Epilogue: Envisioning a New Future
The findings, conclusions, and recommendations in this report make clear the implications of maintaining the status quo and the critical need to find new ways to achieve greater representation in clinical research. The report provides evidence-based recommendations, which, when implemented, would move the nation closer to a more equitable and just society. However, the committee would also like to acknowledge that all of the evidence cited in this report is derivative of a system that is fundamentally oppressive and problematic. Thus, our evidence-based recommendations are constricted by the same forces. This epilogue summarizes some of the large, system-level changes that the committee would like to see in order to truly realize an inclusive and representative clinical research landscape in the United States that leads to greater justice and health equity in this nation.
The committee believes that to improve representativeness in research effectively and sustainably, progress must be made in both the development of a rigorous science of inclusion and in the pursuit of theoretical frameworks that investigate and challenge the “socio-political determinants of exclusion” (Gilmore-Bykovskyi et al., 2021). This combined effort can help deliver a needed paradigm shift in the balance of power from institutions to communities.
THE SCIENCE OF INCLUSION
First, the committee believes there must be intentional efforts to support the development of a rigorous science of inclusion and community engagement. Health equity scholars have long highlighted the importance of investing in the development and adoption of evidenced-based strategies to move the field to-
ward scalable frameworks for engagement, recruitment, and retention (Curry and Jackson, 2003; Dilworth-Anderson, 2011). However, research in this area often evaluates individual-level beliefs and attitudes, site-specific barriers, and qualitative approaches to understanding trust, which are constraints on the evidence presented in earlier chapters of this report. Methodically rigorous approaches are needed to move beyond individual person- and site-specific barriers to facilitate system-level change. This requires a focus and investment in the development of interdisciplinary teams that include community representatives to develop rigorous empiric evaluations of strategies and approaches for driving inclusion in research. As described in Chapter 2, improving these systems is not just desirable, but necessary for a more just, healthy, and equitable world.
Defining Inclusion
Second, the committee recognizes that this report represents one step on the path toward inclusion. Throughout this report, the committee has used the phrase underrepresented and excluded populations, but have focused specifically on women and racial and ethnic minority population groups, as defined by the committee’s charge. As a result, the committee has not focused on the unique needs of rural, frontier, transgender, non-binary, neurodivergent, disabled, lower socio-economic status, illiterate, elderly, pediatric, and countless other populations. The needs of these populations and their contributions to research are as critically important, and no less urgent, than the populations highlighted by the committee in this report. The recognition and inclusion of all underrepresented and excluded populations is an urgent problem that needs to be addressed. It is critical that the clinical trials and research community examine how underrepresented and excluded populations are defined, and who is included or excluded by that definition. The clinical trials and research community will continue to work within a narrow definition of inclusion unless action is taken to change it. This is why the structural changes, at all levels and across systems, recommended by this report are so urgently needed. This is also why it is critical to center whole communities, and not simply specific communities, as part of the research process.
EMBRACING JUSTICE
Third, realizing this vision will require not only the rethinking of conventional practices and investments as outlined in the report but also in the adoption of new theoretical frameworks for conceptualizing research centered in equity and social justice. This includes a close interrogation and understanding of the factors that contribute to the status quo. In the literature, these factors are often presented at the individual level, such as participant trust and beliefs about research, religiosity, and willingness. However, deep gaps still exist in the understanding of the problem, especially when the onus of responsibility for improving
engagement and participation is placed on the individual participant, rather than on institutions and researchers. The committee believes there is a need for stakeholders to broaden the possibilities for transformative solutions by bringing into the forefront the historical, institutional, and social contexts that shape research accessibility. This more emancipatory approach can encourage research stakeholders to reflect and act on the injustice that exists in the communities where they work, enabling actions that center communities and advance justice in the research process (Wesp et al., 2018). It moves beyond equitable engagement of communities in research questions, studies, and processes that already exist to transforming the research enterprise for science beneficial to those communities (Wilkins and Alberti, 2019). While this approach is challenging, the report offers examples of this approach working. For example, Box 5-4 describes the Wisconsin Alzheimer’s Institute Regional Milwaukee Office and its ongoing efforts to invest in community empowerment to address health disparities. Examples like this provide evidence that a paradigm shift is possible and can help advance community health through more equitable research practices.
According to Gilmore-Bykovskyi et al. (2021), “Fulfilling justice in research is foundational to cultivating practices that promote health equity through equal valuation of the wellbeing of all persons, the correction of injustices, and providing resources according to need, rather than impartially, to facilitate access to research.” In the committee’s view, to fully advance representativeness in research, institutions and investigators must recognize the larger systemic context of their work, including historic abuses (e.g., the Tuskegee Syphilis Study) and the ongoing harms that shape the lived experiences of individuals, families, and communities. This new understanding rooted in social justice can position these stakeholders to better design participation pathways with people and communities at the center. Without a paradigm shift that looks beyond tactics and process-oriented changes, disparities in research access and inclusion will persist at the expense of minority population groups and the nation’s public health (Gilmore-Bykovskyi et al., 2021).
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