title: Collaborative international research: ethical and regulatory issues pertaining to human biological materials at a South African institutional research ethics committee.
abstract: Human Biological Materials (HBMs) are an invaluable resource in biomedical research.
  
  
  OBJECTIVE
  To determine if researchers and a Research Ethics Committee (REC) at a South African institution addressed ethical issues pertaining to HBMs in collaborative research with developed countries.
  
  
  METHODS
  Ethically approved retrospective cross-sectional descriptive audit.
  
  
  RESULTS
  Of the 1305 protocols audited, 151 (11.57%) fulfilled the study's inclusion criteria. Compared to other developed countries, a majority of sponsors (90) were from the USA (p = 0.0001). The principle investigators (PIs) in all 151 protocols informed the REC of their intent to store HBMs. Only 132 protocols informed research participants (P < 0.0001). In 148 protocols informed consent (IC) was obtained from research participants, 116 protocols (76.8%) solicited broad consent compared to specific consent (32; 21.2%) [p < 0.0001]. In 105 cases a code was used to maintain confidentiality. HBMs were anonymised in 14 protocols [p < 0.0001]. More protocols informed the REC (90) than the research participants (67) that HBMs would be exported (p = 0.011). Export permits (EPs) and Material Transfer Agreements (MTAs) were not available in 109 and 143 protocols, respectively.
  
  
  CONCLUSIONS
  Researchers and the REC did not adequately address the inter-related ethical and regulatory issues pertaining to HBMs. There was a lack of congruence between the ethical guidelines of developed countries and their actions which are central to the access to HBMs in collaborative research. HBMs may be leaving South Africa without EPs and MTAs during the process of international collaborative research.
authors.forename: Aslam
authors.initials: A
authors.lastname: Sathar
authors.forename: Amaboo
authors.initials: A
authors.lastname: Dhai
authors.forename: Stephan
authors.initials: S
authors.lastname: van der Linde
mesh_terms: D035843:Biomedical Research / Q000941:ethics* / Q000331:legislation & jurisprudence*; D003219:Confidentiality; D003430:Cross-Sectional Studies; D028744:Ethics Committees, Research; D032984:Ethics, Research; D006801:Humans; D007258:Informed Consent / Q000941:ethics; D007391:International Cooperation; D012107:Research Design / Q000592:standards; D012108:Research Personnel / Q000941:ethics; D035842:Research Subjects; D012189:Retrospective Studies; D013019:South Africa; D013048:Specimen Handling / Q000941:ethics*; D014015:Tissue Banks / Q000941:ethics* / Q000331:legislation & jurisprudence*
keywords: Collaborative Research; Developed and Developing Countries; Human Biological Materials