DUKE UNIVERSITY HEALTH SYSTEM
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`Human Research Protection Program
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`BLOOD DRAWING FOR HUMAN SUBJECT RESEARCH
`12/13/2012
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`As a general rule, investigators must not draw more blood from any research subject than is
`needed to answer the research question, and should design the research to minimize that
`volume.
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`A. Blood Drawing Limits for Protocols Reviewed Using the Expedited Procedure
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`Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
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`(a) from healthy, non-pregnant adults who weigh at least 110 pounds. For these subjects, the
`amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur
`more frequently than 2 times per week; or
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`(b) from other adults and children, considering the age, weight, and health of the subjects, the
`collection procedure, the amount of blood to be collected, and the frequency with which it
`will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml
`or 3 ml per kg in an 8 week period and collection may not occur more frequently than 2
`times per week.
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`B. Blood Drawing Limits for Protocols Reviewed by a Convened Board
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`The convened IRB may approve a volume of blood drawn for research purposes that exceeds
`the limits referred to above. As a general rule, blood drawn for research purposes must not
`exceed the following volumes:
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`For an adult, the amount of blood that may be drawn for research purposes shall not exceed 5
`ml/kg in any one 24 hour period, and 7 mL/kg in any eight week period. Any exception to
`these limits must be specifically justified in the research protocol and approved by a convened
`IRB.
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`For a child, the amount of blood that may be drawn for research purposes shall not exceed 3
`ml/kg in any 24 hour period, and 7 mL/kg in any eight week period. Any exception to these
`limits must be specifically justified in the research protocol and approved by a convened IRB.
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`C. Exceptions to Blood Drawing Limits
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`For any subject whose clinical condition might be adversely affected by removal of the
`volumes stated above, for example, a person with significant anemia or compromised cardiac
`output, investigators should further limit the volume of blood withdrawn for research purposes
`so as to minimize harm to the subject.
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`1
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`00001
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`EX1049
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`A subject’s attending physician may determine if phlebotomy for research purposes should be
`further restricted below the limits stated above. Also, the convened IRB in its review of a
`specific protocol may limit the blood volumes to be obtained for research to amounts lower
`than the upper limits provided above.
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`Exceptions shall not be permitted for phlebotomy intended solely for research purposes unless
`the limits have been explicitly increased in a research protocol that has received approval by a
`convened IRB.
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`References:
`Blood drawing policies from the National Institutes of Health, the European Union, Children’s
`Hospital of Philadelphia, and Children's Hospital, Boston
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`Previous Version Date(s): 1/17/2008
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`2
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`00002
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