apply: 
 
1.  Clinical studies of drugs and medical devices only when an investigational new drug 
application (IND)  or investigational device exemption application (IDE) is not required 
 
2.  Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as 
follows: 
a. From healthy, nonpregnant adults who weigh at least 110 pounds. For these 
subjects, the amounts drawn may not exceed 550 ml in an 8 week period and 
collection may not occur more frequently than 2 times per week; or 

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Version:  November, 2017 
b. From other adults and children, considering the age, weight, and health of the 
subjects, the collection procedure, the amount of blood to be collected, and the 
frequency with which it will be collected. For these subjects, the amount drawn 
may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and 
collection may not occur more frequently than 2 times per week. 
 
3.  Prospective collection of biological specimens for research purposes by noninvasive 
means.  Examples include hair and nail clippings, saliva or cheek swabs, sweat, etc. 
 
4.  Collection of data through noninvasive procedures (not involving general anesthesia 
or sedation) routinely employed in clinical practice, excluding procedures involving x-
rays or microwaves. Where medical devices are employed, they must be 
cleared/approved for marketing.  
 
Examples:  
1. Physical sensors that are applied either to the surface of the body or at a distance 
and do not involve input of significant amounts of energy into the subject or an 
invasion of the subject’s privacy  
2. Weighing or testing sensory acuity  
3. Magnetic resonance imaging  
4. Electrocardiography, electroencephalography, thermography, detection of 
naturally occurring radioactivity, electroretinography, ultrasound, diagnostic 
infrared imaging, doppler blood flow, and echocardiography  
5. Moderate exercise, muscular strength testing, body composition assessment, and 
flexibility testing where appropriate given the age, weight, and health of the 
individual 
 
5.  Research involving materials (data, documents, records, or specimens) that have been 
collected, or will be collected solely for nonresearch purposes (such as medical treatment 
or diagnosis)  
 
6.  Collection of data from voice, video, digital, or image recordings made for research 
purposes. 
 
7.  Research on individual or group characteristics or behavior (including, but not limited 
to, research on perception, cognition, motivation, identity, language, communication, 
cultural beliefs or practices, and social behavior) or research employing survey, 
interview, oral history, focus group, program evaluation, human factors evaluation, or 
quality assurance methodologies.  
 
Note:  The IRB will make the final determination on the Type of Review 
*Minimal risk means that the probability and magnitude of harm or discomfort anticipated in 
the research are not greater in and of themselves than those ordinarily encountered in daily life or 
during the performance of routine physical or psychological examinations or tests. 

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Version:  November, 2017 
SECTION E:  STUDY STAFF AND HUMAN SUBJECTS TRAINING 
 
List ALL current members of the research team in the table below.  Add more rows as 
necessary. 
STUDENT RESEARCH:   
The Faculty Advisor must be listed as a co-investigator in this section and must complete 
the Human Subjects training requirements.  Faculty Advisors are responsible for reviewing 
the IRB application, agreeing to serve as the Co-PI for this study with the student and are 
responsible for the ethical conduct of this student’s human subjects research.  Faculty 
Advisors must sign this Application prior to it being submitted to the IRB. 
 
BU CHARLES RIVER CAMPUS (CRC) INVESTIGATORS/STUDY STAFF 
Note: Boston University Medical Campus (BUMC) investigators/study staff should be listed in 
the NON-BU INVESTIGATOR/STUDY STAFF section 
Name, Degree, & 
Department/School 
Study Role (e.g. co-investigator, 
research coordinator, research 
assistant, project manager, lab 
manager) 
Human Subjects Training* 
Daniel Fulford, PhD, 
Occupational 
Therapy/Sargent 
PI 
 CITI 
 Other**:__________ 
Most Recent Date Completed: 2019 
Kim Mueser, PhD, 
Occupational 
Therapy/Sargent 
Co-Investigator 
 CITI 
 Other**:__________ 
Most Recent Date Completed: 2019 
Samuel Abplanalp, 
B.A., Department of 
Occupational 
Therapy, College of 
Health & 
Rehabilitation 
Sciences: Sargent 
College 
Graduate assistant 
 CITI 
 Other**:__________ 
Most Recent Date Completed: _2019 
Kathryn Gill, BA, 
Department of 
Occupational 
Therapy, College of 
Health & 
Rehabilitation 
Sciences: Sargent 
College 
Research Coordinator 
 CITI 
 Other**:__________ 
Most Recent Date Completed: 2018 

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Version:  November, 2017 
Arti Gandhi, 
Department of 
Occupational 
Therapy, College of 
Health & 
Rehabilitation 
Sciences: Sargent 
College 
Research assistant 
 CITI 
 Other**:__________ 
Most Recent Date Completed: _2017 
Christina Colon-
Semenza, PT, MPT, 
NCS, Department of 
Physical Therapy & 
Athletic Training, 
College of Health & 
Rehabilitation 
Sciences: Sargent 
College 
Graduate assistant 
 CITI 
 Other**:__________ 
Most Recent Date Completed: _2017 
Anup Dupaguntla, 
Department of 
Occupational 
Therapy, College of 
Health & 
Rehabilitation 
Sciences: Sargent 
College 
Research assistant 
 CITI 
 Other**: 
Most Recent Date Completed: 2018 
Alisa Gold, 
Department of 
Occupational 
Therapy, College of 
Health & 
Rehabilitation 
Sciences: Sargent 
College 
Research assistant 
☒ CITI 
☐ Other**: 
Most Recent Date Completed: 2018 
Emma Weizenbaum, 
MA, Department of 
Psychological and 
Brain Sciences/ CAS 
Graduate Assistant 
☒ CITI 
☐ Other**:__________ 
Most Recent Date Completed: 2018 
Jessica Mow, 
Department of 
Occupational 
Therapy, College of 
Health & 
Rehabilitation 
Sciences: Sargent 
College 
Graduate Assistant 
☒ CITI 
☐ Other**:__________ 
Most Recent Date Completed: 2018 

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Version:  November, 2017 
Jasmine Mote, PhD, 
Department of 
Occupational 
Therapy, Sargent 
College 
Post-doctoral research associate  
 CITI 
 Other**: 
Most Recent Date Completed: 2018 
Kathy Vong, 
Department of 
Occupational 
Therapy, College of 
Health & 
Rehabilitation 
Sciences: Sargent 
College 
Research assistant 
☒ CITI 
☐ Other**:__________ 
Most Recent Date Completed: _2018__ 
Sophia Aburida, 
Department of 
Occupational 
Therapy, College of 
Health & 
Rehabilitation 
Sciences: Sargent 
College 
Research assistant 
☒ CITI 
☐ Other**: 
Most Recent Date Completed: 2019 
Liam Quidore, 
Department of 
Occupational 
Therapy, College of 
Health & 
Rehabilitation 
Sciences: Sargent 
College 
Research assistant 
 CITI 
 Other**: 
Most Recent Date Completed: 2019 
Tairmae Kanarloo, 
Department of 
Occupational 
Therapy, College of 
Health & 
Rehabilitation 
Sciences: Sargent 
College 
Graduate assistant 
 CITI 
 Other**: 
Most Recent Date Completed: 2019 

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Version:  November, 2017 
Shari Gordon, 
Department of 
Occupational 
Therapy, College of 
Health & 
Rehabilitation 
Sciences: Sargent 
College 
Graduate assistant 
 CITI 
 Other**: 
Most Recent Date Completed: 2019 
Riley Mcdonald, 
Department of 
Occupational 
Therapy, College of 
Health & 
Rehabilitation 
Sciences: Sargent 
College 
Research Assistant  
 CITI 
 Other**: 
Most Recent Date Completed: 2020 
 
 
 
 
*For more information regarding the Human Subjects Training Policy, refer to the ‘Training’ 
section of the Policies & Guidance section IRB website: 
http://www.bu.edu/researchsupport/training-how-to/human-subjects-training/.   This site includes 
a Study Personnel Training List.  You can search this list by name to obtain the completion and 
expiration dates of training for investigators and study staff. 
**If the investigator/study staff did not complete CITI, you must submit a copy of his/her 
training certificate. 
 
 
NON-BU INVESTIGATORS/STUDY STAFF*  
 
 
 N/A 
Note:  BUMC and BMC staff are considered to be non-BU staff and should be listed in this 
section.    Add more rows as necessary.  All the columns in the box below must be 
completed.  In addition, you must complete the box that follows with a description of the 
activities for each staff member.   
 

