Children as participants in health research in South Africa: A response to Labuschaigne, Mahomed and Dhai.
Children as participants in health research in South Africa: A response to Labuschaigne, Mahomed and Dhai.
复制标题
南非儿童作为健康研究的参与者：对 Labuschaigne、Mahomed 和 Dhai 的回应。
DOI：
10.1111/dewb.12403
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发表时间：
2023
影响因子：
2.2
通讯作者：
Thaldar,DonrichW
中科院分区：
文献类型：
--
作者：
Donnelly,Dusty-Lee;Thaldar,DonrichW
由于伦理-法律规则的复杂网络，南非的卫生研究人员很难在不通知父母或征得父母同意的情况下招募青少年参加这类敏感研究。这一条回应了最近关于修改南非2003年第61号《国家卫生法》第71条所载的强制性父母同意的一揽子要求的提案[NHA]。拟议的修正案旨在通过允许卫生研究伦理委员会更大的灵活性来放弃父母的同意，并允许青少年独立同意，使NHA与南非卫生部2015年的卫生研究伦理指导方针保持一致。针对南非2013年第4号《保护个人信息法》[POPIA]的要求，强调了这项提案中的一个漏洞：即使按照提议对《国家卫生条例》进行修正，也不一定能实现使南非法律与南非现行道德规范保持一致的目标，因为POPIA仍可能需要父母的同意。本文调查这一目标(使法律与道德相一致)是否能够以一种符合教皇的方式实现。结论是，这在许多方面确实是可能的，实现这一目标的最佳方式是要求南非信息监管机构发布一份指导说明，大意是，机构卫生研究伦理委员会批准的所有卫生研究项目都将被视为符合公共利益，这将使此类卫生研究项目有资格免于POPIA的同意要求。
A complex network of ethico‐legal rules makes it difficult for health researchers in South Africa tolawfullyrecruit adolescents to the kinds of sensitive studies where it may beethicallyappropriate to proceed without notifying parents or obtaining parental consent. This article responds to a recent proposal to amend the blanket requirement for mandatory parental consent presently contained in section 71 the South African National Health Act 61 of 2003 [NHA]. The proposed amendment is intended to bring the NHA into alignment with South Africa's 2015 Department of Health Guidelines on Ethics in Health Research by permitting greater flexibility for a health research ethics committee to waive parental consent, and permit adolescents to consent independently. A lacuna in this proposal is highlighted with reference to the requirements of South Africa's Protection of Personal Information Act 4 of 2013 [POPIA]: Even if the NHA is amended as proposed, the goal of aligning South African law with prevailing ethics norms in South Africa would not necessarily be attained, as parental consent may still be required by POPIA. This article investigates whether this goal (of aligning the law with ethics) can be attained in a way that is compliant with POPIA. It is concluded that this is indeed possible in a number of ways, and that the best way to attain this goal is by requesting the South African Information Regulator to issue a guidance note to the effect that all health research projects that are approved by institutional health research ethics committees are to be regarded as being in the public interest, which would qualify such health research projects to be exempted from POPIA's consent requirements.