Ethics of inclusion: Cultivate trust in precision medicine

Abstract

Precision medicine is at a crossroads. Progress toward its central goal, to address persistent health inequities, will depend on enrolling populations in research that have been historically underrepresented, thus eliminating longstanding exclusions from such research (1). Yet the history of ethical violations related to protocols for inclusion in biomedical research, as well as the continued misuse of research results (such as white nationalists looking to genetic ancestry to support claims of racial superiority), continue to engender mistrust among these populations (2). For precision medicine research (PMR) to achieve its goal, all people must believe that there is value in providing information about themselves and their families, and that their participation will translate into equitable distribution of benefits. This requires an ethics of inclusion that considers what constitutes inclusive practices in PMR, what goals and values are being furthered through efforts to enhance diversity, and who participates in adjudicating these questions. The early stages of PMR offer a critical window in which to intervene before research practices and their consequences become locked in (3). Initiatives such as the All of Us program have set out to collect and analyze health information and biological samples from millions of people (1). At the same time, questions of trust in biomedical research persist. For example, although the recent assertions of white nationalists were eventually denounced by the American Society of Human Genetics (4), the misuse of ancestry testing may have already undermined public trust in genetic research. There are also infamous failures in research that included historically underrepresented groups, including practices of deceit, as in the Tuskegee Syphilis Study, or the misuse of samples, as with the Havasupai tribe (5). Many people who are being asked to give their data and samples for PMR must not only reconcile such past research abuses, but also weigh future risks of potential misuse of their data.

Perceptions of ‘Precision’ and ‘Personalised’ Medicine in Singapore and Associated Ethical Issues

“…This research will upscale into the National Precision Medicine initiative from 2021. With an under-representation of Asian genomes in global databases (Bentley et al 2017 ; Crider et al 2006 ; Lee et al 2019 ; Popejoy and Fullerton 2016 ), this initiative will contribute to greater diversity in genomics and may lead to more tailored treatment approaches appropriate for Asian populations. As of 2016, only 14% of 2511 genome-wide association studies were on Asian ancestry (Popejoy and Fullerton 2016 ).…”

The Use of Racial Categories in Precision Medicine Research

“…5,12 The major private and public funders of precision medicine research should continue to convene scholars from diverse disciplines, including those who research social determinants of health, to address the challenges raised when investigators categorize research participants. 32 Any future recommendations should be informed by such deliberations, empirical research on how investigators approach diversity and inclusion in research, 12 and lessons learned from engaging with diverse national and international communities. Successful frameworks will hold researchers accountable for how they use variables in research and promote the assessment of additional relevant factors that go beyond racial differences.…”

“…Successful frameworks will hold researchers accountable for how they use variables in research and promote the assessment of additional relevant factors that go beyond racial differences. 5,12 As the leading public funder of biomedical research in the world, NIH's All of US program is on track to collect one of the most comprehensive datasets featuring a significant percentage of traditionally underrepresented populations and is therefore helping to drive the future of precision medicine research. The potential for precision medicine research to translate into individualized treatment for all patients represents an exciting turning point in the progress of research and medicine: the path forward will shape precision medicine researchers' approach to studying underrepresented populations and, in turn, will determine the value of precision medicine research for all.…”

“…13 As others have highlighted, there is immense opportunity for the All of Us program and other precision medicine initiatives to improve the study of underrepresented populations, and to do so using variables that are more specific than race in rigorous and transparent ways. 12 To make progress, the field must confront investigators' use of race as a biological category, 16 and the often inaccurate, inconsistent, and poorly justified uses of racial categories in biomedical research. 3 (p158),5,11(p507-513), [16][17][18] Currently, NIH requires NIH-funded researchers to use the OMB census categories to demonstrate the inclusion of diverse research participants.…”

“…3(p106), 11(p504) Precision medicine research promises a new and meticulous approach to discovery that emphasizes the underlying and multivariate contributors to differences in health outcomes. 12,13 The "All of Us" Research Program sponsored by NIH, for instance, is collecting research data from multiple sources, including health surveys, health records, and digital health technologies. 13 Surveys request personal details, including information on age, race, sex, income, educational attainment, and geographic location.…”