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Version:  November, 2017 
Name, Degree, & Affiliate 
Institution 
Study Role 
Staff Information 
Will IRB Approval be Obtained 
from Affiliate? 
David Gard, PhD 
San Francisco State 
University 
Co-Investigator 
1. Will this staff 
interact with subjects? 
 Yes           No 
 
2.Will this staff have 
access to identifiable 
information? 
 Yes           No 
 
3.Is the work that the 
staff will complete 
related to his/her role 
or coursework at 
his/her affiliate 
institution.? 
 Yes           No 
 
 Yes:  Provide copy of IRB 
approval letter when available: 
 No (provide reason):  ______ 
Lawrence Leung, San 
Francisco State University 
Research assistant 
1. Will this staff 
interact with subjects? 
 Yes           No 
 
2.Will this staff have 
access to identifiable 
information? 
 Yes           No 
 
3.Is the work that the 
staff will complete 
related to his/her role 
or coursework at 
his/her affiliate 
institution.? 
 Yes           No 
 
 Yes:  Provide copy of IRB 
approval letter when available: 
 No (provide reason):  ______ 
Jake Gibson, San Francisco 
State University 
Research assistant 
1. Will this staff 
interact with subjects? 
 Yes           No 
 
2.Will this staff have 
access to identifiable 
information? 
 Yes:  Provide copy of IRB 
approval letter when available: 
 No (provide reason):  ______ 

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Version:  November, 2017 
 Yes           No 
 
3.Is the work that the 
staff will complete 
related to his/her role 
or coursework at 
his/her affiliate 
institution.? 
 Yes           No 
 
James Geri, San Francisco 
State University 
Research assistant 
1. Will this staff 
interact with subjects? 
 Yes           No 
 
2.Will this staff have 
access to identifiable 
information? 
 Yes           No 
 
3.Is the work that the 
staff will complete 
related to his/her role 
or coursework at 
his/her affiliate 
institution.? 
 Yes           No 
 
 Yes:  Provide copy of IRB 
approval letter when available: 
 No (provide reason):  ______ 
Julia Catalano, San 
Francisco State University 
Research assistant 
1. Will this staff 
interact with subjects? 
 Yes           No 
 
2.Will this staff have 
access to identifiable 
information? 
 Yes           No 
 
3.Is the work that the 
staff will complete 
related to his/her role 
or coursework at 
his/her affiliate 
institution.? 
 Yes           No 
 
 Yes:  Provide copy of IRB 
approval letter when available: 
 No (provide reason):  ______ 

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Version:  November, 2017 
Valerie La, San Francisco 
State University 
Research assistant 
1. Will this staff 
interact with subjects? 
 Yes           No 
 
2.Will this staff have 
access to identifiable 
information? 
 Yes           No 
 
3.Is the work that the 
staff will complete 
related to his/her role 
or coursework at 
his/her affiliate 
institution.? 
 Yes           No 
 
 Yes:  Provide copy of IRB 
approval letter when available: 
 No (provide reason):  ______ 
Jocelyn Barete, San 
Francisco State University 
Research assistant 
1. Will this staff 
interact with subjects? 
 Yes           No 
 
2.Will this staff have 
access to identifiable 
information? 
 Yes           No 
 
3.Is the work that the 
staff will complete 
related to his/her role 
or coursework at 
his/her affiliate 
institution.? 
 Yes           No 
 
 Yes:  Provide copy of IRB 
approval letter when available: 
 No (provide reason):  ______ 
Ana Nieto, San Francisco 
State University 
Research assistant 
1. Will this staff 
interact with subjects? 
 Yes           No 
 
2.Will this staff have 
access to identifiable 
information? 
 Yes           No 
 
3.Is the work that the 
staff will complete 
 Yes:  Provide copy of IRB 
approval letter when available: 
 No (provide reason):  ______ 

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Version:  November, 2017 
related to his/her role 
or coursework at 
his/her affiliate 
institution.? 
 Yes           No 
 
Luna Rivera 
Research assistant 
1. Will this staff 
interact with subjects? 
 Yes           No 
 
2.Will this staff have 
access to identifiable 
information? 
 Yes           No 
 
3.Is the work that the 
staff will complete 
related to his/her role 
or coursework at 
his/her affiliate 
institution.? 
 Yes           No 
 Yes:  Provide copy of IRB 
approval letter when available: 
 No (provide reason):  ______ 
 
*If IRB approval will be obtained from the affiliate site, only list the lead investigator from the 
affiliate on this form. 
The box below must be completed.  Include a summary for each staff listed in the above 
box.  If any of the investigators listed on this form are not affiliated with BU, provide a summary 
of the study activities that he/she will conduct.  If IRB approval is not being obtained at the 
2affiliate institution, provide an explanation.  NOTE:  Non-BU staff may be required to 
complete an Individual Investigator Agreement (IIA).  The IRB will notify you if this form 
is required. 
 
Dr. Gard is a Co-Investigator on this grant.  He will be involved with planning of the research 
activities and data analysis.   
 
Lawrence Leung, Jake Gibson, James Geri, Julia Catalano, Valerie La, Jocelyn Barete, Ana 
Nieto, and Luna Rivera are all research assistants who will be responsible for assisting with 
research activities; including participant recruitment, data collection, and analysis.  
 
 
 

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Version:  November, 2017 
REQUIRED GOOD CLINICAL PRACTICE TRAINING FOR NIH-
FUNDED CLINICAL TRIALS 
 
YES* 
NO 
NIH-FUNDED CLINICAL TRIALS 
 
 
Is your study NIH-Funded AND meet the definition of a clinical trial as 
defined below:   
Clinical Trial:  A research study in which one or more human subjects are 
prospectively assigned to one or more interventions (which may include 
placebo or other control) to evaluate the effects of those intervention on 
health-related biomedical or behavioral outcomes.  This definition 
encompasses phase 1 trials of FDA-regulated drug and biological products, 
small feasibility studies of FDA-regulated device products, and studies of any 
intervention not regulated by the FDA, e.g. behavioral interventions. 
Of note, this requirement for GCP training applies to both biomedical and 
behavioral clinical trials funded by the NIH. 
 On January 1, 2017, a new policy of the National Institutes of Health (NIH) 
goes into effect that requires all NIH-funded investigators and staff who are 
involved in the conduct, oversight, or management of clinical trials to be 
trained in Good Clinical Practice (GCP). 
The policy applies to all active grants and contracts, no matter what point they 
are in the life cycle of the trial.   
Currently, there is a GCP course available in our CITI training program 
(https://www.citiprogram.org/).  This current course does have a focus on 
FDA-regulated research.  Please note that online social-behavioral GCP 
courses are under development and we expect to have a social-behavioral 
focused GCP course available in the near future.   
If this study meets the definition, all staff must complete GCP training. 
For more information on this policy please refer to: 
• NIH definition of a Clinical Trial: 
http://osp.od.nih.gov/sites/default/files/NIH%20Definition%20of%20
Clinical%20Trial%2010-23-2014-UPDATED_0.pdf 
• Policy on Good Clinical Practice Training for NIH Awardees 
Involved in NIH-funded Clinical Trials:  
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-148.html 

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Version:  November, 2017 
• Frequently Asked Questions:  
http://osp.od.nih.gov/sites/default/files/FAQs_on_NIH_GCP_Policy.p
df 
 
 
SECTION F:  LOCATION OF THE RESEARCH 
 
YES* 
NO 
 
 
 
Will this research take place at sites/locations other than Boston University? 
Note:  If the research will take place at Boston University, state the location 
(Building and Room number): 
 
*If YES, please complete the boxes below 
 
NOTE:  You are responsible for obtaining permission/letters of support for research conducted 
off-site.  This may include locations such as schools, workplaces, community organizations, etc.  
You must submit the letters/documentation of support with this application. 
 
Institution Name and 
Address (if known) 
Describe Involvement 
(recruiting, consenting, data 
analysis, etc.) of the site.  If the 
site or the site staff is not 
involved (engaged)1 in research 
procedures, state NONE. 
IRB/Ethics Approval/Site 
Permission Attached?  If 
no2, explain the plan to 
obtain this approval.  If the 
site is not engaged in the 
research, you do not need to 
complete the box. 
San Francisco State 
University, 1600 Holloway 
Ave, San Francisco, CA 
94132 
Researcher at SFSU will be 
involved with recruiting, 
consenting, and collecting data. 
No (A cede review form as 
been submitted to indicate 
that BU will be the IRB of 
record.) 
 
 
 
1Guidance on Engagement of Institutions in Human Subjects Research: 
http://www.hhs.gov/ohrp/regulations-and-policy/guidance/guidance-on-engagement-of-
institutions/index.html 
 
 
2If IRB approval will not be obtained at the site, describe the IRB oversight arrangements here:  
 
 
 
 
YES* 
NO 
 
 
 
Is the off-site location requesting that the Boston University IRB review the 
protocol in place of local IRB review? 

