Patients increasingly share online health information with their physicians. However, few studies have investigated factors that may facilitate or inhibit such sharing and subsequent impact on physician-patient relationship. This study conducted a cross-sectional survey among 818 Chinese patients to examine if two patient characteristics -communication apprehension and eHealth literacy- influence their ways of sharing online health information with physicians and subsequently impact physician-patient relationship. The results showed that a majority of surveyed participants searched (...) class='Hi'>health information online, and about half of them used such information during their doctor visits. Less apprehensive patients tend to share the information with their physicians more directly, which can positively affect perceived physician reactions and patient satisfaction. eHealth literacy, however, is not found to be associated with patients’ sharing of online information with physicians. This study underscores the importance of identifying patient characteristic’s role in patient-physician interaction. (shrink)

Very few attempts have been made to survey patient opinions, particularly regarding the use of residual biospecimens and health information in research, to clarify their values. We conducted a questionnaire survey that targeted outpatients of a university hospital to gauge their awareness levels and understand patient perspectives on research that uses these items. Few patients felt that obtaining individual consent for each research study was necessary. Most patients expressed the view that researchers should be obligated to inform them (...) about the research use of their items and be subject to self-directed rules. The research community should try to obtain “societal consent regarding an opt-out system” from the public. A salient value-sharing-based governance structure is necessary for obtaining public trust. (shrink)

As policy makers place great hope in health information technology as a means to lower costs and achieve improvements in health care quality, safety, and efficiency, organizations at the forefront of building health information exchange networks attempt to weave the concept and function of informed consent into an evolving information-driven health care system. The vast amount of information that will become available to both health professionals and patients in the new HIT-driven (...) environment can reasonably be expected to affect the relationship between them in many ways, particularly in the area of informed consent. During this early stage of HIT adoption, it is critical that we engage in discussions regarding informed consent’s proper role in a heretofore unknown health care environment — one in which electronic information sharing holds primary importance. The central and largely unexamined question of whether and how the legal and ethical underpinnings of informed consent will fit into the context of HITenabled treatment is critical to both public policy and clinical practice. (shrink)

Background Rapid ethical access to personal health information to support research is extremely important during pandemics, yet little is known regarding patient preferences for consent during such crises. This follow-up study sought to ascertain whether there were differences in consent preferences between pre-pandemic times compared to during Wave 1 of the COVID-19 global pandemic, and to better understand the reasons behind these preferences. Methods A total of 183 patients in the pandemic cohort completed the survey via email, and (...) responses were compared to the distinct pre-pandemic cohort ; all were patients of a large Canadian cancer center. The survey covered broad versus study-specific consent; opt-in versus opt-out contact approach; levels of comfort sharing with different recipients; perceptions of commercialization; and options to track use of information and be notified of results. Four focus groups were subsequently conducted to elucidate reasons motivating dominant preferences. Results Patients in the pandemic cohort were significantly more comfortable with sharing all information and biological samples, sharing information with the health care institution, sharing information with researchers at other hospitals, sharing PHI provincially, nationally and internationally compared to the pre-pandemic cohort. Discomfort with sharing information with commercial companies remained unchanged between the two cohorts. Significantly more pandemic cohort patients expressed a wish to track use of PHI, and to be notified of results. Thematic analysis uncovered that transparency was strongly desired on outside PHI use, particularly when commercialization was involved. Conclusions In pandemic times, patients were more comfortable sharing information with all parties, except with commercial entities, where levels of discomfort remained unchanged. Focus groups identified that the ability to track and receive results of studies using one’s PHI is an important way to reduce discomfort and increase trust. These findings meaningfully inform wider discussions on the use of personal health information for research during global crises. (shrink)

As an employee, a sports doctor has obligations to their employer, but also professional and widely accepted obligations of a doctor to the patient . The conflict is evident when sports doctors are asked by an athlete to keep personal health information confidential from the coach and team management, and yet both doctor and athlete have employment contracts specifying that such information shall be shared. Recent research in New Zealand shows that despite the presence of an employment (...) contract, there appears to be a wide range of behaviours among sports doctors when an athlete requests that information about them be kept from team management. Many seem willing to honour requests to keep health information about the athlete confidential, thereby being in breach of the employment contract, while others insist on informing team management against the wishes of the athlete. There are a number of potential solutions to this dilemma from forcing doctors to meet their contractual obligations, to limiting the expectations of the employment contract. This paper suggests that at times it may be appropriate to do both, making the position of the doctor clearer and supporting the ability of this group to resist pressure by coaches and management through having a robust code of ethics. (shrink)

Truly transforming the healthcare delivery and payment system turns on the ability to engage in the interoperable electronic exchange of patient health information across and beyond the care continuum. Achieving transformation requires a legal framework that supports information sharing with appropriate privacy and security protections and a trusted governance structure.

