Ethical issues in direct-to-consumer healthcare: A scoping review.

An increasing number of health products and services are being offered on a direct-to-consumer (DTC) basis. To date, however, scholarship on DTC healthcare products and services has largely proceeded in a domain-specific fashion, with discussions of relevant ethical challenges occurring within specific medical specialties. The present study therefore aimed to provide a scoping review of ethical issues raised in the academic literature across types of DTC healthcare products and services. A systematic search for relevant publications between 2011-2021 was conducted on PubMed and Google Scholar using iteratively developed search terms. The final sample included 86 publications that discussed ethical issues related to DTC healthcare products and services. All publications were coded for ethical issues mentioned, primary DTC product or service discussed, type of study, year of publication, and geographical context. We found that the types of DTC healthcare products and services mentioned in our sample spanned six categories: neurotechnology (34%), testing (20%), in-person services (17%), digital health tools (14%), telemedicine (13%), and physical interventions (2%). Ethical arguments in favor of DTC healthcare included improved access (e.g., financial, geographical; 31%), increased autonomy (29%), and enhanced convenience (16%). Commonly raised ethical concerns included insufficient regulation (72%), questionable efficacy and quality (70%), safety and physical harms (66%), misleading advertising claims (56%), and privacy (34%). Other frequently occurring ethical concerns pertained to financial costs, targeting vulnerable groups, informed consent, and potential burdens on healthcare providers, the healthcare system, and society. Our findings offer insights into the cross-cutting ethical issues associated with DTC healthcare and underscore the need for increased interdisciplinary communication to address the challenges they raise.

Crafting impactful papers: Expectations and recommendations for Business and management articles.

This paper introduces Heliyon's Business and Management Section, established in 2023 as a platform committed to maintaining rigorous ethical and scientific publishing standards within the field. Prioritizing scientific correctness and technical soundness over mere novelty, it encompasses a wide range of research domains, encouraging contributions from scholars across diverse backgrounds. Within this guide, we provide insights into the process of preparing effective papers and offer constructive guidelines for the reviewing process. Authors will find valuable tools to align their work with the journal's expectations, incorporating current literature to enhance the probability of successful publication. Both aspiring authors and reviewers will benefit from this resource, which emphasizes academic and professional growth. By promoting collaboration and upholding high-quality standards, we aim to fortify the scholarly publishing community and advance knowledge in the field of business and management.

How the commercial virtual care industry gathers, uses and values patient data: a Canadian qualitative study.

OBJECTIVES: To understand and report on the direct-to-consumer virtual care industry in Canada, focusing on how companies collect, use and value patient data. DESIGN: Qualitative study using situational analysis methodology. SETTING: Canadian for-profit virtual care industry. PARTICIPANTS: 18 individuals employed by or affiliated with the Canadian virtual care industry. METHODS: Semistructured interviews were conducted between October 2021 and January 2022 and publicly available documents on websites of commercial virtual care platforms were retrieved. Analysis was informed by situational analysis, a constructivist grounded theory methodology, with a continuous and iterative process of data collection and analysis; theoretical sampling and creation of theoretical concepts to explain findings. RESULTS: Participants described how companies in the virtual care industry highly valued patient data. Companies used data collected as patients accessed virtual care platforms and registered for services to generate revenue, often by marketing other products and services. In some cases, virtual care companies were funded by pharmaceutical companies to analyse data collected when patients interacted with a healthcare provider and adjust care pathways with the goal of increasing uptake of a drug or vaccine. Participants described these business practices as expected and appropriate, but some were concerned about patient privacy, industry influence over care and risks to marginalised communities. They described how patients may have agreed to these uses of their data because of high levels of trust in the Canadian health system, problematic consent processes and a lack of other options for care. CONCLUSIONS: Patients, healthcare providers and policy-makers should be aware that the direct-to-consumer virtual care industry in Canada highly values patient data and appears to view data as a revenue stream. The industry's data handling practices of this sensitive information, in the context of providing a health service, have implications for patient privacy, autonomy and quality of care.

