arrow_back Back to blog

A new era of health data: The vision and challenges of returning individual research results

| Written by:

Charlene Wong

Pediatrician and co-chair of the Project Baseline Return of Results Committee, Duke School of Medicine and Duke Clinical Research Institute

We have entered a new era of ubiquitous health data. One in which researchers and clinicians have tools to collect amounts of data not previously imaginable. And one in which the people providing the data—whether a research participant or patient—expect their data to be accessible.

A transparent partnership between researcher and participant is ideal, and has not always been the norm in clinical research. Participants often take part in research without visibility into their data or the outcomes of the research. In large part, the challenge with disclosing results to participants has been due to having the ability to return them in an effective and meaningful way, the substantial time and resources that are required to communicate results back to each participant, and the absence of guidelines for how to approach the myriad of practical and bioethical issues that arise around what to return and how to return it. The medical ethics of separating research from clinical care has historically been a key reason for many studies choosing to not return their research results.

At Project Baseline, we decided that we will prioritize the exploration of providing health information back to participants. We are well aware of the challenges linked to returning results but, in support of our philosophy that we want to take a patient-centric approach to clinical research, we are continuing to work through them.

Because no other study to our knowledge has tried to return as many results as we intend to, we are pushing the envelope into a new and exciting area that we believe creates an opportunity to provide something incredibly valuable to our participants. We have been drawing from many sources to design the policies and processes for returning results, and we are still in the early stages. Central to this work is a committee dedicated to the return of individual research results within the Project Baseline team. Our committee includes participant advocates and thought leaders in clinical medicine, clinical research, bioethics, and genetics.

The other key stakeholders in developing these policies and processes are the people most important to this health data endeavor: participants themselves. We have sought input from participants in the form of surveys, interviews and user-experience research interactions to help match our approach to participant preferences and expectations, and we will continue to do so. We have also turned to researchers in other large clinical studies who have chosen to return some or no results for their perspective and recommendations. And we have explored what private health data companies have made available to their customers for inspiration.

We recently released some of the initial results in the Project Baseline study, which were routine labs collected at each participant's first study visit. We were careful to distinguish that we are conducting research, not delivering clinical care and encourage participants to bring any questions or concerns about these results to their own clinical providers.

As we look forward to returning more results back to participants, we are continually incorporating participant feedback into the design of what we hope will be even more engaging reports. We are also building a more sophisticated infrastructure to streamline the process of returning results, both for participants and for our study staff. We hope this work will become an early benchmark for other clinical studies in this new era of ubiquitous and ideally more transparent health data. We appreciate the support and patience of our participants and look forward to sharing learnings with the research community.

Next story: Faces of Baseline: Scott

Scott Jung, 31, a self-proclaimed "gadget guy," said he originally joined the Project Baseline study to contribute his health data to a good cause and use cool technology.