Data Sharing Research Ethics Research Paper

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Abstract

The availability of high quality data is a foundational component of developments in health care, with one step in the research process being to develop an ethically appropriate data sharing policy that will optimize the benefits derived from a particular research project, while protecting rights and interests. The work of devising a policy would benefit from having an ethics framework available, although the impacts on research of the ongoing rapid advances in science and technology constantly bring new challenges for the ethics of data sharing. Some of these challenges are addressed in this entry, starting by making an overview of the main data sharing stakeholders and the most important settings and perspectives that frame the ethics of data sharing. The main ethics principles and positions relevant to an ethics framework are introduced, noting that the moral default position is held to be that data should be shared so as to achieve a just distribution of research benefits, although some conditions must be attached to protect and respect tangential rights and interests. A case study is then described and discussed. The central point of the concluding comments is that “data” is not meaningful object of ethics reflection if disconnected and isolated from its context.

Introduction

An appropriate data sharing policy is needed in order to maximize developments in health care, while protecting rights and interests. This entry addresses the challenges in developing a data sharing ethics framework in view of the ongoing rapid advances in science and technology. The term “data” refers to the results of medical and public health research, including clinical trials. An overview of the main data sharing stakeholders is made (namely, the commercial sector, research funders, and academic researchers and research communities). The important settings and perspectives that frame the ethics of data sharing are then sketched: the national political setting, disadvantaged country setting, and the global public health perspective on data sharing. The main ethics principles and positions relevant to a data sharing ethics framework are then introduced. A case study is then described and discussed. Some concluding comments close this entry on how a research project can develop a data sharing policy.

Background

Progress in individual and public health relies on the fruitful conduct of biomedical research. Research is a convoluted process that starts with a research question, followed by the selection of the research methodology that will best address the question. The process continues with data collection or generation, and the processing and analysis of the data that leads to the production of information and knowledge. The knowledge finally requires translation into effective and efficient interventions, therapeutics and diagnostics. Data is therefore a foundational and necessary component of healthcare and public health development, with one step in the research process being to develop an ethically appropriate data sharing policy that will optimize the benefits that can be derived from the research.

This importance of health data is underlined by attainable health being a fundamental right (WHO 1946), with attainable health allowing the enjoyment of other human rights, and giving an individual or community the capacity to fulfil duties. However, many people do not have access to the health that would be attainable if resources were available. Many health problems in disadvantaged contexts also remain without any known resolution. Undertaking research (including generating and sharing data) is therefore especially important when working with the disadvantaged.

The determinants of individual and public health are manifold, dynamic, and occur at various levels: global, international, national, and local. Each research data sharing situation has a specific context and group of stakeholders. Stakeholders are understood as being the parties who have duties, responsibilities, rights, and interests in a decision to share or not to share. Determinants include the national and international political and health care systems within which research takes place and within which data access and sharing decisions are taken.

Many research data sharing discussions are driven by advances in science and technology that bring new challenges when developing data sharing ethics. In particular, progress in the “–omics” sciences combined with computing technologies lead to the production of vast sets of raw data. The rapid development in informatics means that these unstructured data sets can be structured and analyzed. If “data mining” methods are applied to “big data,” information can be extracted that can be ethically problematic, especially if research participants did not give informed consent for such activities. Health data is often very sensitive, e.g., when referring to racial or ethnic origin, when correlated with physical, mental, and social health, or data on a predictive SNIP. Because of this sensitivity, health data requires special protection to mitigate risks of harm to individuals, communities, and populations.

In addition to the important downstream creation of health benefits, data sharing can also bring risk of harm on an individual, community, population (public health), and global level.

Conceptual Clarification

It is against the complex, multidimensional canvas sketched above that “data sharing” needs to be the subject of ongoing ethical analysis and reflection, with the general and situation-specific questions that need to be the addressed including the following nonexhaustive list:

– Should health data upon which the right to attainable health depends be in private hands or should ownership and control be in the hands of a State (and what rights and duties should a State have)?

