To advance medicine’s future, the NIH tries to win the trust of communities mistreated in the past

CHICAGO — The National Institutes of Health would like six vials of your blood, please.

Its scientists would like to take a urine sample, measure your waistline, and have access to your electronic health records and data from the wearable sensor on your wrist. And if you don’t mind sharing, could they have your Social Security number?

It is a big ask, the NIH knows, and of an equally big group — the agency eventually hopes to enroll over 1 million participants in the next step of what four researchers referred to in a 2003 paper as “a revolution in biological research.”

The appeals, however, are befitting the biggest-ever bet on precision medicine, now more than a decade in the making. The paper’s lead author, Dr. Francis Collins, has been devoted to the project from its inception, riding his vision for a more precise world of medical treatment to his current post as the NIH’s director.

The data-gathering experiment, dubbed “All of Us,” is an important stop on the way to making personalized medicine a reality around the world, Collins and others say. The NIH hopes that the trove of information could one day enable doctors to use increasingly precise diagnostic tests. Eventually, scientists could shape treatments based on an individual’s genetic characteristics.

But one of Collins’s stated goals is ensuring more than half of the participants come from communities that are historically underrepresented in biomedical research — and that’s a gamble.

“People are afraid of being experimented on,” said Dr. Robert Winn, the director of the University of Illinois Cancer Center and a principal investigator on the project.

Researchers know it won’t be easy to find hundreds of thousands of people who have little reason to let the government sequence their DNA but who might be willing to take a chance for a healthier future for their children.

To address the issue, NIH officials made the project’s outreach arm a priority in its hiring, in its over $230 million annual budget, and in its marketing.

They also bought a truck.

That truck spent much of the last week parked near a sidewalk here on the University of Illinois-Chicago’s medical campus.

Its crew — hired marketing hands who travel with the truck from city to city — have spent the last six weeks on the road, taking rest stops in the form of daylong attempts to entice passers-by. Inside is an exhibit on wheels, with high-definition screens mounted on plastic white walls and multilingual displays adorned with phrases like, “I want to be around to see my grandkids grow up.”

Visitors watch a video explaining precision medicine, have questions answered by All of Us “community partners” and staff, and, if they agree to participate, use touch screens to fill out consent forms.

This is the kind of community outreach the NIH views as essential to recruit participants beyond the typical research study sample — disproportionately white, educated, affluent, and male. There is little point, researchers say, in orchestrating an unprecedented precision medicine initiative if the results won’t expand the number of communities who benefit from the research.

So far, the results have been encouraging. Eric Dishman, a former Intel executive who Collins hired as the All of Us program director, announced last week the project had exceeded 2,500 enrollees in its beta phase — some of which came directly from interactions at the “mobile engagement unit.”

But community organizers and some others fear this kind of outreach will not be enough.

“In and out is exactly what builds distrust,” Winn said. “Or the idea that interest in a community is tied to a grant length.”

That’s why health centers that receive federal funds to serve low-income populations have become a centerpiece of the NIH’s outreach strategy. The Mile Square Health Center in Chicago, where Winn works, is a longstanding community resource — residents know it will be there next week and a decade from now.

Over two-thirds of patients at the nation’s federally qualified health centers have annual incomes below the poverty line. Winn said he sees young men who hear about a longitudinal study — “we’ll be following up over the course of the next 10 years” — and who tell him, given the gun violence in their communities, they’re not sure they’ll live that long.

But at least they are speaking to Winn, a fixture in the local community and not a researcher or marketer or other unknown entity. For him, they may put aside their distrust and say they’re willing to join the program. The same is true at other FQHC partner sites across the country.

But such conversations, all too often, are the easy part. The hard part is scheduling future appointments and managing logistics. At most partner sites and at most of the mobile engagement unit’s exhibit stops, enrollees haven’t been able to simply fill out paperwork and walk into a room across the street to get their blood drawn.

Rather, most enrollees require a separate appointment for providers to process their biospecimens and take physical measurements. That’s on top of the paperwork that, especially for enrollees with less than perfect English and computer literacy, can take up to an hour.

“How do you reach out to a population that is computer-illiterate, and in many cases doesn’t have access to the internet?” asked Dr. Febe Wallace, who practices internal medicine at Cherokee Health Systems in Tennessee, another partner FQHC.

“We serve rural Appalachia. I was in a group the other day — I take care of some more severely ill diabetic patients — and I asked the room: How many of you have internet? Out of 14, none of them.”

Dishman said health care providers are developing different approaches to the process. Regardless of which route they choose, he added, it’s vital to “make sure participants understand that the All of Us visit is for research, and completely separate from medical care.”

