Diversity and inclusion for the All of Us research program: A scoping review.

The All of Us Research Program (All of Us) is a national effort to accelerate health research by exploring the relationship between lifestyle, environment, and genetics. It is set to become one of the largest research efforts in U.S. history, aiming to build a national resource of data from at least one million participants. All of Us aims to address the need for more diversity in research and set the stage for that diversity to be leveraged in precision medicine research to come. This paper describes how the program assessed demographic characteristics of participants who have enrolled in other U.S. biomedical research cohorts to better understand which groups are traditionally represented or underrepresented in biomedical research. We 1) reviewed the enrollment characteristics of national cohort studies like All of Us, and 2) surveyed the literature, focusing on key diversity categories essential to the program's enrollment aims. Based on these efforts, All of Us emphasizes enrollment of racial and ethnic minorities, and has formally designated the following additional groups as historically underrepresented: individuals-with inadequate access to medical care; under the age of 18 or over 65; with an annual household income at or below 200% of the federal poverty level; who have a cognitive or physical disability; have less than a high school education or equivalent; are intersex; identify as a sexual or gender minority; or live in rural or non-metropolitan areas. Research accounting for wider demographic variability is critical. Only by ensuring diversity and by addressing the very barriers that limit it, can we position All of Us to better understand and tackle health disparities.

The "All of Us" Research Program.

Knowledge gained from observational cohort studies has dramatically advanced the prevention and treatment of diseases. Many of these cohorts, however, are small, lack diversity, or do not provide comprehensive phenotype data. The All of Us Research Program plans to enroll a diverse group of at least 1 million persons in the United States in order to accelerate biomedical research and improve health. The program aims to make the research results accessible to participants, and it is developing new approaches to generate, access, and make data broadly available to approved researchers. All of Us opened for enrollment in May 2018 and currently enrolls participants 18 years of age or older from a network of more than 340 recruitment sites. Elements of the program protocol include health questionnaires, electronic health records (EHRs), physical measurements, the use of digital health technology, and the collection and analysis of biospecimens. As of July 2019, more than 175,000 participants had contributed biospecimens. More than 80% of these participants are from groups that have been historically underrepresented in biomedical research. EHR data on more than 112,000 participants from 34 sites have been collected. The All of Us data repository should permit researchers to take into account individual differences in lifestyle, socioeconomic factors, environment, and biologic characteristics in order to advance precision diagnosis, prevention, and treatment.

The importance of cultural considerations in the promotion of ethical research with human biologic material.

Although ethical consideration has been given to a wide variety of issues that arise in the collection and storage of human biologic material for research, little attention has been focused on the ethical implications of the diverse cultural meanings often associated with these materials. We explore the rich social meanings of the placenta across cultures and contrast these meanings with the assumption that the placenta is typically considered waste tissue that may find value in biomedical research. We suggest that the incorporation of sensitivity to the cultural meanings people give human biologic material and the use of empirical research, where necessary, to delineate these meanings should enhance the ability to craft and conduct ethically appropriate research.

Burning bridges: policy, practice, and the destruction of midwifery in rural Costa Rica.

The trend toward hospitalization of birth has a long history in Costa Rica and currently approximately 98% of births take place in the clinical setting. Impoverished rural areas, like the town of Buenos Aires, lag behind national trends and only recently has birth moved from the home to the hospital. Costa Rica's midwife certification program co-opted rural midwives as bridges to biomedicalization, responsible for both pushing women into the biomedical setting and filling the gaps left by a limited national health care system. Despite the eventual illegalization of key practices and of home birth itself, local use of midwives' services continues, albeit with local demands that have transformed midwives into bridges to biomedical care in ways unanticipated by and invisible to national programmers. Midwives provide key services like prenatal massage, treatment of pregnancy crises, and attending unforeseen home births and women unable to afford the modest costs of hospitalization. Yet, midwives report increasing dissatisfaction and the desire to stop providing services in their communities. Practices like prenatal massage are in demand, but are no longer embedded in a system of local exchange that is socially and economically meaningful. Midwives blame their clientele for their dissatisfaction, but directly link these changes to the notions of professionalism, compensation, and changing community values. Thus, the social relationship between midwives and their clients must also be understood as a destructive force burning midwifery as a bridge to safe birth. In this essay, I argue that the process of both remodeling and subsequently destroying midwifery practices begun in the formal health care sector at the national level continues at the local level through changing values and meanings associated with midwives' practices.