Be One in a Million

Carl McKinney is one of us.

The seventy-six-year-old retired air traffic controller is participating in All of Us, an ambitious project sponsored by the National Institutes of Health (NIH) to collect detailed health information from one million or more volunteers across the country during the next ten years.

Emory is involved in the effort as a member of the Southeast Enrollment Center network, which includes medical research centers at the University of Miami, Morehouse College, and the University of Florida. These institutions, along with dozens of health care providers and health-related organizations, are soliciting patient data for an enormous database that will serve as an open resource for researchers studying how individual differences in biology and genetics, lifestyle, environment, gender, ethnicity, and other variables may influence overall health and the pathology of complex diseases, according to Michael Zwick, Emory’s principal investigator for the project and assistant vice president for research in the Woodruff Health Sciences Center.

In addition, since the NIH typically doesn’t provide funding for large control groups in disease-related studies, Zwick notes, “By sampling the broad general population, All of Us could make every NIH-funded, targeted study more powerful because you’ll be able to get a well-matched set of control individuals.”

Zwick and faculty from the School of Medicine and the Rollins School of Public Health are enrolling as many Emory Healthcare patients as possible. Participation in All of Us is open to anyone living in the US over age eighteen, regardless of health status and whether or not they receive health care through Emory. Children will be eligible at a later date.

In McKinney’s case, “I’ve been going to Emory since moving to Atlanta from Maryland in 2006—my primary care doctor and cardiologist are attached to Emory Healthcare,” he says. “I’ve been asked before for permission to use my health information when they were trying to find ways to better treat patients with certain diseases, so when I was asked to participate in All of Us, I said yes.

“Initially, I answered some questionnaires online and then went over to Emory where they drew blood and took urine for tests. Basically, that’s been it thus far. They said they would contact me later once they established the database and they require additional information.”

Blood and urine samples are used to evaluate markers of disease, including genetic factors, says Alvaro Alonso, associate professor at Rollins School of Public Health. Measurements from a basic physical exam—including weight, height, and blood pressure—are taken as well.

“Participants also agree to share the information from their electronic medical records with the study, and to be part of the study for at least the next ten years,” he adds. “They also may be asked to complete additional online surveys and invited to participate in additional exams.”

All of Us volunteers will be kept up-to-date about new health-related discoveries stemming from research activities that use the database.

One of McKinney’s concerns was the confidentiality of his personal data. The All of Us collection and storage systems have been designed to meet the requirements of the Federal Information Security Management Act. They are continually tested to ensure the security of patient data and protect against its unintended release, and penalties have been set for the unauthorized reidentification of participants.

“I was told that when my information is sent to the NIH, it would not be attached to my specific name but to a patient number, and I had no problem with that,” McKinney recalls.

To maximize its usefulness, All of Us recruiters expect to reach out to people underserved by the current health care system, such as individuals who lack insurance or live in rural areas without ready access to medical care.

“This is a real challenge,” Zwick says. “There are mechanisms by which these people can participate, and we are engaged in ongoing discussions about ways to recruit them for the database.”

Likewise for minorities, whose participation will help ensure that the database reflects the country’s diverse racial and ethnic makeup, says coinvestigator Arshed Quyyumi, a professor of cardiology and head of the Cardiovascular Research Institute.

“Traditionally, there has been very little minority participation when studies have been done, particularly clinical trials, and therefore the resulting data doesn’t necessarily apply to them,” he observes.

“You’re left with some questions as to whether or not what is found in the studies is applicable to the population at large or only to Caucasians.”