In the Spotlight
We are delighted to announce that our new course, “Ethics and Review of Interventional Clinical Research,” is now available online at OpenWHO.org. This course was developed in partnership with the World Health Organization and aims to meet the growing demand for 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 interventional 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. Please click here to enroll.
Accessibility 101 Training Series
The MRCT Center developed a series of six Accessibility 101 Training modules to complement the Accessibility by Design (AbD) in Clinical Research Toolkit:
- Learning About Disability Inclusion
- Mapping the Participant Journey
- Creating Alt Text
- Assessing Color Contrast
- Using Plain Language
- Developing Accessible PowerPoints
These training modules are in PowerPoint format. They can be taken on-demand by individuals or utilized by organizations to conduct group training sessions on accessibility and supporting greater inclusion of people with disabilities in clinical research, with permission from and credit to the MRCT Center.
Also, check out our recent webinars on Accessibility 101: How to Write Alt-Text and Map Participant Journeys and Designing PowerPoint Presentations to Support Health Literacy and Accessibility to see how these training modules can be adapted and used for training, advocacy, or planning purposes.
Now On Demand: Health Literacy Month webinar series
In celebration of Health Literacy Month, the MRCT Center hosted three webinars in October focused on integrating health literacy and accessibility best practices when communicating clinical research information to participants. Resources from these sessions, including recordings, slides, and supplementary materials, are now available on demand here.
Join Us: 2024 Annual Symposium
The MRCT Center invites clinical research stakeholders—including professionals, patient participants, and advocates—to the 2024 Annual Symposium, a complimentary event celebrating 15 years of advancing ethical, actionable, and practical solutions for clinical trials. This symposium will bring together diverse voices to explore cutting-edge advancements, regulatory updates, and participant-centered approaches shaping the future of clinical research.
Event Details:
- Date: November 14–15, 2024
- Location: Gordon Hall & Countway Library, Harvard Medical School, Boston, MA. A virtual option is also available.
- Cost: Free to all registrants
Click here to view the full agenda and to register.
Join Us: December Biannual Meeting of the Joint Task Force for Clinical Trial Competency
The Joint Task Force for Clinical Trial Competency (JTF), anchored at the MRCT Center, is dedicated to developing and disseminating standards and practices for the clinical research workforce. The JTF fosters a cohesive, global approach to ensuring that professionals have the necessary competencies to conduct clinical trials effectively and ethically.
The public is invited to attend biannual meetings; these meetings are virtual to accommodate our global partners and interested parties. The next meeting is December 10 from 9 – 11 AM ET. Proposed updates include the launch of a participant and patient partner competencies task force, Delphi results from the data management task force, proposed team science competencies, experiences with the Portuguese translation, results from the JTF competency survey in the Philippines, and training community workers using the JTF framework.
Click here to register
Celebrating Dr. Bierer’s Leadership in Research Advocacy!
We are thrilled to announce that Barbara Bierer, Faculty Director of the MRCT Center and Professor of Medicine at Harvard Medical School, will receive the Herbert Pardes Family Award for National Leadership in Advocacy for Research at the 2025 Research!America Advocacy Awards.
Dr. Bierer has championed research ethics, design, and international collaboration. Her contributions, including co-founding the MRCT Center and Vivli, have significantly advanced the global standards for clinical trials and data sharing.
She will be formally presented with the award on March 12, 2025, at the National Academy of Sciences in Washington, D.C.
Click here to read more about the 2025 Research!America Advocacy Awards and Dr. Bierer’s fellow honorees.
MRCT Center Joins National Roundtable to Address Clinical Trial Diversity
MRCT Center Program Manager Hayat Ahmed participated in a Clinical Trial Diversity Roundtable hosted by Congresswoman Robin Kelly (IL-02), Chairwoman of the Congressional Black Caucus (CBC) Health Braintrust, at the La Rabida Children’s Hospital in Chicago on October 8. Congresswoman Robin Kelly gathered various healthcare and research stakeholders to hear about their efforts to diversify clinical trials.
