Engaging Participants and Assuring Equity in the Precision Medicine Initiative

July 14, 2015


The National Institutes of Health (NIH) is convening a series of workshops with members of the Director’s Advisory Committee to inform the design and execution of the 1 million-person “cohort” that will be the centerpiece of the Precision Medicine Initiative (PMI). The third of this summer’s four sessions kicked off on July 1 at NIH in Bethesda, Md., and focused on Participant Engagement and Health Equity

The agenda brought together thought leaders from academia, health providers, and the patient community to discuss how to ensure that participation in, and the benefits of, the PMI are available to all, regardless of race, ethnicity, or socio-economic status.

The workshop’s 10 sessions provided many examples of best practices on recruiting and retaining populations that are historically under-represented in biomedical research studies, such as those of the Jackson Heart Study and the Georgetown Center of Excellence for Health Disparities. Patient organizations also provided their input on how to successfully leverage the power of engaged communities such as the Army of Women and PatientsLikeMe. Discussion also touched on how the PMI could explore the social determinants of health as well as genetic factors.

One of the most interesting – and important – debates that occurred was how best to balance two very powerful concepts: “Do no harm” and “Free the data.”

There are tragic examples in the history of medical research where populations were exploited and medicine’s central tenet of “do no harm” was violated. Lessons from those experiences have been keys to the success of many of the research studies highlighted during the workshop. Other participants discussed how important it is that genetic information be properly interpreted – especially when it is being returned to study participants or released to the public and the media. The scientific and clinical significance of raw genetic information varies widely, and the research community has an obligation to educate individuals and communities and to guard against discrimination that could be fueled by inappropriate headlines.


At the same time, there is a strong call from many corners to “free the data” and make it broadly available to study participants and other researchers through means such as broad consent agreements for study participants, online data repositories, and patient-powered disease registries. Perhaps the strongest advocate at the workshop was Matt Might, who shared his story of using the internet to publish everything about his son’s previously unknown genetic illness in the search for other patients and to stimulate research for a cure.

While in no way mutually exclusive, there is a tension between these two impulses. Does an individual’s desire to disclose their genetic information trump her community’s desire to protect their genetic heritage from possible mis-characterization? Should a study participant be told about a potential risk factor when the significance is unknown, or there is no way to address the problem? How should study participants and their community be engaged when a new research team requests access to data? What right does a researcher, or an institutional review board, have to keep data locked away from a study participant? Do any of those answers change if the study participants come from a community that is economically disadvantaged, marginalized, or subject to discrimination? What about if they are suffering from a lethal illness with no therapeutic options?

None of these questions are unique to the PMI. However, the project’s ambition and goal of mobilizing 1 million participants from all walks of life will likely exacerbate the challenges and require a finely tuned governance system. Fortunately, the team behind the PMI has had the foresight to start the discussion now so that solutions can be built in from day one. We must all benefit from the advances that will come from precision medicine.


Related resource: An Audacious Endeavor: Inside the PMI Research Cohort (June 2015)

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