Making pediatric health equity research truly equitable: An EDI review process

A burgeoning number of studies are examining pediatric health equity, diversity, and inclusion (EDI). But if not done right, health equity research can do a disservice, perpetuating biases and wrong assumptions that actually exacerbate inequities.

To guide EDI-related studies, the Institutional Review Board (IRB) at Boston Children’s Hospital (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 the Boston Children’s Sandra L. Fenwick Institute for Pediatric Health Equity and Inclusion.

This led to the formation of an EDI Research Review Committee. This group includes subject matter experts in health equity, health equity research, community-engaged research, research engaging underrepresented and medically underserved populations, health services research, data analysis, and legal expertise.

Over a 20-month period, the committee reviewed 78 protocols for EDI-related studies and went on to establish a standardized EDI review process, published recently in Pediatrics.

Reviewing proposed research through an equity lens

The committee considered all phases of each proposed study, from design to dissemination of the results. Ahead of each review, it asked research teams to consider EDI-related questions such as: “What underlying biases or assumptions about the identified population might you be bringing to this research project?”

Research teams were also asked to submit a form answering additional EDI-related questions such as:

• How do you plan to engage the patient population, study participants, and/or community?
• What patient-centered barriers and/or health system-barriers might exist for recruitment or participation in your project, and how do you plan to address these barriers?
• What is your plan for disseminating your research findings back to the patient population, study participants, and/or community?

The committee then discussed each project. For protocols that included primary data collection, the committee gave the research team constructive feedback and suggestions on study methodology, both verbally and in a letter detailing the committee’s recommendations and requirements.  

Incorporating EDI principles into research

Of the 78 protocols, 11 already incorporated health equity principles and were approved without recommendations. The other 67 received recommendations to ensure application of health equity principles. These included:

Acknowledge structural and social determinants of health in the study questions and design.

Without considering structural and social factors that can create inequity, investigators may incorrectly attribute health differences to biology. Or they may reach conclusions that seem to blame patients for their own health outcomes.

Housing insecurity is one example of a health-related social need. “A child with asthma may have multiple emergency department visits, for example, not because they’re not taking their medicine, or because their mom hasn’t brought them for checkups, but because they live in a home with mold that can trigger their asthma,” says Shah.

Problems accessing care — including transportation, childcare, and insurance coverage — can also drive inequities in clinical outcomes.

Bring the community voice into the research.

Members of the group, population, or community being studied should have input into the study’s design, interpretation, and dissemination of the findings. Committee reviewers often advised investigators to get 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 engage with study participants should belong to the group being studied. This can increase participants’ comfort, build trust, and likely yield a stronger study. In some cases, community members can be co-authors of the published paper, says Katz-Wise.

Use language that conforms to current health equity standards.

Using outdated terms that participants find offensive may discourage them from participating in health equity studies and may affect how study findings are interpreted. Such language can also be inaccurate, lack precision, and further stigmatize study participants, populations, or communities.

Develop an analytic plan to handle missing data on EDI variables.

Missing sociodemographic data (especially data on race and ethnicity) was a concern in one third of the protocols the committee reviewed. The study’s data analysis should account for this. To get adequate sample sizes, the review committee often provided guidance on recruiting diverse populations.

A roadmap for academic medical centers

Overall, investigators were receptive to the EDI Research Review Committee’s feedback. Some expressed frustration about the added layer of review. However, many saw a benefit to engaging 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,” says Katz-Wise. “Committee members need protected time to conduct reviews.” They also advise 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 is helping the IRB consider the risk and benefits of the research and how the principle of justice applies to each protocol,” says Kornetsky, senior director of Clinical Research Compliance at Boston Children’s. “Many other IRBs look to this review process as a model for consideration at their own institutions. “

The work of Boston Children’s EDI Research Review Committee has been dynamic, 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.