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.
These training modules are in PowerPoint format. They can be taken on-demand by individuals or utilized by organizations (with permission from and credit to the MRCT Center) to conduct group training sessions on Accessibility 101 topics.
Module 1 provides introductory information about disability data, ableism (and non-discrimination), disability rights, the AbD Toolkit, emerging topics in accessibility in clinical trials, and a scientific and business case for collaborating with people with disabilities on universal design.
Module 2 provides a brief background on the participant journey, from accessing transportation to a site to getting into a site to navigating medical offices and equipment within the site. The module then brings users through an exercise where they are asked to see a series of pictures that illustrate different parts of the participant journey in different settings (e.g., fixed sites, mobile sites, virtual apps). For each picture, the module user must consider the challenges for that scenario from the perspective of people with hearing, visual, mobility, cognitive and intellectual, or other disabilities.
“Creating Alt Text” is the third module in the Accessibility 101 Training series that the MRCT Center has developed to complement the Accessibility by Design (AbD) in Clinical Research Toolkit. In this ever-virtual world, we all create materials like PowerPoints and social media posts that include images, and therefore need to know how make those images more accessible for people with low vision or blindness. Module 3 provides a background on Alt Text, instructions on how to create Alt Text so that images can be “read” by screen readers, and an exercise to test the user’s facility with Alt Text.
“Assessing Color Contrast” is the fourth module in the Accessibility 101 Training series that the MRCT Center has developed to complement the Accessibility by Design (AbD) in Clinical Research Toolkit. We all need to know how to make images more accessible for people with visual disabilities. One part of that universal design is using Alt Text, described in Module 3. Another is making sure that images and text boxes have sufficient color contrast between the text color and the fill (or background) color. Module 4 provides a background on color contrast, instructions on how to assess color contrast, and an exercise to test the user’s facility with assessing color contrast and adjusting colors.
“Using Plain Language” is the fifth module in the Accessibility 101 Training series that the MRCT Center has developed to complement the Accessibility by Design (AbD) in Clinical Research Toolkit. Module 5 provides a background on plain language, instructions on how to adapt complex language into plain language (including how to test the grade level for the language), and an exercise to test the user’s skills with plain language.
“Developing Accessible PowerPoints” is the sixth module in the Accessibility 101 Training series that the MRCT Center has developed to complement the Accessibility by Design (AbD) in Clinical Research Toolkit. Module 6 provides a background on PowerPoints and usage in the expanding world of webinars, instructions on how to develop accessible PowerPoints and an exercise to test the user’s skills with plain language. The “how-to” section of the training starts with defining the intended purpose and audience for the PowerPoint; describes design for mental processing, readability, and sensory processing; reviews elements described in other modules (e.g., Alt Text, color contrast, plain language/inclusive language); and concludes by highlighting considerations to support accessibility while the PowerPoint is presented (e.g., closed captioning).
There is widespread recognition, including among pregnant and lactating people, of the need for better evidence on which to base medical treatment decisions during pregnancy and the post-partum period. Despite this, pregnant and lactating people continue to be left out of clinical trials that test drugs, vaccines, devices, and other medical products for safety and efficacy. Study eligibility criteria routinely exclude both pregnant and lactating individuals, even though the biological bases for exclusion of the two populations differ; the effects of exposure of medicinal products to the fetus at the varying stages of development differ from the effects on the neonate or newborn of medicinal products possibly transferred through breast milk Eligibility often requires negative pregnancy tests prior to enrollment and effective methods of contraception for the duration of the study. Further, people who become pregnant while on an interventional trial protocol are typically withdrawn from further participation. Explanations for this are likely to involve perceived ethical, regulatory, and/or legal considerations, reflecting primarily a concern to avoid harming the developing fetus. In the United States, the regulatory framework requires special protections that must be met before pregnant people may participate in clinical research, including limits on the risks they may be asked to undertake. And there are no federal regulations on the exclusion of or additional safeguards for lactating people, despite their common exclusion. In addition, concerns about potential liability and negative public perception are likely to loom large for sponsors, funders, and investigators, motivating them toward the perceived safer strategy of excluding pregnant people from research in many situations.