This paper argues that specific individual informed consent and other forms of consent predicated on a right to autonomy may not in all circumstances be appropriate for the establishment and use of large data sets of health information. We suggest that there are inherent failings in such an approach, shortcomings that we analyse below. We argue that individuals share an obligation to contribute their data, as doing so is cost-free and benefits accrue to the population as a whole. (...) Large health data sets can be considered public goods – goods that are non-rival in consumption and in some cases non-exclusive in use – and contributing to these goods may be an obligation, the meeting of which allows citizens to invest in knowledge infrastructure. The approach argued for here is a variation of a communitarian ethic in which people have an obligation to contribute their data but have no correlative right to expect or receive an individual benefit. (shrink)

Background Immense volumes of personal health information are required to realize the anticipated benefits of artificial intelligence in clinical medicine. To maintain public trust in medical research, consent policies must evolve to reflect contemporary patient preferences. Methods Patients were invited to complete a 27-item survey focusing on: broad versus specific consent; opt-in versus opt-out approaches; comfort level sharing with different recipients; attitudes towards commercialization; and options to track PHI use and study results. Results 222 participants were included (...) in the analysis; 83% were comfortable sharing PHI with researchers at their own hospital, although younger patients were more uncomfortable than older patients. While 56% of patients preferred broad consent, 38% preferred specific consent; 6% preferred not sharing at all. The majority of patients preferred to be asked for permission before entry into a contact pool. Again, this trend was more pronounced for younger patients. Approximately half of patients were uncomfortable sharing PHI with commercial enterprises. Most patients preferred to track PHI usage, with the highest proportion once again reported by the youngest patients. A majority of patients also wished to be notified regarding study results. Conclusions While most patients were willing to share their PHI with researchers within their own institution, many preferred a transparent and reciprocal consent process. These data also suggest a generational shift, wherein younger patients preferred more specific consent options. Modernizing consent policies to reflect increased autonomy is crucial in fostering sustained public engagement with medical research. (shrink)

In discussions of health reform, the increased use of health information technology is a common element of nearly every serious proposal on the table. Health IT includes electronic health records kept by providers, personal health records offered by health insurance plans or owned by consumers, and electronic health information exchanges. Although health reform initiatives being discussed contain little detail regarding health IT, in general they promote health IT to (...) facilitate the electronic sharing of health information to improve individual and population health. During the 2008 presidential campaign, the health care proposals of both President Obama and Senator McCain discussed health IT. President Obama’s proposal invests $50 billion over the next five years to promote the adoption of health IT with privacy safeguards. Senator McCain’s plan also encouraged the adoption of health IT, with an emphasis on coordination. (shrink)

Clinical information about patients is increasingly being stored in electronic form and has therefore become more easily shareable. Data are collected as part of clinical care but have multiple other potential uses in relation to health system planning, audit and research. The use of clinical information for these secondary uses is controversial, and the ability to safeguard personal and sensitive data under current practices is contested.In this study, we investigate the attitudes of a representative sample of the (...) Danish population towards transfer of clinical data from their general practice for secondary use. We specifically study: patients’ trust in different types of healthcare professionals, their interest in being asked about secondary use of data and their willingness to dispense from a requirement of informed consent based on their trust in healthcare professionals.We find that adult Danes are positive towards research that use patient data, and they generally trust general practitioners, hospitals and researchers to treat their data confidentially.Nevertheless, they feel that they have a right to control the use of their data, only 7.3% disagreeing, and that the data belong to them, only 14.0% disagreeing. Answers to further questions about the relation between trust, information and consent show that although trust modifies the wish for information and consent, there is still a strong view that the patient should control the use of data. We find no differences between those who have frequent contact with the healthcare system and those who do not. (shrink)

Introduction Understanding the views of the public is essential if generally acceptable policies are to be devised that balance research access to general practice patient records with protection of patients' privacy. However, few large studies have been conducted about public attitudes to research access to personal health information. Methods A mixed methods study was performed. Informed by focus groups and literature review, a questionnaire was designed which assessed attitudes to research access to personal health information and (...) factors that influence these. A postal survey was conducted of an electoral roll-based sample of the adult population of Ireland. Results Completed questionnaires were returned by 1575 (40.6%). Among the respondents, 67.5% were unwilling to allow GPs to decide when researchers could access identifiable personal health information. However, 89.5% said they would agree to ongoing consent arrangements, allowing the sharing by GPs of anonymous personal health information with researchers without the need for consent on a study-by-study basis. Increasing age (by each 10-year increment), being retired and primary level education only were significantly associated with an increased likelihood of agreeing that any personal health information could be shared on an ongoing basis: OR 1.39 (95% CI 1.18 to 1.63), 2.00 (95% CI 1.22 to 3.29) and 3.91 (95% CI 1.95 to 7.85), respectively. Conclusions Although survey data can be prone to response biases, this study suggests that prior consent agreements allowing the supply by GPs of anonymous personal health information to researchers may be widely supported, and that populations willing to opt in to such arrangements may be sufficiently representative to facilitate valid and robust consent-dependent observational research. (shrink)

Background: Information sharing is one of the most important means of public health nurses collaborating with other healthcare professionals and community members. There are complicated ethical issues in the process. Research objectives: To describe the ethical dilemmas associated with client information sharing that Japanese public health nurses experience in daily practice and to clarify their decision-making process to resolve these dilemmas. Research design: Data were collected using a three-phase consensus method consisting of semi-structured interviews, (...) self-administered questionnaires and a group interview. Participants and research context: We surveyed administrative public health nurses in Shizuoka Prefecture, Japan. The semi-structured interviews were carried out with 12 administrative public health nurses, and the self-administered questionnaires were sent to all 899 administrative public health nurses. The group interview was carried out with eight administrative public health nurses. Ethical considerations: Ethical approval was granted by the ethics committee of the School of Health Sciences, Nagoya University, Japan (8-158, 9-130). Findings: Information-sharing ethical dilemmas occurred most often when clients’ decisions did not coincide with the nurses’ own professional assessments, particularly when they faced clinical issues that were inherently ambiguous. In their decision-making processes, nurses prioritised ‘protection of health and life’. Discussion: These findings suggest that, above all, they sought to address urgent risks to clients’ lives while upholding the principle of client autonomy as much as possible. In such cases, the nurses made decisions regarding whether to share information about the client depending on the individual situation. Conclusion: Public health nurses should protect the client’s health while taking into consideration their relationship with the client. (shrink)

