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.
The Principles of Post-Trial Responsibilities: Continued Access to an Investigational Product are 12 principles that guide the shared responsibilities and actions to provide continued access to an investigational product at the conclusion of a patient’s participation in a clinical trial. The principles, accompanied by an analysis, should be read as a whole.
The principles are designed to be used in coordination with the Framework of Responsibilities (Medicines) and (Devices), a framework of milestones, specific scenarios, and considerations that organizations can utilize to make equitable and fair decisions related to continued access to an investigational product.
Developed by: MRCT Center, in collaboration with ICH, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.
The MRCT Center is pleased to announce the availability of an introductory video for the ICH E8(R1) Guideline – General Considerations for Clinical Studies. Posted on the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) website, the MRCT Center developed this introductory video to provide an overview of the general principles in clinical research and quality by design.
The MRCT Center is currently developing a series of in-depth training modules to complement the video.
To celebrate Health Literacy Month, the MRCT Center presented three engaging and informative webinars to provide practical tools and discussions to incorporate health literacy and accessibility best practices into communicating participant-facing clinical research information.
Description: Spearheaded by the MRCT Center, AAHRPP, PRIM&R, and Mass General Brigham, the Research Ethics Action Collaborative for HRPPs (REACH) is an initiative designed to curate, align, and disseminate tools to advance representative inclusion in research—for all potential participants–tailored for Institutional Review Boards (IRBs), Human Research Protection Programs (HRPPs), and the broader community.
Join the REACH collaborative webinar on improving PowerPoint presentations through clear, accessible, and inclusive methods. We will show, through examples from the Accessibility by Design in Clinical Research Toolkit, how to apply accessibility tools to health literate communications. Because much communication is now virtual, we’ll explore how to make PowerPoint content readable and approachable, formatted for accessibility, and inclusive of people with disabilities.
Description: This webinar features experts from the Dana Farber Cancer Institute who will share their experience in developing a patient advocacy-driven return of results process for making Plain Language Summaries available to participants in breast cancer-related studies.
The moderator, MRCT Center Program Director Sylvia Baedorf Kassis, is joined by panelists from the Dana-Farber Cancer Institute: Paula Steeves, Lead Patient Advocate, Breast Oncology, Christine McLaughlin, Patient Research Advocate, and Timothy Erick, Science Writer.
Key Topics:
The core elements of creating and disseminating Plain Language Summaries.
What results to return, who to involve in the creation process, and how to approach dissemination.
How to start returning results with your study participants. Share your experiences and get answers to your questions in a moderated discussion and Q&A session.
Developed by: MRCT Center, in collaboration with the World Health Organization
Description: This course was developed in partnership with the World Health Organization and aims to meet the growing demand for a training on the scientific and ethical aspects of interventional clinical trials. This course is tailored to research ethics committee members, chairs, administrative staff, and others who review clinical trial protocols. It will also benefit regulators, investigators, study staff, care providers, and others involved in clinical trials. This course is available free of charge worldwide.
Description: This informative webinar leverages experience from the Office of Human Research Protections, the All of Us Research Program, and the MRCT Center to highlight resources and approaches for communicating informed consent information in innovative, participant-centered ways that support empowered decision-making.
The moderator, Sylvia Baedorf Kassis, joins the panelists, Marianna Azar of the Office for Human Research Protections and Katherine Blizinsky from the All of Us Research Program.
Implementing a participant-centric approach, utilizing the Clinical Research Glossary, and integrating innovative elements into the consent process.
Participate in a moderated discussion and Q&A session to delve deeper into ways to enhance the informed consent process. Share your experiences and get answers to your questions.
