TY - JOUR
T1 - Conducting clinical genomics research during the COVID-19 pandemic
T2 - Lessons learned from the CSER consortium experience
AU - Kraft, Stephanie A.
AU - Russell, Heidi
AU - Bensen, Jeannette T.
AU - Bonini, Katherine E.
AU - Robinson, Jill O.
AU - Sahin-Hodoglugil, Nuriye
AU - Renna, Kathleen
AU - Hindorff, Lucia A.
AU - Kaufman, Dave
AU - Horowitz, Carol R.
AU - Waltz, Margaret
AU - Zepp, Jamilyn M.
AU - Knight, Sara J.
N1 - Funding Information:
The Clinical Sequencing Evidence‐Generating Research (CSER) consortium is funded by the National Human Genome Research Institute (NHGRI) with co‐funding from the National Institute on Minority Health and Health Disparities (NIMHD) and the National Cancer Institute (NCI), supported by U01HG006487 (UNC, supporting JTB and MW), U01HG007292 (KPNW, supporting SAK and JMZ), U01HG009610 (Mt Sinai, supporting KEB and CRH), U01HG006485 (BCM, supporting HR and JOR), U01HG009599 (UCSF, supporting NS‐H), U01HG007301 (HudsonAlpha, supporting SJK), and U24HG007307 (Coordinating Center). The contents of this article are solely the responsibility of the authors and do not necessarily represent the official views of the NIH. KR, LAH, and DK are members of the NIH Staff Team, responsible for scientific management of the CSER program. The CSER consortium thanks the staff and participants of all CSER studies for their important contributions and the community stakeholders who provide guidance. In particular, the authors thank Hadley Stevens Smith for contributions to interview analysis. More information about CSER can be found at https://cser-consortium.org/ . : In CSER, we aim to improve the use of genetic information in medicine and reduce barriers to genetic services among underserved groups. Our research seeks to better understand connections between genes, other drivers of health and disease, and health outcomes. We have worked with study participants and community partners to help make our research more inclusive. We still have much more work to do to ensure that our findings are applied in fair and just ways. We also acknowledge the need for more diversity among our own researchers. As we publish the results of CSER, we commit to carrying efforts forward to make sure people of all backgrounds benefit from genomics research and medicine. CSER Diversity and Inclusion Statement
Funding Information:
The Clinical Sequencing Evidence-Generating Research (CSER) consortium is funded by the National Human Genome Research Institute (NHGRI) with co-funding from the National Institute on Minority Health and Health Disparities (NIMHD) and the National Cancer Institute (NCI), supported by U01HG006487 (UNC, supporting JTB and MW), U01HG007292 (KPNW, supporting SAK and JMZ), U01HG009610 (Mt Sinai, supporting KEB and CRH), U01HG006485 (BCM, supporting HR and JOR), U01HG009599 (UCSF, supporting NS-H), U01HG007301 (HudsonAlpha, supporting SJK), and U24HG007307 (Coordinating Center). The contents of this article are solely the responsibility of the authors and do not necessarily represent the official views of the NIH. KR, LAH, and DK are members of the NIH Staff Team, responsible for scientific management of the CSER program. The CSER consortium thanks the staff and participants of all CSER studies for their important contributions and the community stakeholders who provide guidance. In particular, the authors thank Hadley Stevens Smith for contributions to interview analysis. More information about CSER can be found at https://cser-consortium.org/. CSER Diversity and Inclusion Statement: In CSER, we aim to improve the use of genetic information in medicine and reduce barriers to genetic services among underserved groups. Our research seeks to better understand connections between genes, other drivers of health and disease, and health outcomes. We have worked with study participants and community partners to help make our research more inclusive. We still have much more work to do to ensure that our findings are applied in fair and just ways. We also acknowledge the need for more diversity among our own researchers. As we publish the results of CSER, we commit to carrying efforts forward to make sure people of all backgrounds benefit from genomics research and medicine.
Publisher Copyright:
© 2022 Wiley Periodicals LLC.
PY - 2023/2
Y1 - 2023/2
N2 - 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.
AB - 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.
KW - COVID-19
KW - genomic medicine
KW - informed consent
KW - research subjects
KW - telemedicine
UR - http://www.scopus.com/inward/record.url?scp=85141496363&partnerID=8YFLogxK
U2 - 10.1002/ajmg.a.63033
DO - 10.1002/ajmg.a.63033
M3 - Article
C2 - 36341765
AN - SCOPUS:85141496363
SN - 1552-4825
VL - 191
SP - 391
EP - 399
JO - American Journal of Medical Genetics, Part A
JF - American Journal of Medical Genetics, Part A
IS - 2
ER -