Abstract
Criticisms of the traditional clinical research pathway and its extensive oversight often focus on proposals for deregulation or assert that as in clinical treatment, clinical research should always offer benefit to patient-subjects. Proponents of medical innovation take a different, middle path, arguing that innovation is distinguishable from both research and treatment. This article considers this third pathway by examining stem cell-based innovation.Stem cell-based medical innovation is one pathway toward clinical translation. In fact, such an approach was taken in developing umbilical cord blood transplantation, which is now widely viewed as a safe and effective means for treating a range of malignant and non-malignant conditions. While the Guidelines for the Clinical Translation of Stem Cells created by the International Society for Clinical Research (ISSCR) provide an approach to clinical translation that involves “responsible innovation” as an alternative to clinical research, there are at least four sets of unanswered questions regarding the use of an innovation pathway in this context that warrant careful attention.
Publisher
Cambridge University Press (CUP)
Subject
Health Policy,General Medicine,Issues, ethics and legal aspects
Reference31 articles.
1. 5. Id. (ISSCR), Section 7.
2. 9. 45 United States Code of Federal Regulations 46.102.d.
3. 21. See ISSCR, supra note 4, Section 7.
4. “Ethics and Innovation in Medicine,”;Agich;Journal of Medical Ethics,2001
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