NUS Institutional Review Board (IRB)
GUIDELINES ON COLLECTION OF BLOOD
SAMPLES FOR RESEARCH
There are various ways of collecting blood samples from human research subjects.
Collection of blood samples can be done by finger stick (prick), heel prick, ear prick, or
venepuncture. For most researches, the common method is via venepuncture.
Blood should be taken from human research subjects only after the subjects have given
their informed consent. The informed consent should include the amount of blood taken
at each visit, the total amount of blood taken and the frequency at which blood will be
taken. A short statement on the risks and discomforts caused by collection of blood
samples should be included in the patient’s information sheet.
The Department of Health and Human Services, National Institute of Health, USA, has
the following guidelines in terms of volume of blood taken from research subjects:
(a) Healthy, non-pregnant adults who weigh at least 110 pounds (50 kg). 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
(b) Other adults and children2, 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.
The risk of taking such amounts of blood can only be considered minimal, when the
probability and magnitude of harm or discomfort anticipated are not greater than those
ordinarily encountered in daily life or during the performance of routine medical or
psychological examinations or tests.
For example, the risk of drawing a small amount of blood from a healthy individual for
research purposes is no greater than the risk of doing so as part of a routine medical
examination. The assessment of the probability and magnitude of the risk, however,
may be different in sick children or elderly and may vary depending on the diseases or
conditions the subjects may have. For example, obtaining blood samples from a
hemophiliac child may present more than minimal risk to the child.
In the Asian context, it is important that researchers are sensitive to the concerns
of our local population. If possible, the minimum of blood should be taken for the
purposes of the particular research. As a rule of thumb, any volume exceeding 20
ml will have to be justified, taking into consideration the health condition of the
subjects, and the number of scientifically useful tests required to be performed on
the blood sample for the research.
References:
DEPARTMENT OF HEALTH AND HUMAN SERVICES [Federal Register: November 9, 1998 (Volume 63,
Number 216)] Source: 63 FR 60364-60367, November 9, 1998
OHRP 45 CFR 46.110
IRB-GUIDE-004
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Version No: 1.1
Date of Revision: 02/10/2006