The progress of electronic health technologies and biobanks holds enormous promise for efficient research. Evidence shows that studies based on sharing and secondary use of data/samples have the potential to significantly advance medical knowledge. However, sharing of such resources for international collaboration is hampered by the lack of clarity about ethical and legal requirements for transfer of data and samples across international borders. Here, the International Clinical Trial Center Network reports the legal and ethical requirements governing data (...) and sample exchange across four continents. The most recurring requirement is ethical approval, whereas only in specific conditions approval of national health authorities is required. Informed consent is not required in all sharing situations. However, waiver of informed consent is only allowed in certain countries/regions and under certain circumstances. The current legal and ethical landscape appears to be very complex and under constant evolution. Regulations differ between countries/regions and are often incomplete, leading to uncertainty. With this work, ICN illuminates the unmet need for a single international collaborative framework to facilitate DSE. Harmonising requirements for global DSE will reduce inefficiency and waste in research. There are many challenges to realising this ambitious vision, including inconsistent terminology and definitions, and heterogeneous and dynamic legal constraints. Here, we identify areas of agreement and significant difference as a necessary first step towards facilitating international collaboration. We propose the establishment of a working group to continue the comparison across jurisdictions, create a standardised glossary and define a set of basic principles and fundamental requirements for DSE. (shrink)

Online health communities have enjoyed increasing popularity in recent years, especially in the context of the COVID-19 pandemic. However, several concerns have been raised regarding the privacy of users’ personal information in OHCs. Considering that OHCs are a type of data-sharing or data-driven platform, it is crucial to determine whether users’ health information privacy concerns influence their behaviors in OHCs. Thus, by conducting a survey, this study explores the impact of users’ health information (...) privacy concerns on their engagement and payment behavior in OHCs. The empirical results show that users’ concerns about health information privacy reduce their Paid in OHCs by negatively influencing their OHC engagement. Further analysis reveals that if users have higher benefit appraisals and lower threat appraisals, the negative effect of health information privacy concerns on users’ OHC engagement will decrease. (shrink)

Background We aimed to examine the ethical concerns Singaporeans have about sharing health-data for precision medicine and identify suggestions for governance strategies. Just as Asian genomes are under-represented in PM, the views of Asian populations about the risks and benefits of data sharing are under-represented in prior attitudinal research. Methods We conducted seven focus groups with 62 participants in Singapore from May to July 2019. They were conducted in three languages and analysed with qualitative content and thematic (...) analysis. Results Four key themes emerged: nuanced understandings of data security and data sensitivity; trade-offs between data protection and research benefits; trust in the public and private sectors; and governance and control options. Participants were aware of the inherent risks associated with data sharing for research. Participants expressed conditional support for data sharing, including genomic sequence data and information contained within electronic medical records. This support included sharing data with researchers from universities and healthcare institutions, both in Singapore and overseas. Support was conditional on the perceived social value of the research and appropriate de-identification and data security processes. Participants suggested that a data sharing oversight body would help strengthen public trust and comfort in data research for PM in Singapore. Conclusion Maintenance of public trust in data security systems and governance regimes can enhance participation in PM and data sharing for research. Contrary to themes in much prior research, participants demonstrated a sophisticated understanding of the inherent risks of data sharing, analysed trade-offs between risks and potential benefits of PM, and often adopted an international perspective. (shrink)

For decades, health information has been collected and shared for health care delivery and public health purposes. While the “primary use” of patient data for providing direct health care services is the cornerstone of health care practice, health departments rely on data sharing for research and analysis to support disease prevention and health promotion in the population. As the U.S. health system undergoes a digital revolution, health information that (...) was previously captured in paper form now can be captured electronically. Electronic health information has transformed the efficiency, capacity, and functions of the U.S. health system. For this reason, there is increased attention to the “secondary use” of electronic patient data for public health uses, including disease reporting and investigation, syndromic surveillance, and patient-specific or population-level communications about health conditions and their associated risk factors. Secondary uses may also encompass clinical research, licensure, and payment for services. (shrink)

Information is clearly vital to public health, but the acquisition and use of public health data elicit serious privacy concerns. One strategy for navigating this dilemma is to build 'trust' in institutions responsible for health information, thereby reducing privacy concerns and increasing willingness to contribute personal data. This strategy, as currently presented in public health literature, has serious shortcomings. But it can be augmented by appealing to the philosophical analysis of the concept of trust. (...) Philosophers distinguish trust and trustworthiness from cognate attitudes, such as confident reliance. Central to this is value congruence: trust is grounded in the perception of shared values. So, the way to build trust in institutions responsible for health data is for those institutions to develop and display values shared by the public. We defend this approach from objections, such as that trust is an interpersonal attitude inappropriate to the way people relate to organisations. The paper then moves on to the practical application of our strategy. Trust and trustworthiness can reduce privacy concerns and increase willingness to share health data, notably, in the context of internal and external threats to data privacy. We end by appealing for the sort of empirical work our proposal requires. (shrink)

