What Ethical Issues Does the Precision Medicine Initiative Face? | David Raths | Healthcare Blogs Skip to content Skip to navigation

What Ethical Issues Does the Precision Medicine Initiative Face?

July 10, 2017
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Chair of research program’s institutional review board details big challenges ahead

“This is the largest government study ever on its own people.”

Nancy Kass, Sc.D., a professor of bioethics and public health at the Johns Hopkins Bloomberg School of Public Health in Baltimore, was talking about the Precision Medicine Initiative, now called the All of Us Research Program.

Kass says she makes that bold statement deliberately and with humility, because she chairs the institutional review board (IRB) for the project, which aims to create a million-person cohort. “When the government does science on its own people, participant welfare and trust are essential and we may not get second chances,” she said. The promises made must be upheld, she added, and the National Institutes of Health (NIH) is making plenty of promises about issues such as diversity, transparency and ongoing engagement with communities.

Kass was speaking July 7 to an online meeting of the NIH Health Care Systems Research Collaboratory, which aims to improve the way clinical trials are conducted by creating a new infrastructure for collaborative research with healthcare systems.

The idea behind All of Us is that it provides resource efficiency because researchers do not have to recreate a cohort every time a new question comes up, which is how research is done now. Researchers can instead ask questions of a single huge cohort. The size also means people with rare conditions or circumstances are gathered in one place. “The ethical stakes are really high,” Kass said.

Citizens who participate agree to contribute their EHR and pharmacy data, as well as any health tracker data. They also take a minor physical exam and donate blood urine samples. The study will also look at health by Zip codes, too.

NIH is emphasizing that it wants the cohort to be diverse in many ways: geography, gender, race, ethnicity, sexual orientation, as well as health status and computer literacy. There are two methods of outreach and recruitment: One will involve recruitment of people in specific groups by provider organizations that have received grants to participate. The other is through direct volunteer recruitment of people who might see a sign about it on a bus or billboard.

Kass said the values NIH has espoused about the program are relevant to ethics and how the IRB sees its responsibilities. For instance, All of Us says participants will be partners in the program. “That is happening to some degree, but they are thinking further about ways that every site will be expected to uphold it,” she said. Another stated value is that trust will be earned through engagement and transparency. She noted that engagement means different things to different people, and that is why she is glad that three of the 10 members of the IRB are from community groups.

Another value is that participants will have access to information and data about themselves. How that will happen is unclear yet.  “The devil is in the detail there,” she said.

All of Us has moved from pilot to the first phase of deployment and 500 people are enrolled. So far, the IRB has approved advertising material, a master protocol and is now approving recruitment sites. The NIH has funded 137 sites through 50 organizations. The IRB has approved six, with five approvals pending and four applications in process. “We know a lot more are in the pipeline,” she said. “We are helping to make sure the recruitment targets are being met at each stage to meet the goals.”

Kass praised the project’s innovative mobile consent process developed by John Wilbanks at Seattle-based Sage Bionetworks.   

She noted that there are still many questions to work through, and that committees that have not even been created yet will propose policies and present them to the IRB for approval. For instance, one big issue to work through is whether participants entering the program are consenting to unforeseen future studies using their data or whether researchers would have to go back to them for consent each time their data is used. “NIH may set up some type of data access and use committee,” she said. “Our initial push has been getting the protocols approved and the cohort enrolled.”

One webinar participant noted that EHR data is included, and asked about data that insurers have on patients. Participants are told through the consent process that by participating they are agreeing to the study tapping into EHR but also insurance and pharmacy records. “The hope is to be expansive in the definition of electronic medical records, including insurance,” she said.

Rob Califf, M.D., the former FDA director, called into the webinar to ask about how the IRB would deal with the revised “Common Rule,” the federal policy for the protection of human subjects. Revisions were finalized in the January 19, 2017, edition of the Federal Register and subsequently subject to a “regulatory freeze” established by the Trump administration. 

Kass replied that because the revisions haven’t been approved by the administration, the All of Us Research Program is still dealing with the former version. “We haven’t dealt with broad consent yet,” she said. “There will be attempts to make sure people have an understanding of what that means. I will say that  the IRB has been conservative about a few things because of the responsibility it feels about precision medicine and upholding commitments on trust.”

