Wide Support for NIH Study for Precision Medicine Initiative

Tara Haelle

August 26, 2016

A substantial majority of US adults (eight in 10)support a large national cohort study as part of the White House's Precision Medicine Initiative (PMI), and more than half would volunteer as participants in it, according to a results of a nationally representative survey.

The biggest motivator for participants to join the cohort study was learning about their personal health information, researchers report in an article published August 17 in PLoS ONE. The type of consent participants would be comfortable providing varied little if the project was transparent in how participant data would be used.

The PMI is the $215 million project announced by President Barack Obama last year to "enable a new era of medicine in which researchers, providers and patients work together to develop individualized care." Of that budget, $130 million was alloted to the National Institutes of Health to design and carry out national, large-scale prospective cohort study, "one of the most ambitious research projects in history," Gwynne Jenkins, PhD, MPH, chief of staff for the PMI Cohort Program at the National Institutes of Health, told Medscape Medical News.

"Researchers, including citizen scientists, will be able to use de-identified data from the PMI Cohort Program in their own studies to address a wide range of health and disease questions," Dr Jenkins said. "In that way, the PMI Cohort Program may be better understood not as a study per se, but as a massive research resource that will benefit thousands of studies in the future."

The last awards assigned for building the program infrastructure were issued last month, and the project is scheduled to launch in phases starting later this year, according to Dr Jenkins. The goal is an enrollment of a diverse set of at least 1 million participants from across the country.

"We have recently set up governance of the program through a steering committee, an executive committee, and 11 working groups," she said. "The working groups, focusing on such topics as consent, data privacy, engagement, and other areas, are now working to finalize their recommendations for the program implementation plans," which, so far, follow the PMI Working Group's recommendations.

The survey discussed in the new PLoS ONE article is part of the research looking at how to set up consent and recruit participants. The researchers analyzed survey results from a nationally representative sample of 2601 adults, a 54% response rate from the 4777 people invited to complete the 44-question, 20-minute online survey in May and June 2015. The response rate was 51.9% among blacks and 38.6% among Hispanics, and those with less than 12 years of education were underrepresented in the overall sample. The survey opened with a description of the PMI cohort study and then asked respondents whether the study should be done and, if asked, whether they would participate, noting that participants "might get access to the information collected about their health."

Next, the survey randomly presented each respondent with one of eight scenarios describing different types of consent and data-sharing scenarios.

The four types of consent described included broad, study by study, menu, or dynamic consent. Half of the scenarios studied included the statement that study participants would "have access to a website where you would be able to see what studies are going on, which studies are using your information, and what each study has learned." The other half excluded this statement.

Overall, 79% of respondents said the study "definitely" or "probably" should be done, although those with less education (P < .0001) or a lower household income (P = .04) or living outside a metropolitan area (P = .03), were less likely to support it. However, only among those with less than 12 years of education did less than 70% of respondents support the study.

Just more than half the participants (54%) say they would "definitely" or "probably" participate if asked to, and 16% said they "definitely" would not. Individuals more likely to participate were younger (P < .0001), had more years of education (P < .0001) or were lesbian, gay, bisexual, or transgender respondents (P = .01). Hispanics were also slightly more likely than non-Hispanics to say they would participate (P = .009).

Moreover, one in seven of all respondents reported willingness to participate for their lifetime, and an additional 11% would participate for at least 10 years; 42% of those who said they would participate were willing to do so for at least 10 years.

A quarter of the sample said they supported the study concept but would not participate, and 77% of those respondents said the study would take up too much time compared with 30% of those who would participate. Further, 51% of those who supported the study but would not participate trusted the study to protect their privacy compared with 81% of those who would participate.

Regardless of whether they were willing to participate, survey respondents were asked to "imagine" what types of samples or data they would be willing to provide. Seventy-three percent of all respondents said they were willing to provide blood samples if they did participate. In addition, 75% would provide urine, hair, or saliva samples; 75% would provide activity tracker data; 76% would provide genetic information; 77% would provide a family medical history; 83% would provide soil and water samples from home; and 84% would provide lifestyle, diet, and exercise data.

However, only 43% of the 1641 respondents with social media accounts would be willing to share social media information.

Among the 87% of respondents who own a cell phone or smartphone, three quarters would answer text messaged questions at least once a week, and 59% would respond at least once daily.

When asked again at the end of the survey whether they would participate in the study, 70% of the respondents answered the same as the first time asked, 15% responded more positively, and 15% responded more negatively.

The biggest incentive for participation from among six offered in the survey was "learning information about my health," which 90% of respondents considered somewhat or very important. Further, 80% ranked receiving payment for their time as important, and 77% ranked getting healthcare as important. The other incentives presented had less support: free Internet connections (56%), activity trackers (55%), or smartphones and data plans (52%).

"However, the technology incentives were of more interest to younger respondents, those with lower household incomes, and those with fewer years of education," the authors report.

The most popular types of information that respondents who participated would be interested in receiving were laboratory results and genetic results, both of which interested three quarters of respondents. Receiving a copy of their medical record, genetic ancestry information, family history health information, information about water or air quality, nutritional information, and information about other research studies related to their health all received at least 60% support as well.

The different consent models presented had little influence on whether the respondents would participate. Although the broad consent model had the lowest support, at 64%, compared with 72% to 75% for the other three, respondents' willingness to participate was indistinguishable for different consent models if the study included a website describing how participant data would be used.

"The findings suggest that certain groups including older Americans and those with lower socioeconomic status may require additional engagement if they are to take part," write authors David J. Kaufman, PhD, and colleagues from the National Human Genome Research Institute at the National Institutes of Health. "However the survey findings do not support the idea that people from communities that have historically been understudied in research are not interested in participating in this cohort."

Once the cohort study is up and running, Dr Jenkins said, they hope to discover ways to increase individuals' likelihood of lifetime health and successful precision medicine approaches in treating common diseases such as diabetes, heart disease, Alzheimer's, obesity, and mental illnesses, as well as rare diseases.

"As for the timeline, it can take many years to understand the contribution of a single unique variable on a given disease or treatment," Dr Jenkins said. "It will take even more time to develop new treatments and methods of disease prevention. By launching the PMI Cohort Program, we hope to accelerate our understanding of disease onset and progression, treatment response, and health outcomes, but this will certainly be a long-term effort."

The research was conducted by GfK and funded by the Foundation for the National Institutes of Health. Three authors work at the National Institutes of Health, which is sponsoring and developing the PMI cohort study, and they are involved in those efforts. One coauthor also works at the National Institutes of Health but is not involved in the PMI study project. One coauthor worked on the study development at the National Institutes of Health and at the White House.

PLoS ONE. 2016;11:e0160461. Full text

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