– Should researchers who generate data be seen as custodians of the data?

– Do specific categories of data bring a particular duty to share, e.g., data that is very important for health?

– Do specific sources of funding bring a particular duty to share, i.e., public funded research?

– If health data should be shared, are there any conditions of data sharing?

– With whom should health data be shared, i.e., with researchers, with the general public?

– Are there any risks of harm that data sharing might bring; if yes, what preventive/mitigation plans are in place?

– If data is to be shared, what should the timing of data release be; at what point in the value chain should the sharing occur?

– Is it appropriate to pursue intellectual property; if yes, has a strategy been developed after considering stakeholders rights and interests?

– Should the process of developing a data sharing policy be participatory; should the policy require that a participatory process be conducted when taking data sharing decisions?

The task of addressing these issues requires that an ethics of data sharing framework be available. This entry hopes to make a contribution to this ongoing task. The first section outlines some important data sharing stakeholders, with the main data sharing decision settings and perspectives then being sketched. A selection of rights, approaches, and principles central to the ethics of data sharing will be introduced. A case study that illustrates data sharing issues in a global health emergency situation will then be presented, followed by a discussion and concluding comments. As the field of genomics research, it is in the forefront of addressing many of these questions, genomics health research will be frequently used as an example.

Data Sharing Stakeholders

Commercial Sector

Considerable pressure is placed on the commercial health sector to freely share the data generated by their clinical trials based primarily on a utilitarian argument that this will maximize health benefits. A major issue is the intellectual property – patent – policy that should be adopted. A patent is an agreement whereby an inventor shares knowledge for the advancement of society, in exchange for a period of monopoly rights to translate and commercialize a new invention. Although the patent process requires that patented knowledge be shared (published), third parties cannot apply the patented knowledge in the market place for the life of the patent.

Whether patenting furthers or hinders optimizing data sharing and improving attainable health is a complex and contested question. One perception is that being able to secure monopoly rights to commercially exploit patented knowledge is an important motor for innovation, as the super profits associated with such a monopoly allow for the recuperation of research costs. The contrary position is that patents and the resulting absence of competition increases prices and slows innovation, thus limiting access to medicines, vaccines etc., particularly in poorer countries.

Research Funders

In addition to the private pharmaceutical sector, health research can be funded by various institutions including the State; universities; philanthropic foundations; international funding institutions (such as the European Commission), and private-public partnerships. The influence of funders in setting data sharing norms in the research community is considerable. For instance, noncommercial funders increasingly enforce data sharing standards by specifying that data sharing in some form is a condition of funding. Providing entirely open access is however not necessarily seen as being appropriate; access may reasonably be limited to researchers.

Regarding the question if specific sources of funding bring particular duties to share, being subsidized by public money arguably gives rise to specific duties towards the funding public, towards future generations, towards the society in which the research is embedded and from which research participants are drawn.

Academic Researchers and Research Communities

Of the variety of educational systems that exist, this text will focus on public, State-supported higher education, i.e., universities. The academic world is not static, but dynamic; academic freedom has its limits, with academia being subjected to many influences and pressures. The changes include contentious closer connections with the commercial sector, with patents being increasingly pursued. The World Conference on Science Framework for Action (UNESCO and ICSU 1999) supports intellectual property rights in academia, while recognizing that access to data and information is essential for scientific progress. The Budapest Open Access Initiative (Open Society Institute 2002) holds that reasonable delays in data sharing in order to seek a patent can be allowed, although a permanent exemption from publication in order to pursue a patent is not favored.

Political institutions and public opinion often exert pressures on academic research direction and methods (limiting the freedom of science). Pressures also come from increasing competition among scientists. In addition to receiving funding from the State, many academics must also compete for research funding from national and international bodies. Finally as outlined above, some funders attach criteria to their funding that require that data be shared.

