Tools

Exit Survey Inclusive of the LGBTQIA+ Perspective

Published on: November 18, 2024

The “Exit Survey Inclusive of the LGBTQIA+ Participant Perspective” is one tool in the LGBTQIA+ Inclusion by Design in Clinical Research Toolkit, and the third of three tools in the section of the Toolkit directed more toward participants. It is important for participants in clinical research activities to give feedback about their experiences. This feedback helps research teams and organizations better understand the participant’s experience of the research activity and learn where they can improve on efforts to empower research participants and the participants’ supporting families, friends, and communities. One way to gather feedback is through a survey, which may be given to participants periodically (e.g., once a month), and/or (as an exit survey) at the end of research activities. In this tool, we aim to show examples of the topics that participants may be asked about in a survey or interview or, if not asked, that the participant may wish to share with the research team in a patient portal, email, or other format.

LGBTQIA+ Toolkit

LGBTQIA+ Resources and Webpage

2024-11-18 Exit survey_FINAL Download

Related Resources

LGBTQIA+ Inclusion by Design in Clinical Research Toolkit
LGBTQIA+: Inclusive Imagery Case Study
LGBTQIA+: Inclusive Language Checklist
SOGI Data Collection Checklist
SOGI: Data Privacy Checklist
Site Feasibility Decision Tree from the LGBTQIA+ Perspective
Participant Questionnaire from the LGBTQIA+ Perspective
Exit Survey Inclusive of the LGBTQIA+ Perspective

Participant Questionnaire from the LGBTQIA+ Perspective

Tools

Published on: November 18, 2024

The “Participant Questionnaire from the LGBTQIA+ Participant Perspective” is one tool in the LGBTQIA+ Inclusion by Design in Clinical Research Toolkit, and the second of three tools in the section of the Toolkit directed more toward participants. There are numerous questions that participants may want to ask as they move from thinking about possible trials and sites to starting the process of enrolling and participating in a trial. Some of these questions may be covered by informational materials given to participants during the informed consent process and study visits, and some may not be. This list is to help participants prepare so that they can get the answers that they need and feel comfortable before continuing with the trial. The Participant Questionnaire tool is divided into sections that include questions to ask the research team, questions you may want to ask family, friends, and others you trust, and questions to ask yourself. It includes questions that anyone might want to ask and adds questions that LGBTQIA+ people (and/or their accompanying friends and family) might also want to ask.

LGBTQIA+ Toolkit

LGBTQIA+ Resources and Webpage

2024-11-18 Participant questionnaire_FINAL Download

Related Resources

Site Feasibility Decision Tree from the LGBTQIA+ Perspective

Tools

Published on: November 18, 2024

The “Site Feasibility Decision Tree from the LGBTQIA+ Participant Perspective” is one tool in the LGBTQIA+ Inclusion by Design in Clinical Research Toolkit, and the first of three tools in the section of the Toolkit directed more toward participants. This tool is meant to empower potential LGBTQIA+ participants to assess whether a site may be trustworthy and welcoming. This tool is structured in tiers, with checkpoints in between. The first tier is potential capacity, where we provide prompts, or “determination factors” based on what IS happening at a site (or in the area nearby) that LGBTQIA+ people can use in considering whether the site is potentially a good place to participate in a study. In the second tier we focus on “historical capacity,” or the things that the site HAS/HAD done to support the well-being of LGBTQIA+ people that may inspire confidence that the site is trustworthy.

LGBTQIA+ Toolkit

LGBTQIA+ Resources and Webpage

2024-11-18 Site feasibility LGBTQIA perspective_FINAL Download

Related Resources

LGBTQIA+ Inclusion by Design in Clinical Research Toolkit

Toolkit

Published on: November 18, 2024

Sexual orientation and gender identity (SOGI) may influence disease risk, incidence, severity, manifestation, and treatment response. In line with the clinical research guiding principles in the Belmont Report of respect for persons, beneficence, and justice, we have developed a toolkit to support equitable participation of people who are LGBTQIA+. The toolkit contains seven tools. Any audience can use the full toolkit, although it should be noted that first four tools are directed more toward sponsors and research teams, and the latter three are directed more toward participants. The first four tools were publicly released individually in the spring of 2024, and the latter were released in November 2004. We invite you to explore the full toolkit or to focus on the specific tools that you find most important to your individual or organizational journey in clinical research.