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Version:  November, 2017 
*If YES, complete the Single IRB Review Form “Boston University is 
Institution A”: http://www.bu.edu/researchsupport/compliance/human-
subjects/.  
 
 
YES* 
NO 
 
 
 
Is the BU PI the lead investigator OR is BU the lead site for this research? 
Note:  This box only needs to be completed if the off-site location is 
engaged in the research. 
*If YES, provide the following information in this box:  
• The plan for collection and management of data from all the sites: 
After consent, data from pilot testing will be collected and recorded at both locations. This 
data will be de-identified before being shared between locations. Procedures for ensuring 
confidentiality at both sites include training of all study staff and regular meetings among 
Investigative team, including regular review of procedures. Steps to ensure confidentiality 
include: confidentiality training for all new employees and refresher seminars annually for all 
clinical referrers; identifying subjects by an arbitrary number; filing ID number key lists 
separately from data; removing or obscuring participant names from any forms; using an 
acronym in return addresses on any correspondence to participants; sorting all data in locked 
file cabinets; securing all computers that store data; and destroying audio files used for 
interviewer reliability checks and fidelity ratings at the end of the project. All research staff 
will fulfill the educational requirements set forth by NIMH and the Office for Human 
Research Protections. 
• The plan for reporting and evaluating: 
o Unanticipated problems 
o Serious and/or continuing non-compliance 
o Suspensions and terminations of research 
o Interim results 
o Protocol modifications 
Any of the above occurrences will be immediately reported to the PI and proper steps will be 
taken for evaluation. 
 
• The name of the Principal Investigator from each site  
Daniel Fulford (BU), David Gard (SFSU) 
 
• If IRB approval will be obtained at the site, confirmation that you have a copy (or will 
obtain a copy) of the IRB approval letters and the IRB-approved protocols from each 
site  
• If IRB approval will be obtained at the site, confirmation that the site IRB has a 
federalwide assurance (FWA)  

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Version:  November, 2017 
 
 
YES* 
NO 
 
 
 
Will this research be conducted outside of the United States?* 
 
*If YES, complete the International Research Form at 
http://www.bu.edu/researchsupport/compliance/human-subjects/ 
 
 
SECTION G:  STUDY SUMMARY 
 
Summarize the study in lay language (do not copy from the grant/scope of work/proposal, 
etc.).  This summary should include the research design, purpose, objectives, research 
question, hypothesis, and any relevant background information.   
 
Note:  Do not include a list of citations in this section.  Please limit this section to no more 
than 300 words. 
 
Schizophrenia is a severe mental illness that affects millions of people worldwide. The illness is 
often associated with social impairments, including limitations in verbal and non-verbal 
behavior, initiating conversations, and social motivation. People with schizophrenia often report 
a desire to socialize but expend less effort in the actual behavior and set fewer socially-related 
goals than others. While diminished social motivation is not fully understood, past research 
suggests a reduced ability to connect past, pleasurable experiences with current states, resulting 
in reduced effort for social connection in people with schizophrenia. Because this reduced effort 
for social connection may cause people with schizophrenia to have difficulty obtaining 
relationships they desire, it is important to focus on factors that are modifiable, such as social 
skills and motivational deficits. Interventions that target these impairments usually take place at 
mental health clinics, but there is a growing recognition that people with schizophrenia need 
assistance with these skills outside of a clinical setting.  
 
Findings from an ongoing study (i.e., Aims 1 and 2 of the larger grant; (NIMH# R21MH111501-
01, IRB protocol #4394) will inform development of a pilot intervention study examining the 
impact of this mobile application on social functioning over time. We will employ a two-site 
study to test the application in a group of 30 persons with schizophrenia over a 60-day period. 
We will measure social functioning at baseline, intervention termination, and 90-day follow-up 
using clinician administered interviews and self-report questionnaires.  We hypothesize that 
levels of social functioning will increase significantly from baseline to post-intervention and 
follow-up, and that these increases will be accompanied by increased self-reported social 
motivation using periodic measures incorporated into the mobile application.   
 
 
 

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Version:  November, 2017 
SECTION H:  RESEARCH METHODS AND ACTIVITIES (Check all that 
apply) 
 
 
Collection of audio, video, digital, or image recordings 
 
Biological samples ® Complete Biological Samples Form: 
http://www.bu.edu/researchsupport/compliance/human-subjects/ 
Examples:  blood, hair, cheek swab, urine, tears, saliva, etc. 
 
Collection of data that may be sensitive and if disclosed could put subjects at risk for 
legal or social harms. 
Examples:  Illegal behaviors, HIV status, psychiatric illness, information related to 
sexual behaviors, etc. 
 
Coordinating Center/Lead Site 
 
Deception 
 
Devices ® Complete Devices Form: 
http://www.bu.edu/researchsupport/compliance/human-subjects/ 
 
 
Drugs ® Complete Drugs Form: 
http://www.bu.edu/researchsupport/compliance/human-subjects/ 
 
 
Ethnographic: 
The study of people in their own environment through the use of methods such as 
participant observation and face-to-face interviewing 
 
Focus Groups 
 
Genetics Testing ® Complete Genetics Form: 
http://www.bu.edu/researchsupport/compliance/human-subjects/ 
 
MRI 
 
Placebo 
 
Pregnancy Testing 
 
Randomization 
 
Surveys, interviews, questionnaires 
 
Secondary Data Analysis 
 
Other (please describe): Behavioral task (Stop Distance Paradigm) 

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Version:  November, 2017 
 
SECTION I:  SUBJECT POPULATION 
 
Number of Subjects to be Enrolled: 
 
If you have sub-groups or more than one arm, please separate 
out these enrollment numbers. 
 
Note:  Please account for subjects who may drop out or 
be withdrawn from the study.  Any subject who signs a 
consent form is considered to be enrolled regardless of 
whether they complete any study procedures 
50 people with schizophrenia 
or schizoaffective disorder 
 
 
Check all categories that apply to your target population: 
 
 
Adults 
 
 
Children (< 18 years of age) 
 
Cognitively-Impaired Adults 
 
Non-English Speaking 
 
Prisoners 
 
BU Employees 
 
BU Students 
 
Wards of the state 
 
Other (please describe): 
 
If Categories other than ‘Adult’ are checked, describe the additional safeguards that 
have been put in place to protect that subject population.  For Cognitively-Impaired 
Subjects, provide the rationale for including this population in this research study. 
 
 
 
 
 

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Version:  November, 2017 
 
Eligibility Criteria 
Inclusion Criteria:  
 
 
All participants with schizophrenia or schizoaffective disorder (identified either by chart 
diagnosis or by using the Structured Clinical Interview for DSM-5 [SCID-5]), between 18 and 
65 years old (as to not confound developmental issues with our focus), and fluent in English.  
 
Exclusion Criteria (exclusion criteria are the specific criteria which would disqualify an 
individual from participating in the study not simply the opposite of the inclusion criteria):  
 
We will exclude participants with a current (past 6 months) substance use disorder, which will 
be determined by administration of the SCID-5, self-reported current suicidal ideation with 
intent and/or a plan (assessed using attached instrument; i.e., “High” risk), or self-reported 
diagnosis of a current/ongoing neurological disorder (i.e. not managed with medication). We 
will exclude participants who have been hospitalized in the past month for mental health 
reasons or for life threatening physical conditions (such as stroke or heart attack). Potential 
participants who have a guardian and cannot sign consent independently will be excluded.   
 
 
 
 
SECTION J:  RECRUITMENT 
 
Provide a summary of the recruitment process, including who will recruit, when and 
where recruitment will occur, and how subjects will be identified 
 
Note:  Submit any recruitment materials such as advertisements, brochures, flyers, 
letters/e-mails, scripts, etc.  Please submit these materials as separate documents in 
either Word or PDF format. 
 
Participants with schizophrenia or schizoaffective disorder will be outpatients recruited from 
clinics within the Boston and San Francisco community, including the BU Center for 
Psychiatric Rehabilitation (CPR). Flyers will be posted throughout the CPR and around the 
community as well. The investigators have extensive contacts in this community. Potentially 
eligible consumers will also be identified through informing clinicians and recovery center 
instructors at each site about the study and eligibility criteria for participation. We will provide 
clinicians with study flyers.  We will also verbally brief all partnering clinicians on the overall 
study aims and goals.  They will have access to the consent form for review Referrals to the 
study will be made by either consumers’ providers or by recovery center instructors (at CPR). 
When a referral is made, the consumer’s provider/instructor will meet with the consumer to 
briefly explain the project. If the consumer is potentially interested in participating in the 
project, the referrer will arrange for the consumer to contact the Project Coordinator by phone 
or in person, who will ask the screening questions (see attached phone screen form). Eligible 
consumers who express interest in participating in the study and are able to correctly answer 
questions about the project (demonstrating their comprehension) will attend an in-person 

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Version:  November, 2017 
meting to provide signed informed consent. For those participants recruited from CPR, 
diagnostic information will be obtained by self-report, and substance use disorder will be 
assessed by SCID-5.  For participants from outside the CPR interested in the study, we will 
confirm diagnosis and substance use disorder using the SCID-5.  Consumers who complete 
the SCID-5 will be paid $10, regardless of whether they meet additional eligibility criteria 
(i.e., diagnosis). The SCID-5 will be administered by trained research staff.  Consumers who 
do not meet eligibility criteria will be informed of this. 
 
