A conversation with Amanda Howley, Director of Services Solutions at Suvoda
Snapshot:
- Updated international agreement: The World Medical Association (WMA) has released a rare update to its foundational ethical framework – the Declaration of Helsinki.
- Patient-centric focus: A language change from human "subjects" to "participants" signals a shift toward recognizing individuals as active contributors in clinical research.
- Electronic documentation now formally recognized: The Declaration acknowledges digital technologies in clinical trials, validating eConsent adoption.
The World Medical Association (WMA) has updated one of its foundational ethical frameworks - the Declaration of Helsinki. To understand what these changes mean for clinical trial technology and the future directions of clinical research, we spoke with Amanda Howley, Director of Services Solutions at Suvoda.
Q: What is the Helsinki Declaration, and why is it so important for clinical trials?
Amanda Howley: Think of the Helsinki Declaration as the ethical foundation that shapes how we conduct medical research with humans. Established by the World Medical Association in 1964, it emerged in direct response to historical tragedies like the medical experiments during World War II.1 These events highlighted the critical need for ethical oversight in medical research.
Today, these principles form the backbone of what we know as Good Clinical Practice (GCP)—the standard that guides all clinical trials globally. In our increasingly interconnected world, where trials often span multiple countries and cultures, having unified ethical principles is more crucial than ever for protecting all patients.
Q: What are the most significant changes in this update?
AH: The 2024 updates reflect several important changes in the approach to clinical research. One of the most striking changes is the move from referring to 'human subjects' to 'human participants,' representing a fundamental shift in perspective. The Declaration has also embraced the digital age by formally recognizing electronic documentation as a method for informed consent, while adding stronger requirements for research transparency and timely public sharing of results.
The updates tackle emerging challenges in data privacy and artificial intelligence, providing guidance on consent for future participant data and sample use. Additionally, there's a renewed emphasis on research quality, requiring trials to demonstrate scientifically sound design while ensuring ethics committees have adequate resources for proper oversight.2
Q: The change from "subjects" to "participants" seems significant. Why does this shift matter, and what can organizations do in response?
AH: This change is not just about updating our vocabulary, but rather, about recognizing that individuals who take part in clinical trials are active partners in advancing medical knowledge. They're not passive subjects being studied; they're participants contributing to scientific progress.
In practical terms, this means reviewing and updating everything from software interfaces to training materials so that the language aligns with this more respectful, participant-centered approach. It's a chance for the entire clinical research industry to reconsider how we communicate about and with research participants.
Q: The Declaration now specifically mentions electronic consent for the first time. What implications does this have for eConsent?
AH: While electronic consent has been around for two decades, this formal recognition marks a turning point. It signals that electronic consent isn't just an alternative option—it’s moving toward becoming standard practice in modern clinical trials.
This aligns with last year’s FDA guidance emphasizing participant comprehension in the consent process. Modern eConsent solutions can incorporate interactive elements like quizzes, include quick-reference glossaries of confusing terms, and use clear formatting to help participants truly understand what they're agreeing to.
Q: The updates emphasize accountability in several areas. How can technology help meet these new requirements?
AH: The increased focus on accountability—from sound study design to prompt results sharing—will likely require more robust documentation and reporting processes. This is where seamlessly integrated technology solutions become invaluable. When organizations use eClinical solutions such as eConsent, Electronic Clinical Outcome Assessment (eCOA) and Interactive Response Technology (IRT), they can more efficiently manage audit trails and documentation. The benefits are even more pronounced when solutions are housed on a unified platform that shares the same data layer.
I’m very interested in finding new ways to keep participants engaged with eventual research outcomes, as part of our industry’s move toward accountability. And, I’m not alone in that interest – the recent update to the Guidelines for Good Clinical Practice calls for sponsors to inform participants about trial results after unblinding.3 Innovations like patient-facing apps that could update participants on progress in their therapeutic area could help fulfill the Declaration's vision of participants as active partners in research.
Q: As someone deeply involved in the world of clinical trials, what was your initial reaction to news of the update?
AH: When you support clinical trials, the Helsinki Declaration isn't just another document—it’s foundational to everything we do. I still remember studying it while earning my master's degree in clinical research administration. What makes these updates particularly significant is their rarity—there have only been seven revisions since 1964, and each one goes through intense scrutiny and global public input. The last update was over 10 years ago, so any changes now signal important shifts in the approach to clinical research.
Q: Why is Suvoda tracking these updates?
AH: As a technology provider, we have a vital role in supporting ethical clinical research. These updates align with our commitment to patient-centered solutions, especially in areas like eConsent and digital engagement.
The Declaration's emphasis and alignment with the Declaration of Taipei on future data use illustrates why this matters.4 This becomes crucial as we see more AI applications in healthcare. Modern eConsent platforms need sophisticated options that let participants make specific choices about their involvement, such as how their samples might be used in future research.
By closely following these ethical developments, we can build technology that not only meets current needs but also supports the future of participant-centered clinical research.
Q: What's the broader significance of these updates for technology providers in clinical trials?
AH: These updates chart a clear course for the clinical research industry—one that prioritizes patient empowerment, comprehensive consent processes, and increased accountability. For technology providers, this means more than just updating our software to follow new standards; we need to actively advance these ethical principles through our solutions.
As clinical trials become increasingly technology-dependent, we have a growing responsibility to continually update our solutions to not only meet technical requirements but also uphold and advance these crucial ethical principles. We're not just technology providers; we're partners in ensuring ethical, participant-centered clinical research.
References
- “Declaration of Helsinki - Medical Research Involving Human Participants,” World Medical Association, n.d., https://www.wma.net/what-we-do/medical-ethics/declaration-of-helsinki/.
- “World Medical Association Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Participants,” JAMA 333, no. 1 (October 19, 2024): 71–74, https://doi.org/10.1001/jama.2024.21972
- “Guideline for Good Clinical Practice E6(R3),” ICH, January 6, 2025, https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf.
- “WMA Declaration of Taipei on Ethical Considerations Regarding Health Databases and Biobanks,” World Medical Association, October 2016, https://www.wma.net/policies-post/wma-declaration-of-taipei-on-ethical-considerations-regarding-health-databases-and-biobanks/
Amanda Howley
Director, Services Delivery