general, the collection of blood samples meeting the
following criteria can be approved by expedited review
if the Human Research Committee finds that the blood
collection poses only minimal risk to subjects. Although
the removal of blood in these amounts is acceptable,
the amount of blood withdrawn should be limited to that
needed to meet the goals of the particular study.
of blood samples by finger stick, heel stick, or venipuncture
from healthy, non-pregnant adults who weigh at least
110 pounds poses minimal risk. For these subjects, blood
may be drawn not more than twice per
week, total amount not to exceed 550 cc in an 8-week
of blood samples from all other adults (e.g., individuals
who are ill or pregnant) and children must take into
consideration 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, blood may be drawn not more than twice per week, total amount not to exceed
the lesser of 50 cc or 3 cc per kg in an 8 week period.
- Blood sampling in amounts of up to 200 cc, drawn at
general, blood sampling in amounts totaling up to
200 cc may be removed from a volunteer subject that
upon examination appears healthy, without further
- Blood sampling in amounts exceeding 200 cc, drawn
at one time
following guidelines apply when blood sampling in
amounts exceeding 200 cc at one time is proposed:
must be greater than 110 lbs (50 kg);
must be between 50 and 100 beats/minute with
no cardiac irregularity;
must not exceed 37.55oC or 99.5oF;
should be drawn before sampling (and at the
end of the sampling period if relevant; see
must be between: 0.36 - 0.48 for females and
0.38 - 0.54 for males;
HEMOGLOBIN must be between 12.5 and 20;
VOLUME from one subject must not exceed 550
cc for any one sample;
MUST BE 8 WEEKS between samples, if multiple
samples of 550 cc are required from one subject.
Subjects should be monitored after large volume phlebotomy
to ensure that they are feeling well and able to resume
regular activities, as happens after donation at a blood
bank, i.e., check vital signs and ensure volume repletion
with oral fluids.
Iron therapy is not required for healthy adults with normal
diets who donate blood infrequently; this is not recommended
or required by blood banks. If an individual repeatedly
donates blood up to the limits of 550 cc in 8 weeks, or
there is other reason to believe it would be medically
advisable, the investigators should consider rechecking
CBC or hemoglobin at the conclusion of blood drawing (after
repletion of volume status). If hemoglobin at the end
of the sampling period is at or below the lower end of
the normal range, iron therapy should be considered. Usually
320 mg ferrous sulfate or equivalent three times per day
for one month should suffice. If iron therapy is offered,
the consent forms and discussions with the subject should
include discomforts and risks of iron therapy (i.e., GI
upset, constipation, and black stools). Research funds
should pay for repeat lab studies and iron therapy, if
regulations do not allow children to participate in
research unless the research involves minimal risk
or, if more than minimal risk, the research presents
the prospect of direct benefit to the subject. Blood
sampling is considered a risk, albeit small. Blood
volume taken from children must be less than 3 cc/kg
body weight per 8 week period. In studies where the
direct benefit far outweighs this volume restriction,
a full protocol must be submitted for review of the
full committee, and the following guidelines will
more than 3 cc/kg body weight per 8 week period
is required and justified by the potential benefits,
up to 9 cc venous blood/kg body weight/8 week period
may be considered in older children (e.g., not neonates,
toddlers, etc.), with the latter figure being the
absolute upper limit.
child involved in a study involving removal of venous
blood in the range of 3-9 cc/kg body weight per
8 wk period should be placed on iron supplementation
therapy. It is recommended that a dose of 30 mg
ferrous sulfate/kg/day in 3 divided doses be given.
Such therapy should continue for at least 8 weeks
and should be monitored by hemoglobin measurements.
use of EMLA cream is recommended to minimize pain
related to blood draws in young children.
possible, blood should be taken from children at the
same time that a clinically needed blood draw is performed
to avoid "extra" needle sticks
ages 7-17, must assent verbally to blood draws for
research purposes and this should be documented in
research and clinical records.
ages 14-17, may co-sign the parental consent form,
if desired by the investigator or parent.
minors (anyone under 18) must have a parent or guardian
sign a consent form giving permission to draw blood
from their child for research purposes.