Ethical judgments of poverty depictions in the context of charity advertising.

Aid organizations, activists, and the media often use graphic depictions of human suffering to elicit sympathy and aid. While effective, critics have condemned these practices as exploitative, objectifying, and deceptive, ultimately labeling them 'poverty porn.' This paper examines people's ethical judgments of portrayals of poverty and the criticisms surrounding them, focusing on the context of charity advertising. In Studies 1 and 2, we find that tactics that have been decried as deceptive (i.e., using an actor or staging a photograph) are judged to be less acceptable than those that have been decried as exploitative and objectifying (i.e., depicting an aid recipient's worst moments). This pattern occurs both when evaluating the tactics themselves (Studies 1a-1c) and when directly evaluating critics' arguments about them (Study 2). Studies 3 and 4 unpack the objection to deceptive tactics and find that participants' chief concern is not about manipulating the audience's responses or about distorting perceptions of reality. Participants report less concern about non-deceptive manipulation (using emotion to compel donations) and 'cherry-picked' portrayals of poverty (an ad showing an extreme, but real image) so long as there is some truth to the portrayal. Yet they are more sensitive to artificial images (e.g., an actor posing as poor), even when the image resembles reality. Thus, ethical judgments hinge more on whether poverty portrayals are genuine than whether they are representative. This work represents the first empirical investigation into ethical judgments of poverty portrayals. In doing so, this work sheds light on how people make sense of morally questionable tactics that are used to promote social welfare and deepens our understanding of reactions to deception.

Advancing eco-excellence: Integrating stakeholders' pressures, environmental awareness, and ethics for green innovation and performance.

The environment is a major issue for both society and industry. Stakeholder demands, environmental ethics and environmental awareness may all have a substantial impact on a company's environmental performance. In this research, we investigate the impact of stakeholders' pressures, environmental ethics, and environmental awareness on environmental performance, which is mediated through the concept of green innovation. A survey questionnaire is used in the study to gather information from 410 managers working in different Chinese manufacturing firms. Structural equation modeling (SEM) is used to assess the data and test the assumptions that have been put forward. According to the study's results, stakeholders' pressures in terms of regulatory pressures, customer pressures, and competitor pressures; environmental ethics, and environmental awareness all had a positive effect on both green product innovation and green process innovation, which in turn had a favorable impact on environmental performance. Moreover, both green product and process innovation partially mediated the link between stakeholders' pressures, environmental ethics, and environmental performance except in the case of environmental awareness. These findings provide light on the significance of stakeholder demands, environmental ethics, and environmental awareness in encouraging green innovation and increasing environmental performance.

Theory-Based Intervention Module on Occupational Safety and Health (TRIMOSH) in improving knowledge, attitude, and practice among food industry workers: Study protocol for a randomised controlled trial.

