Chapter category: Transplant
Ethical Criteria for Evaluating Hand Transplantation
Hand Transplantation
Edited by: Vijay S. Gorantla and Warren C. BreidenbachISBN: TBA
» Get more information about this book at landesbioscience.com «
Chapter authors:
Mark A. Rothstein and Heather Hinds
Abuses in biomedical research involving human subjects provided a major impetus to establish the field of interdisciplinary, critical inquiry now known as bioethics,1 and regulation of research remains a prime focus of the field. Historically, the main ethical concern of research ethics has been preventing the exploitation of research subjects by researchers who, as a result of their commitment to their research, may be insufficiently sensitive to safeguarding the rights of the subjects.2 In the United States, research at institutions receiving funds from the Department of Health and Human Services and certain other federal agencies and research in contemplation of a drug approval submission to the Food and Drug Administration must comply with the Federal Policy for the Protection of Human Subjects (“the Common Rule”).3 Among other things, unless a specific exemption applies, investigators using human subjects in their research must have their protocols approved by an institutional review board (IRB) applying federally-delineated criteria.4 Three provisions of the Common Rule are particularly important to the ethical analysis of hand transplantation: (1) the risks to the subjects have been minimized, and the remaining risks are reasonable in relation to the anticipated benefits; (2) the selection of the subjects is equitable, and potentially vulnerable subjects are provided with additional safeguards; and (3) informed consent has been obtained and documented. Although the Common Rule embodies the legal requirements for ethical research, it does not contain all of the ethical criteria necessary to evaluate a complex and novel intervention such as hand transplantation. Moreover, the Common Rule would not apply to hand transplantation performed outside the context of a research protocol or in an institution not receiving federal funding. Consequently, in addition to the Common Rule, this chapter will also consider conceptual and procedural protections, subjective factors used by prospective subjects in evaluating the risks and benefits of hand transplantation, and societal perspectives including distributional ethics.
Additional chapters from this book:
Assessment and Management of Rejection in Hand Transplantation
Stefan Schneeberger and Raimund Margreiter
In 18 hand transplant recipients, 25 rejection episodes have been observed within the first year and two hands have been lost due to rejection. Acute rejection therefore represents the major thr...
Psychological Considerations in Hand Transplantation
Martin M. Klapheke
Psychiatric consultation can play an important role in the assessment of candidates for solid organ transplantation.1 It can be even more critical in the assessment and manage- ment of patients w...
T-Cell Depletion Strategies for Tolerance Induction: Potential Application in Composite Tissue Transplantation
Erik Schadde and Stuart J. Knechtle
The clinical experience with immunosuppression in composite tissue allografts (CTA) is still small compared with the experience in solid organ transplantation. By 1998 and 2005, 24 hands have be...
Perspectives on Chronic Rejection after Hand Transplantation
Vijay S. Gorantla, Carolyn D. Burns and Warren C. Breidenbach
World experience has shown us that acute rejection after hand transplantation is immunologically similar to that in solid organ transplants. The risks of chronic rejection are real after hand tr...
Ethical Criteria for Evaluating Hand Transplantation
Mark A. Rothstein and Heather Hinds
Abuses in biomedical research involving human subjects provided a major impetus to establish the field of interdisciplinary, critical inquiry now known as bioethics,1 and regulation of research re...
Decision Analysis in Hand Transplantation
Stephen E. Edgell
Hand transplantation, as with all medical procedures, provides to the patient the possibility of an improved life along with risks. A decision to have or to not have a hand transplant is one t...
The Evolution and History of Hand Transplantation and Current Status of Composite Tissue Allotransplantation
Chad R. Gordon and Charles W. Hewitt
Composite tissue allotransplantation (CTA) involves “transplanting a graft, composed of a variety of heterogeneous antigenic tissues, across a genetic mismatch,” as in the case of a hand (i....
Rationale for Hand Transplantation
Justin M. Sacks and W.P. Andrew Lee
Hand transplantation is a clinical reality that offers immense reconstructive potential. Benefits of human hand allografts based on reviews of replantation literature are fa- vorable for significan...
