Cord Blood Establishing a National Hematopoietic Stem Cell Bank Program (2005) / Chapter Skim
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5 Ethical and Legal Issues
5 Ethical and Legal Issues
Pages 106-119
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From page 106... ...
Because uses of cells from umbilical cord blood are not yet considered routine medical practice, and because of the need for informed decision making, this therapy currently falls within the legal framework of an investigational new drug (IND) application with the Food and Drug Administra 106
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From page 107... ...
In addition, brief mention is given to the potential impact of patent litigation on cord blood banking practices. INFORMED CONSENT OF DONORS Until recently, cord blood was considered one of the many biological waste materials discarded after the birth of a baby (Fernandez, 1998; Gluckman, 2000)
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From page 108... ...
108 CORD BLOOD TABLE 5-1 Consent Practices for Agencies Currently Involved with Cord Blood Consent Parameter FACT/NetCord AABB NMDP Timing Before or within 7 days The consent process Consent should of delivery; consent should should begin before not be undertaken be obtained before the collection and should after the onset collection procedure when be completed within of active labor the cord blood is collected 48 hours and should be with the placenta in utero postponed until the mother has sufficiently recovered from the delivery process Surrogate Consent should be Consent should be Not addressed pregnancy obtained from both the obtained from the surrogate and the biological birth biological mother mother Minor Not addressed Applicable informed- Not addressed consent requirements and regulations shall be met Specific · If for an allogeneic · Description of cord Specific document elements to transplant, the donation collection procedure currently under be included will be made available · Sample collection development in the to other individuals and and storage for consent may not necessarily be possible future available to the donor testing or donor's family at a · Testing for later date infectious diseases · If intended for a related and genetic allogeneic or autologous disorders transplantation, the · Notification of release of the cord blood abnormal results will be limited to the · Review of medical specific family recipients history and family or donor genetic history · An interview for personal · Possible dispositions and family history will be of cord blood unit undertaken · Discussion of · A review of the medical confidentiality record of the mother and · Ownership infant will be performed · A description of the cord collection procedure · Collection of blood from the mother and infectious
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From page 109... ...
Thus, while the committee does not advocate requiring the father's consent, cord blood collection centers should have a plan in place to address paternal objections to the donation of cord blood. Recommendation 5.1: Cord blood collection centers should have clear policies about who must provide consent for donation and a plan in place to address paternal objections to the donation of cord blood.
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From page 110... ...
Thus, while informed consent procedures must be designed to protect the interests of the donor family, they may also need to take into account practicality and demographic realities of the donor communities without
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From page 111... ...
Clarifying Potential Options and Outcomes of Donation In obtaining informed consent it is important to address any assumptions or motivations the donors might have. The attitudes of mothers toward the collection of cord blood units generally reflect their level of knowledge of the process (Sugarman et al., 1998; Fernandez et al., 2003)
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From page 112... ...
Standards for Obtaining Informed Consent of Donors Because cord blood transplantation is considered an experimental procedure, review and approval of the design and implementation of the informed consent process is the responsibility of the IRB1 designated by the collection center. Cord blood collectors must be able to tailor the informed consent process to accommodate the local population, which may have specific cultural, religious, and historical attitudes toward the donation of the body or any of its parts.
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From page 113... ...
However, the record may be incomplete because volunteers for allogeneic cord blood donation are not generally motivated by the threat of the immediate loss of a family member and may therefore be less inclined to provide intimate personal information to anyone beyond their personal physician (Zilberstein et al., 1997) The additional testing of the cord blood unit could reveal unanticipated information about the mother or her child's health that would have otherwise gone unnoticed.
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From page 114... ...
Protecting the privacy of individual patients and the confidentiality of the data is the responsibility of all data users and is necessary to protect individual rights and public expectations. Many groups have focused on privacy concerns related to medical information and medical research and recently enacted regulations aim to improve privacy protections.
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From page 115... ...
When cord blood units are collected for research, even future unspecified research use, donors must be informed of risks that might ensue, including violations of confidentiality. In its 1999 report Research Involving Human Biological Materials: Ethical Issues and Policy Guidance (NBAC, 1999)
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From page 116... ...
Recommendation 5.4: Secure links between the medical records of the donor and the banked cord blood unit must be established to ensure the safety of transplantable products and the patients receiving the trans 3See Guidance on Research Involving Coded Private Information or Biological Specimens, OHRP/DHHS, Aug.
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From page 117... ...
Significant laboratory research is also being conducted with cord blood units but not necessarily under an IND. Although the harvesting of embryonic stem cells from surplus embryos obtained from infertility clinics is controversial, cord blood units offer a relatively noncontroversial source of stem cells, although the versatility of cord blood cannot match that of embryonic stem cells (see Chapter 1)
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From page 118... ...
1999. Linking donors to stored cord blood units: Duties to donors and recipients.
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From page 119... ...
2002. Optimization of informed consent for umbilical cord blood banking.
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