INTRODUCTION: The significant contribution of the food and beverage industry to Malaysia's Gross Domestic Product is projected to increase in the upcoming years. With the industry's expansion, the demand for workers on food premises would also continuously increase. The food industry workers are exposed to risks arising from physical, chemical, biological, ergonomic, and psychosocial hazards while performing their duties. Thus, it is essential for these workers to be equipped with proper knowledge, attitude, and practices (KAP) in safety and health. AIMS: This study aims to develop and evaluate the effectiveness of the safety and health programme TRIMOSH (Theory-Based Intervention Module on Occupational Safety and Health) in improving the knowledge, attitude, and practice among food industry workers. METHODS: TRIMOSH intervention study is a two-arm randomised, single-blinded, controlled, parallel trial that will be conducted among food industry workers in Selangor, Malaysia. In a partnership with Food Handler Training Schools in Selangor, 10 pairs of Food Handler Training Schools with 12 participants per group (n = 240) will be recruited for balanced randomisation intervention and control conditions. Furthermore, data collection of all participants was conducted at four time points: baseline (T0), immediately (T1), one month (T2), and three months (T3) post-intervention. Generalised Linear Mixed Model (GLMM) will be conducted to determine the effects of intervention within and between study groups. Subsequently, the primary outcomes increase the knowledge, attitude, and practice (KAP) of safety and health at food premises. Clinical Trial Registry registration was approved by the ClinicalTrials.gov committee on October 2022 with the ClinicalTrials.gov Identifier: NCT05571995. This study has also been approved by the Ethics Committee for Research Involving Human Subjects of Universiti Putra Malaysia (JKEUPM-2022-346). All participants are required to provide consent prior to participation. CONCLUSIONS: The characteristics of the respondents are expected to show no difference between the groups. It is hypothesised that TRIMOSH is effective in improving the knowledge, attitude, and practices of food industry workers in Selangor. The results will be reported and presented in international peer-reviewed journals, conferences, and other platforms. In addition, the TRIMOSH programme will be offered at the national level by the relevant authorities for the benefit of food industry workers.

Commercial milk formula marketing following increased restrictions in Singapore: A qualitative study.

The promotion of commercial milk formula (CMF) negatively impacts breastfeeding outcomes. In 2019, Singapore updated its 1979 Code of Ethics of the Sale of Infant Foods Ethics Committee Singapore (SIFECS) to increase marketing restrictions on CMF for infants 0-12 months. However, little is known about industry tactics to undermine these restrictions. This qualitative study explores health workers' and mothers' experiences with CMF marketing in Singapore following the 2019 restrictions. We conducted a qualitative study, using semistructured interviews with 14 mothers of infants aged less than 5 months and 20 health workers with expertise in antenatal, maternity, or paediatric care. We analysed data thematically using inductive coding. Five themes were identified. Mothers and health workers reported digital marketing, product line extensions with toddlers' milk and milk for mothers, and CMF sponsorships in the healthcare setting. Expert endorsement, competitive price, nutritional claims, and brand reputation influenced mothers' infant formula choices, yet both mothers and health workers appeared to be unaware of the impact of CMF marketing tactics on their own perceptions. The restriction of CMF marketing and infant feeding practices varied widely between hospitals, with private hospitals and practices having less strict controls on CMF marketing. Despite the updated SIFECS restrictions, CMF companies continue to target mothers and health workers in Singapore. SIFECS restrictions should be tightened to align with international guidelines, by increasing their scope to include toddlers' milk and prohibiting cross-promotion, digital marketing, and any sponsorships of events targeting health workers that may create a conflict of interest.

Call to action: Harmonization of pharmacovigilance regulations for post-marketing pregnancy and breastfeeding safety studies.

Globally, more than 200 million women become pregnant each year, most of whom receive medications despite limited information on their safe use during pregnancy. The paucity of drug safety data on pregnant and breastfeeding women stems from the routine exclusion of this population from clinical trials due to scientific, ethical, regulatory and legal concerns. Consequently, at the time of initial drug approval, there may be scant safety data to inform the drug benefit-risk balance to the mother, foetus or infant. Although momentum is growing to include this underrepresented population in clinical trials, most information on drug exposure outcomes comes from data collected in the postmarketing setting. Regulatory guidance and legislation on medication use in pregnancy and breastfeeding were reviewed globally by the TransCelerate IGR PV Pregnancy and Breastfeeding Team. The International Conference of Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) standards and Council for International Organizations of Medical Sciences guidelines served as benchmarks for national safety regulations and guidance. The landscape assessment identified a lack of harmonization of global regulations on research in pregnant and breastfeeding women and a lack of specific regulations on this topic in the majority of the territories included in the assessment. This article focuses on the ambiguities and lack of harmonization in global regulations on postmarketing pregnancy and breastfeeding safety studies. There is currently no ICH standard to guide these types of safety studies and, in most regions reviewed, there are no clear regulations or guidance on when and how to conduct them. While a challenging undertaking, greater clarity and harmonization would facilitate more timely completion of postmarketing pregnancy safety studies that would ultimately generate the critical data needed to optimize benefit-risk decisions for women who may conceive, as well as pregnant and breastfeeding women.

