The purpose of this guidance 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 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. While some studies involving the collection of blood samples may qualify for an expedited review procedure (45 CFR 46.110), others may not. Studies involving blood draws may qualify for expedited review if the collection process and eligibility criteria outlined below are met.

Collection Process

  1. Collection of samples 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 does not exceed 550ml and collection does 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), does not exceed the lesser of 50 ml or 3 ml per kg in an eight-week period and collection does not occur more frequently than two times per week
  4. No more than three (3) skin punctures 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, e.g.:
    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 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