Evaluating industry attempts to influence public health: Applying an ethical framework in understanding commercial determinants of health.

Objectives: This paper explores industry influence on public health using a specific case study and applies an established ethical framework based on eleven principles to explore Commercial Determinants of Health (CDoH). It demonstrates an application of these principles to evaluate the ethical integrity of industry strategies and practices and their impacts on public health. Methods: Using eleven a priori, deductive, ethical principles as codes, this paper conducted an in-depth analysis of 19 e-mail chains and accompanying documents made publicly available through the Freedom of Information Act (FOIA) from U.S. Right to Know (USRTK) sent between Coca-Cola representatives, lobbyists, academics, and the International Life Sciences Institute (ILSI), founded by former Coca-Cola executives. Results: The three principles violated most frequently amongst the documents were consumer sovereignty (n = 22), evidence-informed actions (n = 21), and transparency (n = 20). Similarly, codes that featured most regularly across documents were transparency (13 out of 19 documents), consumer sovereignty (13 out of 19 documents), evidence-informed actions (9 out of 19 documents), and social justice and equity (9 out of 19 documents). All eleven principles were applied at least four times throughout the documents; however, responsiveness (z = 12), moral responsibility (z = 16), and holism (z = 30) were the least relevant to the data set. Conclusions: This case study of Coca-Cola demonstrates the usefulness of this ethics framework in reviewing actions of corporate actors in the promotion of products that are harmful to human health. It shows that the industry at times has low ethical integrity in their various strategies and practices to promote their products despite the negative impacts of these products on public health.

COVID-19 vaccine mandate for healthcare workers in the United States: a social justice policy.

INTRODUCTION: Vaccination is the most effective strategy to mitigating COVID-19 and restoring societal function. As the pandemic evolves with no certainty of a herd immunity threshold, universal vaccination of at-risk populations is desirable. However, vaccine hesitancy threatens the return to normalcy, and healthcare workers (HCWs) must embrace their ambassadorial role of shoring up vaccine confidence. Unfortunately, voluntary vaccination has been suboptimal among HCWs in the United States, a priority group for whom immunization is essential for maintaining health system capacity and the safety of high-risk patients in their care. Consequently, some health systems have implemented mandates to improve compliance. AREAS COVERED: This article discusses the ethical and practical considerations of mandatory COVID-19 vaccination policies for HCWs utilizing some components of the World Health Organization's framework and the unique context of a pandemic with evolving infection dynamics. EXPERT OPINION: COVID-19 vaccine mandates for universal immunization of HCWs raise ethical and practical debates about their appropriateness, especially when the vaccines are pending full approval in most jurisdictions. Given the superiority of the vaccines to safety and testing protocols and their favorable safety profile, we encourage health systems to adopt vaccination mandates through participatory processes that address the concerns of stakeholders.

Shifts in UNAIDS ethics guidance and implications for ethics review of preventive HIV vaccine trials.

INTRODUCTION: A major change in the ethics framework for preventive HIV vaccine trials worldwide is the release of the UNAIDS 2021 ethical considerations in HIV prevention trials. This new guidance comes at an exciting time when there are multiple HIV vaccine efficacy trials in the field. Research Ethics Committees (RECs) or Institutional Review Boards are a most likely audience for these guidelines. Our objective is to highlight shifts in ethics recommendations from the earlier 2012 UNAIDS guidance. DISCUSSION: We review recommendations related to four key issues, namely standard of prevention, post-trial access to safe and effective vaccines, enrolment of adolescents and enrolment of pregnant women. We outline implications and make recommendations for the ethics review process, including suggested lines of inquiry by RECs and responses by applicants. CONCLUSIONS: There have been several shifts in the UNAIDS ethics guidance with implications for HIV vaccine researchers submitting applications for initial ethics review or re-certification, and for RECs conducting such reviews. This review may assist RECs in a more efficient and consistent application of ethics recommendations. However, additional tools and training may further help stakeholders comply with new UNAIDS ethics recommendations during protocol development and ethics review.

Proceedings of an expert workshop on community agreement for gene drive research in Africa - Co-organised by KEMRI, PAMCA and Target Malaria.

Gene drive research is progressing towards future field evaluation of modified mosquitoes for malaria control in sub-Saharan Africa. While many literature sources and guidance point to the inadequacy of individual informed consent for any genetically modified mosquito release, including gene drive ones, (outside of epidemiological studies that might require blood samples) and at the need for a community-level decision, researchers often find themselves with no specific guidance on how that decision should be made, expressed and by whom. Target Malaria, the Kenya Medical Research Institute and the Pan African Mosquito Control Association co-organised a workshop with researchers and practitioners on this topic to question the model proposed by Target Malaria in its research so far that involved the release of genetically modified sterile male mosquitoes and how this could be adapted to future studies involving gene drive mosquito releases for them to offer reflections about potential best practices. This paper shares the outcomes of that workshop and highlights the remaining topics for discussion before a comprehensive model can be designed.

Commercial determinants of health: an ethical exploration.