Another question the IRB will have to address is how many other researchers will be able to access the data. Could citizen scientists gain access? The IRB needs to work through the safeguards in terms of qualifications of investigators as a mechanism to protect the data, Kass said. Yet another issue is which results should be returned to participants. Genetic results have not been handled that way previously, she noted. “There is a lot of work we have not started yet.”





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Kaiser Creating Evidence-Based Complex Care Models

January 17, 2019
by David Raths, Contributing Editor
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Work aligns with recently published ‘Blueprint for Complex Care’

The National Center for Complex Health and Social Needs recently published a “Blueprint for Complex Care” to develop a collective strategy for promoting evidence-based complex care models. Recognizing that many patient issues have root causes that go beyond the medical, the Blueprint seeks to identify best practices for breaking down silos between the social care delivery system and healthcare.

Perhaps no health system has devoted as many resources to complex care as Kaiser Permanente. Its Care Management Institute, a joint endeavor between the Permanente Medical Groups and Kaiser Foundation Health Plan, has established Complex Needs as one of its national quality initiatives. It has named regional complex care leaders, created common quality measures across regions and established a complex need research arm called CORAL. (Kaiser Permanente has eight Permanente Medical Groups and regions, more than 12.2 million members, more than 22,000 physicians and 216,000 employees.)

In a Jan. 16 webinar presentation, Wendolyn Gozansky, M.D., vice president and chief quality officer, Colorado Permanente Medical Group and national leader for complex needs at the Care Management Institute, described Kaiser Permanente’s efforts and used some personal anecdotes to explain their goals.

She said Kaiser Permanenteis working on the concept of developing core competencies and tools to support a longitiudinal plan of care for patients with complex needs. “These are the folks for whom the usual care is not meeting their needs,” she said. “How do you recognize them and make sure their needs are being met?”

Gozansky gave an example from a patient she had just seen the previous wekend. This women had fallen and broken her hip. She had several chronic conditions, including significant asthma, yet she was not on an inhaled steroid.

“One concept I love from the Blueprint is that this field is about doing whatever it takes to meet the needs of the person in front of you,” she said. In speaking to the woman, she came to understand that singing in a church choir was the most important thing in her life, and the inhaler medication was making her hoarse and unable to sing.  She was fairly isolated socially except for church. “My goal was to get her rehabbed and leverage the patient-defined family that is supportive. Her goals are to sing, so we need to do what is possible to get her back to that. We have to capture that information, put it into a long-term plan of care. The goal is not to get her out of rehab but to get her singing in choir.”


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The health system has to work on care that is preference-aligned. The woman is not on a steroid inhaler but her care is preference-aligned. How does the health system assure that everyone knows they are doing the right thing?

Gozansky said the beauty of Permanente Medicine is that its setup involves an employed medical group focused on value, not volume. They can interact with health plan partners in delivery of new systems of care. “It is a virtuous cycle about value and person-centered care. This is what our complex needs team is trying to understand.”

She described the journey so far: In 2015 there were pockets of work being done across the eight Kaiser Permanente regions. In 2016 they established complex care as a national qualitiy iniative. “We knew we were not meeting these patients’ needs. We had to figure out the right way to do that.” They also realized that most of the previous research on the topic involved examples that were not in integrated systems such as Kaiser Permanente. “We had to figure it out in an integrated system,” she said.

 In 2017 they started working on cross-regional learning — for instance, taking a program from Colorado and trying it in Southern California. Then they sought to align quality measures. In 2018 they got funding to create CORAL, the complex needs research arm.  

The Care Management Institute has created a “community of practice” on complex care to break down silos within the organization and bring together research, operational and administrative executives. They also want to work with external stakeholders to make sure what they are developing is scalable, Gozansky said.

Mark Humowiecki, senior director of the National Center for Complex Health and Social Needs, also spoke during the webinar. He said one of the goals of the Blueprint was to get a clearer definition. Some people get confused about terms such as “hotspotting” and complex care, he said. He said there is a recognition that these patients’ needs are crossing traditional silos, so “there is a need to connect care for the individual but also at the system level.”

The goal, he added, is to create a complex care ecosystem by developing in each community system-level connections between social care delivery and healthcare, which in the past have operated too independently.  The five principles are that complex care is person-centered, equitable, team-based, cross-sector and data-driven. One of the Blueprint’s recommendations is to enhance and promote integrated cross-sector data infrastructures.