Review: Ethical responsibilities and transformation strategies of focal companies in the meat supply chain: the implementation dilemma.

In Germany (and other Organisation for Economic Co-operation and Development countries), the need for a fundamental transformation of livestock farming has become increasingly evident in recent years. Two broad-based stakeholder commissions including the German farmers' association, the meat industry, and Non-Governmental Organizations have endorsed this demand. Nevertheless, major steps towards its implementation are still missing - a circumstance we refer to in this paper as the implementation dilemma. In a globalised economy, farmers cannot solve the problem of low animal welfare standards alone although they are important actors. Moreover, consumer behaviour is changing too slowly, and possibilities for granting more subsidies are limited in the face of multiple economic crises. Against this background, we argue for a stronger focus on voluntary (private) sustainability agreements. We therefore analyse how the German meat supply chain is organised and what responsibility and power the individual actors have to push the sector's transformation. Large slaughterhouses, processors, and the retailing sector seem promising due to their high market concentration and power. Especially retailers can influence the transformation of the market through their role as gatekeepers between suppliers and consumers. Based on business ethics principles of taking responsibility, we consider the focus on sustainability obligations of the retail sector to be ethically justified. However, it is then necessary to give the four retail groups dominating the meat chain in Germany more leeway for sustainability agreements in antitrust law.

Direct-to-Consumer Genomic Testing Through an Ethics Lens: Oncology Nursing Considerations.

BACKGROUND: The use of direct-to-consumer genomic testing (DTCGT) is increasing, but this testing may not be comprehensive and may lack clinical validity and utility. The ethical constructs of beneficence, nonmaleficence, justice, and autonomy provide a framework for coordinating the care of patients and their families. OBJECTIVES: This article provides an overview of the DTCGT process and reviews the ethical implications that affect clinical care. METHODS: A review of the literature was conducted using the following key words: genetics/genomics and direct-to-consumer testing. Common themes were identified, including test types, regulatory standards, marketing practices, ethics, privacy, and nursing implications. FINDINGS: An increased awareness of the clinical and ethical consequences of DTCGT is needed among healthcare providers and the general population. Oncology nurses can assist patients in navigating the field of genomics through consistent and comprehensive risk assessment, patient education about the risks and benefits of DTCGT, and referral to genomics professionals when appropriate.

Registering transparency: the making of the international clinical trial registry platform by the world health organization (2004-2006).

BACKGROUND: This paper examines the events and conditions that led to the creation of the International Clinical Trials Registry Platform (ICTRP) in 2006 by the World Health Organization (WHO), and how the WHO addressed the issue of transparency in global pharmaceutical research. Using historical textual analysis, I trace the scientific debates that advocated for the establishment of official clinical trial registries in medical journals, and the sequence of actions following the GSK Paxil scandal in 2004, identifying the major ethical and scientific arguments that led to the involvement of the WHO as a key actor in trial registration in the context of the Big Pharma business model. RESULTS: Through the questions "Why register?" and "Why registries?" as a roadmap, I examine the issues of publication bias and selective reporting by the industry, scrutinizing two ways in which the practice of publication bias damaged transparency in industry-sponsored research. The first involved ethical concerns regarding human subject exploitation and concealing of negative results. The second addresses the deterioration of the certainty of evidence due to incomplete access to trials results. By reviewing the series of events that occurred between 2004 and 2006 -between the Paxil scandal and the launch of the ICTRP-, I analyze the actions taken by the different actors involved: (1) the International Committee of Medical Journal Editors (ICMJE) and the creation of the Ottawa Group; (2) the WHO, beginning with the Ministerial Summit on Health Research held in November of 2004, and (3) the responses of the pharmaceutical industry and specifically GSK to the call for transparency and trial registration. CONCLUSIONS: The history of trial registration through the ICTRP as a dataveillance apparatus shows the difficulty of regulating a health enterprise turned into a global business. Moreover, it shows the challenges of globalization and how easier and faster it is to globalize business compared to good practices, raising the question of why it has been so hard to undo these trends. Indeed, the history of the movement for trial registration is not a history of regulation success, or at least not yet.