Data Sharing Settings And Perspectives

National Political Setting

An important framework for data sharing is the international and national political and health care systems within which research and data access and sharing decisions take place. Because of the fundamental importance of health, the question arises if health data needs to be considered as being a public good, i.e., a good that should be nationally accessible, with State institutions having a high level of responsibility for their provision, rather than allowing their supply to be regulated by the free market. It is generally accepted that national health agencies have a duty to undertake public health research and monitoring, needing therefore to be mandated with the power to collect, analyze, store, and share data in order to maintain and protect the health of their citizens. They need to be empowered to undertake a range of activities, including data collection and sharing in health emergencies. The mandate that a State receives from its citizens often includes the power to waive the fundamental research ethics requirement of obtaining informed consent based on an “assent” having been given as part of the political process (assuming that a democratic political system is in place).

Disadvantaged Country Setting

Biomedical research conducted in economically less developed or developing countries with weak health care systems and inequalities in access to health resources face many challenges, with developing countries suffering a higher disease burden, and being more vulnerable when compared with financially secure countries.

Socioeconomic difficulties do not weaken the obligations to protect and respect fundamental rights such as the right to attainable health. Although the extent of the responsibilities and degree of accountability of those who enable and conduct research in regions where unjust conditions prevail is contested, the status quo in the host community should not be taken as excusing or requiring that human rights be seen as being relative, rather than universal. Practices that are likely to worsen unjust conditions or contribute to new inequities must be avoided. No advantage should be taken of the relative inability of low-resource countries or vulnerable populations, and research must respond to local health needs and priorities.

NGOs have become increasingly important agents of the health development process and should accordingly be seen as stakeholders in data sharing discussions in disadvantaged settings. Ascertaining the responsibilities of researchers in such settings is challenging. The World Conference on Science Framework for Action (UNESCO and ICSU 1999) states that initiatives to facilitate developing country access to scientific information should be encouraged with scientists, research institutions and learned scientific societies, and other relevant nongovernmental organizations committing to increase international collaboration and the exchange of knowledge and expertise.

Global Public Health Data Sharing Perspective

In a world where many threats to health are global, the scale of the canvas on which data sharing bioethics is developed must likewise be global. For instance, when highly infectious diseases or rapidly spreading threats to health are involved, health emergencies of an international scope arise that need coordinated efforts on a cross-border level in order to respond rapidly and effectively.

Should data that can contribute to global health be seen as a commodity with distribution being according to market forces? Or should essential health data be treated as being a global public good that should be globally accessible, independent from the ability to pay, with State institutions having a high level of responsibility for their provision?

The ethics reflection surrounding genomics research has indeed moved in the direction of considering data as being a global public good (a position that sits uneasily with pursuing intellectual property rights). The UNESCO Universal Declaration on the Human Genome and Human Rights (1997) holds the human genome as underlying “the fundamental unity of all members of the human family”, and as being in a “symbolic sense the heritage of humanity.” This position suggests that the human genome and arguably its associated data is a global public good, being optimally the subject of a liberal global access and data sharing requirements. Indeed, the opinion has been expressed that “genomic ethics must be informed by issues beyond the legal and ethical parameters of autonomy and privacy,” and include reflections at the level of populations (Knoppers and Fecteau 2003).

Health globalization also raises questions such as who is willing and empowered to act on a global level regarding data sharing on an international level, noting the constraining effects of the Westphalian principle of the sovereign rights of States (according to which decisions on cross border sample and data sharing must lie with the State)?

Data Sharing Ethics: Rights, Approaches, And Principles

As observed above, the appropriate ethics principles and positions need to be selected in order to form an appropriate and justifiable data sharing policy. A few of the rights, approaches, and principles are now outlined.

Human Rights Discourse: Attainable Health, Nondiscrimination, And Vulnerability

The position has been quoted above that the highest attainable standard of health is a fundamental right of every human being. The importance of attainable health as a human right is a strong argument that data sharing should be the default position, with sharing occurring in all instances where there are reasonable expectations that it will contribute to improvements in health. The term “default position” indicates that data sharing should be the starting position in a decision making process; those holding different positions have the burden of justifying their position.

