The purpose of this guidance is to provide information for investigators to consider when drawing blood from subjects for research purposes.
Research that Qualifies for Expedited Review
The federal regulations stipulate certain categories of research that may be reviewed through an expedited review process1 under 45 CFR 46.110 and 21 CFR 56.110.
Research activities that (1) present no more than minimal risk to human subjects, and (2) involve only procedures listed in one or more of the following categories, may be reviewed by the IRB through the expedited review. The activities listed should not be deemed to be of minimal risk simply because they are included on this list. Inclusion on this list merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human subjects.
The relevant section for the purpose of this document is the “Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
(a) from healthy, nonpregnant 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
(b) from 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.”
It is well known that blood loss due to cumulative diagnostic phlebotomies can result in significant decreases in hemoglobin resulting in hospital-acquired anemias. If the subject has a compromised health status, the investigator should review the hemoglobin levels before obtaining blood samples for research purposes. Careful attention must be made to the cardiovascular status, general activity, previous clinical blood draws, and overall status of the subject and as needed, consultation with the primary care provider. The investigator should consider the blood collection tubes used to ensure they are collecting the minimum volume needed. It is important to take into consideration the following issues when assessing the risk and benefits of blood draws for research purposes.
- Current health status of the individual
- Volume of blood withdrawn for clinical care
- Withdraw only the minimal amount of blood needed to perform the tests and/or banking
- Obtain research blood at the same time as any clinical labs if possible
It is important to consider the total blood volume of the individual when evaluating their ability to provide blood for research purposes. A reasonable figure for calculation of total blood volume for adults is 70mL/kg of body weight and for infants 80mL/kg. For studies that require blood draws from newborns, please consider utilizing cord blood in lieu of infant’s blood.
Depending on the health status of the research subject, the IRB may require the investigator to justify the need for volume of blood removed in relation to the expected benefit to the subject and safeguards to protect from undue risks.