Resource Type: Tools

Pregnancy Privacy Protections for Participants (P4) Tools

Toolkit

Released on: April 29, 2026

The MRCT Center has released the first three tools in the Pregnancy Privacy Protections for Participants (P4) Toolkit. These resources inform research teams, IRBs, and participants about data privacy risks if a participant becomes pregnant during a study.

Following the Dobbs decision, the changing landscape of reproductive rights in the U.S. has introduced new challenges for clinical trials, both for studies of pregnancy-related conditions and for any trial involving participants who could become pregnant. Because pregnancy testing and outcomes may be tracked during screening and throughout a trial, it is important to carefully consider how, and how well, clinical trial data can be protected, and how to communicate pregnancy privacy risks to potential and enrolled participants. These issues were explored in a MRCT Center Bioethics Collaborative forum,  “Impact of Dobbs on Reproductive Health: Unintended Consequences for and on Research” and in the recent NEJM Evidence paper “Disclosure of Pregnancy-Related Privacy Risks in Clinical Research Post-Dobbs.“

The three tools are:

The first two are directed toward clinical research teams and IRBs. The third is for research staff to adapt and share with participants; it is written in plain language and highlights terms defined in the MRCT Center’s Clinical Research Glossary. Each tool is a prototype; the introductory page instructs teams to revise content according to their specific study and local legislative and site context.

The work draws on MRCT Center efforts in the Impact of Privacy Laws, the Bioethics Collaborative, and Inclusion of Pregnant and Lactating Populations (within the Representation in Research portfolio).

We welcome your feedback as we develop additional tools to complete the P4 Toolkit.

MRCT Center Pregnancy Privacy Protections – Local ContextDownload
MRCT Center Pregnancy Privacy Protections – Recommended Language for ICFsDownload
MRCT Center Pregnancy Privacy Protections – Privacy ConsiderationsDownload
Impact of Dobbs on Reproductive Health: Unintended Consequences for/on Research

Disclosure of Pregnancy-Related Privacy Risks in Clinical Research Post-Dobbs.

Toolkit for Supporting the Design, Conduct, and Reporting of Long-Term Follow-Up Studies for Gene Therapies

Toolkit

Released on: January 23, 2026

Long-term follow-up (LTFU) studies of gene therapy (GT) recipients are crucial for understanding the overall benefit-risk profile of these innovative products. However, LTFU studies are challenging to design, conduct, and execute, and pose significant burdens on both patients and sponsors.

On January 23, 2026, the MRCT Center released version 2.0 of the Toolkit for Supporting the Design, Conduct, and Reporting of Long-Term Follow-Up Studies (CGT), revised and improved based on feedback of a draft that had released for public comment.  

The MRCT Center CGT Toolkit is comprehensive and provides background information, practical resources, and recommendations to support best practices for LTFU studies for both investigational and approved gene therapies—balancing the generation of critical long-term safety and efficacy data with the need to reduce burdens placed on participants, caregivers, sponsors, and investigators. 

Compared to the draft version, the updated Toolkit v2.0 includes two new resources, an Executive Summary and a Patient Resource, which have also been released as standalone versions. Additions included new and/or revised charts, tables, and resources. The Toolkit explores ideas for how LTFU studies could be improved in the future, raising questions that the field should discuss and address.

The Toolkit enables easy navigation to various sections and subsections via multiple clickable, interactive toolbars. The sections are as follows, with the core elements in bold font:

  • Executive Summary (new in v2.0)
  • Introduction and Background
  • Types of LTFU studies for GTs
  • Flowcharts
  • Guiding Principles
  • Considerations and Recommendations for the Design, Conduct, and Reporting of LTFU Studies for GTs
  • Looking Forward
  • Key Design Elements of LTFU Studies for FDA-approved GTs
  • Regulatory Guidance Relating to LTFU of GTs
  • Patient Resource: Long-Term Follow-Up Studies After Gene Therapy (new in v2.0)
  • Compiled Glossary of Scientific LTFU-Related Terminology
  • Easy-to-Understand (Accessible) LTFU-Related Definitions from the MRCT Center’s Clinical Research Glossary
  • Appendices
  • List of Acronyms and Abbreviations Used
  • References Cited

Please email us at mrct@bwh.harvard.edu with any questions or suggestions regarding the Toolkit.

