The ethicolegal framework relevant to human faecal microbiota transplants in South Africa: Part 2. Human stool as tissue?
| Autor: | Melodie Nothling Slabbert, M Labuschaigne, E Hoosien, S Budree, M Blockman, Adrian Brink |
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| Rok vydání: | 2020 |
| Předmět: |
National health
medicine.medical_specialty Tissue and Organ Procurement business.industry General Medicine Fecal Microbiota Transplantation Therapeutic Human Experimentation Faecal microbiota transplantation Feces South Africa Tissue bank medicine Humans Effective treatment Intensive care medicine business Clostridioides Biological Specimen Banks |
| Zdroj: | South African Medical Journal. 110:816 |
| ISSN: | 2078-5135 0256-9574 |
| DOI: | 10.7196/samj.2020.v110i8.15069 |
| Popis: | Faecal microbiota transplantation (FMT) has been shown to be an effective treatment for recurrent Clostridioides difficile infection. The purpose of this article, the second of a series of three articles, is to explore the legal framework governing human FMT in South Africa (SA). FMT involves different modes of administration that require different regulatory considerations. The focus of this article is to explore the legal classification of human stool as tissue in terms of the National Health Act 61 of 2003, as well as the regulation of human stool banks as tissue banks. The article concludes with specific recommendations aimed at improving the current regulatory vacuum relating to the regulation of FMT in SA. |
| Databáze: | OpenAIRE |
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