Correction: Foss et al. The Rise of Population Genomic Screening: Characteristics of Current Programs and the Need for Evidence Regarding Optimal Implementation. J. Pers. Med. 2022, 12, 692.

There was an error in the original publication [...].

Research-Related Stakeholders' Perspectives on Sociocultural Considerations in Biobanking Practice in South Africa.

Background: Biobanking practice continues to proliferate in South Africa, yet little is known about how stakeholders engage with social, cultural, and religious considerations in this area of research. This study was undertaken to establish the perspectives of South African stakeholders (researchers, biobankers, clinicians, and research committee members) on sociocultural considerations in biobanking research. Methods: This in-depth exploratory study used semistructured face-to-face or Skype interviews with 25 purposively selected stakeholders involved in the biobanking-related practice. The study sample comprised biobankers, clinicians, researchers, postgraduate students in biobanking research, and research ethics committee members in South Africa. The interview focused on social and cultural challenges facing the biobanking practice in the country. Further probes included stakeholder perspectives on ownership and custodianship of stored biosamples. Thematic analysis was used to analyze the collected data. Results and Discussion: Several themes arose from the data analysis. These included respondents' perceptions of poor understanding of biobanking among research participants and communities; inconsistency in defining ownership and custodianship of biosamples; variability in respondents' understanding of cultural, religious, and social implications of biobanking; the notion of distrust; and building trust in biobanking. There were also inconsistencies in respondents' recognition of social, cultural, and/or religious influences on participant decision-making in biobanking research. Respondents highlighted that a general climate of distrust existed in the biobanking practice in South Africa. Conclusion: There is a need for greater stakeholder awareness of sociocultural considerations in biobanking practice in South Africa. One possible way to achieve this could be through the availability of training programs aimed at improving stakeholder understanding of the sociocultural context for biobanking practice in addition to greater efforts at community engagement with respect to all biobanking activities and research.

The Rise of Population Genomic Screening: Characteristics of Current Programs and the Need for Evidence Regarding Optimal Implementation.

PURPOSE: Advances in clinical genomic sequencing capabilities, including reduced costs and knowledge gains, have bolstered the consideration of genomic screening in healthy adult populations. Yet, little is known about the existing landscape of genomic screening programs in the United States. It can be difficult to find information on current implementation efforts and best practices, particularly in light of critical questions about equity, cost, and benefit. METHODS: In 2020, we searched publicly available information on the Internet and the scientific literature to identify programs and collect information, including: setting, program funding, targeted population, test offered, and patient cost. Program representatives were contacted throughout 2020 and 2021 to clarify, update, and supplement the publicly available information. RESULTS: Twelve programs were identified. Information was available on key program features, such as setting, genes tested, and target populations. Data on costs, outcomes, or long-term sustainability plans were not always available. Most programs offered testing at no or significantly reduced cost due to generous pilot funding, although the sustainability of these programs remains unknown. Gene testing lists were diverse, ranging from 11 genes (CDC tier 1 genes) to 59 genes (ACMG secondary findings list v.2) to broad exome and genome sequencing. This diversity presents challenges for harmonized data collection and assessment of program outcomes. CONCLUSIONS: Early programs are exploring the logistics and utility of population genomic screening in various settings. Coordinated efforts are needed to take advantage of data collected about uptake, infrastructure, and intervention outcomes to inform future research, evaluation, and program development.

Challenges to biobanking in LMICs during COVID-19: time to reconceptualise research ethics guidance for pandemics and public health emergencies?

Biobanking can promote valuable health research that may lead to significant societal benefits. However, collecting, storing and sharing human samples and data for research purposes present numerous ethical challenges. These challenges are exacerbated when the biobanking efforts aim to facilitate research on public health emergencies and include the sharing of samples and data between low/middle-income countries (LMICs) and high-income countries (HICs). In this article, we explore ethical challenges for COVID-19 biobanking, offering examples from two past infectious disease outbreaks in LMICs where biobanking activities contributed to the perpetuation of global inequities. We focus on how the ethical imperative to promote the common good during public health emergencies can conflict with protecting the interests of biobank participants. We discuss how conducting biobank research under a waiver of informed consent during public health emergencies is ethically permissible, provided guidance is in place to prevent biopiracy and exploitation of vulnerable communities. We also highlight the need for biobank collaborations between LMICs and HICs to promote capacity building and benefit sharing. Finally, we offer guidance to promote the ethical oversight of biobanks and biobank research during the COVID-19 pandemic or other future public health emergencies.

Online Training as a Means to Improve the Understanding of Ethical, Legal, and Social Aspects of Biobanking Research: Stakeholder Perspectives from South Africa.

Introduction: The proliferation of biobanking activities demand a review of current training opportunities for service providers and researchers, specifically related to the ethical, legal, and social issues (ELSI) of biobanking research. Such information could be useful for planning and developing an educational course. However, it is equally important to explore the platform for offering such a course. Aim and Objectives: This study explored stakeholder perspectives on training needs in biobanking research and the use of an online training platform for such educational purposes. Methods: An exploratory study design using qualitative data was used. The study sample comprised selected stakeholders (n = 25) including biobankers, clinicians, researchers, postgraduate students, and research ethics committee members. Semi-structured in-person or Skype interviews were conducted and all ethical considerations were upheld. The interview focused on participants' perspectives on the accessibility and applicability of current available courses, and advantages and disadvantages of online biobanking courses. Data were analyzed using thematic analysis. Results and Discussion: The following themes arose from data analysis: inadequate availability of online courses, and advantages and disadvantages of online courses and opportunities for a successful training course. There was general consensus regarding the limited availability of context-specific training opportunities on the ELSI of biobanking. The majority of participants were previously self-taught and therefore relied on existing literature and collaborations with international biobanking groups for ongoing learning. Some respondents indicated that the costs of such available training courses were exorbitant. Some respondents also felt that available courses were not tailored to the specific needs of a diverse audience in biobanking. Apart from access, respondents reported possible challenges with internet connectivity and availability of data. Conclusion: Respondents expressed a need for affordable and focused online educational opportunities in biobanking, but highlighted that these courses need to be contextualized and integrated into other learning activities.

Ethics of treatment interruption trials in HIV cure research: addressing the conundrum of risk/benefit assessment.

Though antiretroviral therapy is the standard of care for people living with HIV, its treatment limitations, burdens, stigma and costs lead to continued interest in HIV cure research. Early-phase cure trials, particularly those that include analytic treatment interruption (ATI), involve uncertain and potentially high risk, with minimal chance of clinical benefit. Some question whether such trials should be offered, given the risk/benefit imbalance, and whether those who choose to participate are acting rationally. We address these questions through a longitudinal decision-making study nested in a Thai acute HIV research cohort.In-depth interviews revealed central themes about decisions to join. Participants felt they possessed an important identity as members of the acute cohort, viewing their bodies as uniquely suited to both testing and potentially benefiting from HIV cure approaches. While acknowledging risks of ATI, most perceived they were given an opportunity to interrupt treatment, to test their own bodies and increase normalcy in a safe, highly monitored circumstance. They were motivated by potential benefits to themselves, the investigators and larger acute cohort, and others with HIV. They believed their own trial experiences and being able to give back to the community were sufficient to offset participation risks.These decisions were driven by the specific circumstances experienced by our participants. Judging risk/benefit ratios without appreciating these lived experiences can lead to false determinations of irrational decision- making. While this does not minimise vital oversight considerations about risk reduction and protection from harm, it argues for inclusion of a more participant-centered approach.