A management model in blood, tissue and cell establishments to ensure rapid and sustainable patient access to advanced therapy medicinal products in Europe.

Blood, tissue and cell establishments (BTCs) stand out in the management of donor selection, procurement and processing of all types of substances of human origin (SoHO). In the last decades, the framework created around BTCs, including hospitals and national health system networks, and their links to research, development and innovation organizations and agencies have spurred their involvement in the study of groundbreaking advanced therapy medicinal products (ATMP). To further improve strategic synergies in the development of ATMPs, it will be required to promote intra- and inter-European collaborations by creating an international network involving BTCs and major stakeholders (i.e., research organizations, hospitals, universities, patient associations, public agencies). This vision is already shared with the European Blood Alliance, the association of non-profit blood establishments, with 26 member states throughout the European Union and European Free Trade Association states. Herein we present and analyze the "BTC for ATMP Development And Manufacture" (BADAM) model, an ethically responsible business model based on the values and missions of BTCs and their commitment to health equity, patient access and education (based on voluntary donation of SoHO to address unmet clinical needs, while contributing to training professionals and scientific literacy of our Society).

Ethical Guidance for Physicians and Health Care Institutions on Grateful Patient Fundraising: A Position Paper From the American College of Physicians.

Physician solicitation of charitable contributions from patients-also known among other things as grateful patient fundraising-raises significant ethical concerns. These include pressure on patients to donate and the effects of this on the patient-physician relationship, potential expectations of donor patients for treatment that is not indicated or preferential care, justice and fairness issues, disclosure and use of confidential patient information for nontreatment purposes, and conflicts of interest. The patient-physician relationship and knowledge of the patient's medical history, clinical status, personal information, and financial circumstances are some of the reasons development and administrative officials might see physicians as strong potential fundraisers. But those are among the reasons grateful patient fundraising is ethically problematic. This American College of Physicians position paper explores these issues and offers guidance.

Potential Conflicts of Interest Arising from Dualism of Loyalty Imposed on Employees of Medical Institutions-Findings and Tools for Ethics Management.

Background and Objective: Doctors should have full loyalty to their patients, while patients should be able to trust that physicians will act only in their best interests. However, doctors may be faced with situations where they must choose between the patient's interests and those of a third party. This article presents the results of a study that aimed to identify situations of duality in the decision-making process of medical workers, which can compromise their ethical behavior. Materials and Methods: A cross-sectional study was carried out on a sample of 1070 participants, employed in 120 healthcare facilities in the Republic of Moldova. An online questionnaire was completed anonymously. Descriptive statistics for discrete data were performed by estimating absolute and relative frequencies. To perform the multivariate analysis, the logistic regression was applied. Results: A large number (74.4%) of respondents admitted that they had faced situations of conflicts of interest. Every third respondent (35.3%) had experienced ethical dilemmas when access to expensive treatments should be ensured. Every fourth respondent experienced a conflict between the patient's interests and those of the institution (26.1%) or the insurance company (23.3%). As age increases, the probability of reporting the dilemma decreases. Physicians reported such dilemmas almost 3 times more often than nurses. A low rate of staff sought support when faced with dilemmas. Half of the respondents (50.6%) preferred to discuss the problem only with a colleague, and 40.1% preferred to find solutions without anyone's help. There were significant gaps within organizations in terms of the ethical dimension of the decision-making process. Conclusions: Managers should adopt clear institutional policies and tools to identify and prevent situations of dual loyalty. Ethical support should be offered to employees facing such situations. The need to promote an institutional climate based on trust and openness becomes evident.