Intensified and extensive data production and data storage are characteristics of contemporary western societies. Health data sharing is increasing with the growth of Information and Communication Technology platforms devoted to the collection of personal health and genomic data. However, the sensitive and personal nature of health data poses ethical challenges when data is disclosed and shared even if for scientific research purposes. With this in mind, the Science and Values Working Group of the COST Action (...) CHIP ME ‘Citizen's Health through public-private Initiatives: Public health, Market and Ethical perspectives’ identified six core values they considered to be essential for the ethical sharing of health data using ICT platforms. We believe that using this ethical framework will promote respectful scientific practices in order to maintain individuals’ trust in research. We use these values to analyse five ICT platforms and explore how emerging data sharing platforms are reconfiguring the data sharing experience from a range of perspectives. We discuss which types of values, rights and responsibilities they entail and enshrine within their philosophy or outlook on what it means to share personal health information. Through this discussion we address issues of the design and the development process of personal health data and patient-oriented infrastructures, as well as new forms of technologically-mediated empowerment. (shrink)

In health care, the provision of pertinent information to patients is not just a moral imperative but also a legal obligation, often articulated through the lens of obtaining informed consent. Codes of medical ethics and many national laws mandate the disclosure of basic information about diagnosis, prognosis, and treatment alternatives. However, within publicly funded health care systems, other kinds of information might also be important to patients, such as insights into the health care priorities (...) that underlie treatment offers made. While conventional perspectives do not take this as an obligatory part of the information to be shared with patients, perhaps through viewing it as clinically “non-actionable,” we advocate for a paradigm shift. Our proposition diverges from the traditional emphasis on actionability. We contend that honoring patients as equal moral agents necessitates, among other principles, a commitment to honesty. Withholding specific categories of information pertinent to patients’ comprehension of their situation is inherently incompatible with this principle. In this article, we advocate for a recalibration of the burden of proof. Rather than requiring special justifications for adding to the standard set of information items, we suggest that physicians should be able to justify excluding relevant facts about the patient’s situation and the underlying considerations shaping health care professionals’ choices. This perspective prioritizes transparency and empowers patients with a comprehensive understanding, aligning with the ethos of respect for the patient as person. (shrink)

(2012). UK Conference Report: Confidentiality and Collaboration—The Ethics of Information Sharing in Health and Social Care. Ethics and Social Welfare: Vol. 6, No. 1, pp. 74-78. doi: 10.1080/17496535.2012.651888.

Wearable self-tracking devices capture multidimensional health data and offer several advantages including new ways of facilitating research. However, they also create a conflict between individual interests of avoiding privacy harms, and collective interests of assembling and using large health data sets for public benefits. While some scholars argue for transparency and accountability mechanisms to resolve this conflict, an average user is not adequately equipped to access and process information relating to the consequences of consenting to further uses (...) of her data. As an alternative, this paper argues for fiduciary relationships, which put deliberative demands on digital health data controllers to keep the interests of their data subjects at the forefront as well as cater to the contextual nature of privacy. These deliberative requirements ensure that users can engage in collective participation and share their health data at a lower risk of privacy harms. This paper also proposes a way to balance the flexible and open-ended nature of fiduciary law with the specific nature and scope of fiduciary duties that digital health data controllers should owe to their data subjects. (shrink)

Robust technology infrastructure is needed to enable learning health care systems to improve quality, access, and cost. Such infrastructure relies on the trust and confidence of individuals to share their health data for healthcare and research. Few studies have addressed consumers’ views on electronic data sharing and fewer still have explored the dual purposes of healthcare and research together. The objective of the study is to explore factors that affect consumers’ willingness to share electronic health (...) class='Hi'>information for healthcare and research. This study involved a random-digit dial telephone survey of 800 adult Californians conducted in English and Spanish. Logistic regression was performed using backward selection to test for significant associations of each explanatory variable with the outcome variable. The odds of consent for electronic data sharing for healthcare decreased as Likert scale ratings for EHR impact on privacy worsened, odds ratio = 0.74, 95% CI [0.60, 0.90]; security, OR = 0.80, 95% CI [0.66, 0.98]; and quality, OR = 0.59, 95% CI [0.46–0.75]. The odds of consent for sharing for research was greater for those who think EHR will improve research quality, OR = 11.26, 95% CI [4.13, 30.73]; those who value research benefit over privacy OR = 2.72, 95% CI [1.55, 4.78]; and those who value control over research benefit OR = 0.49, 95% CI [0.26, 0.94]. Consumers’ choices about electronically sharing health information are affected by their attitudes toward EHRs as well as beliefs about research benefit and individual control. Design of person-centered interventions utilizing electronically collected health information, and policies regarding data sharing should address these values of importance to people. Understanding of these perspectives is critical for leveraging health data to support learning health care systems. (shrink)

Social workers form part of many healthcare teams. This role can involve in-depth conversations with clients and home visits. These encounters can reveal sensitive information, not all of which may be accessible to other members of the healthcare team. Most modern healthcare systems employ shared care records, which are populated by, and accessible to, multiple members of the healthcare team. Shared care records are valued for their capacity to enhance inter-professional communication and improve patient care. But this very capacity (...) may increase an underlying tension between privacy and efficient, effective care. Ethical tensions can arise for health social workers between comprehensive documentation and protecting client privacy by limiting access to privileged information obtained in the context of a social work encounter. This qualitative empirical ethics study investigated health social workers' experiences of tensions between client privacy and maintaining complete records, and how they thought the tension should be resolved. Participant testimony informed a pragmatist approach to identify principles governing recording of sensitive information in shared care records. Three principles were identified: necessity, accuracy, and neutrality. Participants' reports of moral concerns about recording indicate that ethical tensions can occur. The identified principles offer a starting point for managing such tensions. (shrink)

