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Background: The literature on the ethics of biobanking often overlooks the practical operations of biobanks. The ethics of stewardship requires that biobank resources are used to conduct beneficial science. Networked biobanks have emerged to increase the scientific benefit of biobank resources, but little is known about whether and how operations of networking may accomplish this goal. Methods: As part of a larger study on the ethical, legal, and social implications (ELSI) of networked biobanking, we conducted 38 interviews with representatives of 31 networked biobanks. Interviews explored operations of the networks. We used thematic analysis to examine how respondents describe three topics associated with stewarding biobank resources—funding, utilization, and sustainability. Results: Our results highlight that funding, utilization, and sustainability are critical not only to the operation of biobanks, but also to the ethical obligations that biobankers owe to stakeholders to steward the resources. Based on prior research, we hypothesized that respondents would describe networking as beneficial to increasing funding, utilization, and sustainability of the network. Respondents generally found value in networked biobanking, but networking did not necessarily increase funding, utilization, and sustainability. Conclusion: The results presented here support inclusion of funding, utilization, and sustainability as topics of ethical concern in the practice of biobanking and networked biobanking. These issues are rooted in the stewardship obligations that biobankers feel to their partners, client investigators, and participants. The goal of promoting stewardship through networking requires significant time and effort to build governance models that honor the obligations of each individual biobank to their donors and advance the collective goals of the network. We conclude with suggestions offered by respondents to address improving these aspects of stewardship. [ABSTRACT FROM AUTHOR]

The article focuses on the ethical concerns regarding the potential group harms caused by genomic research, particularly in the area of sociogenomics, which aims to understand genetic contributions to social and behavioral traits. It highlight how key regulations and research practices neglect to consider the impact on LGBTQ+ communities and other groups, particularly when such research leads to discrimination, criminalization, or eugenics.

This open peer commentary refers to the article "Helpful Lessons and Cautionary Tales: How Should COVID-19 Drug Development and Access Inform Approaches to Non-Pandemic Diseases?" by Holly Fernandez Lynch, Arthur Caplan, Patricia Furlong and Alison Bateman-House, that was published within the issue. Topics discussed include modifications to research policies and practices, biobanking and biorepository research, and adoption of novel biobanking operations and governance.

The article discusses bioethics developments and a potential reboot of "The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research" which was released by the U.S. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in 1979. America's Office for Human Research Protections (OHRP), a right to privacy in the U.S., and oversight of research involving human subjects are assessed.

In genomics research, it is becoming common practice to return individualized primary and incidental findings to participants and several ongoing major studies have begun to automatically transfer these results to a participant's clinical medical record. This paper explores who should decide whether to place genomic research findings into a clinical medical record. Should participants make this decision, or does a researcher's duty to place this information in a medical record override the participant's autonomy? We argue that there are no clear ethical, legal, professional, or regulatory duties that mandate placement without the consent of the participant. We conclude that informing participants of results, together with a clear explanation, relevant recommendations and referral sources, and the option to consent to placement in the medical records will best discharge researchers' ethical and legal duties towards participants. [ABSTRACT FROM AUTHOR]

Genomic biobanks present ethical challenges that are qualitatively unique and quantitatively unprecedented. Many critics have questioned whether the current system of informed consent can be meaningfully applied to genomic biobanking. Proposals for reform have come from many directions, but have tended to involve incremental change in current informed consent practice. This paper reports on our efforts to seek new ideas and approaches from those whom informed consent is designed to protect: research subjects. Our model emerged from semi-structured interviews with healthy volunteers who had been recruited to join either of two biobanks (some joined, some did not), and whom we encouraged to explain their concerns and how they understood the relationship between specimen contributors and biobanks. These subjects spoke about their DNA and the information it contains in ways that were strikingly evocative of the legal concept of the trade secret. They then described the terms and conditions under which they might let others study their DNA, and there was a compelling analogy to the commonplace practice of trade secret licensing. We propose a novel biobanking model based on this trade secret concept, and argue that it would be a practical, legal, and ethical improvement on the status quo. [ABSTRACT FROM AUTHOR]

Introduction: The South East Asia Research Collaboration in HIV (SEARCH) RV411 clinical trial in Thailand was a systematic investigation of analytic treatment interruption (ATI) in individuals diagnosed and treated since Fiebig stage I acute HIV infection. Here, we explore decision‐making processes and perceptions of trial participation in a phase I trial that raised important ethical considerations, to identify potential areas of improvement in this relatively new field of HIV research. Similar considerations apply to other HIV phase I trials, especially those involving ATI, making this trial a model to identify challenges and opportunities in promoting informed choice. Methods: Using longitudinal semi‐structured interviews and a validated questionnaire, we examined how decisions to join or decline the trial were made, whether there was evidence of decisional conflict, and reactions to the trial outcomes. We also explored contrasting views and experiences in this small trial cohort. We report analyses of data from these questionnaires and interviews, conducted from February through December of 2016 with the 14 SEARCH cohort participants who either joined (n = 8) or declined (n = 6) participation in RV411. Results: The eight participants and six decliners had low overall decisional conflict, which remained low over time. Decision making was more difficult for decliners than participants, at least initially. While all interviewees described being satisfied with their decisions, our study identified important negative consequences for a few individuals, including seroconversion, negative experiences with optional procedures and disappointment due to rapid viral rebound. Conclusions: Although our results reflect the experiences of a small group invited to join this trial, our overall finding of low decisional conflict even while some individuals reported negative experiences provides lessons for clinical trial investigators. We developed points‐to‐consider in helping participants make informed choices, to support participants during the trial and to support decliners in their decisions. [ABSTRACT FROM AUTHOR]