This meeting was presented to the Bioethics Collaborative. The Bioethics Collaborative is a forum to propose, share, and discuss ethical challenges in multi-national clinical trials. Meetings convene individuals from academia, industry, patient/participant groups, ethics committees, government, and others.
Abstract:The December 2024 session of the MRCT Center’s Bioethics Collaborative, Is It Time to Retire the Concept of Deidentification?, convened experts to explore the limitations of current deidentification standards in the face of advancing technologies and evolving data landscapes. Participants examined the ethical and regulatory frameworks underpinning HIPAA and the Common Rule, debated the feasibility and implications of redefining “identifiability,” and emphasized the growing risk of reidentification, particularly for minoritized groups. Discussions underscored the need for greater public engagement, transparency, and nuanced protections that balance data utility with privacy, while considering interim policy approaches amid calls for systemic reform.
Dr. Carla Saenz, Regional Advisor for Bioethics at the Pan American Health Organization (PAHO), speaks with Willyanne DeCormier Plosky, MRCT Center Program Director, to unpack the clinical trial landscape in Latin America.
They discuss:
How demographics, healthcare infrastructure, and insurance models shape who can—and does—participate
Ethical and regulatory strategies to broaden inclusion
The influence of CIOMS and other international guidance on local trial ethics
Designing global studies that honor regional contexts without sacrificing scientific rigor
This episode highlights the critical need for equitable access and culturally responsive research in today’s global trial environment.
For more about the MRCT Center’s work on Global Representation in Clinical Trials, click here.
Join us for a full day of discussions and presentations on ethical, actionable, and practical solutions to today’s global clinical research challenges. Engage with regulators, industry leaders, patient advocates, and research experts to gain privileged insights, shape the conversation, and forge connections that drive real-world impact. The symposium is free and open to all registrants.
On Thursday morning, October 23, join a co-branded program with Vivli on data sharing, privacy, and regulation (topic specifics TBA)—also complimentary and open to all Symposium registrants.
Register today to secure your spot and help drive responsible innovation in clinical trials.
During Clinical Trials Week, the MRCT Center premiered a weeklong “What’s Your Why?” video series, featuring eleven patients, caregivers, and health professionals who share the personal motivations that drive their commitment to research. From cancer survivors whose trial experiences became today’s standards of care to caregivers finding hope in each study visit, these firsthand stories exemplify why amplifying the voices and lived experiences of participants is vital: to support ethical clinical research that is truly centered on those who stand to benefit.
Now it’s your turn: record a brief video telling us What’s Your Why? and send it to mrct@bwh.harvard.edu or tag us on LinkedIn with #WhatsYourWhy—because every voice counts in shaping safer, more effective treatments.
🎥 A Powerful Why
For Amanda Monteiro, it’s personal. After losing her 20-month-old daughter to leukemia, she champions clinical trials to help uncover new treatments and better outcomes for patients everywhere.
What’s Your Why? #ClinicalTrialsWeek #WhatsYourWhy #ClinicalResearchMatters #MRCTCenterVoices
🎥 A Caring Why
Normand Neault cares for his wife, Marilyn, after her Parkinson’s Disease diagnosis. “Clinical trials give us hope,” he says, highlighting the encouragement they find in being involved—working alongside experts, seeing her neurologist more often, and lifting each other up. For this caregiving duo, trial participation is a positive step forward, together.
What’s Your Why? #ClinicalTrialsWeek #WhatsYourWhy #ClinicalResearchMatters #MRCTCenterVoices
🎥 A Quality-of-Life Why
Living with chronic pain, Linda Hunter strives for the best possible care—and she trusts clinical trials to deliver it. She wants researchers actively working on diagnosis, treatment, and management that help her live fully, and she insists on having a voice in studies that matter to her.
What’s Your Why? #ClinicalTrialsWeek #WhatsYourWhy #ClinicalResearchMatters #MRCTCenterVoices
🎥 A Hope-Driving Why
Marta Botanch—a pediatric research participant turned nurse—experienced firsthand the impact of clinical research. Her trial treatment not only worked for her but has since been approved and is helping countless children. She champions research because it drives innovation, improves patient care, and ensures safe, effective therapies tailored to young patients—offering hope, dignity, and a future where every child has access to the best care.
What’s Your Why? #ClinicalTrialsWeek #WhatsYourWhy #ClinicalResearchMatters #MRCTCenterVoices
🎥 A Bridge-Building Why
After her cancer diagnosis, Roberta Albany recognized a disconnect between the medical community and marginalized populations, especially African American communities. “Clinical trials save lives—not just yours, but lives that come after,” she says, and calls on us to be part of the solution—unlocking breakthroughs that enhance quality of life for all.
What’s Your Why? #ClinicalTrialsWeek #WhatsYourWhy #ClinicalResearchMatters #MRCTCenterVoices
🎥 A Surthriver’s Why
Robert Weker, a 3-time cancer “surthriver,” credits his survival to the bravery of earlier trial participants: “I was able to stand on their shoulders—those treatments became today’s standard of care.” Guided by his belief that all patients deserve to make informed decisions, he champions clinical trials to fuel tomorrow’s breakthroughs.
What’s Your Why? #ClinicalTrialsWeek #WhatsYourWhy #ClinicalResearchMatters #MRCTCenterVoices
🎥 A Survivor’s Why
After battling stage IV melanoma, T.J. Sharpe credits clinical trials with saving his life—and giving hope to thousands walking in his shoes. His message: without research, patients lose access to their best possible options.