The U.S. 2010 Patient Protection and Affordable Care Act exempts members of health care sharing ministries from the individual mandate to have minimum essential insurance coverage. Little is generally known about these religious organizations and even less critical attention has been brought to bear on them and their ACA exemption. Both deserve close scrutiny due to the exemption’s less than clear legislative justification, their potential influence on the ACA’s policy and ethical success, and their salience to current religious (...) liberty debates surrounding the expansion of religious exemptions from ACA responsibilities for both individuals and corporations. Analyzing documents of the United States’ three largest health care sharing ministries and related material, I examine these organizations and their ACA exemption with particular consideration of their ethical dimensions. Here a thick description of the nature and workings of health care sharing ministries precedes a similar account of the ACA exemption. From these empirical analyses, five ethical and policy concerns emerge: the charity versus insurance status of these ministries; the conflation of two ACA religious exemptions; the tension between the values of religious liberty and of justice; the potential undermining of ACA policy goals; and the questionable compliance of health care sharing ministries with ACA exemption requirements. An accurate and informed understanding of HCSMs is required for policymakers and others to justify the ACA exemption of health care sharing ministry members. A sufficient justification would address at least the five ethical and policy concerns raised here. (shrink)

The different and seemingly unrelated practices of Information and Communication Technologies used to collect and share personal and scientific data within networked communities, and the organized storage of human genetic samples and information—namely biobanking—have merged with another recent epistemic and social phenomenon, namely scientists and citizens collaborating as “peers” in creating knowledge. These different dimensions can be found in joint initiatives where scientists-and-citizens use genetic information and ICT as powerful ways to gain more control over their (...) class='Hi'>health and the environment. While this kind of initiative usually takes place only after rights have been infringed —as the two cases presented in the paper show—collaborative scientists-and-citizens’ knowledge should be institutionally allowed to complement and corroborate official knowledge-supporting policies. (shrink)

This study critically examines the concept of benefit‐sharing in the context of health research involving human participants in South Africa, identifying a significant gap in the precision and application of terminology. It introduces a new terminological framework designed to provide clarity and facilitate standardisation in both national and international discourse on benefit‐sharing. The analysis extends to the complex legal landscape in South Africa, highlighting the nuances of mandated, permitted, and prohibited practices of benefit‐sharing across various statutes. (...) This reveals substantial implications for ethics committees, researchers, and participants, emphasising the need for a legal and ethical recalibration. Furthermore, the manuscript critiques South Africa's main ethics instruments for their inadequate guidance on benefit‐sharing and proposes recommendations for enhancing the Department of Health's ethics guidelines. By advocating for a coherent, legally informed approach to ethical decision‐making, the study underscores the need for integrating the proposed framework and legal insights into ethics guidelines. This comprehensive strategy aims not only to advance ethical practices within South Africa but also to contribute significantly to the global discourse on benefit‐sharing in health research. (shrink)

Background Shared decision-making in healthcare is a collaborative process where patients are supported to make informed decisions according to their preferences. Healthcare decisions affect patients' lives which necessitates patients to participate in decisions concerning their health. This study explored experiences and ethical issues related to shared decision-making in a rural healthcare setting. Methods An exploratory qualitative study was conducted at Budumba Health Centre III and Butaleja Health Centre III in rural Eastern Uganda. In this study, 23 in-depth (...) interviews were conducted among 12 healthcare providers and 11 patients. Data was analyzed thematically using NVivo-12 plus software. Results Four themes emerged which included: Paternalistic cultures of care, challenges, strategies for improvement, and ethical issues. Patients at both facilities expressed the need to be involved in decision-making processes. However, many stressed that they are not engaged in decision-making about their health. Many healthcare providers noted that shared decision-making could improve patient prognosis but are faced with challenges related to low male involvement and the influence of cultural and religious practices, including myths and patriarchal attitudes which impact effective patient engagement. Ethical issues identified include concerns about informed consent, privacy and confidentiality, deception, and harm. Conclusions This study highlighted the need for better sensitization of patients and comprehensive training for healthcare providers to minimize and resolve ethical issues that emerge during shared decision-making processes. Therefore, targeted interventions are needed to enhance decision-making processes in rural healthcare including but not limited to developing shared decision-making manual and continuous training of healthcare providers to ethically engage patients. Further research is needed to explore larger facilities with a bigger scope including patients under 18 years of age and and their surrogates. (shrink)

A number of central government policy initiatives in the UK are encouraging the sharing of information between government and other partners. A relatively large amount of information is available to enhance social inclusion but this data does not always have the detail required to investigate small areas. As a result information sharing of locally generated information is increasing in the UK, particularly for issues such as health and crime where information is not (...) readily available for Local Authorities. Legal and ethical issues associated with sharing locally generated information are frequently perceived as problematical. Examples of methods and protocols to overcome these problems are reviewed. It is possible that the activities of the Cabinet Office Committee on data sharing will act as an incentive for data sharing. However, an equally important catalyst will be commitment and support across UK central government and at the local level by Chief Executives and members to the principles and benefits of information sharing for better informed policymaking. (shrink)

Current methods of obtaining an informed consent leave much to be desired. Patients rarely read consent forms or understand all of the risks, benefits, or alternatives associated with their treatment. Evaluating the advantages and disadvantages of treatment options often presents a more significant challenge for patients with lower levels of health literacy. This article reviews the evidence of shortcomings in our informed consent system and then explores the potential for a new approach to engage patients at all levels of (...) health literacy in their treatment decisions. Specifically, the article will examine the potential of shared decision-making to bridge gaps in knowledge, increase patient adherence to treatment, and improve health outcomes in low health literacy patient populations. Leveling barriers to treatment information for disadvantaged populations should be a public health imperative, especially if it can be shown to improve health outcomes and reduce health disparities. (shrink)