OBJECTIVES: This paper seeks to contribute toward a better understanding of commercial determinants of health by proposing a set of ethical principles that can be used by researchers and other health actors in understanding and addressing Commercial Determinants of Health (CDoH). METHODS: The paper is mainly based on a systematic review and qualitative analysis of the existing literature on CDoH and public health ethics frameworks. We conducted searches using selected search engines (Google Scholar and Pubmed). For ethical challenges relating to CDOH, our searches in Google Scholar yielded 17 papers that discussed ethical challenges that affect CDoH. For ethical frameworks relevant for CDOH, our searches in Google Scholar and Pubmed yielded 15 papers that clearly described bioethical models including relevant ethical principles. Additionally, we consulted eight experts working on CDoH. Through these two methods, we were able to identify ethical challenges as well as norms and values related to CDoH that we offer as candidates to comprise a foundational ethics framework for CDoH. RESULTS: Discussing risk factors associated with CDH frequently brings public health into conflict with the interests of industry actors in the food, automobile, beverage, alcohol, ammunition, gaming and tobacco industries including conflict between profit-making and public health. We propose the following candidate ethical principles that can be used in addressing CDoH: moral responsibility, nonmaleficence, social justice and equity, consumer sovereignty, evidence-informed actions, responsiveness, accountability, appropriateness, transparency, beneficence and holism. CONCLUSIONS: We hope that this set of guiding principles will generate wider global debate on CDoH and help inform ethical analyses of corporate actions that contribute to ill health and policies aimed at addressing CDoH. These candidate principles can guide researchers and health actors including corporations in addressing CDoH.

How Should Vaccine Campaigns Balance Need for Clear Communication Against Need for Timely Administration of Large-Scale Programs?

Limited understanding of public health disease prevention programs often leads to resistance, which ultimately results in low vaccine uptake. This article suggests how public health practitioners can improve public understanding of cervical cancer and HPV vaccination programs, which is key to improving health literacy, using culturally appropriate materials and approaches to boost public acceptance of vaccine programs.

Understanding Ethical, Legal and Societal Issues (ELSIs) in Human Biobanking and Genomics for Research and Healthcare in Zimbabwe: The Genomics Inheritance Law Ethics and Society (GILES) initiative.

Biobanks and human genomics applications are key for understanding health, disease and heredity in Africa and globally. Growing interest in these technologies calls for strengthening relevant legal, ethical and policy systems to address knowledge disparities and ensure protection of society, while supporting advancement of science. In Zimbabwe there is limited understanding of ethical, legal, and societal issues (ELSI) for biobanking and genomics. The Genomics Inheritance Law Ethics and Society (GILES) initiative was established in 2015 to explore the current status and gaps in the ethical and legal frameworks, knowledge among various stakeholders, and to establish capacity for addressing ELSI of biobanking and genomics as applied in biomedical and population research, and healthcare. A multi-methods approach was applied including document reviews, focus group discussions and in-depth interviews among health and research professionals, and community members in six provinces comprising urban, peri-urban and rural areas. Emerging findings indicates a need for updating guidelines and policies for addressing ELSI in biobanking and genomics research in Zimbabwe. Emerging terminologies such as biobanking and genomics lack clarity suggesting a need for increased awareness and educational tools for health professionals, research scientists and community members. Common concerns relating to consent processes, sample and data use and sharing, particularly where there is trans-national flow of biospecimens and data, call for nationally tailored ELSI frameworks aligned to regional and international initiatives. This paper describes the strategy undertaken for the development and implementation of the GILES project and discusses the importance of such an initiative for characterisation of ELSI of human biobanking and genomics in Zimbabwe and Africa. Conducting this explorative study among a wide range of stakeholders over a countrywide geographical regions, established one of the most comprehensive studies for ELSI of human biobanking and genomics in Africa.

Strengthening stakeholder engagement through ethics review in biomedical HIV prevention trials: opportunities and complexities.

INTRODUCTION: Clinical trials of biomedical HIV prevention modalities require the cooperation of multiple stakeholders. Key stakeholders, such as community members, may have stark vulnerabilities. Consequently, calls for HIV prevention researchers to implement "stakeholder engagement" are increasingly common. Such engagement is held to benefit inter-stakeholder relations, stakeholders themselves and the research itself. The ethics review process presents a unique opportunity to strengthen stakeholder engagement practices in HIV prevention trials. However, this is not necessarily straightforward. In this article, we consider several complexities. First, is stakeholder engagement a legitimate component of what Research Ethics Committees (RECs) should review for HIV prevention trials? Second, what are the core features of engagement that should be under ethics review? Third, what are the key practices that should be highlighted in ethics review? METHODS: To address these questions, we examined the international ethics guidelines specialized for such trials (UNAIDS 2012, UNAIDS-AVAC GPP 2011) and directly applicable to such trials (CIOMS 2016; WHO 2011). Thematic analysis was used to code and analyse these guidelines. RESULTS AND DISCUSSION: Ethics guidelines support REC review of engagement. Guidance recommends that engagement be broad and inclusive; early and sustained; and dynamic and responsive. Broad engagement practices include evaluating the context, planning in writing, and resourcing. RECs should assess engagement as part of a comprehensive review, and recommend revisions where necessary. Researchers should profile key elements of engagement valued in ethics guidance, when they draft ethics submissions. Importantly, the ethics review process should not undermine the 'dynamic responsiveness' required for excellent engagement in this field. CONCLUSIONS: As evidence-informed engagement strategies emerge, these should inform the ethics submission and review process. Both parties in the review process should strive to avoid a superficial, check-list type approach that caricatures what should be a thorough, nuanced ethics review of a rich, responsive engagement process.

