Informed Consent

Informed consent is routinely a prerequisite for the procedures of UCB banking. Prenatal efforts are often directed at recruiting potential donors. Information regarding the risks and benefits of the collection, storage, and potential uses of UCB are explained to parents of prospective donors. By convention, the mother must consent by proxy as UCB is technically of fetal

Table 97.1 Diseases treated by UCBT

Malignant

Nonmalignant

Acute lymphocytic leukemia

Fanconi's anemia

Acute myeloid leukemia

Severe combined immunodeficiency

Chronic myelogenous leukemia

Severe aplastic anemia

Juvenile chronic myelogenous leukemia

Osteopetrosis

Chronic lymphocytic leukemia

Thalassemia

Hodgkin's lymphoma

Myelofibrosis

Non-Hodgkin's lymphoma

Sickle cell anemia

Neuroblastoma

Hurler's syndrome Myelodysplastic syndrome

Wiskott-Aldrich syndrome

Adrenoleukody-strophy Blackfan-Diamond

Syndrome Hunter syndrome Amegakaryocytic thrombocytopenia Lesch-Nyhan Syndrome Gunther's disease Kostman syndrome X-linked lymphoprolif-erative disorder

Syndrome Hunter syndrome Amegakaryocytic thrombocytopenia Lesch-Nyhan Syndrome Gunther's disease Kostman syndrome X-linked lymphoprolif-erative disorder origin. At least four models of obtaining informed consent exist: before labor, during labor, after collection, and phased.13 Before-labor consent allows the donor parent(s) to review and examine the consent documents weeks to months prior to childbirth. Donors not exposed to recruitment efforts, often as a result of inadequate prenatal care, may be excluded; potential restriction in the diversity of the global UCB bank may result. During-labor consent occurs during the early phase of labor. Consent for testing and donation may also be obtained at this time. The after-collection model does not require consent for UCB collection. Once collected, an informed consent process for testing and donation is engaged. This may be troublesome given various personal, cultural, and religious beliefs toward UCB. In light of the potential advantages and disadvantages of these consent models, a phased consent policy has been adopted by some authorities. The premise upon which this policy is based is that the decision to collect UCB is not necessarily closely linked to the decision to test or donate the unit. In the first phase, information regarding UCB is dispersed during prenatal visits. Consent for the second and third phase may be completed at this time. Omission of the first phase does not preclude progression to the second or third phases. The second phase begins during labor when a consent form is delivered and reviewed explaining the process of UCB collection. The final phase is completed after delivery when the mother may agree to the processing, storage, and potential transplantation of the collected UCB.

Policies and recommendations vary based on patient demographics and the practices of health care providers. Nearly all centers employing in vitro UCB collection methods require prelabor consent. The largest UCB bank in the world, the New York Blood Center, uses the after-collection model. The phased-consent policy has been adopted by the American Red Cross, North Central Blood Services Cord Blood Bank. The American Medical Association Working Group on Ethical Issues of Umbilical Cord Blood Banking states "In general, when UCB collection is anticipated, the norm should be to obtain written informed consent before labor and delivery, followed by an affirmation of this consent after delivery."12

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