What’s Your Why? #ClinicalTrialsWeek #WhatsYourWhy #ClinicalResearchMatters #MRCTCenterVoices
🎥 An Advocate’s Why
Marilynne Quarcoo, a long-time participant and patient advocate, shares how letting go of anxiety around research revealed a powerful truth: each of us can contribute to better health care for countless others.
What’s Your Why? #ClinicalTrialsWeek #WhatsYourWhy #ClinicalResearchMatters #MRCTCenterVoices
🎥 A Determined Why
Diagnosed in her 20s with an unknown subtype of Muscular Dystrophy, Keisha Greaves lives every day without a cure and with only physical therapy as a standard option. “How do we know what will work unless we try it?” she asks—driven by the belief that volunteering for clinical research can unlock treatments not just for her, but for everyone in the disability community.
What’s Your Why? #ClinicalTrialsWeek #WhatsYourWhy #ClinicalResearchMatters #MRCTCenterVoices
🎥 An Empowerment Why
Living with Parkinson’s, Marilyn Neault finds that clinical trials give her a crucial sense of control—helping her benchmark her health and learn more about her condition. “Clinical research is vitally important to me,” she says, driving progress for herself and others.
What’s Your Why? #ClinicalTrialsWeek #WhatsYourWhy #ClinicalResearchMatters #MRCTCenterVoices
🎥 A High School Student’s Why
Having to undergo medical procedures designed for adults catalyzed Anvita Ambardekar’s passion for clinical research and pursuit of a biomedical career. Young people like Anvita are the future of innovation and scientific advancements, and her clear-eyed plea for clinical research that focuses on improving healthcare for children and teenagers is a reminder to all of us who champion representation in clinical trials.
What’s Your Why? #ClinicalTrialsWeek #WhatsYourWhy #ClinicalResearchMatters #MRCTCenterVoices
Published on: November 18, 2024 and updated on May 30, 2025
Sexual orientation and gender identity (SOGI) may influence disease risk, incidence, severity, manifestation, and treatment response. In line with the clinical research guiding principles in the Belmont Report of respect for persons, beneficence, and justice, we have developed a toolkit to support equitable participation of people who are LGBTQIA+. The toolkit contains seven tools. Any audience can use the full toolkit, although it should be noted that first four tools are directed more toward sponsors and research teams, and the latter three are directed more toward participants. The first four tools were publicly released individually in the spring of 2024, and the latter were released in November 2004. We invite you to explore the full toolkit or to focus on the specific tools that you find most important to your individual or organizational journey in clinical research.
The authors press for follow‑up models that reduce patient and caregiver burden, improve retention, and leverage decentralized methods and real‑world evidence. Achieving this vision will require sustained collaboration across disciplines and meaningful engagement with patient communities.
Chapman et al., Patient-centered long-term follow-up for gene therapies aligns with ethics and science, Molecular Therapy (2025), https://doi.org/10.1016/j.ymthe.2025.04.040
Barbara Bierer and Willyanne DeCormier Plosky co-authored an article, led by David Gerber (UT Southwestern), in the Journal of Clinical Oncology titled, “Financial Toxicity in Cancer Clinical Trials: An Issue in Need of Clarity and Solutions.” This work was spearheaded by the Equitable Access to Clinical Trials (EACT) Project, hosted by Lungevity, of which the MRCT Center is one participating organization. The article illustrates some of the non-medical costs that cancer trial participants often pay out-of-pocket, such as an average of $600 US for travel, which are an additional stressor during a difficult time for participants and their families. The authors then detail financial support approaches to address these costs, and special considerations for sponsors, contract research organizations, and sites. Finally, the article highlights recently introduced federal legislation that could significantly ameliorate some of the barriers for sponsors trying to implement financial support approaches and for participants trying to access them.
Published in:The Journal of Empirical Research on Human Research Ethics
Barbara Bierer and Willyanne DeCormier Plosky co-authored an article, led by Emily Nguyen (University of Virginia) and David Resnik (NIEHS/NIH), in the Journal of Empirical Research on Human Research Ethics titled, “An Analysis of Institutional Review Board Policies for Enrollment of Adults with Impaired or Uncertain Decision-Making Capacity.” Some people (at some times) may have uncertain or impaired decision-making capacity, due to medication side-effects, cognitive or developmental disabilities, psychiatric disorders, dementia, physical or emotional trauma, or stress. Unless it is determined that they lack capacity and require a legally authorized representative, people with uncertain or impaired decision-making have the right to decide for themselves, with assistance such as supported decision-making (if desired), whether they would like to participate in clinical trials. However, they must first be offered an equal opportunity to participate. We explore in this paper how this equal opportunity, legally supported by Section 504 of the Rehabilitation Act, may be affected by Institutional Review Board (IRB) policies that are oriented towards exclusion rather than inclusion.
A common misconception is that plain language is only needed in select situations. In reality, applying health literacy best practices—such as using clear, thoughtfully designed language—benefits everyone, including professionals working in highly technical fields like data science.
In this on-demand webinar, originally presented on May 8, 2025, leaders from the Society for Clinical Data Management (SCDM), the Clinical Data Interchange Standards Consortium (CDISC), and the MRCT Center explore the essential role of plain language tools, such as the Clinical Research Glossary, in advancing understanding and engagement. They share how their organizations are fostering a culture of health literacy that supports both industry professionals and the broader research community, including patients, participants, and caregivers.
Innovative approaches to long-term follow-up (LTFU) in gene therapy (GT), including Registries and Platform Trials. While GTs may offer transformative health benefits, long-term safety monitoring is often essential and can span years or decades. Our panelists will explore scientific and logistical challenges, along with emerging solutions.
