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CHEO Research Ethics Board’s

Pediatric Research Blood Volume Draw Guidance

The table below sets out guidance for researchers and REB reviewers for assessing the risk level associated with total research blood volumes (TBV) drawn from children and adolescent research participants. Clinical blood work must always take precedence over research blood work. When research blood volumes are large, the most responsible physician should ensure that the patient’s clinical needs are met first and foremost. In addition, the investigators should make every effort to minimize the discomfort associated with blood draws.

• Research blood volumes falling within the limits outlined below may be considered minimal risk. Additionally, maximal blood draws (5% of TBV monthly) should not occur more than 3 months in a row.

• Research blood volumes falling above the volume indicated in the table below will be required to undergo Full Board review. Justification for these research blood volumes should be described in the REB application, and the study protocol.

• Research blood draws in infants with a body weight of less than 7.3 kg (16 lbs) and/or less than 6 months of age will always be reviewed at the Full Board.

Open the attached link to view the table
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