Dr. Lembit Rago, Secretary-General of the Council for International Organizations of Medical Sciences (CIOMS), delivered a compelling keynote on CIOMS initiatives to define and synthesize professional competencies essential for clinical research and emphasized the importance of cooperative agreements to harmonize workforce development efforts.
The session also highlighted the Joint Task Force for Clinical Trial Competency (JTF) Framework as a foundational tool for training and professional development, addressing the challenges and opportunities in recruiting and retaining a diverse and capable workforce.
Sally Armstrong, CEO of PRAXIS Australia, shared how PRAXIS has incorporated the JTF Framework into their educational offerings—including courses, workshops, and immersive onsite training programs.
Susan Landis, Executive Director of the Association of Clinical Research Professionals (ACRP), discussed ACRP’s “Partners Advancing the Clinical Research Workforce” initiative, which uses the JTF Framework to support a diverse and qualified clinical research workforce through training programs, resources, and strategic collaborations.
A recording of the webinar and the presentation slides are available here:
A key aspect of health literacy—especially in clinical research—is understanding what data is collected, how it is protected, and how it is used during and after a study. Truly informed consent requires transparency about data practices so that participants can make educated decisions.
During this webinar we discuss the importance of data literacy, explore practical applications for research teams, and unveil new materials designed to support participants and the broader research community.
Key Topics:
Advancing Data Literacy as a Component of Health Literacy: Explore how understanding research data supports informed decision-making and aligns with broader health literacy efforts.
Applying Plain Language and Visual Tools to Data Communication: Learn how the MRCT Center and PHUSE have used plain language and infographics to make clinical research data more accessible.
Empowering Participants with Transparent and Actionable Information: Identify ways to integrate data literacy resources into your clinical research processes to support research trust and engagement.
The MRCT Center, on behalf of the Convergence Project hosted a virtual event focused on workforce development strategies to support a more dynamic and competitive clinical research workforce. This meeting brought together community leaders, policymakers, and researchers to discuss how to create and support pathways into the clinical trial workforce (e.g., part-time degree programs, community colleges, fellowships). Key topics included workforce development, targeted recruitment, and actionable steps to drive systemic improvements, and meeting attendees had the opportunity to pose questions to panelists leading programs in Georgia, North Carolina, South Dakota, and other states across the country.
This webinar was co-hosted by the MRCT Center and NYU’s Pediatric Gene Therapy and Medical Ethics (PGTME) Working Group as a part of their 5th Annual Lunchtime Learning Series. The panel on Long-Term Follow-Up (LTFU) was moderated by Dr. Carolyn Chapman and captured the ethical, regulatory, and operational challenges of LTFU studies through diverse viewpoints and perspectives.
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.
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.
The MRCT Center and the Research Ethics Action Collaborative for HRPPs (REACH) presented the first webinar in the Accessibility 101 series on July 9, 2024
People with disabilities are the largest minority population in the United States, yet they are often excluded from clinical trials, both as participants and as researchers. Federal regulations, such as the recently updated Section 504 of the Rehabilitation Act, prohibit discrimination based on disability. Many accommodations are easy and low or no cost. It is incumbent upon all of us to build accessibility into our everyday thinking, meetings, presentations, and planning.
This webinar featured two interactive exercises in which participants learned:
Basic information about disability statistics and disability rights, and, as shown through the Accessibility by Design in Clinical Research Toolkit, different types of support that you can readily implement.
How to find the Check Accessibility and Alt Text features in PowerPoint and write appropriate Alt Text.
How to map out the participant’s (and family caregiver’s or supporter’s) journey from different disability perspectives, from getting to/into the site location, navigating within the site to the different areas they must access, and interacting with different forms of medical equipment and technology.
More about REACH: Research Ethics Action Collaborative for HRPPs (REACH) is 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. Click here to learn more.
The critical role of representation in clinical research, particularly for LGBTQIA+ communities, and an overview of the foundations supporting the LGBTQIA+ Inclusion by Design in Clinical Research Toolkit.
Essential considerations for collecting SOGI data, covering survey and form design, appropriate language in study materials, and the protocols for collecting, storing, and sharing SOGI data.
Practical implementation examples and areas that require further research and guidance.
Federal Committee on Statistical Methodology (FCSM) Sexual Orientation, Gender Identity, and Sex Characteristics Subcommittee: https://www.fcsm.gov/groups/sogisc/
Hafeez H et al. Health Care Disparities Among Lesbian, Gay, Bisexual, and Transgender Youth: A Literature Review. Cureus. 2017;9:e1184. Accessed August 7, 2023. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5478215/
Institute of Medicine (US) Committee on Lesbian, Gay, Bisexual, and Transgender Health Issues and Research Gaps and Opportunities. (2011). The health of lesbian, gay, bisexual, and transgender people. National Academies Press (US). Accessed August 7, 2023. https://www.ncbi.nlm.nih.gov/books/NBK64806/
Landers SJ et al. Sexual Orientation Differences in Asthma Correlates in a Population-Based Sample of Adults. Am J Public Health. 2011:101:2233-2244. Accessed August 7, 2023. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3222437/
Fredriksen-Goldsen KI et al. Health and Access to Care and Coverage for Lesbian, Gay, Bisexual, and Transgender Individuals in the U.S. Am J Public Health. 2017:107:1332-1338. Accessed August 7, 2023. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5508186/
Hughes LD et al. Differences in All-Cause Mortality Among Transgender and Non-Transgender People Enrolled in Private Insurance. Demography. 2022;59:1023-1043. Accessed August 30, 2023. https://doi.org/10.1215/00703370-9942002
Morris M et al. Training to reduce LGBTQ-related bias among medical, nursing, and dental students and providers: a systematic review. BMC Medical Education. 2019;19:325. Accessed August 30, 2023. https://doi.org/10.1186/s12909-019-1727-3
Dahlhamer JM et al. Barriers to Health Care Among Adults Identifying as Sexual Minorities: A US National Study. Am J Public Health. 2016;106:1116. Accessed August 29, 2023. https://doi.org/10.2105/AJPH.2016.303049
Sterling J et al. Cancer screening in the transgender population: a review of current guidelines, best practices, and a proposed care mode. Transl Androl Urol. 2020;9(6):2771-2785. Accessed August 7, 2023. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7807311/
Cahill S et al. Do Ask, Do Tell: High Levels of Acceptability by Patients of Routine Collection of Sexual Orientation and Gender Identity Data in Four Diverse American Community Health Centers. PLoS ONE. 2014;9:e107104. Accessed August 7, 2023. https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0107104
Daniel H et al. Lesbian, Gay, Bisexual, and Transgender Health Disparities: Executive Summary of a Policy Position Paper From the American College of Physicians. Ann Intern Med. 2015;163:135-137. Accessed August 7, 2023. https://doi.org/10.7326/M14-2482
Badgett MVL. (2009). Best Practices for Asking Questions about Sexual Orientation on Survey. Los Angeles: The Williams Institute. Accessed August 7, 2023. https://escholarship.org/uc/item/706057d5
Spade D. Normal Life: Administrative Violence, Critical Trans Politics, and the Limits of Law. Durham, NC: Duke University Press; 2015.
Brown I, McKenzie M, Srirangam A, Patel S. Making an Inclusive Impact: LGBTQ+ Health Equity in Clinical Trials. Poster presented at Drug Information Association Global Annual Meeting: June 25-29, 2023; Boston, MA.
Data on File. Genentech, Inc. South San Francisco, CA.