Discrimination is a distinction, exclusion, or restriction that has the effect or purpose of impairing or nullifying the recognition, enjoyment, or exercise of human rights and fundamental freedoms. Those suffering from discrimination are more vulnerable to poverty and ill health. The nondiscriminatory provision of health services, goods, and facilities is crucial to the enjoyment of the right to the highest attainable standard of health. The writers of a data sharing policy must be cognizant of the interface of data sharing with human rights: the act of sharing data can have a discriminatory impact and risk making individuals, groups, or communities vulnerable. An appropriate approach to data sharing can however also contribute to dismantling the harmful impacts of discrimination.

The human rights discourse is however contested based on epistemological arguments that human rights lack an objective foundation and justificatory power, and are too vague, weak and ambiguous. Nevertheless, the UNESCO Universal Declaration of Human Rights (1948) provides a guideline for operationalization, stating that “everyone has the right to a standard of living adequate for the health of himself and of his family, including food, clothing, housing, and medical care and necessary social services.” The UNESCO 2003 International Declaration on Human Genetic Data specifically states that any collection, processing, use and storage of data shall be consistent with the international law of human rights.

Respect For Persons

The principle of respect for persons is central to many data sharing discussions. The principle incorporates at least two fundamental ethical considerations. Firstly is respect for autonomy, which requires that those who are capable of deliberation about their personal choices should be treated with respect for their capacity for self-determination. One expression of the right to autonomy takes the form of conducting an informed consent process prior to commencing research. The information that must be provided must include information on plans to share data.

Secondly is the need to protect persons with impaired or diminished autonomy, a principle that must be applied to justify sharing a vulnerable person’s data. It should be noted that regarding public health interventions, the State is often empowered to waive the requirement to obtain informed consent.

Finally are the rights to personal privacy and the confidentiality of personal data that flow from the principle of respect for persons. Protecting and respecting such rights are important considerations in data sharing ethics.

Respect At The Community Level

Because research results can have repercussions at the level of the community as well as the individual, developing the ethics of data sharing needs to address both levels. Regarding the principle of respect, a justificatory condition for research on an individual level is that it must be carried out in ways that are acceptable and shows respect for the communities in which the research is carried out (CIOMS 2002). It is reasonable to extend this condition to data sharing, so that the data sharing policy and procedures must be respectful and acceptable to the community. This is reflected in the Human Genome Organization HUGO research ethics principles that state that respect must be shown for the values, traditions, and culture of participants (HUGO 2006). In addition, the human rights discourse has been extended to the community level in the form of contentious “third generation rights” that are concerned with and group and collective rights, a development especially relevant for issues surrounding consent and assent.

Privacy And Data Confidentiality

Regarding how the rights to personal privacy, the confidentiality of personal data, and protection against unauthorized access to data are upheld, the main method is to shield personal identity by removing data that could lead to identification, and by applying a coding system to the data. The risks of reidentification include the release of confidential personal information on medical history, personal habits, financial situation, etc.

However, rapid technological developments provide opportunities to transform anonymous data into personal identifiable data, due to the richness of the data derived from applying sophisticated informatics tools. An ethical problem is if individuals gave consent after being informed that their data would be anonymous or anonymized, and were not informed that reidentification (with its inherent risks) was a possibility. This situation is one of the main arguments against data sharing.

There is a counterargument that research participant’s altruistic willingness to contribute to advancing science for the public good weights very heavily, so that they might be prepared to take the risk of reidentification (Gøtzsche 2011; Doshi et al. 2012). Participants must however be made aware of any risk reidentification and any limitation in the ability of the researchers to secure privacy and confidentiality during the consent process.