It’s almost impossible to talk about minority communities and biomedical research without mentioning Henrietta Lacks, whose 1951 biopsy at Johns Hopkins Hospital in Baltimore yielded one of the most consequential cell lines in cancer research. She died later that year, having never learned of her place in history — the cells were obtained without her knowledge or her consent.

It’s also why Winn and Dr. Dara Richardson-Heron, the All of Us project’s chief engagement officer, sat on a panel with three of Lacks’s descendants to speak to a packed theater on the UIC campus in June. Lacks’s family has agreed to back the project out of a belief that this time is different — and this time, every community should be offered a seat at the table.

“We became the first family of research and medicine without even knowing,” Veronica Robinson, Lacks’s great-granddaughter, told a reporter after the event. “My family is now taking part of that legacy, and we’re trying to bridge that gap with the community, science, and medicine.”

Richardson-Heron acknowledged that the pitch can seem counterintuitive. She and the Lacks family are explaining, essentially, that the way to combat decades of inattention or outright abuse at the hands of biomedical researchers is to go all-in on their most ambitious project yet.

The idea, as she put it, is to “perhaps even eliminate altogether the health disparities that we see every day in the communities.”

Examples of mistrust between African-Americans and biomedical researchers predate Henrietta Lacks and include the infamous Tuskegee syphilis experiment, in which the U.S. Public Health Service enrolled black men in a study to observe the progress of untreated syphilis but under the guise of free health care.

In a recent study commissioned by Research!America, 50 percent of African-Americans surveyed cited “lack of trust” as a barrier to participating in clinical trials, down from 61 percent in 2013, both the highest figures across demographics and substantially higher than levels of distrust among whites.

But many minority communities are uneasy with the idea of clinical research — a reality that Winn and his peers around the country acknowledge and are trying to confront.

Many recruitment efforts in Latino communities, for example, have to take into account the current political climate. The introduction of “we’re with the federal government, we’d like to sequence your genome, we’d like your Social Security number” is not necessarily a welcome one.

“This was always going to be a challenge, and [the 2016 election] hasn’t helped,” said Adolph Falcón, a senior vice president at the National Alliance for Hispanic Health, one of the program’s earliest community partners. “This study and its design and its legislative authority has always said that none of the info provided can be used for any other purpose. We’ve worked with the program to find ways to emphasize that even more.”

The Social Security number is optional, too — the NIH prefers participants submit it so they can ensure electronic health records correctly match enrollees, but can do without.

Perhaps the most difficult ethical conversations, in most communities, haven’t even begun. They will in a year — when All of Us begins enrolling children.

Because of its size, a project like All of Us has largely been untested elsewhere, save for a handful of initiatives including a much smaller precision medicine project in Qatar and the 100,000 Genomes project in the United Kingdom. The Department of Veterans Affairs is running the Million Veterans Program — a far-reaching study but one limited to former service members.

As a result, it is difficult for outside observers to tell whether All of Us is succeeding so far. The project scrubbed plans to send out surveys to participants in 2016, but Dishman said it was only because he and others decided to adjust the enrollment schedule.

“I still get people telling me, ‘Hey, Eric, you’re late,’ when, in fact, we’re quite early,” Dishman said, noting that the project moved earlier than expected to collect biomedical samples. “People just didn’t understand that anything we would have had to launch last year would have been very tiny in scope.”

Dishman said the beta sample, to date, is more diverse than a typical biomedical research study, but declined to share demographic data, citing the project’s currently limited scope and early stages.

Regardless, the project is growing quickly. The NIH now has affiliates at health centers and health provider organizations around the country, where beta-phase enrollment is taking place in various stages.

Researchers also launched a trial “direct volunteer approach” in San Diego, in which people waiting in line at the city’s blood bank are also asked whether they would be willing to enroll in the study.

In that model, researchers assume potential participants have at least some knowledge of precision medicine and genomic sequencing — and allow those who want to enroll to simply walk up and register.

At most locations, however, enrollment is still a tenuous affair. Wanda Montalvo, a nurse at Community Health Center in Middletown, Conn., is facilitating All of Us research there, and decided to enroll herself in the study to boot. But even as a research partner, she hesitated before clicking the button granting access to her electronic health records.

“I think it’s because for a moment there, you realize that you’re giving permission to something that you technically are not used to providing and sharing,” Montalvo said.

But then she considered her family history.

“My great grandmother died at 105, my grandmother died at 103, and we didn’t have dementia and my family doesn’t have a real history of cancer,” Montalvo said.

She hopes All of Us finds something useful.