Empowerment Self-Defense Training for the Prevention of Victimization of Transgender Women
Phase: NA
Conditions: Violence, Sexual
Sponsor: Hunter College of City University of New York

Empowerment Self-Defense Training for the 
Prevention of Victimization of Transgender Women 
ID: R21MD014807 
   
NCT04934189
03/30/2021 

University Integrated Institutional Review Board
205 East 42nd Street
New York, NY 10017
 http://www.cuny.edu/research/compliance.html
Initial Application
2021-0291
Danielle Berke
Table of Contents
1. Summary..................................................................................................................................................................................1
2. Research Personnel.............................................................................................................................................................3
3. Other Personnel.................................................................................................................................................................... 4
4. Research Sites...................................................................................................................................................................... 5
5. Research Design - Overview............................................................................................................................................6
6. Research Design - Procedures and Risks.................................................................................................................11
7. Research Design - Risks and Benefits....................................................................................................................... 15
8. Funding - Sources..............................................................................................................................................................21
9. Participants - Populations................................................................................................................................................22
10. Participants - Projected Enrollment............................................................................................................................23
11. Participants - Eligibility................................................................................................................................................... 24
12. Participants - Recruitment.............................................................................................................................................25
13. Participants - Screening.................................................................................................................................................27
14. Participants - Consent....................................................................................................................................................28
15. Participants - Compensation........................................................................................................................................ 29
16. Participants - Privacy and Confidentiality.................................................................................................................31
17. Attachments....................................................................................................................................................................... 35

University Integrated Institutional Review Board
205 East 42nd Street
New York, NY 10017
 http://www.cuny.edu/research/compliance.html
2021-0291
Initial Application
Danielle Berke
1. Summary
Protocol Title
Empowerment Self-Defense Training for the Prevention of Victimization of Transgender Women- Phase II
Primary College
Hunter College
PI relationship to CUNY
Full-time Faculty
Application Initiated By
Maiya Hotchkiss
Are you seeking an approval for
 a project that is lacking definite
 plans for involvement of human
 subjects (45 CFR 46.118)?
No
Research Type
Social Behavioral
Research Type
Social Behavioral
Are you seeking an exemption from
 IRB review?
No
Lay Summary
Transgender women (TW) are at the highest risk for exposure to interpersonal violence even compared to other
 sexual and gender minority individuals. Empowerment Self-Defense (ESD) training, a specific violence prevention
 approach that teaches participants strategies for actively resisting assault, holds tremendous promise for reducing
 risk of violent victimization. Indeed, research consistently shows that assertive and physical forms of resistance are
 effective in deterring rape. Moreover, in randomized controlled trials, ESD violence prevention training has been
 shown to reduce rates of victimization among college students by nearly half at 1-year follow-up. Unfortunately,
 diverse TW are rarely included in ESD violence prevention research and programming. This exclusion is problematic
 not only because TW comprise the highest need population for targeted violence prevention, but also because
 theoretical models of gender identity stigma hold that social and psychological stressors specific to gender-minority
 identity increase risk for interpersonal violence along multiple unique pathways. Standard ESD violence prevention
 programs do not incorporate content, materials, or strategies tailored to the specific pathways by which TW are
 impacted by interpersonal violence. This study fills this substantial gap in prevention science by developing an
 ESD violence prevention training specifically tailored to TW. The proposed project aims to develop and refine a
 tailored ESD violence prevention training for diverse TW through a series of sequential Aims: a) develop an initial
 draft of an ESD violence prevention curriculum tailored to TW (Aim 1); b) evaluate the feasibility and acceptability
 of recruitment, assessment procedures, retention and follow-up procedures, and implementation of the new
 intervention (Aim 2); and c) assess the preliminary efficacy of the tailored intervention program to increase use of
 self-protective resistance strategies, mitigate minority stressors and attitudinal barriers to self-defense, and reduce
 rates of exposure to violence (Exploratory Aim).We will accomplish these aims using a two-phase research design
 that begins with formative qualitative work engaging research partners on a community board and a small sample
 of research participants. Information for Phase 1 can be located in Protocol number 2020-0017. Further refinement
 and assessment of the feasibility and acceptability of the curriculum using Phase 1 findings will occur in Phase
 2 through the delivery of the tailored ESD curriculum to 3 groups of 16 TW. To assess the preliminary efficacy of
 the tailored intervention, program participants will complete a battery of validated questionnaires assessing use of
 resistance strategies, gender-minority and general psychological factors hypothesized to mediate the behavioral
 effects of the intervention, and exposure to victimization experiences prior to, immediately following, and 6 months

 post-completion of the training. Together, the proposed research will lay the foundation for a large-scale randomized
 controlled trial (RCT) of the tailored ESD violence prevention curriculum. 
Do you have a scientific protocol or
 a sponsors protocol?
No
Page 2 of 36

University Integrated Institutional Review Board
205 East 42nd Street
New York, NY 10017
 http://www.cuny.edu/research/compliance.html
2021-0291
Initial Application
Danielle Berke
2. Research Personnel
Name/Department
Role/Status
Contact
Access
Signature
 Authority
Phone
Email
Danielle Berke /
 Hunter College
PI / 
Yes
Maiya Hotchkiss /
 Hunter College
Study Coordinator / 
Yes
Ashley Smith / The
 Graduate School
 and University
 Center
Study Coordinator / 
Yes
Craig Gilbert / Hunter
 College
Research Assistant / 
Lisbeth Rubi / Hunter
 College
Research Assistant / 
Jessica Palatnik /
 Hunter College
Research Assistant / 
 
Page 3 of 36

University Integrated Institutional Review Board
205 East 42nd Street
New York, NY 10017
 http://www.cuny.edu/research/compliance.html
2021-0291
Initial Application
Danielle Berke
3. Other Personnel
None
 
Page 4 of 36

University Integrated Institutional Review Board
205 East 42nd Street
New York, NY 10017
 http://www.cuny.edu/research/compliance.html
2021-0291
Initial Application
Danielle Berke
4. Research Sites
Name
CUNY
Sub-Location
Hunter College
Site PI
99999999
Role of the site in
 research
9999999
Has IRB?
No
Permission Granted?
No
Page 5 of 36

University Integrated Institutional Review Board
205 East 42nd Street
New York, NY 10017
 http://www.cuny.edu/research/compliance.html
2021-0291
Initial Application
Danielle Berke
5. Research Design - Overview
Research Purpose and Hypothesis
This study leverages the strong evidence-base for Empowerment Self-Defense (ESD) violence prevention to address
 disparities in violence exposure among TW. The overarching goal of this R21 is to develop and refine a tailored ESD
 violence prevention training for diverse TW through a series of sequential Aims: a) develop an initial draft of an ESD
 violence prevention curriculum tailored to TW (Aim 1) (See protocol number 2020-0017); b) evaluate the feasibility
 and acceptability of recruitment, assessment procedures, retention and follow-up procedures, and implementation of
 the new intervention (Aim 2); and c) assess the preliminary efficacy of the tailored intervention program to increase
 use of self-protective resistance strategies, mitigate minority stressors and attitudinal barriers to self-defense, and
 reduce rates of exposure to violence (Exploratory Aim). Together, the proposed research will lay the foundation for a
 large-scale randomized controlled trial (RCT) of the tailored ESD violence prevention curriculum. We will accomplish
 these aims using a two-phase research design that begins with formative qualitative work engaging research
 partners on a community board and a small sample of research participants (See protocol number 2020-0017).
 This data will be used to inform the development and refinement of the ESD violence prevention curriculum for
 TW. Further refinement and assessment of the feasibility and acceptability of the curriculum will occur in Phase
 2 through the delivery of the tailored ESD curriculum to 3 groups of 16 TW. To assess the preliminary efficacy of
 the tailored intervention, program participants will complete a brief survey assessing the program directly after
 completion, as well as a battery of validated questionnaires assessing use of resistance strategies, gender-minority
 and general psychological factors hypothesized to mediate the behavioral effects of the intervention, and exposure
 to victimization experiences prior to, immediately following, and 6 months post-completion of the training. 
Research Design and Methodology
The overall goal of this study is to use findings from Phase 1 (See protocol number 2020-0017) to deliver and
 refine a tailored ESD violence prevention training for diverse trans women. Participants for Phase 2 (n = 48)
 will be recruited from online forums including social media sites (e.g., Facebook, Twitter), banner ads on social
 networking/dating sites (e.g., Scruff, BGC Live, OK Cupid, Lex) that are trans-inclusive and through dissemination
 of paper and/or electronic recruitment flyers with leaders of community organizations that connect transgender
 individuals (e.g., AVP; Callen Lorde, Trans-lantinx network). Participants from prior studies who consented to
 future contact will be sent the study flyer by email.The proposed curriculum will be systematically refined based
 on delivery of the intervention to 3 groups of 16 TW each in a 20-hour training program, in 5 4-hour sessions.
 We have contracted with Prepare, Inc., the New York City chapter of IMPACT International to deliver the tailored
 ESD violence prevention intervention. IMPACT is an international ESD violence prevention organization with
 chapters across the United States. Prepare, Inc. will provide facilitators who have completed IMPACT's nationally
 standardized ESD violence prevention program requirements that include receipt of over 100 hours of training.
 IMPACT training is open to trans and cisgender women. The extensive training of IMPACT facilitators promotes
 intervention efficacy, while the risk of potential bias conferred by their experience with a pre-existing curriculum is
 mitigated by our community-engaged approach (i.e.,TW community members, service providers, and scientists
 [PI and Co-I] collectively shape the content of the final tailored ESD intervention, and TW co-facilitators will be
 present in every training session). Prior to the start of group, facilitators will review the tailored curriculum in detail
 and attend 2-3 supervision/training meetings with the PI. These meetings will consist of reviewing the curriculum,
 role-plays of critical intervention components, and discussion of questions or concerns. The primary outcome of
 Aim 2 is to evaluate our ability to recruit our target (n = 48) and retain >75% over the course of the intervention.
 Successful completion of the pilot trial, including meeting or exceeding these benchmarks for success, will determine
 the feasibility and acceptability of recruiting participants into a future RCT. Preliminary efficacy of the tailored ESD
 violence prevention intervention will be evaluated as an exploratory aim. Participants enrolled in the pilot trial will
 be administered a battery of validated baseline questionnaires at baseline, immediately following the course, and
 6 months after course completion (see Assessment Packet in attached below) including: - Demographics - Social
 Class Ladder- Community Ladder- Service Utilization Form - Sexual experiences Survey - Everyday Discrimination