Standards of Care in Global Health: Identifying the Right Question.

Govind Persad and Ezekiel Emanuel's article "The Case for Resource Sensitivity: Why It Is Ethical to Provide Cheaper, Less Effective Treatments in Global Health," in this issue of the Hastings Center Report, is a reminder of the debates around resources for health care that raged during the years immediately preceding and following the fifth revision of the Declaration of Helsinki, in 2000. In global health, it is a common expectation for rich countries to assist poor countries in resolving health challenges, yet global health involves not only the governments of rich and poor nations but also nongovernmental organizations, pharmaceutical companies, the World Health Organization, philanthropic organizations, and other parties-all of whom take roles in ensuring that health interventions become available to poor countries, including deciding which types of interventions to make available. The question whether it is ethical to provide cheaper, less effective interventions to poor countries is perhaps relevant only in wealthy nations, where there really is a choice to be made.

Understanding, Therapeutic Misconceptions and Perceptions, and Enrollment Decision-Making: A Pediatric Preventive Malaria Trial in Rural Tanzania.

This study entailed conducting extensive qualitative interviews of mothers who had been invited to have their infants participate in the Kilimanjaro Intermittent Preventive Treatment of Malaria in Infants (Kili IPTi) trial, designed to assess the efficacy of intermittent preventive malaria chemoprophylaxis for infants. Our study sought to explore whether there was a relationship between the mothers' understanding of the research and the decision to enroll their infants or to decline. Such empirical data is necessary to address widely voiced concerns that limited understanding of research or exploitive inducement may undermine informed consent among clinical trial recruits in developing countries. The most striking result of the study was that, in general, those who declined to have their children participate in the trial had a better understanding of the trial than those who agreed to have their children participate. Decliners were more likely to understand the experimental nature of the trial and were less likely to confuse research with treatment, the conceptual error often labeled "therapeutic misconception." Notably, in the context of the Kili IPTi trial, perception of clinical benefit may have been an accurate perception rather than therapeutic misconception because ancillary clinical benefits were provided to research participants. Neither participants nor decliners cited "altruistic" reasons for their decisions, despite presumptions among some scholars that such reasons are ethically the most appropriate motivations for participation in clinical research.

Testing the waters: Ethical considerations for including PrEP in a phase IIb HIV vaccine efficacy trial.

BACKGROUND: The field of HIV prevention research has recently experienced some mixed results in efficacy trials of pre-exposure prophylaxis, vaginal microbicides, and HIV vaccines. While there have been positive trial results in some studies, in the near term, no single method will be sufficient to quell the epidemic. Improved HIV prevention methods, choices among methods, and coverage for all at-risk populations will be needed. The emergence of partially effective prevention methods that are not uniformly available raises complex ethical and scientific questions regarding the design of ongoing prevention trials. METHODS: We present here an ethical analysis regarding inclusion of pre-exposure prophylaxis in an ongoing phase IIb vaccine efficacy trial, HVTN 505. This is the first large vaccine efficacy trial to address the issue of pre-exposure prophylaxis, and the decisions made by the protocol team were informed by extensive stakeholder consultations. The key ethical concerns are analyzed here, and the process of stakeholder engagement and decision-making described. DISCUSSION: This discussion and analysis will be useful as current and future research teams grapple with ethical and scientific study design questions emerging with the rapidly expanding evidence base for HIV prevention.

To What did They Consent? Understanding Consent Among Low Literacy Participants in a Microbicide Feasibility Study in Mazabuka, Zambia.

We conducted a study to review the consenting process in a vaginal microbicide feasibility study conducted in Mazabuka, Zambia. Participants were drawn from those participating in the microbicide study. A questionnaire and focus group discussion were used to collect information on participants' understanding of study aims, risks and benefits. Altogether, 200 participants took part in this study. The results of the study showed that while all participants signed or endorsed their thumbprints to the consent forms, full informed consent was not attained from most of the participants since 77% (n = 154) of the participants had numerous questions about the study and 34% (n = 68) did not know who to get in touch with concerning the study. Study objectives were not fully understood by over 61% of the participants. Sixty four percent of the participants were not sure of the risks of taking part in the microbicide study. A significant number thought the study was all about determining their HIV status. Some participants were concerned that their partners were not on the trial as they were convinced that being on the study meant that that they had a lifetime protection from HIV infection. The process of obtaining consent was inadequate as various phases of the study were not fully understood. We recommend the need for researchers to reinforce the consenting process in all studies and more so when studies are conducted in low literacy populations.