At the March 2024 meeting of the Bioethics Collaborative, we examined ethical issues that bear on determining the proper scope of efforts to further the inclusion of people who are pregnant or lactating in clinical research. Discussion sought to build on prior workshops and recommendations asking such questions as: Is the current default of excluding pregnant and lactating people from interventional clinical trials justifiable? Do pregnant people have the right to autonomously choose what level of risk is acceptable for themselves and the fetus they carry? How do clinical research entities circumscribe a reasonable range of, and limits on, risk for pregnant people in research, and does this definition align with the views of pregnant and lactating people? Are there alternatives to including pregnant people in clinical trials that can yield the data needed to improve the care of pregnant and lactating people and avoid the well-known problems that arise with seeking to protect groups by excluding them? What are the justice-based implications of placing restrictions on pregnancy? Might requirements for effective contraception, for example, inadvertently function to discourage or even preclude participation from people who are unable to afford contraception? Could these requirements, which are likely to be perceived as burdensome by some, hinder the participation of people of childbearing potential generally and further exacerbate gender inequities in clinical research?
Comments provided to: U.S. Food and Drug Administration
Description: The MRCT Center comments point to the need for greater transparency on the timing of FDA feedback and the criteria the FDA is using to assess the community engagement, site selection, recruitment, enrollment, and retentions plans in DAPs (both for domestic and for global trials). We also recommend clarifying whether DAPs are required for Phase 3 trials for both new and previously approved products, how to operationalize a “do no harm” approach in enrollment goals (that may involve global trial participants), and when it may be appropriate to disaggregate US enrollment goals/data from global enrollment goals/data. To improve the final guidance, the comments suggest a framework similar to the April 2022 draft, starting with an epidemiological overview and guiding organizations in developing effective diversity strategies.
Comments provided to: National Institutes of Health
Abstract: The MRCT Center recently submitted comments to the National Library of Medicine (NLM) in response to the “Evolving the Network of the National Library of Medicine” initiative (NOT-LM-24-001), emphasizing the importance of enhancing health literacy through better access to clinical research information. Key recommendations included expanding MedlinePlus to include more content related to clinical trials, integrating plain language definitions into ClinicalTrials.gov, and providing aggregate study results in plain language for participants. The MRCT Center also suggested improvements to ClinicalTrials.gov that would allow current participants to access updates on study progress and individual results and harmonize study-specific data elements to facilitate cross-study comparisons. These recommendations aim to improve public engagement, transparency, and trust in the clinical research ecosystem.
The first podcast in our new series, “Trials Beyond Borders: Building Representative Clinical Trials Worldwide.” The podcast features a conversation with MRCT Center Program Director Willyanne DeCormier Plosky and Tinaya Gray, a consultant with ICON plc, focusing on communications between sponsors, CROs, and sites in planning for diversity action plans in the context of global trials.
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.
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.
Comments provided to: National Institutes of Health
Description: The MRCT Center submitted public comments on the NIH Request for Information regarding Strategies for Maximizing Public Engagement in NIH Supported Clinical Research (NOT-OD-24-133). The MRCT Center recommended that NIH encourage researchers and their institutions to establish continuous and bilateral relationships with the communities where they intend to conduct research prior to, during, and after the research. Researchers should cultivate bi-directional partnerships with the communities, budget for those activities, and provide training. Several of our collaborators with meaningful lived experiences, including study participants, patient advocates, and clinical researchers, contributed to the response.
Comments provided to: National Institutes of Health
Description: We recommended that NIH require plain language summaries for all manuscripts submitted to PubMed Central. We supported NIH’s proposal to eliminate the embargo period for publications while requesting further consideration of the practical implementations of the proposed change, sensitive to the potential increase in costs to manuscript submission and other unintended consequences.
