Lack of diversity in clinical trials ranks as one of health care’s most deep-seated problems, because it skews results and ultimately harms untold numbers of people. LDI Senior Fellow Nadir Yehya, Associate Professor of Anesthesiology, Critical Care and Pediatrics at the Perelman School of Medicine, and his team looked at problems in getting consent in the pediatric intensive care unit at Children’s Hospital of Philadelphia, where he is an attending physician.

We asked Dr. Yehya, who was Senior Author, to explain what he learned:

How do you describe the problem?   

Yehya: Different rates of consent have been reported in adult and pediatric research, and this has not been thoroughly investigated in the pediatric ICU (PICU). PICU research is different because parents are often approached about very sick—and sometimes dying—kids for time-sensitive studies.  

What did you do and what did you learn?

Yehya: We reviewed screening logs from the CHOP PICU and showed how multiple social and demographic factors led to lower rates of consent. But when we examined only those who were approached for research studies, many of these disparities went away, although Black children remained less likely to participate in PICU research. We concluded that lower rates of approach — parents not at bedside for consent; need for interpreter — was a substantial mediator for why there were disparate rates of consent, and that most disparities can be partly or completely mitigated by improving approaches.

How does your work compare to others?

Yehya: Our study differs by examining rates of consent relative to eligibility logs. Other studies have looked at rates of consent relative to the pediatric U.S. population, but this is misleading. Black children are more likely to have health needs, be hospitalized, and be admitted to the PICU. Thus, comparing consent rates to the U.S. population would suggest Black kids are over-represented in research, which is not the case. What those studies are finding is that Black kids are over-represented among “sick” kids eligible for studies, but they do not get at whether they are more or less likely to consent.

What are some specific solutions?

Yehya: We need to approach parents on their terms, rather than having it be designed for our convenience. For example: 

• Greater use of telephone consent.
• More use of DocuSign or app/text technology to permit consent documentation (for parents not at bedside).
• Increased use of interpreter services.
• Consent forms in one or two of the most common non-English languages.
• Phone/iPad interpreters.
• Staggered staffing of research coordinator teams to cover evenings (when parents visit after work).
• Increased diversity and representativeness of the research coordinator staff to facilitate trust and communication.  

We often encounter studies that don’t necessarily consider equity when designing their consents. Non-English forms and IRB-approved uses of interpreters need to be considered before an eligible non-English speaking subject becomes eligible. That way, all the paperwork is ready. Also, our PICU has spent considerable effort in diversifying our research staff over the past three years.

---

The study, “Racial and Ethnic Disparity in Approach for Pediatric Intensive Care Unit Research Participation,” was published on May 15, 2024, in JAMA Network Open. Authors include Sarah L. Mayer, Michelle R. Brajcich, Lionola Juste, Jesse Y. Hsu, and Nadir Yehya. CHOP also published this summary. 

---

Author

---