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Article History

Received: 20 December 2025

Accepted: 10 April 2026

First Online: 22 April 2026

Declarations

:

: NIAID staff conferred with the Department of Health and Human Services Office for Human Research Protections (OHRP) regarding potential applicability of the public health surveillance exception [45CFR46.102 (l) (2)] to the IMPACC study protocol. OHRP concurred that the study satisfied criteria for the public health surveillance exception, and the IMPACC study team sent the study protocol and participant information sheet for review and assessment to institutional review boards (IRBs) at participating institutions. Twelve institutions elected to conduct the study as public health surveillance, while three sites with prior IRB-approved biobanking protocols elected to integrate and conduct IMPACC under their institutional protocols (University of Texas at Austin, IRB 2020-04-0117; University of California San Francisco, IRB 20-30497; Case Western reserve university, IRB STUDY20200573) with informed consent requirements. Participants enrolled under the public health surveillance exclusion were provided information sheets describing the study, samples to be collected, and plans for data de-identification and use. Those that requested not to participate after reviewing the information sheet were not enrolled. Participants did not receive compensation for study participation while hospitalized and subsequently were offered compensation during outpatient follow-up.

: Not applicable.

: The authors declare no competing interests.