 
 
SECTION K:  CONSENT AND ASSENT 
 
NOTE:   Please refer to the consent and assent form templates on the IRB website when creating 
your consent/assent documents.  The templates include the required elements of consent and will 
help to ensure that your consent/assent form meets the requirements of the federal regulations 
and the BU CRC IRB.  The consent templates can be located at:  
http://www.bu.edu/researchsupport/compliance/human-subjects/. 
 
Note:  STUDENT RESEARCHERS must: 1) indicate in the consent form/information 
sheet/script that he/she is a student and 2) list the Faculty Advisor as a contact in the 
form/sheet/script. 
 
 
Provide a summary of the consent process, including who will consent, and when and 
where consent will occur.  The summary should include, as appropriate, any waiting 
period between informing the prospective participant and obtaining consent,  that the 
prospective participant or the legally authorized representative has sufficient 
opportunity to consider whether to participate, and steps taken to minimize coercion or 
undue influence. 
 
Note:  Submit copies of all consent forms and scripts.   Please submit these materials as 
separate documents in Word format. 
 
Written consent will be obtained for all study procedures. Those with a guardian who cannot 
independently consent will be excluded from the study. All consent forms will be provided by 
trained researchers. Written consent will be provided prior to participation in the study, and 
participants will have as much time as they would like to consider whether they will 
participate. There is no time limit for making a decision about whether to participate. 
Consenting will take place in private areas at Boston University’s Center for Psychiatric 
Rehabilitation or the PIs’ laboratories.  
 
Prior to the study the researcher/interviewer will ask the person if they could explain what 
their understanding is of the study they are being asked to be involved in. In addition to 
allowing time for participants to read the consent form, the specific contents of the consent 
form will be discussed with each participant, and any questions will be answered. Participants 

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must be fluent in English to participate in this study. The participants will receive a copy of 
the informed consent form with the primary researcher’s contact information.  
 
All consent forms are attached to this application.    
 
 
 
Indicate the consent and/or assent process and document(s) to be used in this study.  Check 
all that apply 
 
Consent:  Adults (>18 years of age)                                      N/A  
 
One of the following MUST apply 
 
Consent Form/Information Sheet 
 
 
 
Verbal Consent (Script) 
 
Note:  If written consent will not be obtained, complete the ‘Waiver of Written 
Documentation Consent’ box (Box 1) located further down in this section 
 
Consent will not be obtained 
 
Note:  If consent will not be obtained, complete the ‘Waiver or Alteration of 
Consent’ box (Box 2) located further down in this section 
 
 
 
Assent of Children (< 18 years of age)                                      N/A  
 
One of the following MUST apply 
 
Assent Form OR Parent Consent Form/Information Sheet (older children may sign the 
parent consent form along with their parents as long as the consent form is written at 
the grade level of the subjects) 
 
 
 
Verbal Assent (Script) 
 
Assent will not be obtained 
 
If assent will not be obtained, one of the following conditions must exist:    
 
1.  The capability of some or all of the children is so limited that they cannot 
reasonably be consulted  
 
2.  The children are  too young to provide assent 

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3.  The intervention or procedure involved in the research holds out the prospect of 
direct benefit to the health or well-being of the children and is available only in the 
context of the research   
 
4.  The research meets the same conditions as those for waiver or alteration of 
informed consent in research involving adults, as specified in the regulations at 45 
CFR 46.116(d)*.   (Complete the ‘Waiver or Alteration of Consent’ box (Box 2) 
located further down in this section) 
 
*45 CFR 46.116(d): 
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html 
 
 
 
Guidance on age requirements for obtaining assent: 
• Parental Permission for minors under 6 years of age 
• Verbal assent for minors 6-11 years of age  
• Written assent from minors ages 12-17 (unless verbal consent is approved for the 
parents/adult subjects 
 
 
 
 
 
Parental Permission                                                                     N/A  
 
One of the following MUST apply 
 
Parental Consent Form 
 
 
 
Parental Verbal Consent (Script) 
 
Note:  If written consent will not be obtained, complete the ‘Waiver of Written 
Documentation of Consent’ box (Box 1) located further down in this section 
 
Parental permission will not be obtained 
 
If parental permission will not be obtained, one of the following conditions must 
exist: 
 
1.  The research protocol is designed to study conditions in children or a 
subject population for which parental or guardian permission is not a 
reasonable requirement to protect the subjects (for example, neglected or 
abused children). 
 

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2.  The research meets the same conditions as those for waiver or alteration of 
informed consent in research involving adults, as specified in the regulations at 
45 CFR 46.116(d)*.  (Complete the ‘Waiver or Alteration of Consent’ box 
(Box 2) located further down in this section) 
 
 
*45 CFR 46.116(d): 
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html 
 
 
Consent:  Cognitively Impaired Adults (>18 years of age)                  N/A  
 
Describe the process for the consent and/or assent process for enrolling cognitively 
impaired adult subjects including how capacity to consent is determined and if there is 
continual assessment of capacity 
 
 
 
Assent will be obtained from: 
 All Subjects 
 Some Subjects, specify: 
 No Subjects 
 
 
Consent will be obtained from the subject’s Legally Authorized Representative 
(REQUIRED) 
 
CONSENT OF NON-ENGLISH SPEAKING SUBJECTS                            N/A                    
 
Describe the process for obtaining consent from non-English speaking subjects.  List the 
individual who will serve as the interpreter and his/her qualifications. 
 
NOTE:  A copy of the translated consent along with the Attestation Form for Translation 
of Consent must be submitted.  The Attestation Form can be located at: 
http://www.bu.edu/researchsupport/compliance/human-subjects/. 
 
 
 
 
 
 
BOX 1—WAIVER OF WRITTEN DOCUMENTATION OF CONSENT 
 

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WAIVER OF WRITTEN DOCUMENTATION OF CONSENT   N/A       
    
Either Criteria 1 or 2 must be met in order to qualify                  
Yes 
No 
 
 
 
  Criteria 1 
The research is NOT FDA Regulated 
 
 
 
The only record linking the subject and the research would be the consent 
document 
 
 
The principal risk would be potential harm resulting from a breach of 
confidentiality 
 
 
Each subject will be asked whether the subject wants documentation linking 
the subject to the research and the subject’s wishes will govern 
 
 
A written statement/information sheet will be provided to subjects.  If NO, 
provide rationale for not providing this information 
 
 
 
  Criteria 2 
The research is NOT FDA Regulated 
 
 
The research presents no more than minimal risk of harm to subjects 
 
 
The research involves no procedures for which written consent is normally 
required outside of the research context 
 
 
A written statement/information sheet will be provided to subjects.  If NO, 
provide rationale for not providing this information 
 
 
 
 
 
 
BOX 2—WAIVE OR ALTERATION OF CONSENT 
 
WAIVER OR ALTERATION OF CONSENT                    N/A                    
 
All of the criteria below must be met in order to qualify 
Yes 
No 
 
 
The research is NOT FDA Regulated  
 
 
The research involves no more than minimal risk to the subjects 
 
 
The waiver or alteration will not adversely affect the rights and welfare of the 
subjects 
 
 
 
The research could not practicably be carried out without the waiver or 
alteration 
 
 
Whenever appropriate, the subjects will be provided with additional pertinent 
information after participation.  If NO, provide rationale for not providing this 
information: 
 
 

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Provide the justification/rationale for why this study meets the above criteria for waiving 
or altering consent (REQUIRED): 
 
 
 
 
SECTION L:  STUDY PROCEDURES 
 
In the box below provide a detailed description of the study procedures to be performed 
(preferably in sequential order).  Be sure to specify which procedures are for research 
purposes versus which procedures are part of standard of care, if applicable.    Be sure to 
include the following information: 
 
• Methods of data collection  
• Details regarding research activities/procedures/interventions 
• Number, frequency, duration and types of subject contacts (visits, phone calls, 
internet surveys, mailings, etc.) 
• Time required from each subject 
• Use of equipment (eye-tracker, treadmill, sensors, etc.).  Provide a brief description 
of equipment that will be used in the study.* 
  
*Note:  The IRB may request more information about the equipment (including equipment 
manuals) and/or request that you submit Appendix C: Device Form. 
 
