A5060008750- Biomedical Ethics and Regulation
- Ethics in Clinical Research
- Legal Issues in South Africa
- Ethics and Legal Issues in Pediatric Healthcare
- Medical Malpractice and Liability Issues
- Human Rights and Development
- Patient Dignity and Privacy
- Ethics in medical practice
- Clostridium difficile and Clostridium perfringens research
- Palliative Care and End-of-Life Issues
- Health Systems, Economic Evaluations, Quality of Life
- Law, AI, and Intellectual Property
- HIV/AIDS Impact and Responses
- Law in Society and Culture
- Healthcare cost, quality, practices
- Judicial and Constitutional Studies
- Children's Rights and Participation
- Medical Coding and Health Information
- Biomedical and Engineering Education
- Public Health Policies and Education
- Healthcare Systems and Reforms
- Health Services Management and Policy
- Adolescent and Pediatric Healthcare
- Healthcare Systems and Challenges
- Medical Research and Practices
University of South Africa
2018-2024
Universidade de Santo Amaro
2023
Genomic research has been identified in South Africa (SA) as important developing a strong bio-economy that the potential to improve human health, drive job creation and offer solutions disease burden harboured by low- middle-income countries. Central success of genomic is wide sharing biological samples data, but true value data can only be unlocked if there are laws policies place foster legal ethical data. The introduction entry into force SA's Protection Personal Information Act (POPIA)...
CITATION: Pepper, M. S., et al. 2018. ASSAf consensus study on the ethical, legal and social implications of genetics genomics in South Africa. African Journal Science, 114(11/12), Art. #a0302, doi:10.17159/sajs.2018/a0302.
The role of health research ethics committees (RECs) has evolved dramatically over the past few decades. Novel and specialised research, multicentre trials across borders commercially sponsored coupled with a huge increase in number complexity protocols, capacity resource constraints on part RECs, have led to serious breaches regarding protection human participants. Research involving exchange or cross-border transfer biological materials (HBMs) requires legal ethical knowledge relating...
While open science gains prominence in South Africa with the encouragement of data sharing for research purposes, there are stricter laws and regulations around privacy – specifically use, management transfer personal information to consider. The Protection Personal Information Act No. 4 2013 (POPIA), which came into effect 2021, established stringent requirements processing has changed regulatory landscape across African borders. At same time, draft national policies on encourage wide...
<ns4:p>Genomic research and biobanking has undergone exponential growth in Africa at the heart of this is sharing biospecimens associated clinical data amongst researchers across world. While move towards open science progressing, there been a strengthening internationally protection regulations that seek to safeguard rights subjects while promoting movement for benefit research. In line with global shift, many jurisdictions are introducing regulations, but limited consideration regulation...
Organ donation after a circulatory determination of death is possible in selected patients where consent given to support and the patient has been legally declared dead by two doctors. The National Health Act (61 2003) regulations provide strict controls for certification organs tissues death. Although expressly recognises that brain death, it does not prescribe medical standards testing (neurological death), (circulatory death) or based on somatic criteria. However, all cases organ...
The Health Professions Council of South Africa (the HPCSA) is a statutory body established in terms section 2 the Act 56 1974 (hereafter "the Act"). One objects HPCSA "to ensure investigation complaints concerning persons registered and to that appropriate disciplinary action taken against such accordance with Act" (s 3(n)). powers institute an inquiry into complaint, charge or allegation unprofessional conduct practitioners are vested professional boards 15 41(1) Act). procedure be followed...
Chapter 19 of the Children’s Act No. 32 2005 regulates practice surrogate motherhood in South Africa and provides legal certainty regarding rights children born as a result surrogacy, including different parties involved. Despite clarity consequences human reproduction by artificial fertilisation women acting mothers, some gaps inconsistencies certain medical ethico-legal issues remain. The purpose this article is to critically examine selected provisions whose implementation hampered lack...
The current legal framework regulating human tissue and organ procurement, removal use is inconsistent, inadequate often ambiguous. By tracing the developments relating to regulation of organs since inception first South African regulatory in 1952, this contribution seeks determine origin existing limitations challenges pertaining field. Case law also discussed illustrate lack understanding complexity regarding application relevant provisions a practical context. study concludes with number...

 The doctor-patient relationship is the foundation of any medical intervention. Over time, has changed, from era paternalism to self-determination or patient autonomy, following changes resulting consumerism and lately, in South Africa, socialised medicine as a result proposed National Health Insurance (NHI). premise this article that autonomy invariably limited by determination who will carry cost In recent years, legislative developments have affected understanding doctor through...
The existing ethico-legal regulation of adolescent children's participation in health research South Africa is currently unclear. article interrogates the framework governing consent to participation, with specific emphasis on discrepancies norms law and ethical guidelines. Against backdrop constitutional directive that requires a child's best interests are paramount importance every matter concerning child, assesses whether sufficient consideration given evolving maturity capacities when...
The demand for human tissue in the medical context has increased rapidly since early 1980s, when use of bone allografts orthopaedic surgery became norm. During 1990s, turned towards tissue-engineered products field regenerative medicine. Tissue engineering, as an established and growing interdisciplinary comprising different specialties, such medicine, materials science, cell biology, genomics chemical aims to develop biological substitutes restore, maintain or improve function, thus...
The legal regulation of faecal microbiota transplantation (FMT) in South Africa (SA) is currently unclear. purpose this article, the first three a series, to explore nature, role and clinical application FMT SA order determine, from perspective, appropriate regulatory pathways governing as procedure that may combine approaches for treatment drugs, human tissue transplantation, or part practice medicine. has been shown be novel, safe effective recurrent Clostridioides difficile infection...
Globally, there has been a move toward ‘open science’ that includes the sharing of health data for research. The importance research is generally acknowledged, but this must only be done with legal and ethical procedures protections in place. use South Africa changed coming into force Protection Personal Information Act (POPIA). POPIA should ensure greater transparency accountability personal information. POPIA, however, adopts principle-based approach to regulation information, lack clarity...
Faecal microbiota transplantation (FMT) has been shown to be an effective treatment for recurrent Clostridioides difficile infection. The purpose of this article, the second a series three articles, is explore legal framework governing human FMT in South Africa (SA). involves different modes administration that require regulatory considerations. focus article classification stool as tissue terms National Health Act 61 2003, well regulation banks banks. concludes with specific recommendations...
Die reg-en-letterkunde-vakterrein, in Suid-Afrika nog ’n ontwikkelende fase, is interdissiplinêre studieveld wat onder andere gemoeid met die vertolking van regsaspekte fiksie. Lesers word staat gestel om krities te besin oor rol en funksie reg breër konteks, asook komplekse maatskaplike regskwessies soos wetteloosheid, diskriminasie ongeregtigheid binne bepaalde konteks evalueer. sentrale tema Zelda Bezuidenhout se 2021-roman waarde stil bure ongeoorloofde stamselnavorsing...

 The purpose of this article is to address the questions as whether a criminal conviction healthcare practitioner should affect his or her professional standing, and such constitutes ‘unprofessional conduct’ in terms Health Professions Act. also explores related matter, namely Council South Africa (HPCSA) has legal duty refer complaints regarding unprofessional conduct that displays elements for prosecution. After considering relevant case law on these issues, concludes practitioner,...
Private medical aids are essentially non-profit organisations that aim to deliver speedy treatment and should prevent members from unexpected, out of pocket expenses for care. However, although the latest statistics show 16.2% individuals in South Africa were aid schemes, making promise private healthcare accessible a small percentage population, they not without their own unique set challenges. The restrictions exist within sector have direct bearing on types services patients can access,...