Mobile health tools are often said to empower users by providing them with the information they need to exercise control over their health. We aim to bring clarity to this claim, and in doing so explore the relationship between empowerment and autonomy. We have identified three distinct models embedded in the empowerment rhetoric: empowerment as information, empowerment as control, and empowerment as values. Each distinct model of empowerment gives rise to an associated problem. These problems, the (...) Problem of Interpretation, the Value Alignment Problem, and the Priority Problem, show that mobile health tools in their current form are either insufficient for empowerment or are self‐defeating. These digital health technologies encourage users to adopt an individualized conception of autonomy, one that may weaken the doctor–patient relationship and undermine practices in shared decision making, and ultimately may not deliver on improving the health outcomes for those that need it the most. (shrink)

In Italy in recent years, an exponential increase in the frequency of medical malpractice claims relating to the issue of informed consent has substantially altered not only medical ethics, but medical practice as well. Total or partial lack of consent has become the cornerstone of many malpractice lawsuits, and continues to be one of the primary cudgels against defendant physicians in Italian courtrooms. Physicians have responded to the rising number of claims with an increase in ‘defensive medicine’ and a prevailing (...) preoccupation with the purely formal aspects of consent. The result is a plethora of consent forms, believed to be a guarantee of ‘informed consent’, as well as a growing reliance on informed consent as a shield against judicial action brought by the patient. Physicians ‘inform’ patients without really sharing information, often delegating the task of communication to other professionals who are not doctors. Italian judges always condemn the physician when information to the patient has been inadequate, thus leading insurance companies to consider the lack of valid informed consent as the total responsibility of the physician and/or the hospital. It is necessary to change tack, to remove this idea of consent which permeates the defensive culture of medical practice. Italian physicians need to be trained, first of all, to become aware that information and consent are two distinct processes, albeit closely connected. Valid communication demands a higher level of professionalism from physicians. (shrink)

Because of the development towards community care, care providers not only exchange information in a team, but increasingly also in networks. This is a challenge to confidentiality. The ethical question is how care providers can keep information about the care receiver confidential, whilst at the same time exchanging information about that care receiver in a team or network? Can shared confidentiality be extended from a team to a network? To clarify this question, the article refers to the (...) advice of an expert ethics committee in mental health care. The advice regards exchange of information in a network as a further step in enhancing collaboration among care providers. Therefore, the good and evident practice of shared confidentiality in a team can be extended to a network if the same conditions are met. First, the care providers participate in a clearly defined and identifiable team or network. Secondly, they have a shared care responsibility. Thirdly, they have a duty of confidentiality. Fourth, they dialogue with the care receiver and obtain his or her consent. Finally, they apply the filter of relevance. Hence, conditional shared confidentiality is an ethical justification for the exchange of information in a team or network. (shrink)

Complementary and alternative medicine is used by many in hopes of achieving important health-related goals. Survey data indicate that 42 percent of the U.S. population uses CAM, accounting for 629 million “office” visits a year and expenditures of 27 billion dollars. This high prevalence of use calls for a careful evaluation of CAM so as to ensure the well-being of those using its modalities. Such an evaluation would obviously include assessments of the safety and efficacy of particular approaches, the (...) training and integrity of practitioners, and the appropriateness of modalities for different conditions or uses. Given the lack of published data concerning many of these aspects of CAM, the likely unfamiliarity of its practitioners to the approaches available to clinicians practicing modern scientific medcine, and the need to respect the unique preferences of persons seeking assistance with achieving health-related goals, it is also important to assess the potential roles of informed consent for the use of CAM. Examining such roles is the central task of this paper. (shrink)

Biobanks are repositories that store human biological materials and their associated data. They are rapidly becoming part of national and international networks and give rise to unique ethico-regulatory issues. Whether consent is informed and whether this term should be used when specimens are collected for biobank research is questionable. Where risks occur, they are usually social and relate to identifiability. Public trust and confidence are important for the success of this type of research. Consensus is growing that governance of biobanks (...) should be harmonised. Controlled specimen and data access agreements are essential. The South African National Health Act and its Regulations, that provide the foundation for the legal framework with regard to human tissue and research in South Africa, are silent on the issue of biobanks and the law lags behind while science and technology advance rapidly. The use of biobank assets will lead to significant benefits in human health and should be encouraged while taking account of the associated ethical, legal and social issues and working towards a balance between these two positions. (shrink)

Patients in around 20 countries worldwide are now offered online access to at least some of their medical records. Access includes test results, medication lists, referral information, and/or the very words written by clinicians (so-called ‘open notes’). In this paper, I discuss the possibility of one unintended negative consequence of patient access to their clinical notes—the potential to increase ‘nocebo effects’. A growing body of research shows that nocebo effects arise by engaging perceptual and cognitive processes that influence negative (...) expectancies, and as a consequence, adverse health effects. Studies show that increased awareness about the side effects of medications, the framing of information and the socioemotional context of care can increase the risk of nocebo effects. Connecting research into the nocebo effect with open notes provides preliminary support for the hypothesis that patient access to clinical notes might be a forum for facilitating unwanted nocebo effects. Furthermore, current findings indicate that we might expect to see systematic differences in how nocebo effects are experienced among different patient populations. The ethical implications of the tension between transparency and the potential for harm are discussed, with an emphasis on what open notes might mean for justice and equity in clinical care for a range of already marginalised patient populations. I argue that to resolve these challenges does not thereby justify ‘closed notes’, and conclude with suggestions for how health systems and clinicians might adapt to this innovation to reduce the risk of potential nocebo effects arising via this novel route. (shrink)

