A growing body of research examines equity, diversity, and inclusion in pediatric healthcare. But if not done well, it can do a disservice to health equity research by perpetuating biases and false assumptions that actually increase inequities.
To guide EDI-related research, Boston Children’s Hospital’s Institutional Review Board (IRB) (through Tina Young Poussaint, MD, and Susan Kornetsky, MPH) asked the hospital’s Office of Health Equity and Inclusion to develop a review process . In 2022, a group led by Snehal Shah, MD, MPH, Sabra Katz-Wise, PhD, and Valerie Ward, MD, MPH, launched an EDI research review process in collaboration with Boston Children’s Sandra L. Fenwick Institute for Pediatric Health Equity . and inclusion.
This led to the establishment of an EDI Research Review Committee. This group includes experts in health equity, health equity research, community-based research, research involving underrepresented and medically underserved populations, health care services research, data analytics, and legal expertise.
Over a twenty-month period, the committee reviewed 78 protocols for EDI-related studies and subsequently established a standardized EDI review process, recently published in Pediatrics.
Assessing proposed research through an equity lens
The committee considered all phases of each proposed study, from design to dissemination of results. Before each assessment, research teams were asked to consider EDI-related questions, such as: “What underlying biases or assumptions about the identified population might you bring to this research project?”
Research teams were also asked to submit a form with answers to additional EDI-related questions, such as:
- How do you plan to engage the patient population, research participants, and/or the community?
- What patient-centered and/or healthcare system barriers may exist to recruitment or participation in your project, and how do you plan to address these barriers?
- What is your plan to disseminate your research results back to the patient population, research participants and/or the community?
The committee then discussed each project. For protocols involving primary data collection, the committee provided the research team with constructive feedback and suggestions on research methodology, both verbally and in a letter describing the committee’s recommendations and requirements.
Integrating EDI principles into research
Of the 78 protocols, 11 already contained the principles of health equity and were adopted without recommendations. The remaining 67 received recommendations to ensure the implementation of the principles of equality in health care. These include:
Recognize structural and social determinants of health in the research questions and design.
Without considering structural and social factors that can cause inequality, researchers may incorrectly attribute health disparities to biology. Or they may reach conclusions that appear to blame patients for their own health outcomes.
Housing insecurity is an example of a social need related to health care. “For example, a child with asthma may have to go to the emergency room several times, not because he or she is not taking his medication, or because his mother has not taken him for check-ups, but because he lives in a house where mold is present. asthma,” says Shah.
Problems with access to care – including transportation, childcare and insurance coverage – can also lead to disparities in clinical outcomes.
Involve the community’s voice in the research.
Members of the group, population, or community being studied should have input into the design, interpretation, and dissemination of the study’s findings. Committee reviewers often advised researchers to obtain input from community advisory boards and patient/family groups. As the saying goes, “Nothing about us without us.”
Ideally, some of the staff who enroll or work with research participants should belong to the group being studied. This can increase participant comfort, build trust, and likely produce a stronger study. In some cases, community members may be co-authors of the published article, Katz-Wise says.
Use language that meets current health equity standards.
Using outdated terms that participants find offensive may deter them from participating in health equity studies and may impact how study results are interpreted. Such language may also be inaccurate, lack precision, and further stigmatize research participants, the population, or the community.
Develop an analytical plan to handle missing data on EDI variables.
Missing sociodemographic data (particularly data on race and ethnicity) was a concern in one-third of the protocols the committee reviewed. The data analysis of the study should take this into account. To obtain adequate sample sizes, the review committee often provided guidelines for recruiting diverse populations.
A roadmap for academic medical centers
Overall, the researchers were receptive to the EDI Research Review Committee’s feedback. Some expressed frustration with the added layer of assessment. However, many saw a benefit in participating in this process.
Shah, Katz-Wise, and their coauthors suggest getting buy-in from hospital leadership before introducing an EDI research review process. “It has to be a priority for the institution,” Katz-Wise said. “Committee members need protected time to conduct reviews.” They also recommend communicating with researchers in advance about the EDI review process so they can plan ahead.
The authors also recommend that review committees include diverse perspectives, including those of people from groups historically underrepresented in biomedical research.
“The input from experts in health equity and EDI will help the IRB consider the risks and benefits of the research and how the equity principle applies to each protocol,” said Kornetsky, senior director of Clinical Research Compliance at Boston Children’s . “Many other IRBs view this review process as a model for consideration within their own institutions. “
The work of the Boston Children’s EDI Research Review Committee has been dynamic and evolving over time. “As we do the work, we learn more,” says Shah.
Learn more about the Office of Health Equity & Inclusion and the Sandra L. Fenwick Institute for Pediatric Health Equity and Inclusion.