INFORMED CONSENT
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THIS PAGE WILL PREPARE YOU TO PROCESS AND SIGN THE INFORMED CONSENT FORMS BEFORE BEGINNING SURGERY OR A BLOOD TRANSFUSION.

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'Informed Consent' refers to the permission that the doctor requests, and that you give the doctor or hospital to perform procedures, after you understand the information about the risks and benefits of that procedure.

Please view an actual Informed Consent form HERE.

Specifically, informed consent is the process whereby the physician informs the patient about the options available to the patient and to the doctor, for the diagnosis and the treatment of the patient's illness. Additionally, the risks of the procedure as well as the benefits are described to the patient so that the patient can make an informed decision regarding what he/she wants to be done. This is the theory: When you need Blood now, or die, the answer is always YES. Our main reason for looking at this question is: why is someone who knows a lot more about this procedure than me, asking me to release them from liability in case of a problem?

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No matter how it may appear, the purpose of informed consent rules, for the patient, (the person who is paying the bill) is to make certain that they have a clear understanding of their situation and all of their options and alternatives. Over the years, "informed consent" has been administered by the medical community as a vehicle to ensure that there will be no legal action against the medical facility, its employees or administrators.

We recommend that you get a early start. Study up on the hospital, clinic and  local Blood services facilities that you are most likely to need in an urgent situation. Get a copy of their informed consent documents and read them thoroughly. We also recommend that, at a minimum, you discuss these with a close family member, and/or your attorney. You may want to sign a sample informed consent document and carry it with you.

Informed consent is a legal doctrine that has been developed by the courts over the last 50 plus years. The doctrine of informed consent may have been derived from the Nuremberg Code, which required that doctors obtain the voluntary informed consent of the subject prior to conducting medical experimentation. The Informed Consent Doctrine requires that medical doctors provide a patient with all relevant information about a proposed procedure or treatment prior to obtaining the consent of the patient to carry out the procedure or treatment.

Four items of information that must be provided are:

The exact nature of the different procedures available,
The risks of each,
The potential benefits of each and,
Each one of the practical alternatives.

Informed consent protects, with some exceptions, the doctor from liability, provided that the procedure is properly executed according to the prevailing standard of care and without negligence. Informed consent also can protect the patient by providing them with complete information on which to make an informed decision. Again, a great problem: if I am in need, and the caregiver at hand has knowledge of a limited set of options, the procedure at hand may be the one that I choose! The adult patient's power to consent is very broad. Inadequate provision of information, however, may invalidate the consent.

How Does Informed Consent Relate To Blood Transfusion?
According to The Rights of Patients: The Basic ACLU Guide to Patient Rights - by George J. Annas, in order to ensure that patients have the information needed to make an informed choice, the information presented by the care giving entity should include at least the following:

  1. A complete description of the recommended treatment or procedure,
  2. A description of the risks and benefits of the recommended procedure with special emphasis on the risks of death or serious bodily disability,
  3. An explanation of the practical alternatives, including other treatments or procedures and the risks and benefits of these alternatives,
  4. The likely results of no treatment,
  5. The probability of success, and what the physician means by success,
  6. The major problems anticipated in recuperation, and the length of time during which the patient will not be able to resume his or her normal activities and,
  7. Any other information generally provided to patients in this situation by other qualified physicians. 

Remember..... it is their job to keep explaining until you understand. When you sign the paper, you have clearly and irrevocably stated that you do understand.

Patients and their families should be concerned about Blood transfusion transmitted diseases. A complete and responsible presentation, however, of transfusion risks will include all infectious risks, as well as the possible consequences of transfusion that do not involve transmission of disease. Perhaps even more than for infectious risks, the consequences and relative importance of non-infectious risks of allogeneic transfusion also identify the types of patients and circumstances in which the risk is of unusual consequence or magnitude.

The United States Government Office for Protection from Research Risks offers a full explanation on this subject.


A complete presentation of transfusion risks during a discussion between a physician and patient to elicit informed consent for transfusion should include the non-infectious risks that may be particularly relevant to the clinical circumstance.

Following here is a list of non-infectious risks, many of which may be reduced with the use of leukocyte reduced Blood components (rather than whole Blood).

Non-infectious Transfusion Risks
and Adverse Consequences
Transfusion Reactions
a. Usually mild
    Allergic reactions to Blood proteins
    Febrile nonhemolytic
    Delayed hemolytic
    Allergic reactions to storage or transfusion equipment
b. Potentially Severe
    Hemolytic
    Severe allergic and anaphylactic
    Transfusion-acquired acute lung injury
    Septic shock*
Alloantibody Formation
a. To red cell antigens
b. To platelet-specific antigens
    Post transfusion purpura
    Neonatal isoimmune thrombocytopenia
c. To HLA antigens
    Platelet refractoriness
Physical Effects*
a. Fluid overload
b. Hypothermia
c. Dilution coagulopathy
Chemical Effects
a. Hypocalcemia
b. Hypercalcemia
c. Iron overload, hemochromatosis
Immunologic Effects
a. Graft-vs-host disease
b. Immune suppression and dysregulation


* These same risks occur with both allogeneic and autologous transfusion. The other non-infectious risks are restricted to allogeneic transfusions, whether from the general Blood supply or directed donations. 

Please view an actual Informed Consent form HERE.



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   last updated 01/10/2005   bloodbook.com