 Scale- Conflict Tactics Scale - Gender Minority Stress Risk and Resilience Scale - Post Traumatic Stress Disorder
 Symptom Checklist for DSM-5 (PCL-5)- Sexual Assertiveness Questionnaire- Resistance Tactics Survey- Dating
 Self-Protection - Illinois Rape Myth Acceptance - Resistance Self-Efficacy - Personal Progress- Transgender
 Congruence Scale - Depression Anxiety and Stress Scale - Quick Drinking Screen - DAST-10Brief acceptability
 checklists will be administered after each course session, which will contain a brief list of topics covered during that
 training session and participants will indicate which of the topics they felt were adequately covered (See page 38
 of Assessment Packet, "Satisfaction and Fidelity Forms" for example items and formatting of this checklist). Lastly,
 an exit interview will be scheduled on the final day of the course, and will take place over the weeks immediately
 following the completion of the course. Interviews will be video recorded using the Zoom videoconferencing platform.
 The video-recorded qualitative interviews will be recorded and transcribed verbatim using the Zoom transcription
 function (omitting identifying information) and verified for accuracy. We will use three strategies to improve retention,
 based on an intensive evidence-based follow-up protocol with which the PI has considerable experience. First,
 participants will be compensated for completion of the assessment appointments at increasing increments over time
 (i.e., $40 for baseline, $30 for follow-up immediately after the course and $30 for the exit interview after the course,
 $80 for 6-month follow-up). Second, at baseline, participants will be asked to provide extensive locating information
 and to provide names of two local persons to be contacted in the event that the participant cannot be reached. This
 information will be updated at the time of follow-up survey administration. Third, participants will receive $10 cash for
 each of the five session acceptability checklists they complete (one per session attended- up to $50 total) which will
 be distributed at session 3/5 (up to $30) and 5/5 (up to $20). Analyses will be of two primary types: (a) examinations
 of whether feasibility targets were met across a variety of measures; and (b) examinations of the efficacy of the
 tailored ESD violence prevention intervention. We will use repeated measures one-way ANOVA to test if the tailored
 ESD curriculum has statistically significant effect on measures of behavioral and psychological/attitudinal change. If
 a significant effect is detected, we will use Tukey's pairwise-comparison procedure to compare all treatment means,
 with a 95% family confidence coefficient. To assess changes in exposure to victimization, we will collapse into three
 levels: (a) no history of victimization; (b) moderate victimization; (c) severe victimization. For this categorical data, a
 chi-square test of independence will be performed to compare posttreatment vs. pre-treatment, and 6-month FU vs.
 pre-treatment respectively to assess the preliminary efficacy of the program, with a family-wise type I error controlled
 at 0.05 using Bonferroni procedure. Our efficacy outcomes are exploratory and powered to detect large effect sizes.
 In the largest scale RCT of an ESD violence prevention program to date, rates of completed assault among women
 receiving resistance training were reduced by half at 1-year follow-up. However, as there are no existing studies that
 report on ESD efficacy among TW, we will use results of our exploratory efficacy analysis to shape power analyses
 for a subsequent, fully powered, RCT
Retrospective Data Review ONLY
No
Funding Requested/Obtained
Yes
Compensation for participation
Yes
Will participants incur any research
 related costs?
No
Is compensation available for
 research related injury?
No
Surveys or Questionnaires
Yes
Will the survey or questionnaire
 be self administered by the
 participants?
Yes
Do you intend to give feedback
 to participants based on survey/
questionnaire results?
No
Attach survey(s) / questionnaire(s)
Title
ESD TW Phase 2 Assessment Packet
 (Survey Battery administration schedule on
 page 2, survey battery page 4-37) 
Upload
Assessment packet_ESD for TW_10.12.20
 (3).pdf

Interviews
Yes
Who will conduct the interview
Danielle Berke, Maiya Hotchkiss, Ashley
 Smith, Craig Gilbert
Will any individual(s) other than
 the research personnel be present
 during the interview?
No
Attach interview questions
Title
ESD TW Phase 2 Assessment Packet
 (Interview on page 44) 
Upload
Assessment packet_ESD for TW_10.12.20
 (3).pdf
Observation
No
Audio or Video Recording or
 Photograph
Yes
Please be sure to insert template language regarding recordings and/or photographs in the
 consent document
Check all that apply
Audio Recording
Yes
List the procedures that will be recorded
We are requesting permission to audio record the one-on-one semi-structured participant exit interview using the
 secure Zoom teleconferencing platform.
State the purpose of recording
The recordings will only be used for verbatim transcription using the transcribe function in the Zoom teleconferencing
 platform (omitting identifying information) to facilitate rapid content analysis of key themes. These themes, in turn,
 will be used to inform the development of a tailored violence prevention curriculum for transwomen. Participants will
 also be offered the option to securely access and download a personal copy of the recording, if they request to do
 so. 
Will participants be permitted
 to review, edit and/or erase the
 recording?
Yes
Will participants be identified in the
 recording?
Yes
How will you maintain participant confidentiality?
During the consenting process, we will communicate with all participants that they have the right to download an
 audio and video recording of the interview. If the participant does not make this request, electronic copies of study
 data will be securely downloaded as two separate files (an audio-only and video recording file) to a local server from
 Zoom. Local video-files will be immediately deleted. The audio-only file will be immediately uploaded for storage
 on an online password-protected, backed up lab server that is accessible only by lab personnel. Local audio file
 copies will be deleted immediately once uploaded to the secure drive. The audio recording files will be labeled
 with a unique participant ID number, and will contain participants' voice but will not contain names. The labels on
 these files will constitute a link between identifiable information and the participant ID number, which will be used to
 link other study data together.   Only members of the study team will be able to access the audio recordings taken
 during the interview session. Participant data will remain confidential.If the participant makes the request to have a
 personal copy of the interview, we will store the audio and video recording file in Zoom for one week, during which
 the participant will have one week to download and store the file using a secure Zoom link to the recording, sent via
 email. Risk of sharing this data with the participant includes risk of loss of confidentiality. However, as the identifiable
 data includes the responses of the participant only (and the interviewer prompts) and would be in the hands of those
 at risk of being identified, risk of confidentiality loss is minimal. At the end of the one week, electronic copies of study
 data will be securely downloaded as two separate files (an audio-only and video recording file) to a local server from
 Zoom. Local video-files will be immediately deleted. The audio-only file will be immediately uploaded for storage on
 an online password-protected, backed up lab server that is accessible only by lab personnel. Local audio file copies
 and Zoom cloud copies will be deleted immediately once uploaded to the secure drive. The audio recording files
 will be labeled with a unique participant ID number, and will contain participants' voice but will not contain names.

 The labels on these files will constitute a link between identifiable information and the participant ID number, which
 will be used to link other study data together.  Only members of the study team will be able to access the audio
 recordings taken during the interview session. Participant data will remain confidential.
Who will have access to the
 recordings?
Danielle Berke, Maiya Hotchkiss, Ashley
 Smith, Craig Gilbert, Lisbeth Rubi, Jessica
 Palatnik
Video Recording
Yes
List the procedures that will be recorded
We are requesting permission to video record the one-on-one semi-structured participant exit interview. 
State the purpose of recording
Zoom offers a video and audio recording option only (no audio-only option), thus virtual participation will include
 video recording.   Interviews with participants who opt to take part in study procedures in-person when this option
 becomes available will also be video recorded, to promote similarity of treatment of virtual versus in-person
 participants.    To ameliorate additional challenges regarding confidentiality with video-recording files, the recording
 will be downloaded such that audio file and video file are downloaded as separate files; the video file will be
 deleted immediately and will never be saved or stored. The audio-only file will be saved for transcription.   The
 audio recordings will only be used for verbatim transcription (omitting identifying information) to facilitate rapid
 content analysis of key themes. These themes, in turn, will be used to inform the development of a tailored violence
 prevention curriculum for transwomen.  Participants will also be offered the option to securely access and download
 a personal copy of the recording, if they request to do so. 
Will participants be permitted
 to review, edit and/or erase the
 recording?
Yes
Will participants be identified in the
 recording?
Yes
How will you maintain participant confidentiality?
During the consenting process, we will communicate with all participants that they have the right to download an
 audio and video recording of the interview. If the participant does not make this request, electronic copies of study
 data will be securely downloaded as two separate files (an audio-only and video recording file) to a local server from
 Zoom. Local video-files will be immediately deleted. The audio-only file will be immediately uploaded for storage
 on an online password-protected, backed up lab server that is accessible only by lab personnel. Local audio file
 copies will be deleted immediately once uploaded to the secure drive. The audio recording files will be labeled
 with a unique participant ID number, and will contain participants' voice but will not contain names. The labels on
 these files will constitute a link between identifiable information and the participant ID number, which will be used to
 link other study data together.   Only members of the study team will be able to access the audio recordings taken
 during the interview session. Participant data will remain confidential.If the participant makes the request to have a
 personal copy of the interview, we will store the audio and video recording file in Zoom for one week, during which
 the participant will have one week to download and store the file using a secure Zoom link to the recording, sent via
 email. Risk of sharing this data with the participant includes risk of loss of confidentiality. However, as the identifiable
 data includes the responses of the participant only (and the interviewer prompts) and would be in the hands of those
 at risk of being identified, risk of confidentiality loss is minimal. At the end of the one week, electronic copies of study
 data will be securely downloaded as two separate files (an audio-only and video recording file) to a local server from
 Zoom. Local video-files will be immediately deleted. The audio-only file will be immediately uploaded for storage on
 an online password-protected, backed up lab server that is accessible only by lab personnel. Local audio file copies
 and Zoom cloud copies will be deleted immediately once uploaded to the secure drive. The audio recording files
 will be labeled with a unique participant ID number, and will contain participants' voice but will not contain names.
 The labels on these files will constitute a link between identifiable information and the participant ID number, which
 will be used to link other study data together.  Only members of the study team will be able to access the audio
 recordings taken during the interview session. Participant data will remain confidential.
Who will have access to the
 recordings?
Danielle Berke, Maiya Hotchkiss, Ashley
 Smith, Craig Gilbert, Lisbeth Rubi, Jessica
 Palatnik
Photograph
No
Deception
No

