Don't Wait On Legislation To Begin Leveraging DEI

By Gelise Littlejohn Thomas, JD, MS

Industry and academia alike are experiencing a greater urgency for awareness, education, understanding, and application of diversity, equity, and inclusion (DEI) in research and medicine. Forty-four percent of medical schools have tenure and promotion policies that reward scholarship on “diversity, inclusion, and equity” while 70 percent require students take a course on “diversity, inclusion, or cultural competence.”¹ The Association of American Medical Colleges (AAMC) also released a set of guidelines on diversity, equity, and inclusion competencies across the learning curriculum in July 2022.² This begs the question of whether people are willing to move from the comfort of “recommended” training to the potential discomfort and discord inherent in “required” training. If the biomedical research enterprise chooses to prioritize DEI beyond statements, it has an opportunity to craft robust strategies and systems that will have intended outcomes and impact reflecting principles and values of DEI in research programs and studies. These research programs and studies that are built on a DEI foundation will inevitably have a positive influence on the trajectory of goals that include increasing diversity in clinical trials and cultivating inclusive environments for the biomedical research workforce.

What Does Pending Legislation Say About DEI Strategy?

Each Congress lasts about two years. During those two years, senators and representatives may introduce thousands of bills — and only some of those bills will become laws. Knowing that most bills will not become laws but may have valid insights regarding issues like diversity in clinical research, we have a collective duty to mobilize those insights by integrating them into the fabric of our research programs and studies — without being led by fear of consequence or penalty embedded in laws that warrant automatic accountability checks.

From 2021 to now alone, numerous bills have been introduced regarding DEI and research. Of note, on Jan. 5, 2021, the Henrietta Lacks Enhancing Cancer Research Act of 2019 was signed into law to address the lack of diversity in cancer clinical trial participants and explore barriers to research participation by traditionally underrepresented communities in federally funded cancer clinical trials.³ Passage of that law illustrates the prioritization of DEI in unforeseen ways. Most study teams do not have a designated law and policy expert; however, the public nature of these bills allows anyone to take notice and develop ways to build DEI strategies that serve short- and long-term purposes. A search on Congress.gov using the terms “clinical research diversity” allows users the option to create a tracking mechanism to follow a bill’s progress and content changes, thereby ensuring accountability for implementation. If you’d like to stay up to date about bills presented to the president, as well as the latest bills, resolutions, etc. presented to the House or Senate, subscribe for regular updates. Let’s explore a few of the bills that have been introduced as of 2021 and their intended purpose.

• Diversifying Investigations Via Equitable Research Studies for Everyone Trials Act or DIVERSE Trials Act⁴: Improve diversity in clinical trials and data collection for COVID-19 and future public health threats to address social determinants of health.
• NIH Clinical Trial Diversity Act of 2022⁵: Direct the secretary of Health and Human Services, acting through the director of the NIH, to take certain steps to increase clinical trial diversity, and for other purposes.
• Equity in Neuroscience and Alzheimer’s Clinical Trials Act of 2021 or the ENACT Act of 2021⁶: Improve access for and outreach to underrepresented populations in Alzheimer’s research via Alzheimer’s Disease Centers that will, among other things, operate clinical trials.
• Pursuing Equity in Mental Health Act⁷: Address mental health issues for youth, particularly youth of color, and for other purposes. It will also require addressing racial and ethnic minority mental health disparities in research.

What Do Most Of These Introduced Bills Have In Common?

Most of the bills that have been introduced that reference clinical trial diversity, health equity, and/or health disparities have a primary goal of increasing diversity in research and clinical trials, with a focus on underrepresented communities. Diverse and inclusive studies reap rewards of truly generalizable research, in alignment with equity, especially when participant numbers match the incidence of the disease or condition in the population that may be disproportionately affected. As with most noble causes, increasing diversity in clinical research — from participants to the workforce — requires a generous allocation of funding and resources for research activities, outreach, and engagement to ensure removal of barriers and increased odds of success.

These bills also will typically acknowledge the pivotal role that digital health technology (e.g., telehealth, remote patient monitoring, mobile technologies) will play in increasing access, as has been proven throughout the COVID-19 pandemic. One final similarity across the bills is that there is an increased emphasis on data collection and dissemination to ensure accountability and ability to evaluate efforts. Noticing patterns will help researchers identify priorities as they build, implement, and continuously evaluate the DEI strategy underlying their research programs and studies.

Where — And When — Do I Start?

The best time to develop a DEI strategy for your trial is now – before you identify a grant that amplifies DEI or requires exploration of health disparities and before you design your study and begin to think about effective ways to approach inclusion and exclusion criteria, inclusive participant recruitment, and equitable community engagements. By thinking DEI first and viewing it as important of a part of your strategy and program or study as a budget, you will be able to plan for desired outcomes and critically examine areas for improvement as you execute on your strategy.

Start with curiosity. Don’t wait for the law to pass or the course or training to be required. Catalogue and compile all information available that could directly or indirectly implicate DEI based on your current understanding. This information will change as you learn more. Identify areas where you can seamlessly integrate exploration of health disparities and health equity and include reach goals for greater nuance. In April 2022, the FDA released draft guidance for industry on Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials.⁸ This draft guidance provides recommended elements of a diversity plan that you can use as inspiration for your plan. Add additional elements, as applicable, from introduced laws and other guiding documents (e.g., strategic plans from your institution and funding agencies) to ensure that DEI is represented throughout your plan and program so that it can be vividly illustrated in your results and impact. Some places to start include: understanding health disparities in the communities that you serve (e.g., by reviewing community health needs assessments or conducting one of your own); aligning research aims with community priorities as identified by community outreach and information from local institutions and organizations; and co-creating a blueprint for and by researchers and the community at-large that shows roles, tasks, and activities that may close preventable gaps in the incidence of diseases/conditions and data pathways (i.e., identification, collection, and dissemination) that can help inform the current state and progress over time.

References

¹ The Power of Collective Action: Assessing and Advancing Diversity, Equity, and Inclusion Efforts at AAMC Medical Schools https://store.aamc.org/downloadable/download/sample/sample_id/578/

² Diversity, Equity, and Inclusion Competences Across the Learning Continuum https://store.aamc.org/downloadable/download/sample/sample_id/512/

³ Henrietta Lacks Enhancing Cancer Research Act of 2019 – Public Law 116-291

Diversifying Investigations Via Equitable Research Studies for Everyone Trials Act or DIVERSE Trials Act – S. 2706

⁴ Diversifying Investigations Via Equitable Research Studies for Everyone Trials Act or DIVERSE Trials Act

⁵ NIH Clinical Trial Diversity Act of 2022 – H.R. 7845

⁶ Equity in Neuroscience and Alzheimer’s Clinical Trials Act of 2021 or ENACT Act of 2021 – S. 1548

⁷ Pursuing Equity in Mental Health Act – S. 1795

⁸ Food and Drug Administration Draft Guidance - Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials

About the Author:

Gelise Littlejohn Thomas, JD, MS, is assistant director, Strategic DEI & Health Disparities at the Clinical and Translational Science Collaborative of Cleveland, Case Western Reserve University. An attorney by trade, she leverages the power and influence of law and policy to help inform research equity, accessibility, diversity, and inclusion in research programs and studies.