Submit copies of all surveys, interview questions, assessments, screening scripts, etc. that 
will be used during the conduct of this study.  Please submit these materials as separate 
documents in either Word or PDF format. 
 
Note:  If subjects will have standard of care procedures in addition to research procedures, 
clearly state which procedures are standard of care and which are for research purposes 
only. 
 
 
Note: The procedures below include only Phase II of this research study. This will include a 
pilot intervention trial of the mobile support tool developed in Phase 1: the Motivation and Skills 
Support (MASS) application (IRB Protocol #4394).   
 
The MASS Application 
 
The MASS application includes 1) the identification of a social goal from a list of prototypes 
(e.g., develop a friendship with someone at school), 2) twice daily reminders of the selected 
social goal and associated steps/subgoals, 3) assessment of progress on the selected social goal 
and associated affect, and 4) social skills training video displays.  All of these features are 
delivered via notifications from the app.  In addition, the app gathers geo-location (i.e., GPS) 
data that is triangulated with self-reported activity as a proxy for goal-striving.  In Phase 1, we 
ran focus groups with consumers and individual interviews with expert clinicians with the aim of 

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identifying meaningful social goals and use of mobile phones in this population.  Qualitative 
feedback informed app development.  We are currently conducting usability testing in a small 
group of consumers over 2-week periods of use of our MASS application.  Consumers provide 
feedback in individual interviews following app use to help improve app features.  All 
procedures in the current study are for research purposes, and not related to standard of care.   
 
Phase II: Pilot Testing of the MASS Application 
 
Following our current usability testing (anticipated completion: August 2018), we will employ a 
two-site study to test the MASS application in a total of 30 persons (we will recruit up to 50 
people to account for attrition, ending up with complete data on 15 persons per site) with 
schizophrenia or schizoaffective disorder over a 60-day period. We will measure social 
functioning at baseline, intervention termination, and 90-day post-intervention follow-up using 
the Social Functioning Scale (SFS) and the Quality of Life Scale (QLS).  Social cognition and 
preference for personal space will be measured with the Stop Distance Paradigm. We will also 
measure symptoms and cognitive function with the Brief Psychiatric Rating Scale (BPRS) or the 
Wide Range Achievement Test (WRAT), the Clinical Assessment Interview for Negative 
Symptoms (CAINS), Penn Emotion Recognition Task (ER-40) and the Brief Assessment of 
Cognition Schizophrenia (BACS). Self-report measures to assess theory of motivation and social 
skills will also be administered. Self-report measures and the ER-40 will be administered 
through Qualtrics. Demographic information will be collected through a custom questionnaire 
and the Structured Clinical Interview for DSM-5 [SCID-5]). Participant satisfaction 
questionnaire will also be administered at termination and a subset of the satisfaction questions 
will be administered at follow up.  
 
Procedures 
 
Baseline Assessment. After providing informed consent, participants will complete diagnostic 
and clinical evaluations at the Center for Psychiatric Rehabilitation or in the Fulford or Gard 
laboratories. The assessment procedures will involve a total of 4 hours for the completion of 
clinical interviews, demographics questionnaires, cognitive/behavioral tests, and community 
functioning measures, conducted over 1-2 days as needed by participants. At the conclusion of 
the assessment, the participant will be issued a mobile phone and trained on its use. They will 
identify a social goal and work with study staff to lay out sub-goals and steps necessary to 
achieve them—this goal will be programmed into the mobile app based on a pre-defined set of 
available goal prototypes. Participants will be oriented to all application components during this 
visit. They will also be given instructions to watch the social skill video clips within the app.  
 
Mobile Intervention. Research assistants will call participants the day after the initial meeting 
and will provide instruction on watching 4 brief summaries of the social skills training video 
clips (each video summary is approximately 10 minutes in length). They will then be called 1-2 
days later to check in on video watching and will be instructed to watch the second video 
summary. 1-2 days later they will receive another call to again check in and will be instructed to 
watch the final summary. Call frequency will be based on participant preference. We will also 
provide follow up calls based on adherence to EMA reports (ascertained by logging onto the 
mobile app’s researcher portal online) throughout the course of the 60-day intervention trial. 

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Participants will always have the option of calling our laboratory to discuss any issues with the 
phone or mobile intervention.   
     Use of the MASS application over the 2-month intervention period will involve interaction 
with social goal-related content based on pre-programmed notifications that alert the participant 
2 times per day, 7 days per week.  These notifications involve reminders of the identified social 
goal and associated steps—once in the morning and once in the evening. All notifications expire 
after a period of one hour.   
     If the phone is lost, that we will do whatever we can to replace the phone.  If the phone 
cannot be replaced (e.g., due to budget availability), we will notify the consumer that their study 
participation will be discontinued.  Data collected up to the point of the phone being lost will be 
used for analysis.   
 
Follow-Up Assessments. Participants will return again after the 60-day intervention period for a 
2-hour follow-up session to complete outcome measures.  They will again complete an in-person 
assessment 90 days following intervention termination. Audio and video recordings of 
participants may also be collected during interviews and assessments for training purposes and 
to verify records collected during the study. Recordings will be kept for 7 years per Boston 
University (BU) Record Retention Policy. 
 
 
 
Some participants may endorse distress during interview-based and self-report measures.  For 
example, the BPRS asks questions around suicidal ideation. To clarify any potential risk 
reported using these measures, immediately following completion of these measures the 
researcher will follow up with any participants reporting on any suicidal ideation.  They will ask 
the participant a series of follow up questions to better understand the general level of risk (see 
attached SI Follow-up Script). For those participants in which there is any concern of current 
suicidal ideation, as indicated by the follow up questions, the research assistant will notify one 
of the study staff clinical psychologists by cellular phone (a clinical psychologist will always be 
available by phone during all study sessions).   
 
The clinical team member on call will then perform a standard risk assessment with the 
participant, guided by the Suicidal Ideation Follow Up Script document. In this situation, the 
clinician will provide recommendations/referrals for mental health services for those deemed at 
any level of risk of suicide. In addition, the clinician will counsel the subject on the benefits of 
seeking help (i.e., with a therapist or other professional). For those expressing suicidal ideation 
with a plan and/or intent (as indicated by responses to the standard follow up questions), the 
clinician will follow standard protocol by assessing risk for immediate harm to self.  If harm is 
immediate, the clinical team member will request to contact the subject’s treatment provider.  
Should no treatment provider be available, the research assistant will arrange for transportation 
to the relevant clinic (i.e., emergency room) with the subject’s confidant (e.g., therapist, friend, 
loved one). If the participant is unwilling/able to do this, the clinician will call 911 to have the 
participant escorted to an emergency room. For those participants for whom there is not 
considered to be a risk of suicide, study staff will provide the participant with information 
regarding local mental health clinics (i.e., contact information for local community mental health 
centers; these materials are located in the PI’s lab and readily available for distribution). In 

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addition, the researcher will counsel the subject regarding the benefits of seeking help from a 
therapist or other provider. 
 
Measures 
 
Name 
Domain 
Time Point 
Social Functioning Scale (SFS) 
Social Functioning 
B, T, F 
Quality of Life Scale (QLS) 
Social Functioning 
B, T, F 
Brief Psychiatric Rating Scale 
(BPRS) 
Psychiatric Symptoms 
B, T, F 
Clinical Assessment Interview for 
Negative Symptoms (CAINS) 
Psychiatric Symptoms 
B, T, F 
Stop Distance Paradigm   
Social Cognition 
B, T, F 
Penn Emotion Recognition Task 
(ER-40) 
Social Cognition 
B 
Brief Assessment of Cognition 
Schizophrenia (BACS) 
Neurocognition 
B 
Wide Range Achievement Test 
(WRAT) 
Neurocognition 
F 
Self-reports:  Implicit Theory of 
Motivation (TOM), Implicit 
Theory of Social Skills (TOSS) 
 
Social Cognition  
B 
Self-Reports: Birchwood Social 
Functioning Scale 
Social Functioning 
B, T, F 
Satisfaction Questionnaire.  
N/A 
T, F 
Demographics 
N/A 
B 
*B = Baseline; T = Termination; F = Follow-up 
 
Analyses 
 
Primary analyses will examine changes in social functioning across the study period using 
multivariate models accounting for covariates of interest (e.g., demographics, cognition). This 
mobile application is both an intervention and assessment tool. Thus, during the intervention we 
will be able to measure additional targets of interest, social motivation and functioning, using the 
EMA reports of positive affect in anticipation of social interactions, as well as reports of actual 
engagement in interactions, throughout the intervention period.  
 