Access to or use of pre-existing
 non-medical records, including
 student records
No
Access or use of medical records
No
Will participants be screened?
Yes
Prospective Biological Sample
 Collection and Existing
 Biospecimens
No
Drugs or Vaccines
No
Devices
No
Page 10 of 36

University Integrated Institutional Review Board
205 East 42nd Street
New York, NY 10017
 http://www.cuny.edu/research/compliance.html
2021-0291
Initial Application
Danielle Berke
6. Research Design - Procedures and Risks
Participant Group
List all research related
 procedures/data
 collection methods
 involving interaction
 or intervention with
 participants; use the
 Add New Procedure and
 Risk button to add each
 method.
List all research related procedures/data collection methods involving interaction or
 intervention with participants; use the Add New Procedure and Risk button to add each
 method.
Procedure
Self-Report Questionnaires
Where it will take place?
Self-report questionnaires will be administered virtually. Participants will have the option
 to complete baseline and course follow-up surveys remotely at home, or using iPads or
 their phones at God's Love We Deliver before and after the course.
When it will take place?
Self-report questionnaires will be administered to each participant 3 times; baseline
 (before the ESD intervention), follow-up directly after the intervention, and 6-month
 follow-up.
Frequency
Self-report questionnaires will be administered to each participant 3 times; baseline,
 follow-up immediately following course completion, and 6-month follow-up.
Is procedure optional for
 participants?
Yes
Associated risk or
 discomfort
Questionnaires include some questions concerning personal or emotional matters that
 could cause mild, temporary psychological discomfort.
Anticipated severity of
 risk or discomfort
No more than minimal risk
Expected frequency of
 risk or discomfort
Self-report questionnaires will be administered to each participant 3 times; baseline,
 follow-up immediately following course completion, and 6-month follow-up.
Risk reduction or
 mitigation method
While every possible step will be taken to minimize such risk, if participants have
 any concerns about any aspect of the study, consent documentation will make it
 clear that they may refuse to continue with the study at any time, without penalty. In
 addition, we will remind participants during the course of all assessments that they
 do not have to respond to any questions they do not wish to and may discontinue
 participation at any time. Participants who report or demonstrate any distress during
 study assessments will be referred to counseling services at local agency with whom
 the PI has established linkages (The Center). All counseling resources are available to
 participants regardless of ability to pay.
Participant Group
List all research related
 procedures/data
 collection methods
 involving interaction
 or intervention with
List all research related procedures/data collection methods involving interaction or
 intervention with participants; use the Add New Procedure and Risk button to add each
 method.

 participants; use the
 Add New Procedure and
 Risk button to add each
 method.
Procedure
Tailored IMPACT Basics Intervention
Where it will take place?
IMPACT Basics Course will take place at a well ventilated space centrally located and
 furnished by God's Love We Deliver (166 Avenue of The Americas NYC 10013).
When it will take place?
There will be three pilot series that will take place as part of this study. Series 1:
 7/11/21, 7/18/21, 7/25/21, 8/1/21, 8/8/21Series 2: 9/19/21, 9/26/21, 10/3/21, 10/10/21,
 10/17/21Series 3: 11/14/21, 11/21/21, 12/4/21, 12/11/21, 12/19/21As participants are
 recruited, they will be assigned to one of the three series based on their availability.
Frequency
As this study involves iterative tailoring of the intervention curriculum, the pilot
 intervention will be rolled out in 3 groups. Each pilot intervention will be followed
 by tailoring before rolling out the intervention to the following group. Thus, ESD
 violence prevention programming will take place 3 times, but each participant will only
 participate in one of the series.
Is procedure optional for
 participants?
Yes
Associated risk or
 discomfort
It is possible that participants may experience some discomfort while participating in
 the ESD violence prevention program.Due to the COVID-19 pandemic, in-person
 participation poses additional risk to participants.
Anticipated severity of
 risk or discomfort
No more than minimal risk
Expected frequency of
 risk or discomfort
The schedule for each of the 3 ESD series is outlined above. Participants will be
 assigned to one of the three series based on best availability match, so frequency of
 risk or discomfort is five times for five course sessions.
Risk reduction or
 mitigation method
By contracting with Prepare, Inc., an organization with over 30-years of experience
 providing ESD training to diverse clientele, we are ensuring that every possible step
 is taken to manage the natural discomfort that may arise when learning new verbal
 and physical skills in a personal safety program. During all group sessions the lead
 instructor will stand near the participant providing ongoing support, encouragement,
 and verbal prompting to participants, as needed, during role-play scenarios. The
 behavior of all instructors in conducting and coaching participants through role plays
 will be carefully thought out and implemented. At no time will participants role-play with
 one another. Consent documentation will make it clear that participants may refuse
 to continue with the study at any time, without penalty. In addition, we will remind
 participants during the course of the group that they do not have to participate in any
 exercise or role-play that they do not wish to and may discontinue participation at any
 time. Participants who report or demonstrate any distress during class will be referred
 to counseling services at local agency with whom the PI has established linkages (The
 Center). Additionally, a licensed clinical psychologist (PI: Danielle Berke, Ph.D.) will
 be present in all ESD classes to support participants in the unlikely event that they
 may need additional assistance in grounding and following a role-play scenario. All
 counseling resources are available to participants regardless of ability to pay.Regarding
 the risk of COVID-19 transmission during participation in in-person procedures, there
 will be safety protocols in place for all participants and research staff present during
 the ESD program sessions. Personal protective equipment will be made available for
 all attendees including hand sanitizer, gloves, face shields, and N95 respirator masks.
 All program sessions will take place in a well-ventilated area furnished by God's Love
 We Deliver (outside). Participants will remain 6 feet apart during sessions, with the
 exception of time limited physical defense drills.
Participant Group
List all research related
 procedures/data
 collection methods
List all research related procedures/data collection methods involving interaction or
 intervention with participants; use the Add New Procedure and Risk button to add each
 method.

 involving interaction
 or intervention with
 participants; use the
 Add New Procedure and
 Risk button to add each
 method.
Procedure
Brief Course Assessment Survey (See pages 38-43 of the Assessment packet attached
 to this protocol).
Where it will take place?
Course Assessment surveys will be administered at God's Love We Deliver.
When it will take place?
The brief self-report course assessment survey will be administered directly following
 completion of each of the 5 course sessions.
Frequency
The brief self-report course assessment survey will be administered to each participant
 up to five times- once after each course session attended.
Is procedure optional for
 participants?
Yes
Associated risk or
 discomfort
No risk is expected from the course assessment questions.
Anticipated severity of
 risk or discomfort
No more than minimal risk
Expected frequency of
 risk or discomfort
No risk is expected from the course assessment questions.
Risk reduction or
 mitigation method
While every possible step will be taken to minimize such risk, if participants have
 any concerns about any aspect of the study, consent documentation will make it
 clear that they may refuse to continue with the study at any time, without penalty. In
 addition, we will remind participants during the course of all assessments that they
 do not have to respond to any questions they do not wish to and may discontinue
 participation at any time. Participants who report or demonstrate any distress during
 study assessments will be referred to counseling services at local agency with whom
 the PI has established linkages. All counseling resources are available to participants
 regardless of ability to pay.
Participant Group
List all research related
 procedures/data
 collection methods
 involving interaction
 or intervention with
 participants; use the
 Add New Procedure and
 Risk button to add each
 method.
List all research related procedures/data collection methods involving interaction or
 intervention with participants; use the Add New Procedure and Risk button to add each
 method.
Procedure
Exit Interview
Where it will take place?
Exit interviews will take place remotely, over Zoom
When it will take place?
Exit Interviews will be scheduled on the fifth and final session of the course, and will
 take place in the weeks immediately following the course.
Frequency
Each participant will be interviewed once.
Is procedure optional for
 participants?
Yes
Associated risk or
 discomfort
No risk is expected from the exit interview questions.
Anticipated severity of
 risk or discomfort
No more than minimal risk

Expected frequency of
 risk or discomfort
No risk is expected from the course assessment questions.
Risk reduction or
 mitigation method
While every possible step will be taken to minimize such risk, if participants have
 any concerns about any aspect of the study, consent documentation will make it
 clear that they may refuse to continue with the study at any time, without penalty. In
 addition, we will remind participants during the course of all assessments that they
 do not have to respond to any questions they do not wish to and may discontinue
 participation at any time. Participants who report or demonstrate any distress during
 study assessments will be referred to counseling services at local agency with whom
 the PI has established linkages. All counseling resources are available to participants
 regardless of ability to pay.
Page 14 of 36