The public health measures implemented in response to the COVID-19 pandemic have resulted in a substantially increased shared reliance on private infrastructure and digital services in areas such as healthcare, education, retail, and the workplace. This development has (i) granted a number of private actors significant (informational) power, and (ii) given rise to a range of digital surveillance practices incidental to the pandemic itself. In this paper, we reflect on these secondary consequences of the pandemic and observe that, even (...) though collateral data disclosure and additional activity monitoring appears to have been generally socially accepted as inevitable consequences of the pandemic, part and parcel of a larger conglomeration of emergency compromises, these increased surveillance practices were not directly justified by appeals to solidarity and public health in the same way that the instigating public health measures were. Based on this observation, and given the increased reliance on private actors for maintaining the digital space, we argue that governments have a duty to (i) seek and ensure that there are justifications for collateral data disclosure and activity monitoring by private actors in the context of (future) public health emergencies like the COVID-19 pandemic, and (ii) regulate and provide accountability mechanisms for and oversight over these private surveillance practices on par with governmental essential services that engage in surveillance activities. (shrink)

Scientific data‐sharing and open science initiatives are increasingly important mechanisms for advancing the impact of genomic research. These mechanisms are being implemented as growing attention is paid to the need to improve the inclusion of research participants from marginalized and underrepresented groups. Together, these efforts aim to promote equitable advancements in genomic medicine. However, if not guided by community‐informed protections, these efforts may harm the very participants and communities they aim to benefit. This essay examines potential benefits and harms (...) of open science and explores how to advance a more just vision of open science in genomics. Drawing on relational ethics frameworks, we argue that researchers should consider their obligations to participants as well as the broader communities that are impacted by their research. We propose eight strategies to provide a foundation of practical steps for researchers to reduce the possibility of harms stemming from open science and to work toward genomic justice. (shrink)

In 2008, Representative John Read of Mississippi recently co-sponsored state legislation that would ban restaurants from serving obese customers. He later admitted that the bill was a publicity stunt,meant to “shed a little light on the number one problem in Mississippi.” Although controversial, Read’s bill exemplifies both the current perception of obesity as a national public health problem and the general sentiment underlying the types of interventions that are being considered to address this issue. The proposed legislation also demonstrates (...) how policymakers can use or, in this case misuse, information about obesity to generate significant discussion on an issue along with ill-conceived legal interventions.Information sharing and the methods used to share best practices are components of the fourth core element of public health legal preparedness. (shrink)

Precision medicine is an emerging approach to treatment and disease prevention that relies on linkages between very large datasets of health information that is shared amongst researchers and health professionals. While studies suggest broad support for sharing precision medicine data with researchers at publicly funded institutions, there is reluctance to share health information with private industry for research and development. As the private sector is likely to play an important role in generating public benefits (...) from precision medicine initiatives, it is important to understand what the concerns are and how they might be mitigated. This study reports outcomes of a deliberative method of citizen engagement in Singapore that asked whether sharing precision medicine data with private industry would be permissible, and if so, under what circumstances. Findings from this citizens’ jury suggest sharing with industry would be permissible under certain conditions that are set out in nine recommendations. Implications of the recommendations and their underlying assumptions for policy decision makers are discussed. This study aligns with prior international studies which found conditional acceptance for data sharing with private industry, a public benefit requirement, specific reluctance to share with insurance companies and an emphasis on accountability and transparency to demonstrate trustworthiness. However, our results differ from prior studies in that opt-in consent did not dominate the deliberations as jurors were able to set it aside as an assumed prerequisite for participation in a precision medicine programme. (shrink)

In the UK, community care has led to more complex relationships for mental health nurses. They need to respect the rights of service users to confidentiality while also respecting the rights of family caregivers to information that directly affects them. An unsatisfactory situation has arisen in which utilitarian and legally driven motives have seen family caregivers’ interests become subsidiary to those of service users and providers. An ethical case is made for sharing information with family caregivers, (...) even against the wishes of service users. Through the use of a conceptual framework based on elements proposed by Thiroux — value of life, goodness or rightness, justice or fairness, truth-telling or honesty, and individual freedom — the article concludes that there is an ethical argument for sharing some information with family caregivers and that nurses should respect caregivers’ rights through their actions. Nurses’ actions are a commitment to seeking what is ‘good’ by making judgements based on what matters. It is argued that people and their relationships matter more than strict adherence to laws and codes. (shrink)

BackgroundThe concept of benefit sharing to enhance the social value of global health research in resource poor settings is now a key strategy for addressing moral issues of relevance to individuals, communities and host countries in resource poor settings when they participate in international collaborative health research.The influence of benefit sharing framework on the conduct of collaborative health research is for instance evidenced by the number of publications and research ethics guidelines that require prior engagement (...) between stakeholders to determine the social value of research to the host communities. While such efforts as the production of international guidance on how to promote the social value of research through such strategies as benefit sharing have been made, the extent to which these ideas and guidelines have been absorbed by those engaged in global health research especially in resource poor settings remains unclear. We examine this awareness among stakeholders involved in health related research in Kenya.MethodsWe conducted in-depth interviews with key informants drawn from within the broader health research system in Kenya including researchers from the mainstream health research institutions, networks and universities, teaching hospitals, policy makers, institutional review boards, civil society organisations and community representative groups.ResultsOur study suggests that although people have a sense of justice and the moral aspects of research, this was not articulated in terms used in the literature and the guidelines on the ethics of global health research.ConclusionThis study demonstrates that while in theory several efforts can be made to address the moral issues of concern to research participants and their communities in resource poor settings, quick fixes such as benefit sharing are not going to be straightforward. We suggest a need to pay closer attention to the processes through which ethical principles are enacted in practice and distil lessons on how best to involve individuals and communities in promoting ethical conduct of global health research in resource poor settings. (shrink)