This study is a within-subject experimental design. Consistent with an experimental therapeutics 
approach, our primary goal is to identify change within the treatment targets (social anticipatory 
pleasure and presence of social interaction). Accounting for up to 20% attrition, we aim to 
recruit 50 participants, allowing for 20 participants to drop out/not meet criteria and still leave 
adequate power for primary analyses. Our primary aims are to pilot test the intervention to 
determine feasibility and efficacy in the treatment targets (social skills and motivation) and 
outcome (social functioning). 
 

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SECTION M:  RISKS 
 
Describe any expected risks to subjects.  Consider physical, psychological, social, political, 
legal, economic, or other risks that are related to the study.   
 
There are some risks associated with participation in the study. The primary risks involve loss of 
confidentiality associated with pilot testing of the mobile application. It is also possible that 
some participants may feel some frustration when participating in the MASS application.  
Participants may also feel discomfort answering questions about their health in the clinical 
assessments.   
 
Describe the plan to minimize risks.  Include in the description the availability of any 
medical or psychological resources.  
 
Research staff will receive guidelines and supervision about how to respond to consumers’ 
distress that may arise (albeit rarely) during the pilot testing (during phone or in-person check-
ins). A number of options are available for dealing with such distress, including discussing the 
distress with the consumer, practicing a relaxation exercise (e.g., relaxed breathing), taking a 
break from app use, evaluating the cause of the distress and addressing it, or meeting with their 
clinician. These strategies have proved useful for our active mobile assessment and intervention 
studies. 
To address possible discomfort that might arise during interviews, all consumers will be 
informed that information obtained during assessments is confidential and that they can choose 
not to answer certain questions if they prefer not to. If consumers feel uncomfortable they will 
be encouraged to take a break and continue the assessment later, or will be offered to stop the 
interview. The research interviewer may also offer to call the consumer’s case manager, another 
staff member, or concerned others (such as a close friend) to make sure the consumer has 
someone to talk to about the assessment. In our prior research on consumers over the past 
several decades, few consumers have expressed discomfort from participating in interviews and 
assessments. In regards to interviews, we will remind all participants before and during the 
sessions that all information shared in these sessions should be held in the strictest confidence.   
Participants will be clearly informed that they may choose not to participate in any of the tasks 
should they experience any discomfort at any time. If a participant chooses to discontinue 
participation at any time, he or she will still receive payment for his or her participation. 
Participants will have the option to turn off the app at any time—they will be informed of this 
option verbally and on the consent form, and shown how to do it prior to initiating the study. 

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SECTION N:  BENEFITS 
 
Describe the potential benefits to subjects related to the study.  State if there are no direct 
benefits. 
 
NOTE:  Compensation and/or course credit are not considered benefits. 
 
There are no known direct benefits related to participation in the study. 
 
Describe the potential benefits to society and/or others related to the study 
 
 
Innovations stemming from this study may help future patients with schizophrenia in coping and 
improving deficits in social functioning. The benefits of this study outweigh the minimal risks of 
psychological discomfort and/or minimal risks of loss of confidentiality. Given possibility of 
only minimal risks, combined with the prospect of improving key aspects of social functioning, 
this study results in a favorable risk/benefit analysis. 
 
 
SECTION O:  COSTS/PAYMENTS 
 
YES* 
NO 
 
 
 
Are there any costs to subjects as a result of participating in this study?  
*If YES, provide a description of the costs: 
 
 
Will subjects be compensated for participating in the study?  Compensation 
may include cash, checks, gift cards, lotteries, course credit, etc. 
*If YES, provide a description of the compensation:  
Those involved in the pilot testing will be paid $15 per hour for the baseline 
assessment (4 hours total), $50 for completing the 60-day mobile intervention, 
and $15 per hour (2 hours) for completing the follow-up assessments. We will 
also give them the mobile phone used during the study to keep.  In addition, 
those who complete the SCID-5 as a screening procedure will be paid $10. 
The $15 per hour rate begins after screening procedures.  
NOTE:  Payments should be prorated to compensate subjects for time and 
procedures completed 

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Will identifiable information be sent to Central University departments 
(Accounts Payable, Post Award Financial Operations, etc.) for payment 
purposes? 
*If YES, this information must be disclosed in the consent form. 
 
 
 
SECTION P:  CONFIDENTIALITY OF DATA 
Describe how data will be stored (e.g. paper, electronic database, etc.) 
 
 
All study staff will be trained on the protection of confidentiality of data at regular project 
meetings. Steps to ensure confidentiality include: confidentiality training for all new employees 
and refresher seminars annually for all clinical referrers; identifying subjects by an arbitrary 
number; filing ID number key lists separately from data; removing or obscuring participant 
names from any forms; using an acronym in return addresses on any correspondence to 
participants; sorting all data in locked file cabinets; securing all computers that store data; and 
destroying audio files used for interviewers at the end of the project.  All data gathered on 
mobile devices is encrypted using industry standard techniques. In the event that the phone is 
lost or stolen, the data is protected. Data is stored in an encrypted format in a directory on the 
phone allocated by operating system for this purpose. Data from this directory is periodically 
uploaded to the server in its encrypted format. Even if the phone were hacked, and the upload 
redirected to another server, the data would be useless to the hacker without the key, stored 
separately on a secure server. Once on the secure server, the data is decrypted, parsed, and 
inserted into an internal server. As soon as the data is successfully uploaded to the servers, 
uploaded data is validated, and then the data is wiped from the phones. All collected data will be 
de-identified before being shared between research sites. All research staff will fulfill the 
educational requirements set forth by NIMH and the Office for Human Research Protections. 
 
 
Per Boston University (BU) Record Retention Policy, records concerning human subjects must 
be retained for 7 years.  Please refer to the policy at: http://www.bu.edu/policies/finance/record-
retention/.  As the investigator, you must also adhere to all applicable requirements as defined by 
regulatory agencies (e.g. FDA, etc.) or Sponsors. 
 
 
YES* 
NO 
 
 
 
Will you collect identifiable information? (e.g. names, social security 
numbers, addresses, telephone numbers, etc.) 
*If YES, complete the box below 

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Describe the coding system* that will be used to protect the information including who 
will have access to the code   
*Coding system:  Coding systems are used to: 1) protect the confidentiality of the 
research data and 2) allow the investigator to link subjects to their responses.    Each 
subject is assigned a unique study ID at the beginning of the study.  A separate document 
(key) should be maintained that links the names of the subjects to the study ID numbers. 
 
All participants will be assigned a (non-identifying) subject number and all data 
pertaining to that consumer for the study will use that number and no identifying information 
(e.g., name, Social Security number). A record linking the assigned research number and 
consumer identity will be maintained in a locked file by the Project Coordinator at each site, 
which will be accessible only to research staff. 
 
YES* 
NO 
 
 
 
Will you share data with others outside of the study? 
*If YES, complete the box below 
Describe how data will be transferred and how confidentiality will be maintained (e.g. 
identifying information will not be sent outside, etc.) 
 
Quality assurance measures will be utilized for subject recruitment, enrollment, enrollment 
targets, and for the validity and integrity of the data. These will involve standard operating 
procedures to ensure that the study is conducted in compliance with Good Clinical Practice. 
Following each in-person interview/assessment, study staff will ensure no personal 
information is included on any study documents (aside from demographics and informed 
consent), and that all questions are answered (unless the participant refuses to do so). Study 
staff will also regularly check EMA data accuracy (e.g., are reports completed and within the 
expected range?). The data will be generated, documented (recorded), and reported in 
compliance with these standards. 
 
Describe how you will maintain the confidentiality of the data (e.g. locked cabinet, 
password-protected files, encryption, etc.) 
 
Note: Confidentiality refers to the researcher’s agreement with the participant about how 
the subject’s identifiable private information will be handled, managed, and disseminated 
 
For further assistance and/or access to resources regarding information security, please 
refer to the BU Information Security website: http://www.bu.edu/tech/security/  
 

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All paper-based information collected during the research will be kept in a locked in a secure file 
cabinet under the PI and Co-I’s supervision. The key to code of names of individual participants 
will be kept in a separate, locked file. Only the PI, Co-I, and associates (collaborating 
researchers and research assistants) involved with the study will have access to the data. All 
participants will have the option to exclude any of their other data from the study. In regards to 
audio/video recordings captured during interviews, all recordings will be saved on password-
protected study computers.  These files will be encrypted for transfer to a professional 
transcription service.  No identifiable information will be included in these transcripts.   
 
