I’m intrigued, on multiple levels, by the ethical, regulatory, and operational challenges of The Precision Medicine Initiative® (PMI) Cohort Program, now called the All of Us^SM Research Program. This program—should it move forward—will be the largest health and medical research program on precision medicine in US history, and proposes to enroll one million or more volunteers in the next few years.

The PMI was introduced to the American public by former President Obama in his 2015 State of the Union address. It was summarized on the White House PMI website¹ at the time as “a bold new research effort to revolutionize how we improve health and treat disease.” An objective of the program as described is to “engage one million or more volunteers living in the U.S. to contribute their health data over many years to improve health outcomes, fuel the development of new treatments for disease, and catalyze a new era of data-based and more precise preventive care and medical treatment.” Talk about lofty goals!

I’m immensely hopeful that this and the program’s other goals can be realized, and soon enough to benefit me and those close to me. I’m experienced enough to have a healthy amount of skepticism about whether that is possible, however. For instance, as an IRB professional, the fact that one IRB is charged with the review of a project of this magnitude is both impressive and terrifying; ensuring that the regulatory review criteria are appropriately applied to a diverse cohort of one million people seems like a daunting task, fraught with potential pitfalls.

At PRIM&R’s 2016 Advancing Ethical Research Conference (AER16), the chair of the All About Us IRB, Nancy Kass, ScD, specifically explored this IRB component in a panel titled Precision Medicine Initiative: What Are the Promises and What Are the Ethical Challenges?

As the panel description, noted, “The success of the PMI relies on individuals’ sustained engagement in the research by sharing their personal data over a long period of time. In return, participants are promised not only access to information, but a partnership role in the research itself. What does this mean to individuals, as well as to the public? This panel will explore issues regarding this partnership; for example: What partnership role will respectfully engage individuals as well as communities, both at the initiation of the PMI and over time?; In an environment of mistrust towards research, is there enough public trust to recruit such partners?; How will ‘individuals as partners’ promote not only individual benefits, but community and national benefits as well?; and How does the variable research literacy of the public effect these partnerships?”

I was impressed by Dr. Kass’ candor about the challenges. Citing the core commitments of all IRBs, she expanded on how risks, benefits, fairness, respectfulness, and respect for autonomy will be applied in this initiative. Fairness, for example, includes recruiting a diverse group of Americans (in terms of health status, physical ability, geography, gender, race/ethnicity, age, literacy, and primary language). The difficulty of ensuring this was highlighted by a member of the audience who expressed concerns about the planned recruitment of only 15,000 individuals who identify as Native American/Eskimo.

Additionally, fairness and respect require that survey questions are appropriate for all who may be recruited—in terms of primary language, literacy level, and cultural considerations. Another member of the audience wondered if nine members of the IRB could adequately consider and address such issues for all of the subgroups that would be included.

These are just two possible pitfalls. The IRB members have a monumental task before them and are fortunate to have Dr. Kass leading the way. It was clear from this panel that the complexity of this project has raised many issues for which there is no precedent in the IRB world. The fact that commencement of recruitment efforts has been delayed reflects that the IRB is cautiously and carefully examining the factors that make review of this project so challenging.

Stay tuned, for if the project moves forward, it will surely pave the way for many others in the future.

AER16 attendees can access the proceedings from this panel here. The access code from sent to you announcing the proceedings’ availability will be required to launch the recording. Readers who did not attend AER16 can purchase the proceedings of this conference and others by completing the order form found here.

Brenda L. Ruotolo, BA, CIP, is executive director of the Human Research Protection Office at Columbia University, and has been affiliated with Columbia since 2003. She has extensive experience with IRB review of both biomedical and social science/behavioral research. As executive director she is responsible for the functions of the seven IRBs and oversight of approximately 6000 active research studies. Ms. Ruotolo has been a member of PRIM&R for approximately 20 years. She presents at local and national conferences on a variety of topics related to the protection of human subjects

¹A recent search for precision medicine initiative on whitehouse.gov returned no results so the status of the project is uncertain.