Protecting participants in health research: The South African Material Transfer Agreement

Labuschaigne, Melodie; Dhai, Ames; Mahomed, S; Behrens, Kevin Gary; Nienaber, Annelize; Moodley, K; Cleaton‐Jones, Peter; Olckers, Antonel; Maepa, N; Penny, Catherine

doi:10.7196/samj.2019.v109i5.13803

Cited by 9 publications

(12 citation statements)

References 13 publications

(20 reference statements)

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“…The SA MTA states that it sets out a 'framework' ([13] paragraph 1). We agree with Labuschaigne et al that this means that the terms in the SA MTA need not be duplicated verbatim [30]. We suggest that the essence of the terms contained in the SA MTA nevertheless must be retained as a basic structure but is one on which the parties are permitted to elaborate.…”

Section: Applicationsupporting

confidence: 82%

“…Labuschaigne et al argue in support of HRECs being parties to MTAs for two main reasons: first, because HRECs are in a position to fulfil an oversight function with regard to MTAs and, secondly, because, in their view, a HREC can act as a neutral third party to a MTA to ensure negotiation in good faith and unbiased implementation [30]. We suggest that these reasons are unconvincing.…”

Section: Hrecs As Parties To the Mtamentioning

confidence: 77%

“…Labuschaigne et al seem to accept that an arbitration agreement indeed can change the legal system and place of adjudication to a jurisdiction other than South Africa [30]. Although Labuschaigne et al recognise that arbitration abroad may be unaffordable to South African parties, nevertheless they take the position that the arbitration option is necessary because in their view it is 'in keeping with standards prescribed by Western counterparts' [30]. This argument raises important policy questions, such as: Should South African policy making be prescribed to by entities in other countries?…”

Section: Dispute Resolutionmentioning

confidence: 99%

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South Africa’s new standard material transfer agreement: proposals for improvement and pointers for implementation

2020

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Background Whenever South African (SA) research institutions share human biological material and associated data for health research or clinical trials they are legally compelled to have a material transfer agreement (MTA) in place that uses as framework the standard MTA newly gazetted by the South African Minister of Health (SA MTA). Main body The article offers a legal analysis of the SA MTA and focuses on its substantive fit with the broader legal environment in South Africa, and the clarity and practicality of its terms. The following problematic aspects of the SA MTA are highlighted: (a) Where only data and no human biological material are transferred, the SA MTA does not apply, leaving a lacuna; (b) Health Research Ethics Committees are required to be parties to a MTA despite it being outside their legal mandate and undermining their oversight function; (c) the SA MTA’s consent provisions are not aligned with extant law; and, similarly, (d) its provision on donor ownership is misaligned with extant law; (e) its creation of fictitious performance can only cause frustration on the part of an injured party; (f) its benefit-sharing provision is vague and will have little practical effect; (g) its dispute-resolution provisions fail to adequately protect South African research institutions and research participants; (h) it fails to provide substantive guidance regarding intellectual property as its provisions relating to intellectual property may cause practical problems; and, finally, (i) its data privacy provision is insufficiently specific, is overbroad, and fails to provide terms that in general would facilitate the international sharing of human biological material and associated data in terms of existing privacy law. Conclusions While some of the problematic aspects of the SA MTA are intricate and require consultative processes with stakeholders and others, to develop comprehensive solutions, most of the problematic aspects can be resolved immediately through amendments by the South African Minister of Health. The formulation of such amendments is proposed and, where possible, interim measures are suggested that may ameliorate the problems presented by the SA MTA.

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Section: Applicationsupporting

confidence: 82%

Section: Hrecs As Parties To the Mtamentioning

confidence: 77%

Section: Dispute Resolutionmentioning

confidence: 99%

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South Africa’s new standard material transfer agreement: proposals for improvement and pointers for implementation

2020

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“…The South African National Health Act (NHA) provides that all proposed health research studies must be approved by a HREC that is registered as such with the National Health Research Ethics Council. HRECs have an ethical oversight function, with a particular focus on protecting the interests of research participants (Department of Health, 2015).…”

Section: Discussionmentioning

confidence: 99%

One material transfer agreement to rule them all? A call for revising South Africa’s new standard material transfer agreement

Thaldar

2020

Humanit Soc Sci Commun

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In 2018, the South African Minister of Health gazetted a material transfer agreement (SA MTA) that must be used as a framework whenever a researcher based in South Africa is involved in the transfer of human biological material. The SA MTA therefore impacts not only on the South African research community, but also its international research partners. The SA MTA has been portrayed in a positive light by Labuschaigne et al. in a recent article. By contrast, in this present article, the position taken is that the SA MTA is deeply problematic, and it is argued that Labuschaigne et al. have erred with regard to three key propositions of their account of the SA MTA. The first proposition, namely that a Health Research Ethics Committee should be a party to a material transfer agreement, as contemplated in the SA MTA, is shown to be unfeasible. Similarly, the second proposition, namely that under the SA MTA a research participant retains proprietary rights in donated human biological material, is shown to be legally untenable. The third proposition, namely that the arbitration option in the SA MTA (which allows parties to opt out of the jurisdiction of South African courts) is both necessary and adequate, is shown to be false. Not only is the claim that the arbitration option is required by international collaborators contradicted by Labuschaigne et al.'s own example, but the present SA MTA's dispute resolution provisions are shown to be inadequate. In this light, a more appropriate solution in respect of dispute resolution is proposed. In the interest of both the South African research community and their international research partners, the South African Minister of Health is called upon to engage in open public consultation on the SA MTA and to fundamentally revise it as a matter of urgency.

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“…The purpose of MTAs generally is to regulate the exchange of HBMs and associated data between researchers/institutions, as well as to safeguard the interests of research participants, researchers and their institutions. [13] The HPCSA guidelines and national ethical guidelines require the conclusion of MTAs before HBMs are transferred out of SA. [11,12] The national ethical guidelines, in addition, state at section 3.5.2.3, that 'where data or materials are shared with researchers in other institutions, the recipient institution should agree to comply with the requirements of the donor institution' as well as 'any additional requirements of the recipient institution' .…”

Section: Critical Role Of Hrecs In Reviewing Health Research Proposalmentioning

confidence: 99%

The role of research ethics committees in South Africa when human biological materials are transferred between institutions

Mahomed

Labuschaigne

2019

S Afr J BL

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The exchange of human biological materials (HBMs) and associated data between institutions, within countries and across national boundaries, has become a common feature of biomedical research and biobanking activities globally. Previously, HBMs were informally exchanged between researchers. However, as engagement between universities and industry intensified, with an emphasis on commercialising the outcomes of research, issues of biosafety, traceability of samples and data, and transparency and accountability of researchers and biobanks required that exchanges become more formalised. [1] Material transfer agreements (MTAs) play a critical role in the exchange of these specimens and their associated data. Parties to MTAs are usually research and academic institutions, and private and commercial entities. The terms of these MTAs are governed by, among other regulation, relevant national laws and ethical guidelines relating to consumer protection, health research, protection of research participants and fundamental rights generally. Where HBMs are transferred from one jurisdiction to another, the governance framework for the collection, use and storage of the material becomes more complex. Research ethics committee (REC) oversight in this milieu is critical. In

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Protecting participants in health research: The South African Material Transfer Agreement

Cited by 9 publications

References 13 publications

South Africa’s new standard material transfer agreement: proposals for improvement and pointers for implementation

South Africa’s new standard material transfer agreement: proposals for improvement and pointers for implementation

One material transfer agreement to rule them all? A call for revising South Africa’s new standard material transfer agreement

The role of research ethics committees in South Africa when human biological materials are transferred between institutions

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