University Integrated Institutional Review Board
205 East 42nd Street
New York, NY 10017
 http://www.cuny.edu/research/compliance.html
2021-0291
Initial Application
Danielle Berke
7. Research Design - Risks and Benefits
Does your research claim to
 present a therapeutic benefit to the
 participants?
No
Expected Direct Benefit(s)
In participating in this study, participants may gain insight on the role of individual (e.g., history of victimization),
 interpersonal (e.g., romantic and peer relationships), and societal level factors (e.g., laws, policies, gender norms
 and ideology) contributing to violence, develop a comprehensive set of skills for resisting violence, and develop
 greater understanding of their bodies and minds as sources of strength.
Benefit to Society
Developing feasible, acceptable, and effective interventions to prevent violent victimization presents clear public
 health implications, especially among transgender individuals. In participating in this study, participants may gain
 insight on the role of individual (e.g., history of victimization), interpersonal (e.g., romantic and peer relationships),
 and societal level factors (e.g., laws, policies, gender norms and ideology) contributing to violence. Benefits to
 society in general are anticipated through the dissemination of study findings and the development of an ESD
 curriculum tailored for TW. Results will better inform local and national public health initiatives about violence
 prevention among TW and provide a tailored curriculum for targeting transgender-specific violence.
Will data safety monitoring be
 done?
Yes
Data Monitoring method
DSMB
    DSMB members should not have any involvement in the research other than that of
 serving on the DSMB. Other involvement in the research would be perceived as a conflict
 of interest. 
Identify members of DSM Board (DSMB):
Name
Katie Edwards
Affiliation
University of Nebraska
Qualifications
Katie Edwards, Ph.D., is an Associated Professor of Psychology at the University of Nebraska-Lincoln. She
 specializes in development and implementation of violence prevention programming, particularly focused on
 marginalized populations including sexual and gender minorities. 
How frequently will the DSMB
 meet?
Quarterly
Provide description of stopping rules and justification for the stopping rules
Adverse Event (AE): Defined as any untoward medical occurrence in a patient or research subject administered
 a pharmaceutical product or other research intervention and that does not necessarily have a causal relationship
 with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory
 finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product or research
 procedure, whether or not related to the medicinal (investigational) product or procedure.Negative events that occur
 during study involvement do not constitute adverse events unless they lead to physical harm (in which case the
 injury is the AE) or deterioration of mental health functioning (in which case the symptoms are the AE). Negative
 events that may potentially affect response to the intervention or study involvement should be reported as AEs. See
 IRB Reporting Requirements below for instructions on how to report these events. Examples might include legal

 problems or traumatic events.The program facilitator should query about adverse events (AEs) at every session
 by asking about any notable events since the last visit. These should be reviewed in a timely manner with the
 supervisor.Serious Adverse Event (SAE): An AE occurring in a patient or subject enrolled in a research study is
 serious if it results in any of the following outcomes: death, a life-threatening adverse drug experience, inpatient
 hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or is a
 congenital anomaly/birth defect.Unanticipated Problems Involving Risk (UPR): Defined as being (1) unexpected
 given the research procedures and characteristics of the population, (2) related (or possibly related) to participation
 in the research and (3) indicative that the research may place the subject or others at a greater risk of harm than
 was previously known.Examples of possible UPRs for psychotherapeutic interventions:1. Psychosis or mania2.
 New onset or clinically significant exacerbation of a psychiatric disorder3. Suicide and suicide attemptsAn incident,
 experience, or outcome that meets UPR criteria generally will warrant consideration of substantive changes in the
 research protocol or informed consent process/document or other corrective actions in order to protect the safety,
 welfare, or rights of subjects or others. Examples of corrective actions or substantive changes that might need to be
 considered in response to an unanticipated problem include: modification of inclusion or exclusion criteria to mitigate
 the newly identified risks;implementation of additional procedures for monitoring subjects;suspension of enrollment
 of new subjects;suspension of research procedures in currently enrolled subjects;modification of informed consent
 documents to include a description of newly recognized risks; andprovision of additional information about newly
 recognized risks to previously enrolled subjects.Reporting Requirement: All UPRs/AEs/SAEs, regardless of
 relatedness to the intervention, are to be reported to the local IRB as soon as possible, no later than 10 business
 days from the date the investigator or research staff becomes aware of the event/problem. Fill out an AE form, SAE
 form, and/or UPR form, obtain the study PI's signature, and submit to the Hunter IRB. Then forward each AE/SAE/
UPR form to Data Safety Monitoring Board as soon as possible. The study PI will maintain a record of all AEs/SAEs/
UPRs to report to the Hunter IRB in summary or table form at the end of the study.  The PI will notify NIMHD of any
 UPR, AE, or SAE promptly via email. Protocol Deviation/ViolationA protocol deviation or violation is any change,
 divergence, or departure from the study design or procedures of a research protocol. Investigators are required
 to conduct their research according to the plans reviewed and approved by the IRB.  Instances where this does
 not occur, either inadvertently due to circumstances beyond the investigator's control, or due to errors of omission
 or commission by research project staff, must be reported.Reporting Requirement: Fill out a Protocol Deviation/
Violation form, and submit to local IRB within 3 days of the occurrence (one day if there was harm to the participant).
 Also email the form (with encryption) to the PI and Study Coordinator, who will maintain a record of all Protocol
 Deviations/Violations to report to the Hunter IRB.
DSMB?s prospectively identified criteria for discontinuing the study
Adverse Event (AE): Defined as any untoward medical occurrence in a patient or research subject administered
 a pharmaceutical product or other research intervention and that does not necessarily have a causal relationship
 with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory
 finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product or research
 procedure, whether or not related to the medicinal (investigational) product or procedure.Negative events that occur
 during study involvement do not constitute adverse events unless they lead to physical harm (in which case the
 injury is the AE) or deterioration of mental health functioning (in which case the symptoms are the AE). Negative
 events that may potentially affect response to the intervention or study involvement should be reported as AEs. See
 IRB Reporting Requirements below for instructions on how to report these events. Examples might include legal
 problems or traumatic events.The program facilitator should query about adverse events (AEs) at every session
 by asking about any notable events since the last visit. These should be reviewed in a timely manner with the
 supervisor.Serious Adverse Event (SAE): An AE occurring in a patient or subject enrolled in a research study is
 serious if it results in any of the following outcomes: death, a life-threatening adverse drug experience, inpatient
 hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or is a
 congenital anomaly/birth defect.Unanticipated Problems Involving Risk (UPR): Defined as being (1) unexpected
 given the research procedures and characteristics of the population, (2) related (or possibly related) to participation
 in the research and (3) indicative that the research may place the subject or others at a greater risk of harm than
 was previously known.Examples of possible UPRs for psychotherapeutic interventions:1. Psychosis or mania2.
 New onset or clinically significant exacerbation of a psychiatric disorder3. Suicide and suicide attemptsAn incident,
 experience, or outcome that meets UPR criteria generally will warrant consideration of substantive changes in the
 research protocol or informed consent process/document or other corrective actions in order to protect the safety,
 welfare, or rights of subjects or others. Examples of corrective actions or substantive changes that might need to be
 considered in response to an unanticipated problem include: modification of inclusion or exclusion criteria to mitigate
 the newly identified risks;implementation of additional procedures for monitoring subjects;suspension of enrollment
 of new subjects;suspension of research procedures in currently enrolled subjects;modification of informed consent
 documents to include a description of newly recognized risks; andprovision of additional information about newly
 recognized risks to previously enrolled subjects.Reporting Requirement: All UPRs/AEs/SAEs, regardless of

 relatedness to the intervention, are to be reported to the local IRB as soon as possible, no later than 10 business
 days from the date the investigator or research staff becomes aware of the event/problem. Fill out an AE form, SAE
 form, and/or UPR form, obtain the study PI's signature, and submit to the Hunter IRB. Then forward each AE/SAE/
UPR form to Data Safety Monitoring Board as soon as possible. The study PI will maintain a record of all AEs/SAEs/
UPRs to report to the Hunter IRB in summary or table form at the end of the study.  The PI will notify NIMHD of any
 UPR, AE, or SAE promptly via email. Protocol Deviation/ViolationA protocol deviation or violation is any change,
 divergence, or departure from the study design or procedures of a research protocol. Investigators are required
 to conduct their research according to the plans reviewed and approved by the IRB.  Instances where this does
 not occur, either inadvertently due to circumstances beyond the investigator's control, or due to errors of omission
 or commission by research project staff, must be reported.Reporting Requirement: Fill out a Protocol Deviation/
Violation form, and submit to local IRB within 3 days of the occurrence (one day if there was harm to the participant).
 Also email the form (with encryption) to the PI and Study Coordinator, who will maintain a record of all Protocol
 Deviations/Violations to report to the Hunter IRB.
Name
Jillian Shipherd
Affiliation
VA Boston
Qualifications
Jillian Shipherd, Ph.D, is the co-director of LGBT health in national office of the VA, and oversees development and
 implementation of LGBT health policy across medical care system. She has particular expertise in trans health with
 particular expertise in trauma among trans people. 
How frequently will the DSMB
 meet?
Quarterly
Provide description of stopping rules and justification for the stopping rules
Adverse Event (AE): Defined as any untoward medical occurrence in a patient or research subject administered
 a pharmaceutical product or other research intervention and that does not necessarily have a causal relationship
 with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory
 finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product or research
 procedure, whether or not related to the medicinal (investigational) product or procedure.Negative events that occur
 during study involvement do not constitute adverse events unless they lead to physical harm (in which case the
 injury is the AE) or deterioration of mental health functioning (in which case the symptoms are the AE). Negative
 events that may potentially affect response to the intervention or study involvement should be reported as AEs. See
 IRB Reporting Requirements below for instructions on how to report these events. Examples might include legal
 problems or traumatic events.The program facilitator should query about adverse events (AEs) at every session
 by asking about any notable events since the last visit. These should be reviewed in a timely manner with the
 supervisor.Serious Adverse Event (SAE): An AE occurring in a patient or subject enrolled in a research study is
 serious if it results in any of the following outcomes: death, a life-threatening adverse drug experience, inpatient
 hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or is a
 congenital anomaly/birth defect.Unanticipated Problems Involving Risk (UPR): Defined as being (1) unexpected
 given the research procedures and characteristics of the population, (2) related (or possibly related) to participation
 in the research and (3) indicative that the research may place the subject or others at a greater risk of harm than
 was previously known.Examples of possible UPRs for psychotherapeutic interventions:1. Psychosis or mania2.
 New onset or clinically significant exacerbation of a psychiatric disorder3. Suicide and suicide attemptsAn incident,
 experience, or outcome that meets UPR criteria generally will warrant consideration of substantive changes in the
 research protocol or informed consent process/document or other corrective actions in order to protect the safety,
 welfare, or rights of subjects or others. Examples of corrective actions or substantive changes that might need to be
 considered in response to an unanticipated problem include: modification of inclusion or exclusion criteria to mitigate
 the newly identified risks;implementation of additional procedures for monitoring subjects;suspension of enrollment
 of new subjects;suspension of research procedures in currently enrolled subjects;modification of informed consent
 documents to include a description of newly recognized risks; andprovision of additional information about newly
 recognized risks to previously enrolled subjects.Reporting Requirement: All UPRs/AEs/SAEs, regardless of
 relatedness to the intervention, are to be reported to the local IRB as soon as possible, no later than 10 business
 days from the date the investigator or research staff becomes aware of the event/problem. Fill out an AE form, SAE
 form, and/or UPR form, obtain the study PI's signature, and submit to the Hunter IRB. Then forward each AE/SAE/
UPR form to Data Safety Monitoring Board as soon as possible. The study PI will maintain a record of all AEs/SAEs/
UPRs to report to the Hunter IRB in summary or table form at the end of the study.  The PI will notify NIMHD of any
 UPR, AE, or SAE promptly via email. Protocol Deviation/ViolationA protocol deviation or violation is any change,
 divergence, or departure from the study design or procedures of a research protocol. Investigators are required
 to conduct their research according to the plans reviewed and approved by the IRB.  Instances where this does

 not occur, either inadvertently due to circumstances beyond the investigator's control, or due to errors of omission
 or commission by research project staff, must be reported.Reporting Requirement: Fill out a Protocol Deviation/
Violation form, and submit to local IRB within 3 days of the occurrence (one day if there was harm to the participant).
 Also email the form (with encryption) to the PI and Study Coordinator, who will maintain a record of all Protocol
 Deviations/Violations to report to the Hunter IRB.
DSMB?s prospectively identified criteria for discontinuing the study
Adverse Event (AE): Defined as any untoward medical occurrence in a patient or research subject administered
 a pharmaceutical product or other research intervention and that does not necessarily have a causal relationship
 with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory
 finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product or research
 procedure, whether or not related to the medicinal (investigational) product or procedure.Negative events that occur
 during study involvement do not constitute adverse events unless they lead to physical harm (in which case the
 injury is the AE) or deterioration of mental health functioning (in which case the symptoms are the AE). Negative
 events that may potentially affect response to the intervention or study involvement should be reported as AEs. See
 IRB Reporting Requirements below for instructions on how to report these events. Examples might include legal
 problems or traumatic events.The program facilitator should query about adverse events (AEs) at every session
 by asking about any notable events since the last visit. These should be reviewed in a timely manner with the
 supervisor.Serious Adverse Event (SAE): An AE occurring in a patient or subject enrolled in a research study is
 serious if it results in any of the following outcomes: death, a life-threatening adverse drug experience, inpatient
 hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or is a
 congenital anomaly/birth defect.Unanticipated Problems Involving Risk (UPR): Defined as being (1) unexpected
 given the research procedures and characteristics of the population, (2) related (or possibly related) to participation
 in the research and (3) indicative that the research may place the subject or others at a greater risk of harm than
 was previously known.Examples of possible UPRs for psychotherapeutic interventions:1. Psychosis or mania2.
 New onset or clinically significant exacerbation of a psychiatric disorder3. Suicide and suicide attemptsAn incident,
 experience, or outcome that meets UPR criteria generally will warrant consideration of substantive changes in the
 research protocol or informed consent process/document or other corrective actions in order to protect the safety,
 welfare, or rights of subjects or others. Examples of corrective actions or substantive changes that might need to be
 considered in response to an unanticipated problem include: modification of inclusion or exclusion criteria to mitigate
 the newly identified risks;implementation of additional procedures for monitoring subjects;suspension of enrollment
 of new subjects;suspension of research procedures in currently enrolled subjects;modification of informed consent
 documents to include a description of newly recognized risks; andprovision of additional information about newly
 recognized risks to previously enrolled subjects.Reporting Requirement: All UPRs/AEs/SAEs, regardless of
 relatedness to the intervention, are to be reported to the local IRB as soon as possible, no later than 10 business
 days from the date the investigator or research staff becomes aware of the event/problem. Fill out an AE form, SAE
 form, and/or UPR form, obtain the study PI's signature, and submit to the Hunter IRB. Then forward each AE/SAE/
UPR form to Data Safety Monitoring Board as soon as possible. The study PI will maintain a record of all AEs/SAEs/
UPRs to report to the Hunter IRB in summary or table form at the end of the study.  The PI will notify NIMHD of any
 UPR, AE, or SAE promptly via email. Protocol Deviation/ViolationA protocol deviation or violation is any change,
 divergence, or departure from the study design or procedures of a research protocol. Investigators are required
 to conduct their research according to the plans reviewed and approved by the IRB.  Instances where this does
 not occur, either inadvertently due to circumstances beyond the investigator's control, or due to errors of omission
 or commission by research project staff, must be reported.Reporting Requirement: Fill out a Protocol Deviation/
Violation form, and submit to local IRB within 3 days of the occurrence (one day if there was harm to the participant).
 Also email the form (with encryption) to the PI and Study Coordinator, who will maintain a record of all Protocol
 Deviations/Violations to report to the Hunter IRB.
Name
Dennis Reidy
Affiliation
Georgia State University
Qualifications
Dennis Reidy, Ph.D., is a violence prevention researcher. He previously worked at the CDC for 8 years in the Center
 for Violence Prevention. He has extensive expertise in monitoring and evaluating the rigor of IPV clinical trials
 research. 
How frequently will the DSMB
 meet?
Quarterly
Provide description of stopping rules and justification for the stopping rules

Adverse Event (AE): Defined as any untoward medical occurrence in a patient or research subject administered
 a pharmaceutical product or other research intervention and that does not necessarily have a causal relationship
 with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory
 finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product or research
 procedure, whether or not related to the medicinal (investigational) product or procedure.Negative events that occur
 during study involvement do not constitute adverse events unless they lead to physical harm (in which case the
 injury is the AE) or deterioration of mental health functioning (in which case the symptoms are the AE). Negative
 events that may potentially affect response to the intervention or study involvement should be reported as AEs. See
 IRB Reporting Requirements below for instructions on how to report these events. Examples might include legal
 problems or traumatic events.The program facilitator should query about adverse events (AEs) at every session
 by asking about any notable events since the last visit. These should be reviewed in a timely manner with the
 supervisor.Serious Adverse Event (SAE): An AE occurring in a patient or subject enrolled in a research study is
 serious if it results in any of the following outcomes: death, a life-threatening adverse drug experience, inpatient
 hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or is a
 congenital anomaly/birth defect.Unanticipated Problems Involving Risk (UPR): Defined as being (1) unexpected
 given the research procedures and characteristics of the population, (2) related (or possibly related) to participation
 in the research and (3) indicative that the research may place the subject or others at a greater risk of harm than
 was previously known.Examples of possible UPRs for psychotherapeutic interventions:1. Psychosis or mania2.
 New onset or clinically significant exacerbation of a psychiatric disorder3. Suicide and suicide attemptsAn incident,
 experience, or outcome that meets UPR criteria generally will warrant consideration of substantive changes in the
 research protocol or informed consent process/document or other corrective actions in order to protect the safety,
 welfare, or rights of subjects or others. Examples of corrective actions or substantive changes that might need to be
 considered in response to an unanticipated problem include: modification of inclusion or exclusion criteria to mitigate
 the newly identified risks;implementation of additional procedures for monitoring subjects;suspension of enrollment
 of new subjects;suspension of research procedures in currently enrolled subjects;modification of informed consent
 documents to include a description of newly recognized risks; andprovision of additional information about newly
 recognized risks to previously enrolled subjects.Reporting Requirement: All UPRs/AEs/SAEs, regardless of
 relatedness to the intervention, are to be reported to the local IRB as soon as possible, no later than 10 business
 days from the date the investigator or research staff becomes aware of the event/problem. Fill out an AE form, SAE
 form, and/or UPR form, obtain the study PI's signature, and submit to the Hunter IRB. Then forward each AE/SAE/
UPR form to Data Safety Monitoring Board as soon as possible. The study PI will maintain a record of all AEs/SAEs/
UPRs to report to the Hunter IRB in summary or table form at the end of the study.  The PI will notify NIMHD of any
 UPR, AE, or SAE promptly via email. Protocol Deviation/ViolationA protocol deviation or violation is any change,
 divergence, or departure from the study design or procedures of a research protocol. Investigators are required
 to conduct their research according to the plans reviewed and approved by the IRB.  Instances where this does
 not occur, either inadvertently due to circumstances beyond the investigator's control, or due to errors of omission
 or commission by research project staff, must be reported.Reporting Requirement: Fill out a Protocol Deviation/
Violation form, and submit to local IRB within 3 days of the occurrence (one day if there was harm to the participant).
 Also email the form (with encryption) to the PI and Study Coordinator, who will maintain a record of all Protocol
 Deviations/Violations to report to the Hunter IRB.
DSMB?s prospectively identified criteria for discontinuing the study
Adverse Event (AE): Defined as any untoward medical occurrence in a patient or research subject administered
 a pharmaceutical product or other research intervention and that does not necessarily have a causal relationship
 with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory
 finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product or research
 procedure, whether or not related to the medicinal (investigational) product or procedure.Negative events that occur
 during study involvement do not constitute adverse events unless they lead to physical harm (in which case the
 injury is the AE) or deterioration of mental health functioning (in which case the symptoms are the AE). Negative
 events that may potentially affect response to the intervention or study involvement should be reported as AEs. See
 IRB Reporting Requirements below for instructions on how to report these events. Examples might include legal
 problems or traumatic events.The program facilitator should query about adverse events (AEs) at every session
 by asking about any notable events since the last visit. These should be reviewed in a timely manner with the
 supervisor.Serious Adverse Event (SAE): An AE occurring in a patient or subject enrolled in a research study is
 serious if it results in any of the following outcomes: death, a life-threatening adverse drug experience, inpatient
 hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or is a
 congenital anomaly/birth defect.Unanticipated Problems Involving Risk (UPR): Defined as being (1) unexpected
 given the research procedures and characteristics of the population, (2) related (or possibly related) to participation
 in the research and (3) indicative that the research may place the subject or others at a greater risk of harm than
 was previously known.Examples of possible UPRs for psychotherapeutic interventions:1. Psychosis or mania2.

 New onset or clinically significant exacerbation of a psychiatric disorder3. Suicide and suicide attemptsAn incident,
 experience, or outcome that meets UPR criteria generally will warrant consideration of substantive changes in the
 research protocol or informed consent process/document or other corrective actions in order to protect the safety,
 welfare, or rights of subjects or others. Examples of corrective actions or substantive changes that might need to be
 considered in response to an unanticipated problem include: modification of inclusion or exclusion criteria to mitigate
 the newly identified risks;implementation of additional procedures for monitoring subjects;suspension of enrollment
 of new subjects;suspension of research procedures in currently enrolled subjects;modification of informed consent
 documents to include a description of newly recognized risks; andprovision of additional information about newly
 recognized risks to previously enrolled subjects.Reporting Requirement: All UPRs/AEs/SAEs, regardless of
 relatedness to the intervention, are to be reported to the local IRB as soon as possible, no later than 10 business
 days from the date the investigator or research staff becomes aware of the event/problem. Fill out an AE form, SAE
 form, and/or UPR form, obtain the study PI's signature, and submit to the Hunter IRB. Then forward each AE/SAE/
UPR form to Data Safety Monitoring Board as soon as possible. The study PI will maintain a record of all AEs/SAEs/
UPRs to report to the Hunter IRB in summary or table form at the end of the study.  The PI will notify NIMHD of any
 UPR, AE, or SAE promptly via email. Protocol Deviation/ViolationA protocol deviation or violation is any change,
 divergence, or departure from the study design or procedures of a research protocol. Investigators are required
 to conduct their research according to the plans reviewed and approved by the IRB.  Instances where this does
 not occur, either inadvertently due to circumstances beyond the investigator's control, or due to errors of omission
 or commission by research project staff, must be reported.Reporting Requirement: Fill out a Protocol Deviation/
Violation form, and submit to local IRB within 3 days of the occurrence (one day if there was harm to the participant).
 Also email the form (with encryption) to the PI and Study Coordinator, who will maintain a record of all Protocol
 Deviations/Violations to report to the Hunter IRB.
Page 20 of 36

University Integrated Institutional Review Board
205 East 42nd Street
New York, NY 10017
 http://www.cuny.edu/research/compliance.html
2021-0291
Initial Application
Danielle Berke
8. Funding - Sources
Grant or Contract Title
Empowerment Self-Defense Training for the Prevention of Victimization of Transgender
 Women
Grant or Contract 
 Number
R21MD014807-01A1
Funding Status: 
Funded
Grant/Contract PI:
Danielle Berke
Department
Hunter College
Division
Phone
Email
db2800@hunter.cuny.edu
Funding Source:
National Institutes of Health (NIH)
Contact
Funding Category:
Federal
Do the protocol and
 funding proposal
 match?
No
Identify the substantive
 differences
The funding protocol includes a proposal for a two study project: Study 1 entails the
 qualitative interview study described in protocol number 2020-0017. Study 2 entails a
 pilot efficacy trial of the tailored ESD curriculum described herein. In this protocol, we
 are exclusively seeking IRB approval for Study 2. Other changes from the R21 include:
 Compensation for survey completion will now be in the form of an Amazon gift card
 for ease of remote distribution. Study documents will now be stored electronically on a
 password-protected secure lab server accessible only by lab personnel. Recruitment
 procedures have also been expanded to include recruitment outside of The Center.
Page 21 of 36

University Integrated Institutional Review Board
205 East 42nd Street
New York, NY 10017
 http://www.cuny.edu/research/compliance.html
2021-0291
Initial Application
Danielle Berke
9. Participants - Populations
Age Range(s)
18 to 65 years
Targeted Population(s)
Healthy Adults
Page 22 of 36

University Integrated Institutional Review Board
205 East 42nd Street
New York, NY 10017
 http://www.cuny.edu/research/compliance.html
2021-0291
Initial Application
Danielle Berke
10. Participants - Projected Enrollment
Please provide the upper limit of anticipated enrollment
Projected Enrollment
80
Page 23 of 36

University Integrated Institutional Review Board
205 East 42nd Street
New York, NY 10017
 http://www.cuny.edu/research/compliance.html
2021-0291
Initial Application
Danielle Berke
11. Participants - Eligibility
Inclusion Criteria and Rationale
Transgender women (i.e., male assigned at birth, currently identified on the transfeminine spectrum) between the
 ages of 18 and 65. This inclusion criteria is necessary to iteratively tailor and finalize the adapted ESD violence
 prevention program for transgender women.
Exclusion Criteria and Rationale
Cisgender men and women, and transgender men will be excluded, as our research question pertains to trans
 women specifically. 
Page 24 of 36

University Integrated Institutional Review Board
205 East 42nd Street
New York, NY 10017
 http://www.cuny.edu/research/compliance.html
2021-0291
Initial Application
Danielle Berke
12. Participants - Recruitment
Method(s)
Flyers, posters, brochures or print ads,
 Website posting, Other
Outline the recruitment process in a step-by-step fashion
The LGBT Community Center of New York (The Center) will serve as the primary recruitment site for participants.
 The LGBT Center has over 200 TW who utilize their services each year, and has extensive experience recruiting
 participants for similar projects using both active and passive recruitment methods. Potential participants will
 be identified through the PI's professional network with The Center staff.  Additional recruitment will be done
 using snowball sampling techniques, with fliers posted around The Center and Hunter College, and recruitment
 through social media (e.g., Facebook, Twitter) and banner ads on social networking/dating sites (e.g., Scruff, BGC
 Live, OK Cupid) that are trans-inclusive and through dissemination of paper and/or electronic recruitment flyers
 with leaders of community organizations that connect transgender individuals (e.g., AVP; Callen Lorde, Trans-
lantinx network). Participants from prior studies who consented to future contact will be sent the study flyer by
 email.Various recruitment flyers, banner ads, and email advertisements will be generated by combining content
 and images contained in the below attachment (see "Recruitment Text and Images.") tailored to local formatting
 demands.Participants recruited through social media/networking sites and community recruitment will self-refer to
 the study by following the link provided in recruitment materials to the online Qualtrics screener consent form and
 screener questions (see "ESD for TW P2 Screening Consent and Survey"). Participants who meet eligibility criteria
 based on the screener questions will be able to self-administer online consent through Qualtrics. They will also
 be invited to contact study staff via email or telephone to complete Oral consent or to ask any questions they may
 have. Following completion of consent, participants will be linked to the a survey where they will be asked to provide
 contact information for themselves and one friend/family member should we become unable to reach them (see
 ESD Phase 2 Contact Sheet in Attachments Tab). This contact sheet will be updated when participants complete
 their second survey (following course completion) (see ESD Phase 2 F/U Contact Sheet in Attachments Tab). 
  Reviewer should be able to clearly follow your process from subject identification to
 recruitment        Are recruitment methods well defined?  Are the location and timing of the
 recruitment process appropriate?                     
Indicate how and where these materials will be displayed, distributed or published
The LGBT Community Center of New York (The Center) will serve as the primary recruitment site for qualitative
 interview participants. The LGBT Center has over 200 TW who utilize their services each year, and has extensive
 experience recruiting participants for similar projects using both active and passive recruitment methods. Potential
 participants will be identified through the PI's professional network with The Center staff.  Additional recruitment
 will be done using snowball sampling techniques, with fliers posted around The Center and Hunter College, and
 recruitment through social media (e.g., Facebook, Twitter) and banner ads on social networking/dating sites
 (e.g., Scruff, BGC Live, OK Cupid) that are trans-inclusive and through dissemination of paper and/or electronic
 recruitment flyers with leaders of community organizations that connect transgender individuals (e.g., AVP; Callen
 Lorde, Trans-lantinx network). Participants from prior studies who consented to future contact will be sent the study
 flyer by email. Various recruitment flyers, banner ads, and email advertisements will be generated by combining
 content and images contained in the below attachment (see "Recruitment Text and Images.") tailored to local
 formatting demands.Regardless of recruitment method, potential participants will complete the screener by following
 the link provided in recruitment materials to the online Qualtrics screener consent form and screener questions (see
 "ESD for TW P2 Screening Consent and Survey").
Attach copy of each
Type
Flyers

Title
Recruitment Text and Images
                                                                 var toDel = model.getValue("document/@docLink",
 contextNode);   if(toDel) model.Frm.deleteDocumentRef(toDel, ins);     
Identify the web site(s) by name and URL
For social media/networking site recruitment we will post on websites such as Reddit, Instagram, Instagram,
 Facebook, Twitter, SCRUFF, BGC Live, OK Cupid, and Lex, and through dissemination of paper and/or electronic
 recruitment flyers with leaders of community organizations that connect transgender individuals (e.g., AVP; Callen
 Lorde, Trans-lantinx network). 
Indicate who controls the web site
These social media/networking sites are independently operated.
Attach text of web site content you will use
Type
Web site postings
Title
Recruitment Text and Images
Page 26 of 36

University Integrated Institutional Review Board
205 East 42nd Street
New York, NY 10017
 http://www.cuny.edu/research/compliance.html
2021-0291
Initial Application
Danielle Berke
13. Participants - Screening
Authorizes IRBs to approve a research proposal to obtain information directly from a
 prospective subject, or to obtain already collected identifiable private information or
 identifiable biospecimens by accessing records or stored biospecimens for the purposes
 of screening, recruiting or eligibility assessment, without informed consent of the
 prospective subject or the subjects legally authorized representative.
Method(s)
Internet based screening
Internet based screening
Identify the web site that will be used for screening by name and URL
Qualtrics (Qualtrics.com)
Indicate who controls the web site
Qualtrics XM owns this site and associated products and services. Control is shared with a local "brand
 administrators" at Hunter College who oversees operation of the local Qualtrics license. 
Attach the script for Internet screening
Title
ESD for TW P2 Screening Consent and
 Survey
Description of Screening Activities
Outline the screening procedures in a step-by-step fashion, including a timeline
Upon identification of an eligible participant, whether the participant contacts the PI after seeing a flyer, or participant
 hears of the study through snowball sampling techniques, the potential participant will be given a link which will
 direct them to a set of screening questions. Screening questions will establish that the participant identifies as a
 transfeminine/trans woman individual, is age 18-65, and that they understand the procedures and commitment
 involved in the study.
Page 27 of 36

University Integrated Institutional Review Board
205 East 42nd Street
New York, NY 10017
 http://www.cuny.edu/research/compliance.html
2021-0291
Initial Application
Danielle Berke
14. Participants - Consent
Documented informed consent and/
or parent or guardian permission
No
Are you requesting Broad Consent
No
Oral or internet based informed
 consent and/or parent or guardian
 permission
Yes
Waiver of informed consent and/or
 parent or guardian permission
No
Waiver of Informed Consent
 Involving Public Benefit and
 Service Programs
No
Alteration of Informed Consent
 Involving Public Benefit and
 Service Programs
No
Oral or internet based informed consent and/or parent or guardian permission
Select the criteria for a waiver of
 documented informed consent that
 applies to your research
The research involves minimal risk and
 includes no procedures for which written
 consent is normally required outside of the
 research context.
Is this a longitudinal study?
Yes
Please indicate how frequently you will re-consent participants
Consent will occur once at study enrollment. Participants will not be reconsented before the two follow-up surveys as
 participants will have a copy of the consent form. Participants will have lab contact information if they wish to obtain
 a new copy of the consent form. 
Page 28 of 36

University Integrated Institutional Review Board
205 East 42nd Street
New York, NY 10017
 http://www.cuny.edu/research/compliance.html
2021-0291
Initial Application
Danielle Berke
15. Participants - Compensation
Type
Monetary
Amount
$180.00
Justification
Time
Description (Address
 the compensation
 schedule for participants
 that withdraw from the
 research protocol.)
Compensation will be in the form of an Amazon gift card. To promote retention,
 financial compensation for study participation will be distributed in three payments
 paired with the completion of each of the three surveys. Compensation increases
 overtime (i.e., $40 for baseline, $30 for followup directly after course completion and
 $30 for completion of the exit interview after course completion, and $80 for 6-month
 follow-up). Participants who consent to take part in the ESD training and self-report
 questionnaire sessions will be informed that they are free to withdraw from the ESD
 program and/or the research study at any time, without penalty. As such, participants
 will be compensated for any questionnaires completed, regardless of premature
 withdrawal from the ESD program.
When will participants be
 compensated?
End of each visit
Explain when
Describe mechanism
 in place to ensure
 confidentiality
 when distributing
 compensation
Participants will be sent an email with a link to an Amazon gift card code upon
 completion of each questionnaire. Emails will be collected in a separate Qualtrics
 survey at the time of enrollment that will collect email contact information. This
 information will be kept separate from participation study data and any identifying
 information, ensuring confidentiality.
Type
Monetary
Amount
$50.00
Justification
Time
Description (Address
 the compensation
 schedule for participants
 that withdraw from the
 research protocol.)
In addition to compensation provided for surveys completed at baseline, directly
 following the course, and 6 months after the course (outlined above) participants
 will receive $10 compensation for each of the five course session evaluations they
 complete (one per class), to earn up to $50 total. This cash incentive will be distributed
 after the third class (up to $30) and after the fifth class (up to $20).
When will participants be
 compensated?
End of each visit
Explain when
Describe mechanism
 in place to ensure
 confidentiality
 when distributing
 compensation
Participants will receive this cash incentive as they leave the third and fifth course
 sessions. As participants will be receiving cash, their name or other identifying
 information will not be attached to the compensation in any way. Additionally, as the
 course will be held in a private location at God"s Love We Deliver, confidentiality of
 participants as they receive this compensation will be maintained, as only course
 participants and course facilitators will be present during compensation distribution.

Page 30 of 36

University Integrated Institutional Review Board
205 East 42nd Street
New York, NY 10017
 http://www.cuny.edu/research/compliance.html
2021-0291
Initial Application
Danielle Berke
16. Participants - Privacy and Confidentiality
Describe the mechanisms in place to protect the privacy of participants during recruitment, consent process
 and research procedures
Strict confidentiality will be maintained and all data will be assigned a subject number. Participants will complete
 screening individually at a time most convenient for them. Screening procedures do not involve the collection of
 identifying information. If participant completes internet-based consent, participants identities will not be known to
 study staff until they have provided consent. If participant completes oral consent, no identifying information will be
 collected until oral consent is received.  Strict confidentiality will be maintained and all data will be labeled using the
 participant's self-assigned ID. Participants will complete screening individually at a time most convenient for them.
 Screening procedures do not involve the collection of identifying information. Consent (if completed online) and
 self-report questionnaires will be self-administered by the participant at a time most convenient and comfortable for
 them. If participants opt to complete consent orally, a single member of the lab is responsible for guiding participants
 through the consenting process, and the member of the lab will complete this in a private space. The participant
 will complete baseline and follow-up self-report questionnaire batteries online at a time and place most comfortable
 to them, or on their personal device or lab iPad at God's Love We Deliver (before or after the first and last course
 sessions). The 6 month follow-up survey must be completed remotely.  The institutional Zoom account of the PI
 will be used for video interviewing. Participants will receive a secure and private Zoom link to access the video
 interview, which will restrict access to any users other than the participant and the single member of the research
 staff responsible for administering the interview. Research staff will conduct the video interview in a private room,
 and the participant will have the ability to participate in the interview at a time and location most comfortable for
 them, thus protecting the privacy of the participant. During the consenting process, we will communicate with all
 participants that they have the right to download an audio and video recording of the interview. If the participant
 does not make this request, electronic copies of study data will be securely downloaded as two separate files (an
 audio-only and video recording file) to a local server from Zoom. Local video-files will be immediately deleted. The
 audio-only file will be immediately uploaded for storage on an online password-protected, backed up lab server that
 is accessible only by lab personnel. Local audio file copies will be deleted immediately once uploaded to the secure
 drive. The audio recording files will be labeled with a unique participant ID number, and will contain participants'
 voice but will not contain names. The labels on these files will constitute a link between identifiable information
 and the participant ID number, which will be used to link other study data together.  Only members of the study
 team will be able to access the audio recordings taken during the interview session. Participant data will remain
 confidential.If the participant makes the request to have a personal copy of the interview, we will store the audio and
 video recording file in Zoom for one week, during which the participant will have one week to download and store
 the file using a secure Zoom link to the recording, sent via email. At the end of the one week the video recording
 will be downloaded such that audio file and video file are downloaded as separate files; the video file will be deleted
 immediately and will never be saved or stored. The audio-only file will be saved for transcription and immediately
 uploaded to the secure password-protected online lab server.Strict confidentiality will be maintained and all data will
 be coded by a subject number. Personal identifier records will be kept in a secure password-protected online server
 accessible only by research personnel. Any forms with identifying information will be stored separately from other
 study data. Records will be kept confidential to the level allowed by law and only the staff assigned to the study will
 have access to non-anonymous records. Information provided by study participants will not be released to outside
 sources unless written consent is provided by the study participant. Participants in the course will be made aware
 prior to consenting that participation involves a group Empowerment-Self Defense program where other participants
 will be present during physical training and group discussions. All program participants will be asked not to share
 any information about other program participants that may have come up during the program with anyone outside
 of the group. However, complete confidentiality cannot be guaranteed. For the interview administration, only the
 interviewer will be present in the private virtual call.  Participants will receive a secure and private link to access
 the video-conferencing exit interview after course completion, which will restrict access to any users other than
 the participant and the single member of the research staff responsible for administering the interview. Research

 staff will conduct the video interview in a private room, and the participant will have the ability to participate in the
 interview at a time and location most comfortable for them, thus protecting the privacy of the participant. We have
 considered the privacy concerns associated with including LGBTQ status in recruitment materials placed in public
 locations, and have determined that the benefits of this procedure outweigh its minimal risk. Individuals who see the
 flyer will have complete control over whether or not they decide to respond to the advertisement or to take a tab from
 the advertisement when they see it. By including transgender population recruitment information in the flyer, we are
 minimizing the number of ineligible people who will complete the screening process. We also anticipate that most
 participants will be recruited via online platforms using online flyers, thus allowing for privacy when interacting with
 study flyers. 
Describe the mechanisms in place to maintain confidentiality of participant data
Screening and survey responses as well as the internet-based consent form will be submitted to Qualtrics free
 of identifiable information. Electronic copies of those data will be stored on a secure password-protected online
 backed up lab server that is accessible only by lab personnel. If the participant completes consent orally, the oral
 consent form will also be stored on a secure password-protected online lab server free of identifiable information
 (containing participant ID only). Participant contact sheets will be stored separately from the study data, so that the
 study data will be collected using only a unique participant ID number, and are not identifiable by participant name.
 The self-assigned participant ID number will be used to link consents, questionnaire responses and interviews
 to one another. The Qualtrics anonymize responses feature will be used to ensure that IP addresses or other
 identifying information are not collected. Electronic copies of those data will be stored on a secure password-
protected online backed up lab server in an encrypted and password protected data file (consistent with section 12
 of CUNY Policy on Acceptable Use of Computer Resources) that is accessible only by lab personnel. Qualtrics'
 database does not hold sensitive or confidential response information after it is downloaded, however they do hold
 all survey responses in their data centers. The data centers utilize many security measures. Qualtrics' database
 access is restricted and requires authorization. All computer equipment (servers, SANs, switches, routers, etc.)
 is redundant and is located in secure, environmentally controlled data centers with 24/7 monitoring. Web traffic
 does not directly access the database and database requests are reversed proxy via an application server to the
 database. All information is secured via industry standard firewalls and stringent IT security policies and procedures.
 Qualtrics utilizes industry standard web application firewalls and DDOS protection. At no time will the downloaded
 or Qualtrics data be physically portable; the server system negates any need for USB drives or CDs for electronic
 data. A final copy of the downloaded data will be stored for a minimum of three years after the study is complete
 and closed out with IRB.  If the participant makes the request to have a personal copy of the interview, we will
 store the audio and video recording file in Zoom for one week, during which the participant will have one week
 to download and store the file using a secure Zoom link to the recording, sent via email. At the end of the one
 week the video recording will be downloaded such that audio file and video file are downloaded as separate files;
 the video file will be deleted immediately and will never be saved or stored. The audio-only file will be saved for
 transcription and immediately uploaded to the secure password-protected online lab server.  Audio files from the
 secure Zoom video interview will be uploaded to the secure password-protected online lab server. Only members
 of the research staff will be able to access the audio recordings taken during the lab session, and the participant
 if they request a personal copy. Participants will be informed that their responses will remain confidential, and
 that they have the right to erase the recording taken as part of this research. The audio recording will be stored
 electronically on a secure password-protected online lab server, labeled with the participant-generated ID number.
 The audio recordings will be used for verbatim (de-identified) audio transcription. Upon transcription, audio files
 will be stored for one additional week. This will allow an additional lab member to perform a quality-check on the
 transcription. Following quality assurance, the audio files will be destroyed.    Personal identifier records will be
 kept in a secure online password-protected file on the secure password-protected online server, and any forms
 with identifying information will be stored separately from other study data.Personal identifier records will be kept
 in a secure online password-protected file on the secure password-protected online server, and any forms with
 identifying information will be stored separately from other study data. Records will be kept confidential to the level
 allowed by law and only the staff assigned to the study will have access to non-deidentified records. Information
 provided by study participants will not be released to outside sources.Data will not be stored or distributed for future
 studies. Regarding participants who agree to be contacted for future studies - we will store this contact information
 in a separate password protected file, on our secure online password-protected server. We will assign a new ID
 number to the current participant's study ID number. Participant's contact information will be stored with this new
 ID. The file that links participants' contact information and new ID will be stored in a separate password protected
 file, on the secure online password-protected lab server. The document that links both ID numbers will be password
 protected and stored in a separate password-protected file on the secure online password-protected lab server. If an
 individual requests their contact information be removed, we will remove their contact information from our database.
  Participant contact information will only be accessible to approved personnel.DSM Board Information Outlined in the
 NIH Grant: A DSMB is being created for this study by the study PI and NIH program officer. The PI has proposed

