Evidence map›Paper›PMID 38533256›Full record

ArticleFrontiers in pharmacology2024

Forcing a square into a circle: why South Africa's draft revised material transfer agreement is not fit for purpose.

Paul Esselaar, Lee Swales, Devarasi Bellengère, Banele Mhlongo, Donrich Thaldar

Abstract read
In one paragraph

Article in Frontiers in pharmacology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Paul EsselaarSchool of Law, University of KwaZulu-Natal, Durban, South Africa.
Lee SwalesSchool of Law, University of KwaZulu-Natal, Durban, South Africa.
Devarasi BellengèreSchool of Law, University of KwaZulu-Natal, Durban, South Africa.
Banele MhlongoSchool of Law, University of KwaZulu-Natal, Durban, South Africa.
Donrich ThaldarSchool of Law, University of KwaZulu-Natal, Durban, South Africa.

Funding

DS-I Africa - LAWU01MH127690 · NIMH · UNIVERSITY OF KWAZULU-NATAL · PI THALDAR, DONRICH WILLEM · 2021 to 2023
$1.2M
NIMH NIH HHS U01 MH127690
6 · The paper itself

Abstract

The South African National Health Research Ethics Council (NHREC) recently released a final draft revision of the standard material transfer agreement (MTA) that was promulgated into law in 2018. This new draft MTA raises pertinent questions about the NHREC's mandate, the way in which the draft MTA deals with data and with human biological material, and its avoidance of the concept of ownership. After South Africa's data protection legislation, the Protection of Personal Information Act (POPIA), became operational in mid 2021, the legal landscape changed and it is doubtful that the NHREC has a residual mandate to govern personal information in health research. Furthermore, data is dealt with in a superficial, throw-away fashion in the draft MTA. The position with human biological material is not substantially better, as the draft MTA fails to recognise that human biological material can contain pathogens, which has important legal and ethical ramifications that are not sufficiently addressed. A central problem with the draft MTA is its use of the term 'steward', and avoidance of the legal concept of 'ownership'. This is not only misaligned with the South African legal framework, but also fails to consider the ethical case for recognising ownership. Finally, a call to embrace decolonial thinking in health research underscores the importance of recognising ownership in order to foster the growth of the local bio-economy. Key recommendations to reshape the draft MTA include: Making use of the eventual revised MTA optional, and allowing it to evolve with input from scientific and legal communities; regulating the transfer of associated data in a separate data transfer agreement that can be incorporated by reference in the MTA; enhancing guidance on liability and risk management in respect of human biological material that contains pathogens; and, finally, adopting a decolonial approach in health research governance, which requires recognising the ownership rights of South African research institutions.

Indexed as

datadecolonialhuman biological materialmaterial transfer agreementownershippathogensPOPIAstewardship

Identifiers

PMID38533256
PMCPMC10963597

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.