2026_LTFU-Toolkit-Version02_01-23-2026Download

Navigation Highlights

The Toolkit incorporates several interactive features designed to support intuitive navigation and ease of use:

  • Clickable Table of Contents for rapid access to major sections and subsections.
  • Right-hand vertical navigation bar on every page, enabling quick movement between tools within the document.
  • Interactive table of LTFU study types, mirrored by color-coded tabs that remain clickable throughout the associated pages.
  • Secondary navigation bar at the top of each page within the Considerations & Recommendations section. This feature highlights your location within the nine subsections, allows you to jump directly between subsections by clicking the dots, and includes a grey diamond icon that returns you to the full list of subsections.
Navigating the MRCT Center’s Long-Term Follow-Up Toolkit for Gene Therapies
Long-Term Follow-Up for Gene Therapies: Toolkit Release
MRCT Center Annual Symposium: Panel 3 – Cell and Gene Therapies Long-Term Follow-Up (LTFU).
Panelists:
Pamela Tenaerts, MD, MBA, Chief Medical Officer, Medable
Daniel Kavanagh, PhD, RAC – Senior Scientific Advisor, Gene Therapy, Vaccines, & Biologics, WCG
Lara Gehl, Executive Director, Global Trial Management – Bristol Myers Squibb
𝗠𝗼𝗱𝗲𝗿𝗮𝘁𝗼𝗿:
Carolyn Riley Chapman, PhD, MS – Lead Investigator, Brigham and Women’s Hospital; Member of the Faculty, Harvard Medical School
Patient-Centered Long-Term Follow-Up for Gene Therapies
Innovative Approaches for Gene Therapy Long-Term Follow-Up
Cell and Gene Therapies

Research Ethics Review: Guidance for Clinical Trials

Tool

Published: July 16, 2025

This guidance document is intended to be used as a tool to supplement the review, discussion, and deliberation of Research Ethics Committees reviewing clinical trial protocols.

This tool was developed by Barbara E. Bierer, MD (The MRCT Center of Brigham & Women’s Hospital and Harvard), Jeffrey D’Souza, PhD (University of Toronto), Caroline M. Kithinji, PhD (Kenya Medical Research Institute), and Winfred B. Nazziwa, MS (Uganda National Council for Science & Technology), in collaboration with the African Vaccines Regulatory Forum (AVAREF).

With Fillable Comment Boxes
For Print – without fillable comment boxes
2025_MRCT_AVAREF_Ethics-Review-Tool_07-10-2025_Comment-boxes_FillableDownload
Research Ethics Committee Systems Optimization


LGBTQIA+ Inclusion by Design in Clinical Research Toolkit

Toolkit

Published on: November 18, 2024 and updated on May 30, 2025

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 2024. 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
2025-05-30 LGBTQIA Toolkit_with Appendix_finalDownload

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

Exit Survey Inclusive of the LGBTQIA+ Perspective

Tools

Published on: November 18, 2024 and updated on May 30, 2025

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.

Please note that the Exit Survey Inclusive of the LGBTQIA+ Participant Perspective has been comprehensively updated in the 2.0 version, particularly in questions 21c-f and in the footnotes for those questions and response options. We have also included a new appendix to this tool, which provides a summary of Key Resources and Recommendations for SOGI Data Collection. These resources and recommendations are drawn from documented best practice and are meant to support researchers designing surveys and research participants that are considering how they might give feedback on their participation experience.

LGBTQIA+ Toolkit
LGBTQIA+ Resources and Webpage
2025-05-21 LGBTQIA Toolkit_with Appendix_final_Tool07Download

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 and updated on May 30, 2025

 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
2025-05-21 LGBTQIA Toolkit_with Appendix_final_Tool06Download

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


Site Feasibility Decision Tree from the LGBTQIA+ Perspective

Tools

Published on: November 18, 2024 and updated on May 30, 2025

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
2025-05-21 LGBTQIA Toolkit_with Appendix_final_Tool05Download

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

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_DAPDownload

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 RoadmapDownload

Additional Resources

Sexual Orientation and Gender Identity (SOGI) Data Privacy Checklist

Tool

Published on: June 11, 2024 and updated on May 30, 2025

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
2025-05-21 LGBTQIA Toolkit_with Appendix_final_Tool04Download

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