Investigating demographic differences in patients’ decisions to consent to COVID-19 research

Abstract

Objective

COVID-19 disease severely impacted pregnant persons, resulting in a significant increase in poor maternal health outcomes, with a disproportionate impact on minority populations and individuals with low socioeconomic status. We sought to determine demographic differences between birthing parents with SARS-CoV-2 infections who consented to research study participation versus those who declined. By analyzing demographic differences, we are able to ensure the generalizability of study outcomes and to aid in future prospective research design, with the ultimate goal of recognizing and ameliorating research disparities.

Methods

We conducted a secondary analysis to investigate demographic differences in patients who consented to versus declined study participation, in an effort to confirm the external validity of the study results and ensure minority populations most affected by SARS-CoV-2 infection were accurately represented. An IRB waiver was obtained to conduct retrospective chart review for demographic data collection of all patients approached for the COVID-19 Analysis on Perinatal Specimens Related to ExpoSure (CARES) research study. Pregnant patients with SARS-CoV-2 infection were identified at a single hospital center and approached either in person or via phone, with a translator if primary language listed as non-English. Demographic variables including race, ethnicity, primary language, and insurance type were obtained from the electronic medical record and analyzed via Chi-square to determine significant differences between individuals who consented to participation and those who declined participation.

Results

One hundred and fifty-eight pregnant patients with SARS-CoV-2 infection were approached for CARES study participation. Eighty-nine patients consented to study participation, while 69 declined study participation. A retrospective chart review was conducted on all 158 patients. Patients who identified as Black race or non-White race were more likely to decline participation (23.2%, p = .031, 68.1%, p = .026), compared to patients who identified as White (31.9%) (Table 1). Patients with public insurance were also more likely to decline study participation (72.5%, p = .049) compared to those with private insurance (27.5%). There was no significant difference between primary language spoken or ethnicity in patients who participated or declined. There was no difference in study participation between patients who identified as Asian race or Other race, compared to patients who identified as White race.

Conclusions

We found significant differences in race and insurance type between pregnant patients with SARS-CoV-2 infection who consented versus declined research study participation. Our study showed that patients who identify as Black race or have public insurance are less likely to consent to research study participation. However, when demographics of consented patients are compared to county, state, and national demographics of female patients age 18–49 with confirmed SARS-CoV-2 infection obtained from a dataset collected by the Center for Disease Control and Prevention (CDC), there was no significant difference between race representation of patients who consented to study participation. This suggests that though the external validity of the CARES study is confirmed, more efforts need to be made to address racial and socioeconomic disparities in research participation.

Keywords:

• COVID-19
• research participation
• consent
• socioeconomic demographics
• maternal health

Disclosure statement

The authors report no conflict of interest.

Additional information

Funding

Research reported in this manuscript was supported by the Worcester Foundation Grant and the University of Massachusetts COVID-19 Pandemic Research Fund.