Download the LGBTQIA+ Toolkit

LGBTQIA+ Resources and Webpage

2024-11-18 LGBTQIA Toolkit_with cover_FINAL Download

Related Resources

LGBTQIA+: Inclusive Imagery Case Study
LGBTQIA+: Inclusive Language Checklist
SOGI Data Collection Checklist
SOGI: Data Privacy Checklist
Site Feasibility Decision Tree from the LGBTQIA+ Perspective
Participant Questionnaire from the LGBTQIA+ Perspective
Exit Survey Inclusive of the LGBTQIA+ Perspective

Model Diversity Action Plan (DAP)

Tool

Published: September 4, 2024

The Model Diversity Action Plan (DAP) was developed in response to the FDA’s latest directive aimed at improving diversity within clinical trial participation. Built upon the MRCT Center’s Recruitment Strategy Document, this framework supports compliance with FDA standards. The Model DAP also outlines clear objectives that extend beyond the FDA’s initial guidelines, emphasizing a broader international viewpoint. Sponsors are encouraged to delineate specific regions and countries targeted for trial inclusion, detailing proactive strategies designed to overcome obstacles related to diverse, inclusive, and equitable recruitment practices, particularly outside the United States. While these additional details may not always be mandatory for FDA submissions, they are pivotal in fostering a comprehensive approach to trial design and execution. Moreover, the Model DAP expands on the FDA’s suggested five sections within their draft guidance, ensuring alignment with regulatory expectations while advancing global standards in clinical research diversity and inclusion. This dynamic document will evolve as the FDA guidance is finalized.

Download the Model DAP

View the Global Representation Roadmap

08-27-2024_DAP Download

Related Resources

Global Representation Roadmap

Tool

Published on: September 4, 2024

The Global Representation Roadmap provides a structured approach for stakeholders to define and implement DEI strategies across their global clinical research portfolios. It guides organizations through a seven-stage process tailored to account for varying dimensions of DEI across different countries and contexts. Key focuses include clarifying organizational DEI objectives, defining epidemiology by therapeutic area in target countries, and considering ethical implications in site selection. The Global Representation roadmap prompts stakeholders to address country-specific regulatory requirements related to diversity and outlines minimum actions in their absence. It advocates for proactive DEI targets and capacity-building initiatives, while emphasizing ongoing community engagement and accountability through periodic ethics checkpoints. Additionally, it encourages the use of program-specific Diversity Action Plans to enhance recruitment effectiveness and ensure continuous improvement and transparency in Global Representation efforts.

Download the Global Representation Roadmap

View the Model Diversity Action Plan (DAP)

08-27-2024_Global DEI Roadmap Download

Additional Resources

Sexual Orientation and Gender Identity (SOGI) Data Privacy Checklist

Tool

Published on: June 11, 2024

Abstract: Data privacy is a critical not only for the safe and ethical conduct of clinical trials, but also for supporting and maintaining the trust of clinical trial participants. For clinical trial participants who may be discriminated against or otherwise harmed if their personal identifying information were to be disclosed, data privacy all the more important. In the SOGI Data Collection Checklist, we advocate for the collection of sexual orientation and gender identity (SOGI) data, where appropriate and feasible. In the SOGI Data Privacy Checklist, which is meant to accompany the SOGI Data Collection Checklist, we provide thinking prompts to support researchers, sites, and sponsors, and others in maintaining privacy when collecting, storing, and sharing SOGI data. These prompts center on how to make the research environment/site a welcoming a place where individuals can trust that they and their data will be respected and protected, and where to consider implementing necessary safeguards to protect participant identity and privacy. We also include an addendum on special considerations for pediatric populations, in addition to a list of references with links to more detailed guidance.

