Two of Erricka Hager’s family members were stricken with disabling and life-threatening diseases.
Her grandmother was diagnosed with breast cancer, and her great-aunt was diagnosed with amyotrophic lateral sclerosis, also known as Lou Gehrig’s disease — a progressive and often fatal condition in which nerve cells that control movement slowly die.
“ALS is a disease not prevalent with my family or the African-American community,” said Hager, a health advocate for the Urban League of Greater Pittsburgh, so the diagnosis came with additional challenges.
Protecting private data
Privacy and security of volunteers’ information was among the topics raised at the May 2 news conference announcing Pitt and UPMC’s collaboration with the NIH’s All of Us Research Program.
The data gathered from All of Us volunteers will be encrypted and stored in a central data and research center. Vanderbilt University Medical Center, Verily Life Sciences (a Google company) and the Broad Institute in Cambridge, Massachusetts, will take part in storing information. Vanderbilt and the Broad Institute are setting up the processes for handling electronic health records and genomic data, respectively, while all of the data will be stored on Verily’s servers.
In addition to rigorous security measures to prevent unintended release of data, there are penalties for unauthorized re-identification of volunteers.
“Privacy and security concerns are a very important piece of this study in retaining information,” said Shyam Visweswaran, associate professor of biomedical informatics at Pitt and a principal investigator for the All of Us Pennsylvania research study.
Visweswaran said there will be three levels of access to volunteers’ information:
- The broadest level of access will be available to the general public and will consist of general statistics from the study, including the number of volunteers.
- The second tier of access is for research purposes, but researchers nationwide will not have access to volunteers’ identifiable information. They also have to follow policies to not re-identify volunteers.
- The third level and most restrictive tier of access is for participating researchers who want to follow up and recontact volunteers for studies. These researchers will sign agreements saying they will use any information for research purposes only.
Volunteers’ information is also protected by the 21st Century Cures Act, meaning law enforcement agencies cannot issue subpoenas to obtain it.
Several studies have found that African-Americans make up less than 10 percent of cases of ALS, and little research exists to indicate how the disease should be treated for people of African-American descent.
However, a recently announced collaboration between the University of Pittsburgh, UPMC and the National Institutes of Health (NIH) aims to eliminate “one-size-fits-all” medicine and better treat populations historically underrepresented in research.
The All of Us Pennsylvania Research Program, part of the national All of Us Research Program, will enable researchers and clinicians to more precisely prevent and treat a wide variety of health conditions, using information shared by volunteers collected by the program. With the goal of enrolling 1 million participants — 120,000 planned to be from western and central Pennsylvania — this program will become the largest, most diverse resource of its kind.
“It’s important to have a more diverse (volunteer population) so that the future of medication will be personalized and have positive success for families,” said Hager, who volunteered for the program, citing her family members as reasons she joined the study.
Precision medicine is an essential approach to disease treatment, especially in underrepresented populations, said Steven Reis, a principal investigator for the All of Us Pennsylvania study and associate vice chancellor for clinical research at Pitt. One of the NIH requirements for the program is that at least 51 percent of volunteers have to be from underrepresented populations.
“If everyone went to their (health care) provider with high blood pressure that requires treatment, there’s a good chance most will come out with prescriptions to the same medications,” Reis said at a joint press conference on May 2. “Why is that? If you look around, you’ll see that we’re all different, so why are we receiving the same treatment? Simply, it’s because there is not enough scientific data to enable a precision approach to diagnoses and treatments to a wide array of diseases.”
Mylynda Massart, co-investigator of the study and assistant professor of family medicine and medical director at the UPMC Matilda Theiss Health Center, said this program is “very different” from how data has been gathered historically for large research projects.
“In the past when someone did research, they had to recruit their own participants. That took a lot of time and money,” she said. “Here, we’re creating our own national cohort and researchers can access that central data to answer their research questions.”
Anyone over the age of 18 can participate in the program, though Reis said he anticipates that could be expanded to younger age groups in the future.
As one of more than 100 partner organizations for the program, Pitt will receive $60 million over the next five years from the NIH. Other researchers leading the Pitt effort include Philip Empey, associate director for pharmacogenomics at the University of Pittsburgh/UPMC’s Institute for Precision Medicine, and Shyam Visweswaran, associate professor of biomedical informatics and another principal investigator for the All of Us program.
“The time is now to transform how we conduct research — with participants as partners — to shed new light on how to stay healthy and manage disease in more personalized ways. This is what we can accomplish through All of Us,” said NIH director Francis Collins.
Volunteers will be asked to contribute information about their medical history and lifestyle. They may also be asked to have their physical measurements taken at a local enrollment center, or donate a blood and urine sample.
From there, their information will be stored in a secure central database created by Vanderbilt University Medical Center, Verily Life Sciences (a Google company) and the Broad Institute in Cambridge, Massachusetts. Volunteers will have access to their study results, along with summarized data from across the program.
Volunteers share the personal side of precision
Hager, along with fellow volunteers Joyce Yasko and Andrew Brown, spoke at the May 2 press conference about why they signed up for the program.
Yasko, an Evans City, Pennsylvania, resident, said through volunteering, she wanted to create a better health care future for her family and friends and that patients could feel better about their custom treatments after all the data for this precision study is assessed.
“I couldn’t find an easier way to participate in a study than I did with All of Us,” she said. “I can’t think of a better thing to do for the future.”
Brown, senior program manager for commercial translation at sciVelo, noted how difficult it is for researchers to recruit volunteers for studies, a challenge he faced as an undergraduate student at Pitt.
“Since then, I’ve gone out of my way to volunteer for studies where I feel like I can contribute to some impact on human health,” said Brown, who is also a clinical assistant professor in Pitt’s Department of Periodontics and Preventive Dentistry. “Of course, none of them have been as big as the All of Us campaign. This will not only have great impact on health across the nation, but also Pitt, the city of Pittsburgh and the state of Pennsylvania are leading the charge.”
Join All of Us
Anyone over 18 years of age can volunteer for the All of Us Research Program by visiting www.joinallofus.org. Users must have an email address to register. After signing up and creating an online account, expect the following:
- Volunteers will be asked to enroll, give consent and agree to share health records, either online or at a partner center.
- They will be asked to complete health surveys and may be asked for physical measurements and biosamples (blood and urine samples).
- In the future, volunteers may be invited to share more data through additional health surveys, health trackers or other research studies.