Comparing Attitudes Toward Different Consent Mediums: Semistructured Qualitative Study.

BACKGROUND: As consent for data sharing evolves with the digital age, plain-text consent is not the only format in which information can be presented. However, designing a good consent form is highly challenging. The addition of graphics, video, and other mediums to use can vary widely in effectiveness; and improper use can be detrimental to users. OBJECTIVE: This study aims to explore the expectations and experiences of adults toward consent given in infographic, video, text, newsletter, and comic forms in a health data sharing scenario to better understand the appropriateness of different mediums and identify elements of each medium that most affect engagement with the content. METHODS: We designed mock consent forms in infographic, video, text, newsletter, and comic versions. Semistructured interviews were conducted with adults who were interviewed about their expectations for consent and were then shown each consent medium and asked about engaging elements across mediums, preferences for consent mediums, and the value of document quality criteria. We transcribed and qualitatively co-coded to identify themes and perform analyses. RESULTS: We interviewed 24 users and identified different thematic archetypes based on participant goals, such as the Trust Seeker, who considered their own understanding and trust in organizations when making decisions. The infographic was ranked first for enhancing understanding, prioritizing information, and maintaining the proper audience fit for serious consent in health data sharing scenarios. In addition, specific elements such as structure, step-by-step organization, and readability were preferred engaging elements. CONCLUSIONS: We identified archetypes to better understand user needs and elements that can be targeted to enhance user engagement with consent forms; this can help inform the design of more effective consent in the future. Overall, preferences for mediums are highly contextual, and more research should be done.

The regulation of health data sharing in Africa: a comparative study.

The sharing of health data is an essential component in the provision of healthcare, in medical research, and disease surveillance. Health data sharing is subject to regulatory frameworks that vary across jurisdictions. In Africa, numerous factors complicate the regulation of health data sharing, including technological, motivational, economic, and political barriers, as well as ethical and legal challenges. This comparative study examines the regulation of health data sharing in Africa by comparing and contrasting the legal and policy frameworks of five African countries. The study identifies gaps and inconsistencies in the current regulatory regimes and provides recommendations for improving the regulation of health data sharing in Africa.

The multidimensional legal nature of personal genomic sequence data: A South African perspective.

This article provides a comprehensive analysis of the various dimensions in South African law applicable to personal genomic sequence data. This analysis includes property rights, personality rights, and intellectual property rights. Importantly, the under-investigated question of whether personal genomic sequence data are capable of being owned is investigated and answered affirmatively. In addition to being susceptible of ownership, personal genomic sequence data are also the object of data subjects' personality rights, and can also be the object of intellectual property rights: whether on their own qua trade secret or as part of a patented invention or copyrighted dataset. It is shown that personality rights constrain ownership rights, while the exploitation of intellectual property rights is constrained by both personality rights and ownership rights. All of these rights applicable to personal genomic sequence data should be acknowledged and harmonized for such data to be used effectively.

A deliberative public engagement study on heritable human genome editing among South Africans: Study results.

This paper reports the results of a public engagement study on heritable human genome editing (HHGE) carried out in South Africa, which was conducted in accordance with a study protocol that was published in this journal in 2021. This study is novel as it is the first public engagement study on HHGE in Africa. It used a deliberative public engagement (DPE) methodology, entailing inter alia that measures were put in place to ensure that potential participants became informed about HHGE, and that deliberations between the participants were facilitated with the aim of seeking consensus. A diverse group of 30 persons was selected to participate in the DPE study, which took place via Zoom over three consecutive weekday evenings. The main results are: Provided that HHGE is safe and effective, an overwhelming majority of participants supported allowing the use of HHGE to prevent genetic health conditions and for immunity against TB and HIV/Aids, while significant majorities opposed allowing HHGE for enhancement. The dominant paradigm during the deliberations was balancing health benefits (and associated improvements in quality of life) with unforeseen health risks (such as loss of natural immunity). The seriousness of a health condition emerged as the determining factor for the policy choice of whether to allow an application of HHGE. More generally, equal access to HHGE qua healthcare service featured as an important value, and it was uncontested that the South African government should allocate resources to promote scientific research into HHGE. These results are aligned with the policy principles for regulating HHGE in South Africa suggested by Thaldar et al. They call for urgent revision of South African ethics guidelines that currently prohibit research on HHGE, and for dedicated HHGE legal regulations that provide a clear and comprehensive legal pathway for researchers who intend to conduct HHGE research and clinical trials.

Future of global regulation of human genome editing: a South African perspective on the WHO Draft Governance Framework on Human Genome Editing.

WHO in 2019 established the Advisory Committee on Developing Global Standards for Governance and Oversight of Human Genome Editing, which has recently published a Draft Governance Framework on Human Genome Editing. Although the Draft Framework is a good point of departure, there are four areas of concern: first, it does not sufficiently address issues related to establishing safety and efficacy. Second, issues that are a source of tension between global standard setting and state sovereignty need to be addressed in a more nuanced fashion. Third, it fails to meaningfully engage with the extent to which the conceptualisation of human dignity may justifiably vary between jurisdictions. Fourth, the meaning of harm to the interests of a future person requires clarity. Provided these four areas of concern can be addressed, the future of the global governance of human genome editing may hold promise.

A virtual deliberative public engagement study on heritable genome editing among South Africans: Study protocol.

This article outlines the protocol for a prospective study for virtual deliberative public engagement on heritable genome editing in humans. The study intends to create a platform for a diverse group of 25-30 South Africans to engage with a facilitator and each other on 15 policy questions regarding heritable genome editing, with a focus on: a) the prevention of heritable genetic conditions; b) editing for immunity; and c) editing for enhancement. The aim is to understand the views on these issues so as to inform further research and policy, and to analyse the process and effect of deliberation on opinion. Participants will be expected to study the provided resource materials and pass the entrance exam-aligning with the protocols of the Harvard Personal Genome Project. In this way, the commitment, openness and basic knowledge of the candidates will be tested to ascertain whether they are suitable participants for the deliberative engagement.

Correction to: South Africa's new standard material transfer agreement: proposals for improvement and pointers for implementation.

An amendment to this paper has been published and can be accessed via the original article.

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

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.