LGBTQIA+ Inclusion by Design Toolkit

2024-11-18 SOGI Data Privacy_FINAL Download

Related Resources

Sexual Orientation and Gender Identity (SOGI) Data Collection Checklist

Tool

Published on: June 11, 2024

Abstract: All study participants should be able to see themselves in the research data. However, standard demographic variables of sexual orientation and gender identity (SOGI) have rarely been reported for clinical trials. We therefore don’t know whether LGBTQIA+ people are able to participate in clinical trials, or whether the safety and efficacy of tested products differs for any LGBTQIA+ participants. To begin to address this gap in respect for participants, study generalizability, and beneficence, the National Institutes for Health and Institute for Medicine now recommend collecting SOGI data. To support research teams, sites, and sponsors in following this recommendation we developed the SOGI Data Collection Checklist.

This SOGI Data Collection draws together key points from published guidance and the insights of LGBTQIA+ Inclusion by Design in Clinical Research Working Group members who have been leading in this field and piloting survey methodology. It provides prompts to think the process of SOGI data collection, which includes steps like defining the purpose of the data collection, mapping the proposed data elements, and working with groups and/or advisory boards that are inclusive of people who are lesbian or gay, and people who are transgender, non-binary, or intersex. While we do not provide standardized data collection questions (e.g., gender identity, sex at birth), response choices (e.g., [for sexual orientation] lesbian or gay, straight, bisexual, other), and response formats (e.g., open response), we do provide references with links to current guidance. Finally, please note that this SOGI DATA Collection Checklist is meant to be utilized in tandem with the SOGI Data Privacy Checklist.

LGBTQIA+ Inclusion by Design Toolkit

SOGI Data Collection Checklist

2024-11-18 SOGI Data Collection_FINAL Download

Related Resources

LGBTQIA+ Inclusion by Design in Clinical Research Toolkit

LGBTQIA+: Inclusive Imagery Case Study
LGBTQIA+: Inclusive Language Checklist
SOGI Data Collection Checklist
SOGI: Data Privacy Checklist
Site Feasibility Decision Tree from the LGBTQIA+ Perspective
Participant Questionnaire from the LGBTQIA+ Perspective
Exit Survey Inclusive of the LGBTQIA+ Perspective

MRCT Center Comment on the American Community Survey SOGI Test

LGBTQIA+ Inclusion – Inclusive Language Checklist

Tool

Published: April 11, 2024

Abstract: In the checklist below, the MRCT Center provides recommendations for the use of language that is respectful to and inclusive of LGBTQIA+ populations. The checklist can be used by stakeholders across the clinical research spectrum, from sponsors to patient navigators, when creating participant-facing documents (e.g., recruitment materials, informed consent forms), drafting study protocol eligibility criteria, and speaking with participants face-to-face. It is our shared responsibility to listen to participants’ and communities’ choice of wording and address, continually learn from each other, and ensure that all eligible people are encouraged to participate by the language that we use.

Download the Checklist

2024-11-18 Inclusive Language_FINAL Download

Related Resources

Accessibility by Design (AbD) Toolkit

Toolkit

Date: May 4th, 2023

Description: The Accessibility by Design (AbD) in Clinical Research Toolkit is a comprehensive resource intended to be used by sponsors, institutions, investigators, ethics committees/IRBs, participants, and patient advocacy groups to support greater inclusion of people with disabilities in clinical research. It was developed by the MRCT Center in collaboration with people with disabilities, family caregivers, allies, disability rights advocates, and stakeholders working in clinical research, and aligns with the MRCT Center’s Achieving Diversity, Inclusion, and Equity in Clinical Research Guidance Document and the Equity by Design in Clinical Research Metrics Framework.