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NIH’s All of Us Program Teams with Fitbit for Data Collection

January 16, 2019
by Heather Landi, Associate Editor
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The All of Us Research Program, part of the National Institutes of Health (NIH), has launched the Fitbit Bring-Your-Own-Device (BYOD) project. Now, in addition to providing health information through surveys, electronic health records, and bio-samples, participants can choose to share data from their Fitbit accounts to help researchers make discoveries.

According to All of Us research program officials, the project is a key step for the program in integrating digital health technologies for data collection.

The All of Us Research Program, established by the White House in 2015, aims to advance precision medicine by studying the health data of 1 million diverse Americans over the next five years. One aim of the project is to include groups that have been historically underrepresented in research. As of September 2018, more than 110,000 people have registered with the program to begin the participant journey, and more than 60,000 have completed all elements of the core protocol.

The participants are sharing different types of information, including through surveys, access to their electronic health records and blood and urine samples. These data, stripped of obvious identifiers, will be accessible to researchers, whose findings may lead to more tailored treatments and prevention strategies in the future, according to program officials.

Digital health technologies, like mobile apps and wearable devices, can gather data outside of a hospital or clinic. This data includes information about physical activity, sleep, weight, heart rate, nutrition, and water intake, which can give researchers a more complete picture of participants’ health.” The All of Us Research Program is now gathering this data in addition to surveys, electronic health record information, physical measurements, and blood and urine samples, working to make the All of Us resource one of the largest and most diverse data sets of its kind for health research,” NIH officials said.

“Collecting real-world, real-time data through digital technologies will become a fundamental part of the program,” Eric Dishman, director of the All of Us Research Program, said in a statement. “This information, in combination with many other data types, will give us an unprecedented ability to better understand the impact of lifestyle and environment on health outcomes and, ultimately, develop better strategies for keeping people healthy in a very precise, individualized way.”

All of Us participants with any Fitbit device who wish to share Fitbit data with the program may log on to the All of Us participant portal at https://participant.joinallofus.org and visit the Sync Apps & Devices tab. Participants without Fitbit devices may also take part if they choose, by creating a free Fitbit account online and manually adding information to share with the program.

All of Us is developing additional plans to incorporate digital health technologies. A second project with Fitbit is expected to launch later in the year, NIH officials said, and this project will include providing devices to a limited number of All of Us participants who will be randomly invited to take part, to enable them to share wearable data with the program.

The All of Us research program plans to add connections to other devices and apps in the future to further expand data collection efforts and engage participants in new ways.

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NorthShore to Lead “Largest Primary Care-Based Genomics Program in U.S.”

January 14, 2019
by Rajiv Leventhal, Managing Editor
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The Chicago-based NorthShore University HealthSystem and genomics technology company Color are partnering on a new initiative that will aim to deliver the power of genomics to routine primary care at population scale.

Known as "DNA10K," the initiative will engage more than 10,000 patients and will be the largest known primary care-based genomics program in the U.S., according to officials who made an announcement last week.

The approach will build on NorthShore's years of experience in genomics and actionable electronic medical records (EMR) information, while providing access to Color's clinical-grade genetic testing and whole genome sequencing to inform patients about their risk for certain hereditary conditions, according to company executives.

“The knowledge will help patients learn about their genetic makeup, including risk factors for certain disease types such as common hereditary cancers and heart diseases. This insight will help NorthShore personalize care for each patient to support improved outcomes, prevention and overall health,” officials noted.

The announcement comes on the heels of a recent pilot between NorthShore and Color that looked to unlock the benefits of genetic information in routine care.

As officials explained, in less than two months, more than 1,000 patients signed up for the Color population health program as a part of their primary care visit, an adoption rate of more than 40 percent of those eligible and significantly beating expectations of the pilot program. “This is a strong indicator of patients' interest in understanding genetic factors that can influence health and the opportunity to work with NorthShore care providers to make more informed treatment or prevention decisions,” they attested.

Overall, the DNA10K initiative supports NorthShore's efforts to improve patients' health outcomes at a population level, with genomics as a foundation for informing individualized healthcare.

Patients who take advantage of the "DNA10K" offering will provide a blood sample, which is then analyzed in Color's CLIA-certified, CAP-accredited lab, and results are returned to healthcare providers and their patients. In addition to their NorthShore primary care provider, patients will also have access to board-certified genetic counselors and clinical pharmacists from Color and NorthShore, officials explained.

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