IntroductionInternational sharing of health data opens the door to the study of the so-called ‘Big Data’, which holds great promise for improving patient-centred care. Failure of recent data sharing initiatives indicates an urgent need to invest in societal trust in researchers and institutions. Key to an informed understanding of such a ‘social license’ is identifying the views patients and the public may hold with regard to data sharing for health research.MethodsWe performed a narrative review of (...) the empirical evidence addressing patients’ and public views and attitudes towards the use of health data for research purposes. The literature databases PubMed, Embase, Scopus and Google Scholar were searched in April 2019 to identify relevant publications. Patients’ and public attitudes were extracted from selected references and thematically categorised.ResultsTwenty-seven papers were included for review, including both qualitative and quantitative studies and systematic reviews. Results suggest widespread—though conditional—support among patients and the public for data sharing for health research. Despite the fact that participants recognise actual or potential benefits of data research, they expressed concerns about breaches of confidentiality and potential abuses of the data. Studies showed agreement on the following conditions: value, privacy, risk minimisation, data security, transparency, control, information, trust, responsibility and accountability.ConclusionsOur results indicate that a social license for data-intensive health research cannot simply be presumed. To strengthen the social license, identified conditions ought to be operationalised in a governance framework that incorporates the diverse patient and public values, needs and interests. (shrink)

International health research in malaria-endemic settings may include screening for sickle cell disease, given the relationship between this important genetic condition and resistance to malaria, generating questions about whether and how findings should be disclosed. The literature on disclosing genetic findings in the context of research highlights the role of community consultation in understanding and balancing ethically important issues from participants’ perspectives, including social forms of benefit and harm, and the influence of access to care. To inform research practice (...) locally, and contribute to policy more widely, this study aimed to explore the views of local residents in Kilifi County in coastal Kenya on how researchers should manage study-generated information on sickle cell disease and carrier status. (shrink)

BackgroundIn this article, we address questions regarding how people consider what they do or do not consent to and the reasons why. This article presents the findings of a citizen forum study conducted by the University of Geneva in partnership with the Geneva University Hospitals to explore the opinions and concerns of members of the public regarding predictive oncology, genetic sequencing, and cancer. MethodsThis paper presents the results of a citizen forum that included 73 participants. A research tool titled "the (...) mechanics of consent" was designed for this study. This tool is a table encouraging participants to reflect on social and research actors, types of data, and desired levels of control while sharing different types of data with different actors. Participants’ discussion that led to the completion of each table were audio-recorded, transcribed, and analyzed using thematic analysis.ResultsThe results are a compilation of responses from the mechanics of consent tool divided into two sections; the first presents quantitative results of collective responses regarding attitudes to consent to donate their data. The second section present qualitative findings emerged from the discussion amongst participants.DiscussionChoice and control of personal data is crucial for the public to be able to decide who and how to trust. Key information to be disclosed to potential research participants shall include information about potential risks and benefits; who will be accessing and using their data; as well as assurances that their choice will be respected. Furthermore, researchers ought to make sure they are trustworthy, by acting in a competent, reliable, and honest manner. Governance systems ought to be better equipped to address ethical issues raise by the growing presence of non-traditional research actors, consent of exchanges of data via digital devices and online activity such as social media and fairness of data trading. Finally, informed consent is one of the various elements that contribute to conducting ethical research. More needs to be done to strengthen governance and ensure adequate protection of research participants, particularly to address issues related to predictive health analytics. (shrink)

The exponential digitization of medical data has led to a transformation of the practice of medicine. This change notably raises a new complexity of issues surrounding health IT. The proper use of these communication tools, such as telemedicine, e-health, m-health the big medical data, should improve the quality of monitoring and care of patients for an information system to "human face". Faced with these challenges, the author analyses in an ethical angle the patient-physician relationship, sharing, (...) transmission and storage of medical information, setting pins to an ethic for the digitization of medical information. Drawing on good practice recommendations closely associated with values, this model is developing tools for reflection and present the keys to understanding the decision-making issues that reflect both the technological constraints and the complex nature of human reality in medicine. (shrink)

ABSTRACT Data from digital technologies are increasingly integrated in public health research. In April of 2020, we interviewed a subset of participants who completed a survey approximately one month earlier. Using the survey, we contacted and interviewed participants who had expressed their willingness or unwillingness to share digital data for use in public health. We followed a directed content analysis approach for the analysis of the interview data. Among participants who had reported being unwilling to share data, concerns (...) about privacy, confidentiality, and the purpose of the research were cited. During the interviews, 76.9% of the participants who had who had previously indicated that they were unwilling to share their data, expressed willingness to share data in order to assist with COVID-19 prevention. Our results contribute to our understanding of people’s perspectives on sharing personal data and of the way their perspectives can vary as a function of potential uses of their personal information. (shrink)