Beneficence

A benefit is a good that contributes to the wellbeing of an individual or a group; the principle of beneficence refers to an obligation to maximize benefits. One of the groups who can benefit from a liberal data sharing policy of current and future patients vulnerable person’s data. Other beneficiaries are research communities, as the sharing of data supports the testing of new or alternative hypotheses and methods of analysis; permits the creation of new datasets when data from multiple sources are combined; supports reproducing and validating analyses and secondary-hypothesis testing; enables comparisons with previous studies and simplifies and enhances subsequent systematic reviews and meta-analyses. Sharing also realizes the full scientific and social value of data by enabling the combining of datasets (NIH 2003). From the perspective of research funders, sharing data helps reduce an unnecessary duplication of scientific effort and the squandering of resources. Sharing increases the return on a funder’s investment in research. Sharing data also helps the health care and medical professions make a full risk benefit analysis, and support patients being able to make a more informed decision.

Nonmaleficence

The principle of nonmaleficence – do no harm – proscribes the deliberate infliction of harm on persons. The release or sharing of health data can have harmful implications on various levels (particularly when data from genomics research is involved): the individual, a community, as well as having implications for family members of participants. The concerns include that research findings could lead to discrimination and stigmatization, such as genetic research findings that suggest a connection between ethnic background and disease predisposition.

Justice, Solidarity, And Benefit Sharing

Justice refers to the ethical obligation to treat each person in accordance with what is morally right and proper, to give each person what is due to him or her. In the ethics of research involving human subjects, the principle refers primarily to distributive justice. This requires the equitable distribution of both the burdens and the benefits of participation in research. Differences in distribution of burdens and benefits are justifiable only if they are based on morally relevant distinctions between persons. The principle of distributive justice can be held to be relevant for the ethics of data sharing at two levels: firstly is that data should be shared in order to ensure an equitable distribution of research benefits. Secondly is to consider how to apply the principle when drafting a data sharing policy, i.e., how best to serve distributive justice, with one approach being to incorporate in a policy a clear and fair position on “benefit sharing” (taking the position that data can be seen as an important benefit that should be shared). The benefit sharing concept holds that the principles of distributive justice and reciprocity should be implemented by returning to and sharing with research participants and their communities the benefits of research. Benefit sharing also expresses solidarity (understood as being the bond that integrates individuals into a people, a society, and a community as a greater entity than a mere collection of persons). It is becoming an established international research ethics principle, although the entitlement and content of the concept is still being developed, especially when conducting research in less developed countries.

Research Ethics In Academia

Academic data producers are key data sharing stakeholders in the question to-share-or-not-toshare. What position should researchers take in the debate; what does research ethics prescribe? A traditional value is that research should be the common property of the whole scientific community, and be reciprocally shared among scientists. The reasoning is primarily utilitarian, i.e., that this will maximize the chance that the research will contribute to raising the level of attainable health. A scientist does however have rights, including receiving due recognition and appropriate reward for their achievements; a scientist does not traditionally have sole property rights, indicating that academia supports data sharing and the adoption of an open access paradigm. That academia has the power to influence the development of data sharing ethics is illustrated by the field of genomics that promulgates a culture of the rapid open release of data, with “open” meaning primarily towards the scientific community. Several normative documents have arisen from academia (Bermuda Principles 1996 and Fort Lauderdale Agreement 2003).

In furtherance of a position of supporting data sharing, many academic institutions are pursuing “Open Access” models of data release. “Open Access” (OA) refers to a paradigm whereby research findings should be universally accessible free of charge. OA combines the power of the internet with the traditional willingness of scientists to submit their work to peer review and publish research results without payment. OA removes price and permission barriers, moving towards treating knowledge as a public good. A main driving force for OA is dissatisfaction with the financially based system whereby access to data and knowledge requires an expensive journal subscription, thus limiting access to those who have the necessary purchasing power.

