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Research ethics committees in a tight spot : approving consent strategies for child research that are prima facie illegal but are ethical in terms of national guidelines

SAMJ: South African Medical Journal, 2018-10, Vol.108 (10), p.828-832 [Peer Reviewed Journal]

COPYRIGHT 2018 Health & Medical Publishing Group ;COPYRIGHT 2018 Health & Medical Publishing Group ;This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License. ;ISSN: 0256-9574 ;ISSN: 2078-5135 ;EISSN: 2078-5135 ;DOI: 10.7196/SAMJ.2018.v108i10.13203 ;PMID: 30421709

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  • Title:
    Research ethics committees in a tight spot : approving consent strategies for child research that are prima facie illegal but are ethical in terms of national guidelines
  • Author: Strode, A.E. ; Slack, C.M. ; Singh, P.P. ; Wassenaar, D.R.
  • Subjects: Adolescent ; Child ; Ethical aspects ; Ethics Committees, Research ; Evaluation ; Guidelines as Topic ; Health Care Sciences & Services ; Health Policy & Services ; Humans ; Informed consent ; Informed consent (Medical law) ; Informed Consent By Minors - ethics ; Informed Consent By Minors - legislation & jurisprudence ; Legal Guardians ; Medical Ethics ; Medicine, General & Internal ; Medicine, Legal ; Medicine, Research & Experimental ; Parental consent ; Parental Consent - ethics ; Parental Consent - legislation & jurisprudence ; Pediatric research ; Research ethics ; South Africa
  • Is Part Of: SAMJ: South African Medical Journal, 2018-10, Vol.108 (10), p.828-832
  • Description: It is an internationally accepted principle that ethics norms should be applied and enforced in research with humans through ethics review by research ethics committees (RECs). This places RECs at the very heart of the system for protecting participants and enforcing their rights. In the South African ethical-legal framework for child research, there are divergent approaches to consent. That is, section 71 of the National Health Act (No. 61 of 2003) (NHA) requires mandatory parental consent for child research, and limits the authority for proxy consent to parents and legal guardians. However, national ethics guidelines authorised by section 72 of the NHA and issued by the National Health Research Ethics Council (NHREC) acting in terms of its mandate (National Department of Health, 2015) allow a more nuanced approach – i.e. self-consent by older adolescents, provided certain conditions are met, and consent by a range of parental substitutes where there are no available parents or legal guardians. We have argued elsewhere that the consent approach in section 71 is inappropriately restrictive and are of the view that the consent approach endorsed in national ethics guidelines is more defensible. An REC that elects to approve a consent strategy allowable in ethics guidelines is effectively electing to not follow section 71, which raises the question of what the consequences might be for that REC. This article examines the legal liability of RECs through three ‘threads’ of accountability: the NHREC, the institutions hosting RECs, and the courts. We conclude that: (i) if an REC approves a child protocol with consent strategies allowable in terms of national ethics guidelines but not in terms of section 71, it is unlikely that the NHREC would discipline the REC in the face of a complaint – provided the REC acted within national ethics guidelines issued by the NHREC in terms of the latter’s section 72 mandate to set national norms and standards; (ii) if an REC approves a consent approach allowed for in ethics guidance, it is also unlikely that the host institution would discipline the REC in the face of a complaint – especially if the institution is aware of the REC’s explicit decision to follow national ethics guidelines that are authorised by section 72 of the NHA; and (iii) an REC could only be sued by a participant in terms of the law of delict (and be liable for damages) if several demanding components are proven, such as that the harm suffered by the participant resulted directly from the REC’s actions in approving a particular consent strategy for that research. Furthermore, the court may well look to national ethics guidelines in making determinations about whether an REC’s conduct was wrongful for the purposes of liability in civil law. RECs are protected from being collectively liable by insurance taken out by their host institutions. We make a series of recommendations to address this issue.
  • Publisher: South Africa: Health and Medical Publishing Group (HMPG)
  • Language: English;Portuguese
  • Identifier: ISSN: 0256-9574
    ISSN: 2078-5135
    EISSN: 2078-5135
    DOI: 10.7196/SAMJ.2018.v108i10.13203
    PMID: 30421709
  • Source: Sabinet African Journals Open Access Collection
    SciELO
    Geneva Foundation Free Medical Journals at publisher websites
    African Journals Online (Open Access)
    MEDLINE
    Alma/SFX Local Collection
    DOAJ Directory of Open Access Journals
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