 
 
SECTION Q:  CERTIFICATE OF CONFIDENTIALITY 
 
 
Complete this box if the study is UNFUNDED or  FUNDED by any entity (e.g 
department, foundation, NSF, or other federal agencies) other than the NIH 
 
On October 1, 2017 the NIH updated its policy for issuing Certificates of Confidentiality.  
The updated policy is located at:  https://grants.nih.gov/grants/guide/notice-files/NOT-
OD-17-109.html 
 
Additional information regarding the policy can be found on the NIH FAQ’s website at: 
https://humansubjects.nih.gov/coc/faqs.  Note:  Sections C and D describe the process for 
obtaining a Certificate for studies not funded by NIH 
 
 
YES 
NO 
 
 
 
Will you obtain a Certificate of Confidentiality? 
The NIH has updated the required consent form language.  The language is at 
the following website:  https://humansubjects.nih.gov/coc/suggested-consent-
language.  Note:  A consent form with the applicable language must be 
included with this submission. 
 
Certificates of Confidentiality are issued by the National Institutes of Health 
(NIH).   A Certificate of Confidentiality (Certificate) protects the privacy of 
research participants enrolled in biomedical, behavioral, clinical or other 
research. With limited exceptions, researchers may not disclose names or any 
information, documents or biospecimens containing identifiable, sensitive 

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information. The Certificate prohibits disclosure in response to legal demands, 
such as a subpoena.  
 
 
 
 
 
 
 
 
 
 
 
Complete this box if the study is FUNDED by the NIH 
 
On October 1, 2017 the NIH updated its policy for issuing Certificates of Confidentiality.  
The updated policy is located at:  https://grants.nih.gov/grants/guide/notice-files/NOT-
OD-17-109.html 
 
Note:  Under the new policy, the investigator will not need to apply for a Certificate.  All 
eligible research studies that are funded by NIH are automatically issued a certificate 
under the NIH Policy on Certificates of Confidentiality 
 
Additional information regarding the policy can be found on the NIH FAQ’s website at: 
https://humansubjects.nih.gov/coc/faqs 
 
YES 
NO 
 
 
 
Does this study qualify for a Certificate of Confidentiality under the NIH 
Policy or Issuing Certificates of Confidentiality? 
To determine if this study (which is conducted or supported by NIH) qualifies 
for a Certificate of Confidentiality, please answer the following question: 
• Is the activity biomedical, behavioral, clinical, or other research? 
 YES 
 NO 
If the answer to the above question is “NO”, then this study will not be issued 
a Certificate of Confidentiality by the NIH.  If the answer is “YES”, please 
consider the questions below: 
§ Does the research involve Human Subjects as defined by 45 CFR 46? 

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§ Are you collecting or using biospecimens that are identifiable to an 
individual as part of the research? 
§ If collecting or using biospecimens as part of the research, is there a 
small risk that some combination of the biospecimen, a request for the 
biospecimen, and other available data sources could be used to deduce 
the identity of an individual? 
§ Does the research involve the generation of individual level, human 
genomic data? 
If the answer to any one of the four questions above is “YES”, then this NIH 
policy will apply and will be considered to have a Certificate of 
Confidentiality by the NIH. 
If this study is covered under this policy, the consent form must include 
language about the protections and exceptions allowed with the Certificate.  
The NIH has updated the required consent form language.  The language is at 
the following website:  https://humansubjects.nih.gov/coc/suggested-consent-
language.  Note:  A consent form with the applicable language must be 
included with this submission.  
Certificates of Confidentiality are issued by the National Institutes of Health 
(NIH).  A Certificate of Confidentiality (Certificate) protects the privacy of 
research participants enrolled in biomedical, behavioral, clinical or other 
research. With limited exceptions, researchers may not disclose names or any 
information, documents or biospecimens containing identifiable, sensitive 
information. The Certificate prohibits disclosure in response to legal demands, 
such as a subpoena 
 
 
 
 
SECTION R:  PRIVACY 
 
Describe how you will protect the privacy of subjects.  Include the following information: 
location of data storage, who will have access to study information, and location of study 
visits 
 
Note:  Privacy can be defined in terms of having control over the extent, timing, and 
circumstances of sharing oneself (physically, behaviorally, or intellectually) with others 
 
In-person meetings will take place in private rooms either at BU’s Center for Psychiatric 
Rehabilitation or Dr. Fulford’s research laboratory at Sargent College.  All phone calls between 

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study staff and participants will be conducted in the research teams’ private offices and inaudible 
to people not affiliated with the study. Procedures for ensuring compliance with the monitoring 
plan at both sites include training of all study staff on the contents of the document and regular 
meetings among Investigative team, including regular review of the plan. Steps to ensure 
confidentiality include: confidentiality training for all new employees and refresher seminars 
annually for all clinical referrers; identifying subjects by an arbitrary number; filing ID number 
key lists separately from data; removing or obscuring participant names from any forms; using 
an acronym in return addresses on any correspondence to participants; sorting all data in locked 
file cabinets; securing all computers that store data; and destroying audio files used for 
interviewer reliability checks and fidelity ratings at the end of the project. All research staff will 
fulfill the educational requirements set forth by NIMH and the Office for Human Research 
Protections. 
 
 
 
 
SECTION S:  MONITORING STUDY DATA 
 
How will data be monitored?: 
 
Note:  The Data and Safety Monitoring Plan should be tailored to the nature, size, and 
complexity of the research protocol, the expected risks of the research, and the type of 
subject population being studied  
 
 
Principal Investigator 
 
Monitor/Monitoring Group 
 
Data and Safety Monitoring Board (DSMB) 
Note:  The DSMB Charter must be submitted with this Application 
For more information regarding a DSMB, please refer to the following website: 
http://www.nidcr.nih.gov/Research/ToolsforResearchers/Toolkit/DSMBGuidelines.htm  
 
 
Describe the plan for monitoring study data.  This should include a description of how data 
will be collected and analyzed as the project progresses to assure the appropriateness of 
the research, its design, and subject protections. 
 

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Data will be collected until we reach our pre-determined sample sizes.  Analyses will be 
conducted only after all data have been collected (for each phase of the project).  The PI will 
observe data collection during both piloting and during active study recruitment to determine if 
particular tasks and/or procedures are problematic.  If this is the case, modifications will be 
made and the IRB will be notified of such changes. 
 
 
 
SECTION T:  HEALTH INSURANCE PORTABILITY AND 
ACCOUNTABILITY ACT (HIPAA) 
 
YES* 
NO 
 
 
 
Is this research being conducted in a covered entity?  
The following components have been determined to be covered entities on the 
Boston University Charles River Campus: 
• Sargent College Rehabilitation Services 
o Physical Therapy Center at the Ryan Center for Sports 
Medicine and Rehabilitation 
o Sargent Choice Nutrition Center 
• The Danielsen Institute 
• Boston University Health Plan 
 *If YES, contact the IRB office for assistance. 
 
 
 
 
SECTION U:  FAMILY EDUCATIONAL RIGHTS AND PRIVACY ACT 
(FERPA): FERPA is the federal law that protects the privacy of student education records.  
Research funded by the Department of Education or research conducted in educational 
institutions that receive funds from the Department of Education (for research or other purposes) 
must comply with FERPA. 
 
YES* 
NO 
 
 
 
Does this study involve collection of information from student 
school/university records?  
*If YES, refer to the  following websites for guidance on FERPA: 

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• http://www.bu.edu/researchsupport/compliance/human-subjects/ 
• http://www.bu.edu/reg/general-information/ferpa/ 
• http://www2.ed.gov/policy/gen/guid/fpco/ferpa/index.html 
 
If FERPA applies, you must complete the box below: 
In accordance with FERPA, written consent must be obtained to access student records.  The 
consent must:  
• 
Specify the records that may be disclosed 
• 
State the purpose of the disclosure 
• 
Identify the person or class of parties to whom the disclosure can be made 
 
 YES 
(REQUIRED) 
I confirm that I will comply with the FERPA policy that is in place at the 
educational institution where I am conducting my research.  This 
includes, if applicable, the requirements for written agreement when 
requesting a waiver of consent for personally identifiable information.  If 
an agreement is required, this agreement must be submitted to the 
IRB. 
 
 
 
 
SECTION V:  PROTECTION OF PUPIL RIGHTS AMENDMENT (PPRA): 
PPRA is a federal law that affords certain rights to parents of minor students with regard to 
surveys that ask questions of a personal nature.  Research funded by the Department of 
Education or research conducted in educational institutions that receive funds (for research or 
other purposes) from the Department of Education must comply with the PPRA. 
 