The roundtable addressed critical challenges, particularly the historical mistrust in the Black community stemming from unethical research practices. Participants highlighted ongoing efforts to educate the community and diversify the scientific and medical workforce to restore confidence in the clinical trial process.
Congresswoman Kelly listened to insights from representatives of leading organizations, including the MRCT Center at Brigham and Women’s Hospital and Harvard, Cancer Support Community, Patient-Centered Outcomes Research Institute, Genentech, Howard Brown Health-Sheridan, Bristol Myers Squibb, Walgreens Boots Alliance, City of Hope Chicago, and ATW Health Solutions. Key government partners such as the Illinois Department of Public Health, the Department of Health and Human Services, and the NIH were also present, showcasing a united front in tackling these essential issues.
Click here to read the comments that were presented.
Join us for a Virtual Meeting on Clinical Trial Diversity
On December 9, the MRCT Center, in collaboration with the Clinical Trials Transformation Initiative (CTTI) and Milken Institute’s FasterCures, and with contributions from the National Academies of Sciences, Engineering, and Medicine, will host a virtual meeting to discuss the current state of diversity in clinical trials.
This meeting is part of the ongoing Diversity Convergence Project series, which began in 2023 and will feature insights from community leaders, policymakers, and researchers. Together, we will examine how the post-election policy landscape may impact efforts to enhance diversity in clinical trials.
The webinar is free to attend and will take place from 10:00 am to 1:00 pm ET.
Click here to register.
New ICH E8(R1) Video
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 view the video, click here.
Events & Presentations
October 8: Willyanne DeCormier Plosky, MRCT Center Program Director, presented with Zary Amirhosseini (Program Manager, Disability Program, Mass General Hospital), Martha Jones (Vice President, Human Research Affairs, Mass General Brigham), and Jeanhee Chung (Principal Investigator, Lab of Computer Science, Mass General Hospital; Instructor in Medicine, Harvard Medical School) on “Empowering Voices: Strategies for Involving Individuals with Disabilities in Research.” This webinar is part of the Chester Pierce Research Society Speaker Series.
October 10: Barbara Bierer and Mark Barnes, Co-Faculty Directors of the MRCT Center, each presented at the University of Pennsylvania’s Symposium entitled, “Advancing Trust in Science: Institutional Obligations to Promote Research Integrity.” Dr. Bierer spoke on “Managing Multi-Institutional Jurisdiction in Cases of Research Misconduct,” and Mr. Barnes addressed “Defamation Claims Arising from Research Misconduct Cases: Best Practices for Institutions.”
October 10: Now On Demand: Designing Impactful Informed Consent Processes that Empower Participants webinar.
October 17: Now On Demand: Creating and Sharing Plain Language Summaries: One Team’s Experience webinar.
October 21: Willyanne DeCormier Plosky presented at Penn State College of Medicine/ Penn State Clinical & Translational Science Institute on “Mapping the Participant Journey: Disability Inclusion in the Research Process.”
October 22: Now On Demand: Designing PowerPoint Presentations to Support Health Literacy and Accessibility webinar.
October 22: Barbara Bierer was invited to join the discussion of “Operationalizing Ethics into Online Safety and AI Research” held by the White House Office of Science and Technology Policy (OSTP) in Washington, DC.
October 31 – November 1: Willyanne DeCormier Plosky will deliver a keynote speech at the University of Monterrey (Mexico) 2nd International Symposium on Medical Education. The keynote title is “Gender Perspectives and Inclusion: Key Elements in Transforming Medical Education for a Future of Personalized and Safe Care.”
Nov 13 – 15: MRCT Center Annual Symposium. Click here to learn more about the agenda and to register.
November 15, 9 am – 2 pm ET: Vivli Annual Meeting, in conjunction with the MRCT Center: “Innovations in Data Sharing.” Click here to register for this event or all MRCT Center Annual Symposium events.
