Conducting clinical genomics research during the COVID-19 pandemic: Lessons learned from the CSER consortium experience

Stephanie A Kraft^{1

2}, Heidi Russell³, Jeannette T Bensen⁴, Katherine E Bonini⁵, Jill O Robinson⁶, Nuriye Sahin-Hodoglugil⁷, Kathleen Renna^{8

9}, Lucia A Hindorff⁸, Dave Kaufman⁹, Carol R Horowitz¹⁰, Margaret Waltz¹¹, Jamilyn M Zepp¹², Sara J Knight¹³

Affiliations

¹ Department of Pediatrics, University of Washington School of Medicine, Seattle, Washington, USA.
² Treuman Katz Center for Pediatric Bioethics, Seattle Children's Research Institute, Seattle, Washington, USA.
³ Department of Pediatrics, Baylor College of Medicine, Houston, Texas, USA.
⁴ Department of Epidemiology, University of North Carolina-Chapel Hill, Chapel Hill, North Carolina, USA.
⁵ Institute for Genomic Health, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
⁶ Center for Medical Ethics and Health Policy, Baylor College of Medicine, Houston, Texas, USA.
⁷ Institute for Human Genetics, University of California-San Francisco, San Francisco, California, USA.
⁸ Division of Genomic Medicine, National Human Genome Research Institute, Bethesda, Maryland, USA.
⁹ Division of Genomics and Society, National Human Genome Research Institute, Bethesda, Maryland, USA.
¹⁰ Institute for Health Equity Research, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
¹¹ Department of Social Medicine, University of North Carolina-Chapel Hill, Chapel Hill, North Carolina, USA.
¹² Department of Translational and Applied Genomics, Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon, USA.
¹³ Department of Internal Medicine, Division of Epidemiology, University of Utah, Salt Lake City, Utah, USA.

PMID: 36341765
PMCID: PMC9839535
DOI: 10.1002/ajmg.a.63033

Conducting clinical genomics research during the COVID-19 pandemic: Lessons learned from the CSER consortium experience

Stephanie A Kraft et al. Am J Med Genet A. 2023 Feb.

. 2023 Feb;191(2):391-399.

doi: 10.1002/ajmg.a.63033. Epub 2022 Nov 7.

Authors

Affiliations

¹ Department of Pediatrics, University of Washington School of Medicine, Seattle, Washington, USA.
² Treuman Katz Center for Pediatric Bioethics, Seattle Children's Research Institute, Seattle, Washington, USA.
³ Department of Pediatrics, Baylor College of Medicine, Houston, Texas, USA.
⁴ Department of Epidemiology, University of North Carolina-Chapel Hill, Chapel Hill, North Carolina, USA.
⁵ Institute for Genomic Health, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
⁶ Center for Medical Ethics and Health Policy, Baylor College of Medicine, Houston, Texas, USA.
⁷ Institute for Human Genetics, University of California-San Francisco, San Francisco, California, USA.
⁸ Division of Genomic Medicine, National Human Genome Research Institute, Bethesda, Maryland, USA.
⁹ Division of Genomics and Society, National Human Genome Research Institute, Bethesda, Maryland, USA.
¹⁰ Institute for Health Equity Research, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
¹¹ Department of Social Medicine, University of North Carolina-Chapel Hill, Chapel Hill, North Carolina, USA.
¹² Department of Translational and Applied Genomics, Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon, USA.
¹³ Department of Internal Medicine, Division of Epidemiology, University of Utah, Salt Lake City, Utah, USA.

PMID: 36341765
PMCID: PMC9839535
DOI: 10.1002/ajmg.a.63033

Abstract

Clinical research studies have navigated many changes throughout the COVID-19 pandemic. We sought to describe the pandemic's impact on research operations in the context of a clinical genomics research consortium that aimed to enroll a majority of participants from underrepresented populations. We interviewed (July to November 2020) and surveyed (May to August 2021) representatives of six projects in the Clinical Sequencing Evidence-Generating Research (CSER) consortium, which studies the implementation of genome sequencing in the clinical care of patients from populations that are underrepresented in genomics research or are medically underserved. Questions focused on COVID's impact on participant recruitment, enrollment, and engagement, and the transition to teleresearch. Responses were combined and thematically analyzed. Projects described factors at the project, institutional, and community levels that affected their experiences. Project factors included the project's progress at the pandemic's onset, the urgency of in-person clinical care for the disease being studied, and the degree to which teleresearch procedures were already incorporated. Institutional and community factors included institutional guidance for research and clinical care and the burden of COVID on the local community. Overall, being responsive to community experiences and values was essential to how CSER navigated evolving challenges during the COVID-19 pandemic.

Keywords: COVID-19; genomic medicine; informed consent; research subjects; telemedicine.

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Conflict of interest statement

The authors declare no conflicts of interest related to this work.

Figures

**FIGURE 1**
CSER consortium map. US map illustrating locations of the six extramural CSER projects and their sub‐sites, as well as one intramural project (ClinSeq, not discussed in this manuscript as recruitment was closed before the COVID‐19 pandemic), the CSER coordinating center, and the NIH institutions funding the CSER consortium

See this image and copyright information in PMC

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Conducting clinical genomics research during the COVID-19 pandemic: Lessons learned from the CSER consortium experience

Affiliations

Conducting clinical genomics research during the COVID-19 pandemic: Lessons learned from the CSER consortium experience

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

References

MeSH terms

Grants and funding

LinkOut - more resources

Full Text Sources

Medical