YES* 
NO 
 
 
 
Does PPRA apply to this study?  
*If YES, refer to the  following websites for guidance:  
• http://www2.ed.gov/policy/gen/guid/fpco/ppra/index.html 
• http://www.bu.edu/researchsupport/compliance/human-subjects/ 
 
If PPRA applies, you must complete the box below: 

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In accordance with PPRA, written parental consent must be obtained prior to subjects 
participation in the study.  
 
 YES 
(REQUIRED) 
I confirm that I will comply with the PPRA policy that is in place at the 
educational institution where I am conducting my research.   
 
 
 
SECTION W:  CLINICAL TRIALS REGISTRATION: 
The Food Drug and Administration Amendments Act (known as FDAAA 801) requires that 
“applicable clinical trials” be registered and have results reported on clinicaltrials.gov. The 
Responsible Party for a clinical trial must register the trial and submit results information.  In 
addition, the International Committee of Medical Journal Editors (ICJME) and the National 
Institutes of Health (NIH) also have requirements for registration.  Please see box below to 
determine if your study requires registration in accordance with either FDAAA 801, ICJME, or 
NIH. 
 
YES 
NO 
FDAAA 801 Requirements 
 
 
Does your study meet the definition of an applicable clinical trial and require 
registration AND results submission in accordance with FDAAA 801?  
. Applicable Clinical Trials include the following: 
• 
Trials of drugs and biologics: Controlled clinical investigations, other 
than phase 1 clinical investigations, of drugs or biological products 
subject to Food and Drug Administration (FDA) regulation 
• 
Trials of devices (see note): 1) Controlled trials with health outcomes 
of devices subject to FDA regulation, other than small feasibility 
studies, and 2) pediatric postmarket surveillance required by FDA 
The Responsible Party is defined as: 
• 
The sponsor of the clinical trial or  
• 
The principal investigator (PI) of such clinical trial if so designated by 
a sponsor, grantee, contractor, or awardee, so long as the PI is 
responsible for conducting the trial, has access to and control over the 
data from the clinical trial, has the right to publish the results of the 
trial, and has the ability to meet all of FDAAA's requirements for the 
submission of clinical trial information 
Refer to the following website for guidance:  

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• FDAA 801 Requirements: https://clinicaltrials.gov/ct2/manage-
recs/fdaaa 
Note:  If your study meets the requirement for registration and 
reporting, you must submit the National Clinical Trial (NCT) Identifier # 
to the IRB prior to IRB approval. 
NCT #:__________________ 
 
 
YES 
NO 
ICMJE Requirements 
 
 
Does your study meet the definition of a clinical trial and require registration 
in accordance with ICMJE?  
ICMJE definition of clinical trial:  Any research study that prospectively 
assigns human participants or groups of humans to one or more health-related 
interventions to evaluate the effects on health outcomes. Health-related 
interventions include any intervention used to modify a biomedical or health-
related outcome (for example, drugs, surgical procedures, devices, behavioral 
treatments, dietary interventions, and process-of-care changes). Health 
outcomes include any biomedical or health-related measures obtained in 
patients or participants, including pharmacokinetic measures and adverse 
events. Purely observational studies (those in which the assignment of the 
medical intervention is not at the discretion of the investigator) will not 
require registration. 
Refer to the  following websites for guidance:  
• ICMJE Clinical Trials Registration: http://www.icmje.org/about-
icmje/faqs/clinical-trials-registration/ 
 
Note:  If your study meets the requirement for registration, you must 
submit the National Clinical Trial (NCT) Identifier # to the IRB prior to 
IRB approval. 
NCT _03404219___ 
 
 

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YES 
NO 
NIH Requirements 
 
 
Does your study meet the definition of an applicable clinical trial and require 
registration AND results submission in accordance with NIH?  
As of January 18, 2017, NIH is requiring that clinical trials be registered at 
ClinicalTrials.gov.  Confirm whether this study meets the registration 
requirements for clinical trial registration in accordance with the definition of 
a clinical trial as defined by NIH.  See definition below. 
Clinical Trial:  A research study in which one or more human subjects are 
prospectively assigned to one or more interventions (which may include 
placebo or other control) to evaluate the effects of those intervention on 
health-related biomedical or behavioral outcomes”.  This definition 
encompasses phase 1 trials of FDA-regulated drug and biological products, 
small feasibility studies of FDA-regulated device products, and studies of any 
intervention not regulated by the FDA, e.g. behavioral interventions. 
Of note, this requirement for registering and results reporting includes clinical 
trials beyond those already required by the FDA.  The requirements are 
expanded to include to Phase I drug studies and NIH-funded clinical trials of 
social-behavioral interventions.   
For more information on this policy please refer to:   
• NIH Policy on the Dissemination of NIH-Funded Clinical Trial 
Information:  https://s3.amazonaws.com/public-
inspection.federalregister.gov/2016-22379.pdf 
• Checklist:  https://prsinfo.clinicaltrials.gov/ACT_Checklist.pdf 
• NIH Definition of Clinical Trial:  
http://osp.od.nih.gov/sites/default/files/NIH%20Definition%20of%20
Clinical%20Trial%2010-23-2014-UPDATED_0.pdf 
 

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Note:  If your study meets the requirement for registration and 
reporting, you must submit the National Clinical Trial (NCT) Identifier # 
to the IRB prior to IRB approval. 
NCT #:__03404219___ 
 
 
 
 
 
 
Certification / Signatures 
 
 
• By submitting this protocol I attest to the fact that all research activities to be implemented 
related to human subjects have been completely and accurately described herein. 
 
• I agree to conduct the describe research in an ethical manner.  
 
• I agree to comply with all institutional policies and procedures related to human subjects 
research and will not begin any human subjects research activities until I have obtained full 
approval from the IRB. 
 
• I agree to conduct the research as described in this protocol and not to make any changes 
(except to eliminate immediate harm to subjects) without first obtaining approval for the 
changes from the IRB.  
 
• I agree to immediately report any unanticipated problems involving risks to subjects or 
others, any subject complaints, and any incidents of non-compliance with the requirements of 
this protocol as soon as I become aware of them.  
 
• I agree to comply with any relevant HIPAA and FERPA regulations if applicable.  
 
• I verify that all those responsible for the design, conduct, or reporting of the proposed 
program, including at minimum, all Senior/key personnel in the grant application, have 
completed the financial interest disclosure forms and completed training as dictated at 
http://www.bu.edu/orc/coi/forms/, and returned the forms to   the Office for Research 
Compliance COI Unit.  NOTE: If anyone checked “yes” to any of the questions on either 
the FIND1 or NONFIND1 form, the IRB Director will contact the COI office to obtain 
the disclosure information. 
 
PI printed name ___Daniel Fulford, PhD_____ 
 
 

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PI Signature: ___ ______                                          Date: __4/8/2020___ 
 
 
Submission 
This form can be completed, signed, scanned and submitted to the IRB at irb@bu.edu.   Faxed 
documents and handwritten materials are not accepted.   Be sure to include all relevant 
attachments.   
 
FACULTY Research: 
 
The Department Chair signature is required: This application must be signed by the 
Department Chair for all faculty researchers.  If the PI is the Department Chair then signature by 
the appropriate Dean is required. Department Chair signature is not required for student research.  
By signing this form you are indicating that you have reviewed the application, the 
faculty/staff person listed as PI on this protocol is a member of your department, hat he/she 
is qualified to serve as the PI for this study, he/she has the adequate resources, and the 
research utilizes acceptable practice for the discipline. 
 
Department Chair (print name): Wendy Coster 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
Department/School: Occupational Therapy; College of Health & Rehab Sciences: Sargent 
 
 
 
 
 
  
 
 
 
 
 
 
 
              
Signature:  Wendy Coster 
 
 
 
 
 
 
  
  
 
Date: 6/26/18 
 
 
 
 
 
  
 
 
STUDENT Research 
 
Student research: Student research must be signed by the faculty advisor AND the designated 
School IRB pre-reviewer (if applicable) PRIOR TO submission to the IRB.  Students should 
check with their School to determine if School IRB pre-review is required.  Students must submit 
a copy of their dissertation with the IRB Application  
 
By signing this form you are indicating that you have reviewed the application, that you 
agree to serve as the Co-PI for this study with the student and that you will be responsible 
for the ethical conduct of this student’s human subjects research.   
 
Faculty Advisor (print name): 
 
 
 
 
 
  
 

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Signature: 
 
 
 
 
 
 
  
 
 
Date:  
 
 
 
 
  
 
 
 
 
IRB School Reviewer, if applicable (print name): 
 
 
 
 
 
  
 
 
Signature: 
 
 
 
 
 
 
  
 
 
Date: