Understanding and Reducing Health Disparities Faced by Transgender and Gender Non-conforming (TGNC) Individuals in Cleveland Through TGNC-Directed Advocacy
Phase: NA
Conditions: Gender Identity
Sponsor: Case Western Reserve University

Title: TRANSLATE: Transgender and Gender Nonconforming Individuals' Access to Healthcare 
Identifiers: 
NCT03808883    
Unique Protocol ID: IRB-2018-2194 
 Last Update: 5/11/2018

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PROTOCOL TITLE:
Proposal for Understanding and Reducing Health Disparities Faced by Transgender and Gender 
Nonconforming (TGNC) Individuals in Cleveland through TGNC-Directed Advocacy
PRINCIPAL INVESTIGATOR:
Name Misty Luminais
Primary Department Begun Center for Violence Prevention Research & Education
Telephone Number 216-368-1329
Email Address misty.luminais@case.edu
UH FACULTY ADVISOR:
If the principal investigator’s primary role at UH is resident, fellow or student, identify a faculty 
advisor. N/A
OTHER DEPARTMENTS INVOLVED IN THIS STUDY (IF APPLICABLE):
VERSION NUMBER:
2.0 
DATE: 
11/5/2018 
5/11/2018

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Indicate the origin of this protocol (who conceived of and leads the development of the 
protocol regardless of funding):
☒     Investigator initiated (Investigator(s) developed protocol, regardless of funding)
☐     Industry (Pharmaceutical, Device, etc.) (Industry developed protocol)
☐     Federal (NIH, DOD, etc.)
☐     Cooperative Group (SWOG, GOG, etc.)
☐     Other - Please specify:    
Funding
NIH pass through grant from Centers for Reducing Health Disparities (MetroHealth)
Objectives
RESEARCH QUESTION: Do interactive dialogues between trans and gender nonconforming 
(TGNC) -  trained in health literacy and advocacy - and healthcare providers and staff seeking 
cultural competency around TGNC primary care result in 1) more confidence on the part of 
TGNC in navigating the healthcare system, 2) more confidence on the part of providers in 
responding to the needs of TGNC patients, (sub question – is there a measurable difference 
between types of providers’ responses to trainings, i.e., medical doctors compared to nurse 
practitioners) 3) person-to-person networks between the two populations resulting in ongoing, 
sustainable dialogue, 4) TGNC individuals prepared to train other TGNC in a peer-to-peer role to 
act as advocates on behalf of the TGNC population within the healthcare system, all of which 
ultimately result in increased access to and use of primary care services and reduce the health 
disparities faced by TGNC individuals?
Background
Research has shown repeatedly that transgender people are more at risk for poor health outcomes than 
the general population and even others with whom they share the LGBTQ+ moniker (Bradford, Reisner, 
Honnold, & Xavier, 2013; Grant, Mottet, Tanis, Herman, & Keisling, 2011; James et al., 2016; NPR, 
Robert Wood Johnson Foundation, & Harvard T.H. Chan School of Public Health, 2017; Whitehead, 
Shaver, & Stephenson, 2016). Although little data is available, Ohio is consistent with larger national 
trends of transgender people having negative interactions in healthcare settings (National Center for 
Transgender Equality, 2016; National Center for Transgender Equality & National Gay and Lesbian Task 
Force, 2011). The paucity of research of transgender health is a possible source of health disparities 
(Institute of Medicine (US) Committee on Lesbian, 2011; Shelton & Bond, 2017; Snyder, Burack, & 
Petrova, 2017; Stephenson et al., 2017) and researchers have become more cognizant of barriers faced 
by LGBT people to participate in research (Fisher & Mustanski, 2014; Murphy, 2014; Owen-Smith et al., 
2016). Gender nonconforming individuals may face even greater challenges in receiving appropriate 
care, as they refute the gender binary so ingrained in medicine (Eckstrand, Ng, & Potter, 2016; Lykens, 
LeBlanc, & Bockting, 2018). Work done on the stigmatization of TGNC individuals broadly (Grant et al., 
2011; James et al., 2016; NPR et al., 2017) and on the treatment of TGNC individuals medically (Bradford 
et al., 2013; Cruz, 2014; Shelton & Bond, 2017) recognizes their experiences are influenced by other 
aspects of identity, including race and class. TGNC individuals of color are even more likely to have 
negative experiences with healthcare providers than their white counterparts (Grant et al., 2011; NPR et 
al., 2017). The recent uptick in research specific to TGNC health needs (Imborek, Graf, & McCune, 2017; 
Thompson, 2017; Whitman & Han, 2017) was spurred in part by federal funding opportunities (Institute 
of Medicine (US) Committee on Lesbian, 2011) but mostly as a result of LGBTQ+ advocacy (Pandya, 

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2014; The Fenway Institute, 2017). Studies on reducing LGBTQ+ health disparities have included 
restructuring electronic health records and data collection methods (Cahill et al., 2014; Callahan, 
Hazarian, Yarborough, & Sánchez, 2014), addressing myths and establishing best practices (McNamara & 
Ng, 2016), and macro-analysis of intersectionality between institutions providing transgender healthcare 
(Stroumsa, 2014). More in line with our proposal are studies that focus on direct, personal intervention 
with healthcare providers (Lelutiu-Weinberger et al., 2016), advocacy led by community members 
(Cartwright, Desiderio, Green, Persson, & Tescher, 2012), and based directly on self-assessed patient 
needs (Alpert, CichoskiKelly, & Fox, 2017; Bevan, 2013). The annual Philadelphia Trans Wellness 
Conference includes a professional track for medical providers on issues such as primary care 
management and gender affirming medical procedures, exemplifying both a community need for 
improved quality of care and interest within in the medical field (Mazzoni Center, 2018).
Inclusion and Exclusion Criteria
Directions: Describe how individuals will be screened for eligibility. Using the tables below, 
describe the inclusion and exclusion criteria that will define who will be included and 
excluded in your final study sample.
 
Inclusion
1.
Age range: 14 years old and up
2.
Self-identifies as transgender or gender non-conforming
3.
4.
Exclusion
1.
Under the age of 14
2.
Non-English speaking
3.
4.
Number of Research Participants
We will enroll 20 participants in the transgender/gender non-conforming cohort, 12 medical 
providers, and 12 clinic staff.
Vulnerable Populations
1. Indicate specifically if you will include each of the following special populations by 
checking the appropriate box: 
☐
Adults unable to consent
☒
Minors (infants, children, teenagers) 
☐
Wards of the state
☐
Foster Children
☐
Pregnant Women 
☐
Neonates
☐
Neonates of Uncertain Viability
☐
Employees of CWRU or UHHS

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☐
Prisoners
☐
Illiterate Individuals
☐
Non-English Speaking
☐
University Students
☐
None
2. If the research involves individuals that are included in a vulnerable population, describe 
the additional safeguards included to protect the rights and welfare of the individuals for 
each population indicated. Minors (aged 14-17) will be invited to participate in the study 
with their parent’s permission. Assent forms with appropriate language will be provided 
and youth will be invited to take them home to discuss with trusted individual. It will be 
emphasized that participation is voluntary and can end at any time and that a decision to 
participate will not result in negative consequences (including loss of services through the 
LGBT Community Center).
3. If excluding pregnant women, illiterate or non-English speaking individuals, provide a 
scientific rationale for the exclusion.  Inconvenience or cost is not an acceptable 
rationale.
Non-English speakers will be excluded from this study because the primary intervention 
is a discussion-based group that requires a grasp of English.
Recruitment Methods
Note: Attach all applicable recruitment materials to the last section of the Smart form under 
“Recruitment Materials.”
1. Which of the following methods will be used to recruit research participants. – Select all 
that apply
☒  Email
☒  Phone call
☐  Letter
☒  Advertisement (e.g., poster, flyer, etc.)
☒  Social media
☐  Other. Please specify: 
2. Describe when, where, and how potential research participants will be recruited. 
Research participants will be recruited from the LGBT Community Center’s existing 
database of people who attend meetings at the Center or have participated in events such 
as TRANS in the CLE. Flyers will go up about 1 month before the beginning of the 
program. Emails and phone calls will be sent out about 3 weeks prior. Social media posts 
on the LGBT Community Center’s accounts (Facebook, Instagram, Twitter) will begin 
about 3 weeks prior. Coordinators at the Center may refer people to flyers at other 
meetings. Similar contact schedules will follow for medical providers and staff.
3. Describe the source (e.g., from what department, EMR, etc.) of the research participants.

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LGBT Community Center, Preterm, Planned Parenthood, MetroHealth, Neighborhood 
Family Practice
4. Describe the methods that will be used to identify potential research participants.
Potential research participants will be asked to fill out a screening tool so that we can create a 
sample that is reflective of the diversity in Cleveland. 
5. Describe the feasibility of recruiting the required number of suitable research participants 
within the agreed recruitment period. For example, how many potential research 
participants do you have access to? The LGBT Center regularly sees over 100 unique 
TGNC individuals each month for their transgender programming, with an additional list 
of 300 individuals in Cleveland who participate less regularly. Recruiting 20 from that 
list is feasible. We have the support of several clinics to recruit medical providers and 
staff.
Setting
Research (in the form of cohort meetings and facilitated discussions) will occur at the LGBT 
Community Center. Recruitment for the TGNC cohort will occur in the same location. 
Recruitment for medical providers and staff will be done via email and phone.
Consent Process
1. Indicate whether you will be obtaining consent:
☒ Yes
☐ No
If yes, answer the following questions:
1. Describe where the consent process will take place:
When an individual first expresses interest in the study by filling out an 
application, the consent form will be provided. When an individual is confirmed, 
the PI or Research Associate will review the consent form in detail at the LGBT 
Center and then the person will sign, if they so choose.  
2. The time that will be devoted to the consent discussion: 
At least 5 minute discussion, with the individual able to review the document at 
their leisure beforehand. When the cohort begins, consent will be reviewed and 
then revisited periodically.
3. Any waiting period available between informing the prospective subject and 
obtaining the consent: 
Yes – consent form given when screening tool filled out
4. Steps that will be taken to ensure the research participants’ understanding: 
Consent form will be written in age appropriate language and investigators will 
set time aside to answer any questions
5. Any process to ensure ongoing consent: 
Check in at the beginning of meetings
6. The role of the individuals listed in the application as being involved in the 
consent process: 
Misty Luminais and Margaret McGuire
7. Steps that will be taken to minimize the possibility of coercion or undue influence 
to the subjects: 

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Reiteration of the voluntary and on-going ability to end participation at any time 
without negative effects
2. Indicate if you will be asking for a waiver or alteration of consent process or 
documentation (consent will not be obtained, written consent will not be documented)
☐ Yes
☒ No
If yes, indicate which part of the consent process you are requesting be waived or 
altered and the rationale for requesting the waiver or alteration:
☐
I will obtain consent, but not participant’s signature
☐
I will obtain consent, but request a waiver for pre-screening purposes
☐
 I will obtain consent, but request a waiver of some of the elements of consent 
                      (e.g. use of deception)
☐
 I will not obtain consent, and I am requesting a full waiver of consent
1. Give the rationale for the request of a waiver or alteration of the consent process 
or documentation:      
2. Explain how the research involves no more than minimal risk    
3. Explain why the waiver or alteration of consent will not adversely affect the rights 
and welfare of the participants:    
4. Explain why the research could not practicably be carried out without the waiver 
or alteration of consent.    
5. If you will obtain consent, but not document consent in writing (e.g. over the 
phone, verbally, electronic survey, etc.), please describe and provide a rationale. 
  
  ☐ N/A   
6. Describe how you will be documenting that a research participant has consented     
*Be sure to upload a consent script or information sheet with your study protocol
Additional Considerations for Consent Process with Adults
Non English Speakers (Please select one)
☒  I am not enrolling non-English speaking individuals in this research study. The following is 
justification for why non-English speaking individuals cannot be enrolled: 
The intervention is based on participation in ongoing, fast paced discussion groups that require a 
good grasp of spoken English.
☐  I will be targeting non-English speaking adults

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1. Describe the process to ensure that the oral and written information provided to those 
research participants will be in that language during initial consent as well as throughout 
the study. 
2. List the language(s) other than English that will be targeted:  
☐  I am not targeting non-English speaking individuals. If a non-English speaking individual is 
eligible for the trial, we will use the following procedures to enroll: 
1. Describe the process to ensure that the oral and written information provided to those 
research participants will be in that language during initial consent as well as throughout 
the study. 
2. List the language(s) other than English that will be targeted: 
Adults Unable to Consent
☒ I am not enrolling adults unable to consent in this research study – please leave the rest of 
this section blank.
☐ There is an anticipated direct benefit to the subject. Explain:
☐ There is NOT an anticipated direct benefit to the subject. Explain:
1. Describe the process to determine whether an individual is capable of consent.
2. List the individuals from whom permission will be obtained in order of priority (e.g. 
durable power of attorney for health care, court appointed guardian for health care 
decisions, spouse, and adult child). 
3. For research conducted outside of the state, provide information that describes which 
individuals are authorized under applicable law to consent on behalf of a prospective 
subject to their participation in the procedure(s) involved in the research.
☐ N/A  
4. Describe the process for assent of the research participants. Indicate:

Which subjects that are unable to consent will be required to give assent? If not all, 
explain why. 

Describe whether assent of the research participants will be documented and the 
process to document assent. 
☐The subject will be informed about the research to the extent compatible with the 
subject’s understanding.
☐ Subjects will be closely monitored.
☐ The subject will be withdrawn if they appear unduly distressed.

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Research Participants Who Are Not Yet Adults (infants, children, teenagers)
☐  I am not enrolling participants who are not yet adults in this research study. – please leave the 
rest of this section blank
1. Will parental permission be obtained from:
☒  One parent even if the other parent is alive, known, competent, reasonably 
available, and shares legal responsibility for the care and custody of the child
☐  Both parents unless one parent is deceased, unknown, incompetent, or not 
reasonably available, or when only one parent has legal responsibility for the 
care and custody of the child
☐  Waiver of parental permission
2. Describe whether permission will be obtained from individuals other than parents, and 
if so, who will be allowed to provide permission. Describe the process used to 
determine these individuals’ authority to consent to each child’s participation in 
research. Legal guardians will be asked for consent if the child is under their care. If a 
youth wants to participate with the permission of the legal guardian, the guardian will 
be asked to provide proof of guardianship.
3. Indicate whether assent will be obtained from all, some, or none of the children. If 
assent will be obtained from some children, indicate which children will be required to 
assent. Assent will be obtained from all children participating.
4. When assent of children is obtained, describe how it will be documented. Because all 
children must be at least 14 years old, assent will be written.
5. For children who are pregnant, describe how assent and permission are obtained.
☒ N/A 
6. Describe how the risk is justified by the anticipated benefit to the subjects.
Although minimal, the risks of embarrassment, stigma, or group stereotyping are 
present. Many TGNC individuals already face these issues in their everyday lives. 
Working as an advocacy team working with healthcare providers, subjects may 
experience those feelings. We will employ a trained facilitator who understands the 
challenges faced by TGNC individuals and can redirect the conversation with 
healthcare providers to a productive dialogue rather than a rehashing of stereotypes. 
Discussing health disparities may bring up these feelings as well. We will have access 
to the full complement of services provided by the LGBT Center, including support 
groups for TGNC individuals and referrals for counseling if anyone becomes so 
distressed that this is necessary. 
There may be the perception that lack of participation could result in the loss of 
services offered by the LGBT Center since they are the community partners and the 
events will occur in their space. We will make it abundantly clear in all written and 

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spoken communication that this is not the case and will convey the information at the 
time an individual calls to get more information when recruited through the flyer. 
However, because the LGBT Center offers a number of these types of groups, either 
for support or advocacy, the culture supports the belief that participation in such a 
project is completely voluntary.
There is the possibility that someone may not be "out" as transgender or gender 
non-conforming in some aspects of their lives. Participation in this group may expose 
them to the risk of disclosure because it is a public group in which the researchers 
cannot guarantee complete confidentiality. At the beginning of the program and 
periodically throughout, we will discuss the importance of maintaining confidentiality. 
We will be upfront about the possibility of breach of confidentiality and encourage 
those who feel it could adversely impact their lives severely not participate. As far as 
the data collection goes, we will store all fieldnotes, audio recordings, surveys, and 
any other data collected on Box, a secure, encrypted server. Access to the data will be 
limited to the PI, co-PI, community partner (to be hired), and the RA (Margaret 
McGuire). 
At the heart of this project is addressing the ways that stigma can result in 
disparate healthcare outcomes. Therefore, a forthright discussion of what constitutes 
stigma and how it impacts healthcare decisions is necessary. We believe it is important 
for healthcare providers to actually hear the concerns of TGNC people from those 
people directly in order to increase their cultural competency. By employing a trained 
facilitator to moderate the discussion, we hope that both groups will benefit from the 
discussion, ultimately resulting in a more welcoming atmosphere for TGNC people at 
clinics and more knowledge and comfort on the part of TGNC people in seeking 
healthcare. This is a relatively low-cost intervention that has the potential to greatly 
increase access and use of health care by a population that suffers great disparities. If 
successful, it could be reproducible in other locations.
7. Describe how the relation of the anticipated benefit to the risk is at least as favorable 
to the subjects as that presented by available alternative approaches.
There are no available alternatives.
Sharing of Results with Research Participants
☐  Results will not be shared with research participants
☐  Results will not be shared with research participants’ doctors
Results will be co-created and shared with participants over the course of the study through 
constant feedback. Final results will be presented at the LGBT Center, probably through TRANS 
in the CLE conferences and other LGBT-directed gatherings. Final reports will be available at 
the Center. Medical providers and staff will have access to all final reports.
Study Design
Non-random participatory action research consisting of discussion groups and facilitated 
meetings
Study Procedures
Over the course of the grant year, each step of the project is divided into three 
month portions. The first quarter will be dedicated to recruiting and forming a 

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cohort of TGNC individuals, drawn mostly from the LGBT Center’s extensive 
contact lists and centrality within the TGNC population. We plan on recruiting 20 
individuals to ensure we meet the minimum retention of 12 subjects throughout the 
study needed for qualitative saturation (Guest, Bunce, and Johnson 2006), and 
individuals between 14-18 years of age will be able to participate with guardian 
permission. Interested individuals will fill out applications to identify their interests 
and ability to commit to the project and will allow us to create a cohort that reflects 
the diversity of the TGNC community in Cuyahoga County, including gender 
identity, types of gender-affirmative care required (including whether or not 
someone is considering, in the process of, or completed physical transition), racial 
and ethnic identity, age (over 14), and socio-economic class. Upon accepting the 
invitation to participate, each member of the cohort will complete a pretest that 
will elicit data on their experiences in the healthcare system, their knowledge of 
basic and transgender-specific medical terminology, their familiarity with 
healthcare providers in Cuyahoga County, and the likelihood of seeking care under 
a number of conditions (acute, chronic, moderate, severe). We expect this to take 
one month. The following two months will consist of meeting as a cohort twice a 
month. The first two meetings will be dedicated to understanding the group’s 
collective experiences with health care, what they would like to see change, and 
what strategies can be used to accomplish those ends. We recognize that TGNC 
people come from a variety of backgrounds and each will bring their own 
strengths, networks, and perspectives to the table which will allow us to make full 
use of the indigenous expertise of the group. In consultation with the Nursing 
School of CWRU, we will develop a health literacy training that meets the 
expressed needs of the cohort and Jesse Honsky will present it during the 3rd 
meeting. The goal here is not to provide all possible health education but rather to 
arm the cohort with the skills and language to empower them to act as advocates 
on their own behalf when navigating the healthcare system. The final meeting (the 
4th) in this first quarter will be with a trained facilitator (Shemariah Arki) who 
will, under the direction of the TGNC cohort, plan a series of three interactive 
dialogues between the TGNC cohort and the healthcare providers. By meeting with 
the TGNC cohort first, without the healthcare providers, the TGNC cohort will 
have the opportunity to ensure the dialogues are designed to meet their objectives. 
Individual healthcare practitioners and medical staff will be recruited during the 
first quarter from the aforementioned clinics. We will recruit at least twelve 
providers and twelve staff members, who will attend one meeting each. All of the 
clinics we have documented support from and those we are in current dialogue 
with have previously reached out to the LGBT Center for training in this area, and 
CMEs may be available through MetroHealth. In the second quarter, we will 

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conduct a pretest that will collect data on attitudes towards TGNC individuals, 
TGNC-specific healthcare concerns, depth and breadth of referral networks for 
TGNC providers. Once the healthcare provider group is solidified, the LGBT 
Center will host three evening meetings (once per month) with the trained 
facilitator wherein TGNC individuals lead a conversation about what they see as 
barriers to their care, how they would like to be treated, and what they want 
healthcare providers to know about them as people. The first two meetings will be 
with healthcare practitioners and the final meeting will be medical staff so that the 
meetings can be more specific and without the interference of power dynamics 
within the provider groups. Healthcare providers and staff will only attend one 
meeting each. During this second quarter, the TGNC cohort will continue to meet 
on its own once a month to debrief from meetings, respond to what they have 
learned so far, and possibly refine the strategies for future meetings with healthcare 
providers as the series goes forward. At the end of the three months of dialogue, 
each participant, from both the TGNC cohort and healthcare provider, will be 
given a post-test to measure changes in attitude, practice, and knowledge. 
Participants will also have the opportunity to engage in a reflective interview.
The third quarter will diverge onto two different paths: the LGBT Center project 
coordinator will continue to engage with the cohort as they shift into the role of 
peer educators and advocates with other members of the TGNC community that 
interact at the LGBT Center. Luminais will conduct follow-up interviews with any 
TGNC cohort member that notifies the researchers that they have sought medical 
care and with any healthcare provider that notifies the researchers that they have 
had a clinical interaction with a TGNC individual. We will not be seeking any 
protected medical information or the identity of patients, in the case of healthcare 
providers, but rather a discussion of the ease or difficulty in communication, levels 
of comfort, and comparison with other interactions in general. 
Throughout the process, both Luminais and the LGBT Center coordinator will be 
engaged in participant observation (Bernard, 2002; Denzin & Lincoln, 1994) and 
keep detailed field notes on all the meetings. All participant observation will take 
place during the scheduled cohort meetings which will not be recorded except 
through note-taking. All interviews will be transcribed unless the participant 
chooses not to be recorded; interviews and field notes will be coded with a priori 
codes (Bernard & Ryan, 2010) derived from the literature on reducing health 
disparities and TGNC-specific health care by a research assistant. Participants may 
choose to participate in an optional reflective interview where they are asked to 
reflect on the appropriateness and effectiveness of the project in meeting their 
expectations. Pre- and post-tests will be analyzed to determine the success of 
facilitated dialogue in improving confidence and knowledge by both the TGNC 

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cohort and the healthcare providers, and depending on sample size, we will 
determine if there are any statistically significant changes. This analysis and write 
up will encompass the last quarter of the project.
Study Timeline
Devices
If the research involves device(s), describe your plans to use the device(s).
☒  N/A
ClinicalTrials.gov Information
Case Western Reserve University Protocol Record IRB-2018-2194,
TRANSLATE: Transgender and Gender Nonconforming Individuals' Access to 
Healthcare, has been reviewed and will be made public on ClinicalTrials.gov.
List of Data to be Collected
Note: If using REDCap, all selected identifiers below must be indicated as PHI.
1. Indicate what identifiers you will collect
☒
Name
☐
Address (e.g., Zip code, other geographical designation, etc.)
☐
Dates related to an individual (e.g., Date of admission, birth, surgery, etc.)
☐
Telephone number
☐
Fax number
☐
Email address
☐
Social security number
☐
Medical record number
☐
Health plan beneficiary number
☐
Account number
☐
Certificate/license number
☐
Any vehicle or other device serial
☐
Device identifiers or serial numbers
☐
Web URL
☐
Internet protocol (IP) address
☒
Finger or voice prints
Pre-Screening
Meetings 
1-18
Facilitated 
meetings
Optional 
interviews
Estimated time requirement of 
visit for TGNC cohort
Fill out on 
own
1.5 hours
1.5 hours
Estimated time requirement of 
visit for medical providers
2 meetings, 1.5 
hours each 
1.5 hours
Estimated time requirement of 
visit for medical staff
1 meeting, 1.5 
hours
1.5 hours

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☐
Photographic images
☐
Other: Any characteristic that would uniquely identify the individual
2. List all other data to be collected for the research study (e.g. laboratory values, physician 
notes, length of stay, etc.) 
Data Analysis Plan
Pre and post tests will analyze knowledge gained. Qualitative data analysis with atlas.TI will be 
performed on field notes based on meeting observations and any optional interviews completed.
Confidentiality of Data
1. To maintain the confidentiality of the data:
☒
I will use a unique study identifier (not derived from the participants personal
            identifiers) to code individuals’ data  and I will store this ID log separate from 
            study data.
☒
Other (please explain) Upon completion of the study, identifiers will be 
destroyed, leaving only the unique coded identifier in fieldnotes and transcripts. Voice 
recordings will be destroyed as soon as interviews are transcribed. 
Screening data will be collected by LGBT team member (Gulnar Feerasta, CREC 
certified) on paper and scanned to an electronic file that will be uploaded to Box, after 
which the paper and local file will be destroyed. People who choose to answer the 
screener online through Qualtrics will have their data exported to Box. After the sample 
is composed, all electronic documents will be destroyed. 
2. How are you storing your electronic data?
☐
UH Redcap
☐
CWRU Redcap 
☐
Secure Research Environment (SRE)
☒
CWRU Box
☐
OnCore
☐
UH Secure Network Drive
☐
CWRU Secure Network Drive
☐
Other - List storage method and provide justification:
3. ☒
I acknowledge that paper research data and documents will be stored in a double-
            locked secure environment in the following location: 
            Location: ☒ Misty Luminais’s office (MSASS 375J)
4. Will data be shared?
☒ Yes 

List the exact data elements that will be shared:
1.
Code books will be shared with NIH

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2.
Fieldnotes (deidentified) may be shared with researchers at LGBT 
Community Center

Describe how data will be sent: via CWRU Box
☐ No
☐ N/A  
 (Please note: if sharing data, please contact your Grants and Contracts Specialist to ensure 
the proper contracts are in place.)
HIPAA Authorization 
If you are going to be accessing PHI (Protected Health Information), indicate how HIPAA 
authorization will be obtained (check all that apply): N/A
☐  
HIPAA authorization is in the consent form
☐  
Requesting a full or partial waiver of HIPAA for prescreening
☐  
Requesting a full or partial waiver of HIPAA
1. Describe why the study cannot be completed without the specified identifiable 
information. 
2. If the identifiable information will be used or disclosed by anyone other than the research 
team, please state who those individuals/entities are and provide justification for the 
disclosure.
☐  Identifiable information will not be used or disclosed by anyone other than the 
research team 
☐  Identifiable information will be used or disclosed to:  
3. Describe how long identifiers will be kept for in relation to study length and data 
collection and analysis. 
☐  I assure that protected health information collected for purposes of this research study will 
not be reused or disclosed to any other person or entity, except as required by law, for 
authorized oversight of the research study, or for other research for which the use of 
disclosure of protected health information for which an authorization or opportunity to 
agree or object is not required by 45 CFR 164.512
Devices
☒  This is not device study. The protocol is considered non-therapeutic (non-therapeutic is defined 
as research not intended to diagnose, prevent, cure, mitigate, treat, etc. a disease or condition) 
by the FDA. – You may delete the rest of this section.
OR
☐  This is a device study. The protocol is considered therapeutic (research intended to diagnose, 
prevent, cure, mitigate, treat a disease or condition) by the FDA. 

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1. Is there an IDE (Investigational Device Exemption) for the proposed study?
☐  Yes, provide an official letter of support or proof of approval which identifies the IDE 
holder and IDE number. Please attach this in the SpartaIRB smartform
☐  No, see question below:
2. Is the device (and its use) a non-significant risk device for the proposed study design?
☐  Yes, please identify the authorized party who made the determination and provide 
supporting documentation as applicable.
☐ No NOTE: either an active IDE or an exemption would be required for 
investigational product use in a therapeutic protocol.
☐   N/A
3. If the research involves device(s), describe your plans to store, handle, administer and track 
those device(s) to ensure that they will be used only on research participants and be used only 
by authorized investigators.
Risks to Research Participants
1. List the reasonably foreseeable risks such as breach of confidentiality, discomforts, 
hazards, or inconveniences to the research participants related to their participation in the 
research. Include a description of the probability, magnitude, duration, and reversibility 
of the risks. Include the physical psychological, social, legal, and economic risks. 
Although minimal, the risks of embarrassment, stigma, or group stereotyping are present. 
Many TGNC individuals already face these issues in their everyday lives. Working as an 
advocacy team working with healthcare providers, subjects may experience those 
feelings. We will employ a trained facilitator who understands the challenges faced by 
TGNC individuals and can redirect the conversation with healthcare providers to a 
productive dialogue rather than a rehashing of stereotypes. Discussing health disparities 
may bring up these feelings as well. We will have access to the full complement of 
services provided by the LGBT Center, including support groups for TGNC individuals 
and referrals for counseling if anyone becomes so distressed that this is necessary. 
There may be the perception that lack of participation could result in the loss of services 
offered by the LGBT Center since they are the community partners and the events will 
occur in their space. We will make it abundantly clear in all written and spoken 
communication that this is not the case and will convey the information at the time an 
individual calls to get more information when recruited through the flyer. However, 
because the LGBT Center offers a number of these types of groups, either for support or 
advocacy, the culture supports the belief that participation in such a project is completely 
voluntary.
There is the possibility that someone may not be "out" as transgender or gender non-
conforming in some aspects of their lives. Participation in this group may expose them to 
the risk of disclosure because it is a public group in which the researchers cannot 
guarantee complete confidentiality. At the beginning of the program and periodically 
throughout, we will discuss the importance of maintaining confidentiality. We will be 

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upfront about the possibility of breach of confidentiality and encourage those who feel it 
could adversely impact their lives severely not participate. As far as the data collection 
goes, we will store all fieldnotes, audio recordings, surveys, and any other data collected 
on Box, a secure, encrypted server. Access to the data will be limited to the PI, co-PI, 
community partner (to be hired), and the RA (Margaret McGuire).
2. If applicable, indicate which experimental procedures may have risks to the research 
participants that are currently unforeseeable. 
☒ N/A  
3. If applicable, describe the risks to others who are not research participants. 
☒ N/A  
4. Describe the availability of medical or psychological resources that research participants 
might need. 
☐ N/A 
The LGBT Community Center maintains contacts with May Dugan for crisis intervention and other community 
support, so if someone needs assistance, that connection can be made quickly. 
Provisions to Protect the Privacy Interests of Research Participants
We will encourage confidentiality among participants in group settings but also be upfront about the fact 
that this is not a guarantee of confidentiality. We will not use identifiable information in any reports or 
publications. Interviews will be held privately.
Potential Benefit to Research Participants
☒   There is potential benefit to research participants.
1. Describe the potential benefits that individual research participants may experience from 
taking part in the research. Include the probability, magnitude, and duration of the 
potential benefits.
TGNC participants will be offered training on medical literacy to increase their own 
knowledge of the medical system. Medical providers will be offered training on cultural 
competency to increase their own knowledge of how to treat TGNC patients. These 
benefits could make navigating the space easier for each set of individuals.
☐   There is no direct benefit to research participants.
2. If no direct benefit, state the potential benefit to society or others. By reducing stigma and 
increasing knowledge about TGNC concerns, the medical profession can reduce the 
health disparities faced by TGNC people.
Withdrawal of Research Participants
Directions: Describe the anticipated circumstances under which research participants will 
be withdrawn from the research without their consent. Also include the procedures that 
will be followed when a research participant withdraws or are withdrawn from the 
research, including partial withdrawal from procedures with continued data collection.
☐ N/A If participants cannot continue to participate in bi-monthly meetings, they will be withdrawn after discussion. The data 
collected up to that point will continue to be used; field notes will not have participants’ names and it would be very difficult to 
remove individuals’ contributions. If the person had decided to give an interview, they would have the choice of whether or not 
that interview would be used.
Alternatives to Participation

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Directions: List other available clinical treatments, what would be included if a subject 
continued on standard of care therapy. If this is not a clinical trial, you may select the box 
indicating that the alternative is not to participate. If there is a viable alternative you must 
list it in the consent.
☒   The alternative is for research subjects not to participate.
Costs to Research Participants
☒  There are no costs to research participants or their insurance companies (there are no clinical 
visits or billable procedures.) – You may delete the rest of the section.
1. Describe what costs research participants will be responsible for as a result of their 
participation in the research, including but not limited to: clinical services required by the 
protocol deemed billable to insurance, transportation to study visits, parking, costs of drugs, cost 
of therapy, lost broken or stolen devices, etc. 
2. Explain who will be responsible for payment of provided services in the event of insurance 
denials. 
3. List what procedures, drugs, devices, supplies will be paid by the study sponsor or covered by 
other funding. List the other funding source. 
Research Participant Compensation
☐  There is no compensation for research participants 
☒  There is compensation for research participants. 
TGNC individuals will receive a $25 gift card for each meeting (up to 18 meetings) they 
attend in full at the end of that meeting. Medical providers will be offered CME credits and 
medical staff will be offered professional development credits.
☐  There will be reimbursement for research participants. 
Describe the schedule, payment method, and payment total of any reimbursement that 
research participants will receive for participation in the research (e.g., gift cards or cash with 
amount, etc.)
Compensation for Research Related Injury
Describe who will pay for the costs of medical treatment and/or compensation in the event of a 
research related injury:
☐  
Funding agency is providing some/all payment for injury
☐  
Funding agency is providing no payment for injury
☒  
N/A 
Provisions to Monitor the Data to Ensure the Safety of Research Participants
1. Describe how often the data will be monitored for completeness, accuracy and adherence 
to the protocol.

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Every quarter, the PI will review protocols to make sure they are being adhered to and spot 
check data collection.
2. Indicate if there will be a Data and Safety Monitoring Board or Committee:
☒
There will not be a formal Data and Safety Monitoring Board/Committee.
☐
There will be a formal Data and Safety Monitoring Board/Committee. 
Provide information about the DSMB/C including the contact information of the committee 
member(s) (as applicable); whether it is independent from the study sponsor; how often it 
meets; the type of data that will be used; written reports, etc.
Community-Based Participatory Research
☐  
This is not a community-based participatory research project – please leave the rest of 
this section blank
☒
This is a community-based participatory research project
The LGBT Center has been integral in the development of this design and will be a full 
partner in carrying out the work. Their staff is currently training on CREC and will be added 
when that is complete. A coordinator is being hired with the expectation they will also be a 
research partner. They will be involved in analysis and dissemination.
 
Note: Community based research is research that is conducted as an equal partnership between 
academic investigators and members of a community. In Community Based Participatory 
Research (CBPR) protects, the community participates fully in all aspects of the research 
process.  
MULTI-SITE RESEARCH (when UH or CWRU is the IRB of Record)
Does this project have multiple sites?
☐  
Yes
☒  
No – please leave the rest of this section blank
Non-Local Site Information for Multi-Site Studies
If this is a multi-site study where you are the lead investigator, list the following information for 
each relying site:
1. Name of site: 
2. PI of relying site: 
3. Name of IRB contact: 
4. Phone number of IRB contact: 
5. Email address of IRB contact: 
Non-Local Recruitment Methods for Multi-Site Studies
If this is a multi-site study and research participants will be recruited by methods not under the 
control of the local site (e.g. call centers, national advertisements) describe those methods. 
Local recruitment methods are described above. 
1. Describe when, where, and how potential research participants will be recruited. 

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2. Describe the methods that will be used to identify potential research participants. 
3. Describe the materials that will be used to recruit research participants. 
Multi-Site Research Communication Plan (when you are the lead investigator)
If this is a multi-site study where you are the lead investigator, describe the processes to ensure 
communication among sites including:
☐  
All sites will have the most current version of the protocol, consent document, and 
HIPAA authorization     
☐ 
All required approvals (initial, continuing review and modifications) have been obtained 
at each site (including approval by the site’s IRB of record)    
☐ 
All modifications have been communicated to sites, and approved (including approval of 
the site’s IRB of record) before the modification is implemented    
☐ 
All engaged participating sites will safeguard data, including secure transmission of 
data, as required by local information security policies
☐ 
All engaged participating sites will safeguard data, including secure transmission of 
data, as required by local information security policies     
☐ 
All local site investigators conduct the study in accordance with applicable federal 
regulations and local laws     
☐ 
All non-compliance with the study protocol or applicable requirements will be reported 
in accordance with local policy     
If this is a multi-site study where you are the lead investigator, describe the method for 
communicating to engaged participant sites the following: 
1.   Problems:     
2.   Interim results:     
3.   The closure of the study:     
Additional Information
If you have any additional information regarding your study not covered in the template, please 
include it here.
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Please reference the Investigator Manual for local institutional requirements.