However, does removing the subscription financing structure risk compromising the quality of published research findings and quality of published knowledge? In spite of the scientific ethos that authors and reviewers are not remunerated, all publication models do need resources, with a major cost area flowing from upholding the research integrity norm of conducting peer reviews.

Public Health Ethics Perspective

Medicine focuses on the treatment, diagnosis, or palliative care of individuals. In contrast, the tasks of public health are proactive and preventive rather than therapeutic; public health operates at the level of a population. It aims to understand, ameliorate, or improve the health of a population or prevent its deterioration. While clinical and medical ethics are dominated by the obligation to respect the individual patient’s right to autonomous decisions and actions, public health is concerned with actions in relation to a population. When considering public health in multinational settings, an appropriate definition is that public health is the process of mobilizing local, State, national, and international resources to solve the major health problems affecting communities.

An analysis from a public health perspective typically requires taking a pluralist ethics approach, making use of deontological principles on both the individual and societal level such as global justice, fairness, procedural justice, solidarity, and community based rights and duties towards communities. Issues of fiduciary responsibility towards a population, and the need to uphold standards of accountability and transparency are important, as is taking a utilitarian approach of balancing benefits and harms. Other relevant approaches are human rights, communitarianism, and relational ethics. Although public health ethics acknowledges the default position taken by individual-focused medical ethics that the rights and interests of the individual must take priority over societal interests, situations do arise on a public health level where the individualistic default position must be overridden by health concerns on a societal level. As work on the ethics of data sharing progresses, the body of work on public health ethics is certainly an area that could give some important insights.

Data Sharing Case Study

An exemplary case is now presented to render more concrete the challenges in forming an ethics of data sharing.

The case is concerned with the H5N1 – bird flu – Wave III outbreak that started in 2004. The WHO is the focal surveillance organization regarding dangerous pathogens of international concern. The WHO relies on the cooperation of member States in reporting outbreaks and providing samples from which the WHO obtains the necessary data.

Indonesia’s first human H5N1 cases were identified in July 2005. The Indonesian government sent all clinical specimens to the WHO’s reference laboratories in their influenza surveillance network until the end of 2006.

However, they announced in 2007 that they would stop sending H5N1 viruses samples to the WHO’s laboratories.

Indonesia’s decision raised national and international concern that international public health could be endangered because the reason that scientists need H5N1 isolates is to extract data and track the virus’s evolution, develop vaccines, and monitor drug resistance. The Indonesian concerns that led to this decision included the following:

(a) It was reported that a company planned to develop an H5N1 vaccine from a virus provided by that Indonesia had provided to the WHO network; it was feared that the developing countries will not be able to afford any resulting vaccines.

(b) Concerns that samples provided freely by developing countries are used by companies in wealthy countries to generate profits that would not be shared.

(c) Reports were received from scientists attending international meetings that results of analyses of H5N1 viruses from Indonesia were being presented, without first getting permission from or notifying Indonesia.

The Indonesian government demanded that a guarantee be given that all countries in this position in the future will be given a share in the benefits derived from the material provided, and support in developing its own vaccine manufacturing capacity. Ethics of science norms previously ignored must be applied, i.e., that Indonesia’s scientists be fully informed, involved, and acknowledged in all publications. Fair benefit sharing must be introduced, and a data sharing policy established. (As postscript, Indonesia did resume sharing materials after discussions with the WHO).

Case Discussion

The aim of this section is not to judge any of the decisions taken in 2007, but to identify and consider the ethics of data sharing principles and approaches that are helpful to analyze events and identify the lessons that should be learnt as the moral community moves forward in the development of data sharing ethics.

In spite of international pressure to collaborate and follow the established norms in health emergencies, the case shows a State that was not prepared to provide samples that were needed to allow data to be generated and shared. The main consequence of such a decision is to delay the development of antivirals and vaccines. Such decisions bring a shorter-term risk of harm to those locals who are infected or are at risk of infection from the virus. On the longer term, holding back data sharing increased the risk from infection in both disadvantaged and developed populations. If a government slows the research process in a health emergency, the risk of longer-term global harms is increased.

