The purpose of this guidance is two-fold: the first purpose is to provide researchers with information that can be used in consent documents and protocols when developing a research plan that includes the collection of blood samples; the second purpose is to assist researchers in determining whether the blood draw procedures will be considered to present no more than minimal risk of harm to subjects.

The guidance provided here combines the requirements from the federal regulations with the guidelines and best practices set forth by the American Red Cross.

The collection of blood samples for research purposes is a common practice. In all cases, justification for the volume selected should be included in the protocol. In some instances, the collection of blood samples may be considered to present no more than minimal risk to research subjects and may be reviewed by an expedited procedure (45 CFR 46.110). In other instances, the collection of blood samples may be considered to be greater than minimal risk and must be reviewed by the full board review.

In order for a blood draw to be considered minimal risk, and therefore considered for expedited review, the protocol must follow the process and eligibility criteria outlined below.

Collection Process

  1. Collection of samples should be done by finger stick, heel stick, ear stick, or venipuncture
  2. The cumulative volume of blood drawn from a healthy adult for any purpose (clinical or research) over an eight-week period of time should not exceed 550ml and collection may not occur more frequently than two times per week
  3. The cumulative volume of blood drawn from other adults or from children for any purpose (clinical or research), may not exceed the lesser of 50 ml or 3 ml per kg in an eight-week period and collection may not occur more frequently than two times per week
  4. No more than three (3) skin punctures should be made in any single attempt to draw blood solely for research purposes

Adult Subject Eligibility Criteria

  1. At least 18 years old
  2. At least 110 lbs.
  3. Non-pregnant
  4. Generally healthy by self-report
    1. Free of cold and flu symptoms the day of collection
    2. No infections within two weeks prior to collection
    3. No symptoms of a heart condition within the six months prior to collection
    4. No known sickle cell disease
    5. Based on the specifics of a population and the amount of blood planned for collection in one sitting, researchers may need to consider excluding subjects with anemia
  5. Including the study draw, blood donation for clinical or research purposes during the preceding eight weeks will not exceed 550 ml
  6. No more than one blood draw has occurred during the preceding week

The full board will review all protocols that involve blood sample collection that does not align with the above process and eligibility criteria. When the collection of blood samples is to be done in research that involves greater than minimal risk to subjects (such as pharmacokinetic or other monitoring studies that require frequent sampling over a short period of time) the collection must be reviewed by the full board.

The IRB may request additional safeguards based on the specifics of the population and proposed volume of the draw.

Consent Language

Activity: We will draw about {insert teaspoons/tablespoons and cc} of blood by putting a needle into a vein in your arm. This is the standard method used to obtain blood for tests.  If more than one draw will occur insert the following sentence:   We will take a total of {insert teaspoons/tablespoons and cc} of blood over the course of this study.

Risk: The risks of having blood drawn from your arm include some pain when the needle goes in and a small risk of bruising and/or infection at that site.  Some people get lightheaded, nauseous, or faint.  You are less likely to have these problems if you drink at least 2 glasses of water and have a snack before the blood draw {Modify for fasting draws}.  The American Red Cross recommends that you do not donate more than 1 pint (32 tablespoons) of blood within a 2 month period.  Tell the study team if you have recently had your blood drawn for any reason.

Sample eligibility checklist