The MRCT Center at PRIM&R Annual Conference:
- November 18, 12:30 – 1:30 pm PT: Barbara Bierer and REACH Collaborative colleagues Michelle Feige (AAHRPP), Ivy Tillman (PRIM&R), Martha Jones (Mass General Brigham) will present “REACH: the Research Ethics Collaborative for HRPPs for Justice.”
- November 18, 1:45 – 3:00 pm PT: Barbara Bierer and Benjamin Silverman (Mass General Brigham) will present “Accessing Capacity to Consent for Research Participation: When and How Do You Actually Do It?”
- November 19, 10:30 – 11:45 am PT: Willyanne DeCormier Plosky will join Sarah Muenster-Blakeley (University of St. Thomas) and Cecilia Brooke Cholka (Weill Cornell Medicine) to present “Accessibility Basics: Making Word Documents and Videos Accessible.”
- November 19: 1:45 – 3:00 pm PT: Barbara Bierer and Adam Berger (NIH) will present “Building Trust in Science: Enabling Frameworks for Returning Individual Research Results to Research Participants.”
- November 19, 1:45 – 3:00 pm PT: Willyanne DeCormier Plosky will be presenting with Christina Dragon (GMRO, NIH), Amy Ben-Arieh (The Fenway Institute), and Keith Dawson (Genentech) at a plenary session titled “(E01) Fast Forward: Update on Inclusion of Sexual and Gender Minorities in Clinical Research.”
- November 20, 10:30 – 11:45 am PT: Willyanne DeCormier Plosky will moderate a panel titled “Protecting Third Parties in Research: Whose Job Is it Anyway?” The panel will feature Iris Jenkins (Virginia Tech) and Marilyn Lamm (Clinical Biosafety Services) as speakers.
December 5: 12-1:15 pm ET: Carolyn Chapman, MRCT Center Member of the Faculty and Lead Investigator, will moderate and co-sponsor a webinar, “What’s up with Long-Term Follow-Up: ethical, regulatory, operational challenges,” with the Pediatric Gene Therapy and Medical Ethics (PGTME) Working Group at the Division of Medical Ethics, NYU Grossman School of Medicine. The webinar is part of PGTME’s fifth annual Lunchtime Lecture Series.
December 10, 9 – 11 am ET: Biannual Global Meeting of the Joint Task Force for Clinical Trial Competency. This virtual meeting is open to all registrants.
December 12, 9 – 11:30 am ET: Meeting of the Bioethics Collaborative. Topic: Is it Time to Retire the Concept of Deidentification?
Publications
September 2024: Barbara Bierer, Sylvia Baedorf Kassis and Alyssa Panton co-authored an article with Devaki Thavarajah and Trishna Bharadia entitled, “Creating educational materials about clinical research data for patients and the public: A multifaceted journey in the current digital age,” published in Medical Writing.
The article discusses the importance of creating educational materials to improve public understanding of clinical research data, particularly in light of misinformation during the COVID-19 pandemic. It emphasizes the need for transparency and clarity in addressing issues like data privacy and the ethical sharing of information. Modern tools such as videos and infographics can make clinical research more accessible and build trust with patients and the public.
October 19: Barbara Bierer authored a viewpoint article, “Declaration of Helsinki – Revisions for the 21st Century,” in JAMA.
The article addresses the significant updates to the recent 2024 revision of the Declaration of Helsinki, now celebrating its 60th anniversary. It highlights the expansion of ethical responsibilities to all researchers, the shift from “subject” to “participant” to emphasize autonomy, and the importance of “free and informed consent.” Additionally, it discusses complex ethical issues like vulnerability, inclusivity, post-trial access, and use of data for research. It also addresses the complexity of ethical issues in multi-national clinical research.
The MRCT Center provides a unique and trusting community to improve the integrity, safety, and rigor of global clinical trials. Join us in our efforts to develop innovative solutions and aligned approaches to global clinical research.
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