拟议的南非研究行为准则:尽管取得了良好的进展,但仍存在未解决的问题
1School of Law, University of KwaZulu-Natal, Durban, South Africa.
概括
南非提出的研究行为准则需要修订. 关键问题包括数据识别,商业用途,基因组数据库和根据"个人信息保护法"的遗传数据例外情况.
科学领域:
- 法律与道德 法律与道德
- 生物信息学是一种生物信息学.
- 数据治理数据治理
背景情况:
- 南非科学院 (ASSAf) 制定了一项拟议的研究行为准则 (CCR).
- CCR旨在规范研究活动和数据共享,以补充"个人信息保护法" (POPIA).
研究的目的:
- 分析向南非信息监管机构提交的拟议的CCR.
- 在CCR批准之前确定需要修订的关键问题.
- 为解决悬而未决的问题提供建议.
主要方法:
- 审查拟议的研究行为准则.
- 分析其与"个人信息保护法" (POPIA) 的一致性.
- 在拟议框架中确定法律和道德方面的挑战.
主要成果:
- 拟议的CCR解决了一些以前的问题,但提出了新的挑战.
- 关键问题包括数据主体的可识别性,研究数据的商业重新利用,以及开放的基因组数据库.
- 对POPIA遗传数据的法律上不可持续的例外是一个重大问题.
结论:
- 拟议的CCR需要进行实质性修订,以确保法律可持续性和有效的治理.
- 提供了建议,以解决有关数据识别,商业用途,基因组数据和POPIA例外问题的问题.
- 在信息监管机构批准之前,审查至关重要,以确保强有力的研究监管.
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