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.
Abstract:Each of us feels more welcome to participate in a clinical trial if we see ourselves represented in the visual information communicated about the study, study site/s, and study staff. In the case study below, we illustrate how the MRCT Center worked to build LGBTQIA+ representation into the imagery that was developed for a specific product, the Clinical Research Glossary. The tool shares lessons learned by the MRCT Center based on insights and comments shared by the LGBTQIA+ Inclusion by Design in Clinical Research working group and mock-ups of two of the resulting images.
With over 160 definitions, including images and supportive information, the Clinical Research Glossary has been designed to support the communication of clear research information, along with tailored, shareable images to foster engagement and understanding.
Learn more about:
Building trust and transparency with participants through plain language information sharing.
The dedicated team members, and robust process that is followed, to create this global standard.
Strategies and approaches to implement the Clinical Research Glossary content into patient-facing materials.
Description: Barbara Bierer and Sarah White summarized salient ethical issues in the design and conduct of decentralized clinical trials, including participant safety, privacy and confidentiality, consent, digital access and proficiency, and trial oversight. Given the increasing involvement of decentralized study components, it is necessary to develop processes and cooperative solutions to promote safe, ethical trials, as well as focus on decreasing burden and increasing access for all participants.
Introducing Research Ethics Action Collaborative for HRPPs (REACH), an initiative spearheaded by the MRCT Center, AAHRPP, PRIM&R, and Mass General Brigham to curate, align, and disseminate tools to advance access to and inclusion in research—for all potential participants–tailored for Institutional Review Boards (IRBs), Human Research Protection Programs (HRPPs), and the broader community.
We Need Your Voice: Your perspective is invaluable to us. Help guide our efforts to improve research access and inclusion by sharing your thoughts via our brief survey. Your feedback is critical in shaping the tools and resources we develop and disseminate.
Comments provided to: World Medical Association (WMA)
The WMA’s Declaration of Helsinki is an often-referenced, foundational guidance document for the clinical research enterprise. The MRCT Center submitted targeted recommendations to the WMA on areas such as health literacy, accessibility, informed consent, participant autonomy, and post-trial responsibilities (among others) in the first of two public consultation periods. We await the second public consultation with interest.
