Blood Sample Collection

For IRB review involving less than minimal risk, the following guidelines must be met. If the research protocol involves greater than minimal risk, the protocol must be submitted to the IRB and wait to get full board approval.

• The sample must be collected through finger stick, heel stick, ear stick, or
• The subject must be healthy, non-pregnant, at least 110
• The amount of blood may not exceed 550 This amount can only be collected through a maximum of an eight week period.
• For age and weight based consideration, the volume collected should not exceed either 50 mL or 3 mL/kg. This amount can only be collected through a maximum of an eight week
• The collection frequency can not be more than two times per
• Expedited category involves less than minimal risk.

If any of these criteria are not met, the IRB will do a full board review. In addition, the IRB may require further study to determine if the level of risk identified is appropriate to the study. If they believe the risk level is not appropriate, a full board review will be conducted to make those changes.

To determine the risk category, there are two classifications:

• Healthy: having none to minimal blood draws for clinical
• Affected: having larger amounts of blood drawn for clinical reasons. The allowable limit is generally decreased for this population because of possible blood transfusions between blood draws.

Collection of blood is done by finger stick, heel stick, ear stick, or venipuncture. The cumulative level of blood drawn from a healthy adult should not exceed 550 mL over an eight-week period. In terms of age and weight, the amount of blood drawn should not exceed either 50 mL or 3 mL per kilogram. The maximum collection frequency is two times per week. No more than three skin punctures should be made in a single collection.

For a research purposes of blood draws, an adult is defined as meeting the following requirements:

• At least 18 years old
• At least 110 pounds
• Not pregnant
• Self reporting as healthy on the day of blood draw
  • No flu or cold symptoms the day of blood draw
  • No infections in the two week period prior to blood draw
  • No symptoms of heart condition six months prior to blood draw
  • No diagnosis of sickle cell disease

The following table outlines blood volume range for healthy individuals.

Investigators should modify their research protocol for patients that would be placed at a health related risk from a standard blood draw procedure. Exceptions to keep in mind of include:

• Severely Sick Patients: For patients that have a health condition, researchers should consider limiting the standard maximal amount of blood drawn. Prior review of patient hemoglobin levels is also recommended. Possible conditions include but are not limited to anemia, low cardiac output, blood pressure problems, pulmonary issues, diabetes, or heart related disease. For these scenarios, it is also suggested to have an overseeing physician in the case of an Furthermore, it is also encouraged that participants note any health related issues when filling out the informed consent form.
• Extra Sticks: The use of extra sticks should be minimized and also consider the reasoning for the draw. For example, consider if it is clinically indicated or if it is used for biobanking. Consider setting a limit as to how many times a participant can be struck for a standard blood draw.
• Iron Supplementation and Hemoglobin Monitoring: Extra parameters may need to be monitored when drawing blood from children or possible immunocompromised

Just like any research study, a fully executed informed consent must be implemented prior to drawing blood. Researchers should provide a general description of how the blood will be drawn as well as outline possible risks. These risks include pain, slight bruising, light headed, nauseous, or even fainting. To minimize these risks, participants should have at least two glasses of water and a snack prior to a blood draw (modified for fasting based blood draws). They should also closely be monitored right after their blood is drawn to note for any lightheadedness or possible fainting.