Building coherence in the regulation of health research: A reply to Thaldar

V Bronstein; D T Nyachowe

doi:10.7196/SAMJ.2023.v113i11.1394

Building coherence in the regulation of health research: A reply to Thaldar

Authors

V Bronstein Associate Professor, School of Law, University of the Witwatersrand, Johannesburg, South Africa
D T Nyachowe Junior Researcher, Sydney Brenner Institute of Molecular Bioscience, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

DOI:

https://doi.org/10.7196/SAMJ.2023.v113i11.1394

Keywords:

health research regulation

Abstract

References

Bronstein V, Nyachowe DT. Streamlining regulatory processes for health researchers: To what extent does POPIA apply? S Afr Med J 2023;113(8):1319-1321. https://doi.org/10.7196/SAMJ.2023. v113i8.781

Protection of Personal Information Act 4 of 2013. https://www.gov.za/documents/protection- personal-information-act (accessed 6 April 2022).

Burris SC, Berman ML, Penn MS, Holiday TR. The New Public Health Law: A Transdisciplinary Approach to Practice and Advocacy. 2nd ed. New York: Oxford University Press, 2022:122.

Bronstein V. Reconciling regulation or confronting inconsistency? Conflict between national and provincial legislation. S Afr J Hum Rights 2006;22(2):283-300. https://doi.org/10.1080/19962126.20 06.11864891

Tribe LH. American Constitutional Law, vol. 1. 3rd ed. New York: Foundation Press, 2000.

Sagar A. Federal supremacy and the occupied field: A comparative critique. Publius 2013;43(2):251-

https://doi.org/10.1093/publius/pjs034

Grossi P, O’Connor D. FDA preemption of conflicting state drug regulation and the looming battle over

abortion medications. J Law Biosci 2023;10(1):lsad005. https://doi.org/10.1093/jlb/lsad005

Luif P. The division of powers/competences between the EU and the member states: What can we learn from preemption in the United States? In: Rossi LS, Casolari F, eds. The EU after Lisbon: Amending or Coping with the Existing Treaties? Cham, Switzerland: Springer, 2014:37-55. https://doi.

org/10.1007/978-3-319-04591-7_3

Davis MJ. The ‘new’ presumption against preemption. Hastings Law J 2009;61(5):1217. https://

repository.uclawsf.edu/hastings_law_journal/vol61/iss5/3 (accessed 12 September 2023).

R v Gwantshu 1931 EDL 29 at 31. The presumption is generalia specialibus non derogant.

National Department of Health, South Africa. Ethics in health research: Principles, processes and

structures. 2nd ed. Pretoria: NDoH, 2015. https://www.ru.ac.za/media/rhodesuniversity/content/ ethics/documents/nationalguidelines/DOH_(2015)_Ethics_in_health_research_Principles,_ processes_and_structures.pdf (accessed 12 September 2023).

Wouters B, Shaw D, Sun C, et al. Putting the GDPR into practice: Difficulties and uncertainties experienced in the conduct of big data health research. Eur Data Prot Law Rev 2021;7(2):206- 216. https://doi.org/10.21552/edpl/2021/2/9

Health Professions Council of South Africa. Guidelines for good practice in the health care professions: General ethical guidelines for health researchers. Booklet 13. Pretoria: HPCSA, 2016. https://www. hpcsa.co.za/Uploads/professional_practice/ethics/Booklet_13_Gen_Ethical_Guidelines_for_Health_ Researchers.pdf (accessed 16 May 2022).

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Published

2023-11-06

Issue

Vol. 113 No. 11 (2023)

Section

Correspondence

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How to Cite

Bronstein V, Nyachowe DT. Building coherence in the regulation of health research: A reply to Thaldar. S Afr Med J [Internet]. 2023 Nov. 6 [cited 2024 Oct. 5];113(11):6-8. Available from: https://samajournals.co.za/index.php/samj/article/view/1697

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Building coherence in the regulation of health research: A reply to Thaldar

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