Returning Individual Trial Data To Patients: How And Why It Needs To Happen

By Jessica Scott, MD, JD, CEO, and Jennifer Millman, JD, senior director of strategy and operations, Legacy Health Strategies

While the primary purpose of medical research is to generate new knowledge, this goal can never take precedence over the rights and interests of individual research subjects.¹

The ethics of returning results to participants in clinical trials is a complex issue that has garnered significant attention in recent years. This topic is grounded in a rich framework, underpinned by foundational documents that have shaped the landscape of human research ethics. The Declaration of Helsinki (DoH), first established in 1964 by the World Medical Association, is a cornerstone in this domain. It emphasizes respect for the individual, their right to self-determination, and the necessity of informed consent both at the outset and throughout research. The Belmont Report, published in 1978 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, introduced three core principles: respect for persons, beneficence, and justice, which continue to guide ethical considerations in clinical trials. More recently, representatives from industry, academia, regulatory agencies, patients, and advocacy organizations have come together to reassess how these ethical principles apply to the return of individual data and results. The Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard released a Guidance, Toolkit, and Principles in 2017 that was updated in 2022. The National Academies of Sciences, Engineering, and Medicine published Returning Individual Research Results to Participants: Guidance for a New Research Paradigm (NASEM Report) in 2018. And finally, the EU-funded FACILITATE project is exploring the issue in a four-year project that kicked off in 2022.

The role of patient volunteerism in clinical trials is increasingly challenging as clinical trials become more complex. According to the Tufts Center for the Study of Drug Development, the average patient in a Phase 3 clinical trial is expected to attend 18 to 20 planned visits and undergo 34 to 38 procedures, representing a substantial investment of their time, energy, and resources. This commitment underscores the importance of acknowledging participants' contributions by considering their desire for information about the results of the research they support. What’s more, studies indicate that many participants expect to receive their personal results, driven by a natural curiosity about their health and the outcomes of the research to which they contributed. This expectation persists regardless of whether the consent process promises the return of results.²

Challenges To Providing Patients With Clinical Trial Data

Balancing the interests of patients and sponsors in this context is challenging. Historically, the inclination has been to avoid sharing individual results to mitigate the risks associated with disclosing unvalidated data and in recognition of the complexity and burden that it places on sponsors. This practice has been criticized as “helicopter research,” where investigators engage with participants only to withdraw without further communication. Yet, there has been a noticeable shift toward greater transparency and engagement with participants, reflecting a broader cultural transition. Participants increasingly see themselves as active partners rather than passive subjects in clinical trials. This shift comes with an increased connection and commitment to clinical trial participation with the hope of contributing to improving patient care and necessitates a reevaluation of traditional practices. Indeed, our core ethical principles of respect for persons, beneficence, and justice are implicated in the acknowledgment that clinical trial participants’ needs and interests should be addressed in new and innovative ways wherever possible in the development of new medical products, including seeking more data and results during and after their participation.

The critical question is: How do we balance the competing interests of patient desires, ethical principles, and the practical considerations of running a clinical trial? Below are key considerations to guide the ethical return of individual data and results in clinical trials.

Why We Should Return Clinical Trial Data To Patients

If I had two trials in front of me to choose from, and one of them told me up front when we are done you will get your kid’s data… I always felt I would pick the one that told me up front it is your data and I’m going to give it to you.³

Four ethical benefits of returning data to patients in alignment with the above foundational documents include:

1. Respect for participant autonomy and reciprocation: Returning data to patients acknowledges their valuable contribution to the research process, honors their autonomy and voluntary participation, and strengthens the trust and partnership between researchers and participants. It also demonstrates reciprocity and appreciation, aligning with the principles of respect, reciprocity, and justice in research ethics by providing benefits and feedback to participants.
2. Transparency and accountability: Sharing research findings with participants promotes transparency in the research process and enables stakeholder accountability. It fulfills participants' right to know how their contributions impacted the study results and the generalizability of knowledge, as well as how the results might affect their health or well-being.
3. Empowering participants with information about their individual results: Disclosing individual results to participants empowers them with knowledge about potential health risks or benefits, allowing them to make informed decisions about their health and well-being. This is particularly important because participants have invested time and resources.
4. Ethical stewardship of environmental resources: Returning individual results to participants also can have positive environmental implications. By reducing the need for duplicate tests and procedures, sponsors can help minimize the environmental footprint associated with these activities. This includes decreasing the use of disposable medical supplies, reducing energy consumption related to medical equipment and facilities, and minimizing the generation of medical waste. Furthermore, by empowering participants with their individual results, sponsors can encourage more informed decision-making and potentially reduce unnecessary healthcare interventions, leading to a more sustainable and environmentally conscious approach to healthcare delivery.

Returning individual data to clinical trial participants is an ethical imperative that aligns with foundational principles of research ethics. It respects participant autonomy, promotes transparency, and empowers individuals with valuable health information. While challenges exist in implementing data return practices, the benefits to participants and the research community are significant. In part two of this article, we will explore practical strategies for sponsors to approach patient data return, including steps to build a comprehensive business case, prioritize patient engagement, and integrate data return into protocol development.

In part two of this series, discover four steps to returning individual patient data. 

References:

1. World Medical Association. 2013. Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects, 64th WMA General Assembly, Fortaleza, Brazil, October 2013. General Principle #8.
2. National Academies of Sciences, Engineering, and Medicine. 2018. Returning Individual Research Results to Participants: Guidance for a New Research Paradigm. Washington, DC: The National Academies Press, p. ix.
3. Legacy Health Strategies. Design Thinking Workshop, June 2023. Care partner-participant comment.

About The Authors:

Jessica Scott, MD, JD, is the CEO of Legacy Health Strategies, where she brings a unique blend of expertise as a physician, attorney, and former pharmaceutical executive to drive patient-centered solutions. Inspired by the loss of her sister to osteosarcoma, Jessica has dedicated her career to improving patient outcomes and experiences. Her background includes a decade as a family medicine physician, legal experience in healthcare, and executive roles at GlaxoSmithKline and Takeda, where she successfully integrated patient perspectives into global program teams. An award-winning leader in patient engagement, Jessica is recognized for her work in clinical trial transparency and developing patient-centered approaches in drug development. She serves as a strategic advisor to various organizations and is committed to transforming the healthcare industry by fostering collaboration between patients, healthcare providers, and pharmaceutical companies. Married with three children, Jessica exemplifies how personal loss can drive positive change in making healthcare more inclusive and compassionate.

Jennifer Millman, JD, is the senior director of strategy & operations at Legacy Health Strategies, where she leverages her diverse background to accelerate awareness and access to clinical trials through equity-centered engagement. Prior to joining Legacy, Jennifer transitioned from a successful 14-year legal career to the non-profit sector, where she led a women’s leadership program and managed a foundation focused on community grantmaking. This experience honed her skills in strategic thinking and passion for mission-driven work, which she now applies to bridging the gap between clinical research and the patients it aims to serve. Together with her husband, she has raised two children in the vibrant Baltimore community that shaped her own upbringing.