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Remnant Blood Quantification: Informing the Definition of Minimal Risk in Clinical Research.

Adam L Gottula¹, Sara Constand², Sandra Cabrera³

¹Critical care fellow physician in the Department of Emergency Medicine and Anesthesiology at the University of Michigan.

Ethics & Human Research

|March 28, 2023

Summary

Remnant blood volumes from routine clinical tests exceed current minimal risk limits for research. This suggests increasing allowable blood draw volumes for expedited institutional review board (IRB) review in non-healthy adults.

Keywords:

clinical research expedited review human subjects research institutional review board minimal risk determination remnant blood volume

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Area of Science:

Medical research ethics
Clinical pathology
Regulatory science

Background:

Institutional Review Boards (IRBs) use expedited review procedures for minimal risk research.
Current guidelines limit blood volumes for minimal risk research, impacting study design.
Minimal risk is defined by the Common Rule as comparable to routine clinical tests.

Purpose of the Study:

To evaluate remnant blood volumes from routine clinical tests in patients.
To compare these volumes against current regulatory limits for minimal risk research.
To inform potential adjustments to blood volume guidelines for expedited IRB review.

Main Methods:

Prospective, cross-sectional study at a single institution.
Evaluation of blood draws from 122 adult patients.
Analysis of remnant blood volumes post-routine clinical testing.

Main Results:

Median daily remnant blood volume was 11.6 ml for all patients.
Median daily remnant blood volume was 12.9 ml for intensive care unit patients.
Remnant blood volumes frequently exceeded current minimal risk limits.

Conclusions:

Current blood volume limits for minimal risk research are less than typical amounts drawn during routine testing.
Findings support increasing allowable blood volumes for expedited IRB review in non-healthy adults.
Adjusting these limits can better align research regulations with clinical practice.