The reasons offered for withholding data take a means-justifying-the-ends structure. A longitudinal, utilitarian position is taken, based on the argument that the pressure created by withholding data would lead to changes in distributive justice and benefit sharing that would make future responses to global health threats more just, effective, efficient, and timely. Indonesia’s position can be seen as a rejection of the prima facie research ethics position that the individual must have priority over the society (as reflected by Helsinki Declaration that holds the first duty of researchers to be the health of participants, with this responsibility taking priority over the generation of new knowledge with its future benefits for society).

Are these arguments for withholding data convincing when considering the risks outlined above of doing so? The Westphalian principle of the sovereign rights of States must be noted that reads that decisions on the strategy to be taken towards cross-border sample and data sharing lies with the State.

Additional points raised by the case include the role of the commercial health care sector and the fear that their pricing structures will put vaccines out of the reach of some of the most needy; doubts whether the involved companies had the right to use the H5N1 samples and data in the development of antivirals and vaccines, and if they adopted the appropriate benefit sharing arrangements. However, in addition to the legitimate aim of pursuing profit maximization (within the given legal and regulatory framework), the commercial health care sector is increasingly held as having some responsibilities to further and support global health. It should be noted that companies increasingly offer tiered pricing with lower market prices being offered in lower income settings. Furthermore, although reports of the case do not clarify if patents were a concrete issue, some important international WTO principles have been developed that strive to preserve the commercial benefits of patents while applying principles of distributive justice. One is the use of “compulsory license”: the permission to use another’s intellectual property in a given territory without the consent of the proprietor. The granting of a compulsory patent license typically requires the sanction of a governmental entity and is most often granted with relation to a serious public health problem (see the WTO 2001 Doha Declaration on the TRIPS agreement and public health).

Conclusion

Data sharing decisions take place in contexts defined by national and global political systems and arrangements, socioeconomic circumstances, and cultural specificities. “Data” has a foundational place in the health research process and needs to be the subject of ongoing multidisciplinary ethical analysis and reflection. The case suggests that the data sharing norms adopted or rejected can have far-reaching consequences. The goal of achieving the a norm of selfless international data sharing that is needed in order to respond rapidly, effectively, and efficiently to global health threats remains aspirational in the face of continuing global health inequalities. The development of data sharing ethics needs international debate, based on a full appreciation of differing health priorities and the political complexities of working in a globalized world. Research projects should establish a data sharing policy that draws on a framework of data sharing ethics that has been systematically developed. Both the development of data sharing ethics and a project specific policy must be transparent and follow an ethically acceptable process that ensures the free expression of various viewpoints (UNESCO 2003).

According to the moral status quo, at the heart of a data sharing ethics framework should be the default position that data should be shared, although there is a range of rights and interests that lead to justifiable (or even necessary) conditions being imposed that limit data sharing. These conditions and limitations to data sharing reasonably include: any condition needed to take into account special needs and vulnerabilities, especially if developing countries are involved; any limitation needed to prevent or mitigate potential risks to human rights and fundamental freedoms caused by data sharing; the undertaking of measures that protect the privacy of individuals and the confidentiality of human data. However, it is understandable (although regrettable), that political reasons can be held as existing that limit the duty to share.

Perhaps one of the most important conditions attached to data sharing in today’s international research environment is that a fair and just benefit-sharing plan must be in place. The appropriate conditions may vary according to the nature of a research project, e.g., whether the data sharing party is a State, an academia body, an NGO, or a commercial enterprise.

In conclusion, this entry doubts if “data” is meaningful object of ethics reflection if disconnected and isolated from its context. The proposal is that each class and setting of research project must develop its own data sharing policy by considering the research design and various steps of the research process within which data sharing takes place and the social, political, and cultural context in which the research project is embedded, and by applying a pluralistic ethics analytical framework.

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