 a board comprising of; Katie Edwards, Jillian Shipherd, and Dennis Reidy (Outlined in the Research Design tab).
 The DSMB is tasked with independently ensuring the safety of study participants and scientific goals. The DSMB will
 review the initial protocol and any proposed amendments, meet and complete reports quarterly, perform expedited
 monitoring of all serious adverse events, perform ongoing monitoring of drop-outs and non-serious adverse events,
 determine whether study procedures should be changed or the study should be halted for reasons related to
 the safety of study subjects, and perform periodic review of the completeness and validity of data to be used for
 analysis of safety and efficacy.  The DSMB will also ensure subject privacy and research data confidentiality. A
 statistical penalty will not be assessed for the ongoing unblended review of safety by the DSMB. Unblinded data
 will not be released to investigators unless necessary for safety reasons. Suspected information security and
 privacy incidents will be reported within one hour to the DSM Board.Adverse Event (AE): Defined as any untoward
 medical occurrence in a patient or research subject administered a pharmaceutical product or other research
 intervention and that does not necessarily have a causal relationship with this treatment. An AE can therefore be
 any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally
 associated with the use of a medicinal (investigational) product or research procedure, whether or not related to
 the medicinal (investigational) product or procedure.Negative events that occur during study involvement do not
 constitute adverse events unless they lead to physical harm (in which case the injury is the AE) or deterioration
 of mental health functioning (in which case the symptoms are the AE). Negative events that may potentially affect
 response to the intervention or study involvement should be reported as AEs. See IRB Reporting Requirements
 below for instructions on how to report these events. Examples might include legal problems or traumatic events.The
 program facilitator should query about adverse events (AEs) at every session by asking about any notable events
 since the last visit. These should be reviewed in a timely manner with the supervisor.Serious Adverse Event (SAE):
 An AE occurring in a patient or subject enrolled in a research study is serious if it results in any of the following
 outcomes: death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing
 hospitalization, a persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.Unanticipated
 Problems Involving Risk (UPR): Defined as being (1) unexpected given the research procedures and characteristics
 of the population, (2) related (or possibly related) to participation in the research and (3) indicative that the research
 may place the subject or others at a greater risk of harm than was previously known.Examples of possible UPRs
 for psychotherapeutic interventions:1. Psychosis or mania2. New onset or clinically significant exacerbation of a
 psychiatric disorder3. Suicide and suicide attemptsAn incident, experience, or outcome that meets UPR criteria
 generally will warrant consideration of substantive changes in the research protocol or informed consent process/
document or other corrective actions in order to protect the safety, welfare, or rights of subjects or others. Examples
 of corrective actions or substantive changes that might need to be considered in response to an unanticipated
 problem include: modification of inclusion or exclusion criteria to mitigate the newly identified risks;implementation
 of additional procedures for monitoring subjects;suspension of enrollment of new subjects;suspension of research
 procedures in currently enrolled subjects;modification of informed consent documents to include a description of
 newly recognized risks; andprovision of additional information about newly recognized risks to previously enrolled
 subjects.Reporting Requirement: All UPRs/AEs/SAEs, regardless of relatedness to the intervention, are to be
 reported to the local IRB as soon as possible, no later than 10 business days from the date the investigator or
 research staff becomes aware of the event/problem. Fill out an AE form, SAE form, and/or UPR form, obtain the
 study PI's signature, and submit to the Hunter IRB. Then forward each AE/SAE/UPR form to Data Safety Monitoring
 Board as soon as possible. The study PI will maintain a record of all AEs/SAEs/UPRs to report to the Hunter IRB
 in summary or table form at the end of the study.  The PI will notify NIMHD of any UPR, AE, or SAE promptly via
 email. Protocol Deviation/ViolationA protocol deviation or violation is any change, divergence, or departure from the
 study design or procedures of a research protocol. Investigators are required to conduct their research according
 to the plans reviewed and approved by the IRB.  Instances where this does not occur, either inadvertently due to
 circumstances beyond the investigator's control, or due to errors of omission or commission by research project
 staff, must be reported.Reporting Requirement: Fill out a Protocol Deviation/Violation form, and submit to local IRB
 within 3 days of the occurrence (one day if there was harm to the participant). Also email the form (with encryption)
 to the PI and Study Coordinator, who will maintain a record of all Protocol Deviations/Violations to report to the
 Hunter IRB.
How will you store participant data
With participant's direct identifier(s)
List the identifier(s) that will be stored
Audio recordings containing participants' voices, and any other identifying information that remains on the recording
 after participants have been made aware of/exercised their right to erase the recording, will be stored electronically,
 labeled with the participant-generated ID number.  Regarding participants who agree to be contacted for future
 studies - we will store this contact information in a separate password protected file, on our secure online password-
protected server. We will assign a new ID number to the current participant's study ID number. Participant's contact
 information will be stored with this new ID. The file that links participants' contact information and new ID will be

 stored in a separate password protected file, on the secure online password-protected lab server. The document
 that links both ID numbers will be password protected and stored in a separate password-protected file on the
 secure online password-protected lab server. If an individual requests their contact information be removed, we
 will remove their contact information from our database.  Participant contact information will only be accessible to
 approved personnel. 
Will identifiers be deleted (and data
 anonymized) at a later date? 
No
What will you do with the data once
 the research has been completed?
Retain data for three years, or longer when
 required by the study sponsor, then destroy
 it.
Page 34 of 36

University Integrated Institutional Review Board
205 East 42nd Street
New York, NY 10017
 http://www.cuny.edu/research/compliance.html
2021-0291
Initial Application
Danielle Berke
17. Attachments
Type
Name
Version Status
Filename
Uploaded
 Date
Curriculum Vitae
CITI HSR Certificate-
 Maiya Hotchkiss
1
approvedHSR_Hotchkiss.pdf
10/12/2020
Curriculum Vitae
CITI HSR Certificate-
 Ashley Smith
1
approvedAshley Smith_CITI
 HSR_CompletionCert_08.07.20.pdf
10/12/2020
Curriculum Vitae
CITI HSR Certificate-
 Danielle Berke
1
approvedDB_CITI_HSR.pdf
10/12/2020
Curriculum Vitae
CITI COI Certificate-
 Danielle Berke
1
approvedDB_CITI_COI.pdf
03/18/2021
Curriculum Vitae
CITI HSR Certificate-
 Craig Gilbert
1
approvedCRAIG HSR.pdf
03/18/2021
Curriculum Vitae
CITI HSR Certificate-
 Lisbeth Rubi
1
approvedRubi_HSR
 Certificate.pdf
03/18/2021
Curriculum Vitae
CITI HSR Certificate-
 Jessica Palatnik
1
approvedCertificate.pdf
03/18/2021
Funding proposal/
Grant application/
Contract
NIH R21 Grant
1
approved4374967_Egrant
 (1).pdf
03/25/2021
Advertisement
RecruitmentMaterials_ESDTWPhase2_03_25_21_DB_MH
 (1).docx
1
approvedRecruitmentMaterials_ESDTWPhase2_03_25_21_DB_MH
 (1).docx
03/30/2021
Website Text
RecruitmentMaterials_ESDTWPhase2_03_25_21_DB_MH
 (1).docx
1
approvedRecruitmentMaterials_ESDTWPhase2_03_25_21_DB_MH
 (1).docx
03/30/2021
Internet Screening
 Script
Screening Consent
 and Survey
 03:25:21.pdf
1
approvedScreening Consent
 and Survey
 03:25:21.pdf
03/30/2021
Informed Consent/
Permission
 Document
Verbal Consent
 Script
1
approvedOral Informed
 Consent Script -
 ESD TW Phase 2
 03:30:21.docx
03/30/2021
Informed Consent/
Permission
 Document
Online Consent
1
approvedOnline Consent ESD
 P2.pdf
03/30/2021
Email Text
Scheduling Text/Call/
Email Templates
1
approvedScheduling Email
 Template_03:25:21.docx
03/30/2021
Survey/Questionaire
ESD Phase 2
 Contact Sheet
1
approvedESD Phase 2
 Contact:Informant:Scheduling
 Sheet.pdf
03/30/2021
Survey/Questionaire
ESD Phase 2 F/U
 Contact Sheet
1
approvedESD P2 F:U Contact
 Sheet.pdf
03/30/2021
Survey(s)
Assessment
 packet_ESD for
 TW_10.12.20 (3).pdf
1
approvedAssessment
 packet_ESD for
 TW_10.12.20 (3).pdf
03/30/2021

 
Page 36 of 36