Emerging Applications of Nanotechnology in Healthcare and Medicine.

Knowing the beneficial aspects of nanomedicine, scientists are trying to harness the applications of nanotechnology in diagnosis, treatment, and prevention of diseases. There are also potential uses in designing medical tools and processes for the new generation of medical scientists. The main objective for conducting this research review is to gather the widespread aspects of nanomedicine under one heading and to highlight standard research practices in the medical field. Comprehensive research has been conducted to incorporate the latest data related to nanotechnology in medicine and therapeutics derived from acknowledged scientific platforms. Nanotechnology is used to conduct sensitive medical procedures. Nanotechnology is showing successful and beneficial uses in the fields of diagnostics, disease treatment, regenerative medicine, gene therapy, dentistry, oncology, aesthetics industry, drug delivery, and therapeutics. A thorough association of and cooperation between physicians, clinicians, researchers, and technologies will bring forward a future where there is a more calculated, outlined, and technically programed field of nanomedicine. Advances are being made to overcome challenges associated with the application of nanotechnology in the medical field due to the pathophysiological basis of diseases. This review highlights the multipronged aspects of nanomedicine and how nanotechnology is proving beneficial for the health industry. There is a need to minimize the health, environmental, and ethical concerns linked to nanotechnology.

Conflict of interest and funding in health communication on social media: a systematic review.

OBJECTIVES: To synthesise the available evidence on the reporting of conflicts of interest (COI) by individuals posting health messages on social media, and on the reporting of funding sources of studies cited in health messages on social media. DATA SOURCES: MEDLINE (OVID) (2005-March 2022), Embase (2005-March 2022) and Google Scholar (2005-August 2022), supplemented with a review of reference lists and forward citation tracking. DESIGN: Reviewers selected eligible studies and abstracted data in duplicate and independently. We appraised the quality of the included studies using the Mixed Methods Appraisal Tool. We summarised the results in both narrative and tabular formats. We followed the PRISMA 2020 checklist for reporting our study. RESULTS: Of a total of 16 645 retrieved citations, we included 17 eligible studies. The frequency of reporting of conflicts of interest varied between 0% and 60%, but it was mostly low. In addition, a significant proportion, ranging between 15% and 80%, of healthcare professionals using social media have financial relationships with industry. However, three studies assessed the proportion of conflicts of interest of physicians identified through Open Payment Database but not reported by the authors. It was found that 98.7-100% of these relationships with industry are not reported when communicating health-related information. Also, two studies showed that there is evidence of a potential association between COI and the content of posting. No data was found on the reporting of funding sources of studies cited in health messages on social media. CONCLUSIONS: While a significant proportion of healthcare professionals using social media have financial relationships with industry, lack of reporting on COI and undisclosed COI are common. We did not find studies on the reporting of funding sources of studies cited in health messages on social media. TRIAL REGISTRATION: dx.doi.org/10.17504/protocols.io.5jyl8jj4rg2w/v1.

Attitude of Romanian Medical Students and Doctors toward Business Ethics: Analyzing the Influence of Sex, Age, and Ethics Education.

This study investigated the attitude of Romanian medical students and doctors toward business ethics by measuring the preference for a particular ethical philosophy, namely, the preference for Machiavellianism, moral objectivism, social Darwinism, ethical relativism, and legalism. At the same time, this study aimed to explore the influence of sex, age, and ethics education on the attitude toward business ethics. The data collection was performed using a voluntary self-administered online survey including the Attitudes Toward Business Ethics Questionnaire (ATBEQ) instrument. Our findings show that the values based on which Romanian medical students and doctors make business decisions belong predominantly to the moral objectivism philosophy, which is grounded on rational actions based on a set of objective moral standards.