Additional principles such as sustainability may also be pertinent for HPSR ethics. Further work to capture the breadth and depth of potential ethics issues in HPSR will likely speak to the possible relevance of other ethical principles. It also remains unclear who bears responsibility for addressing particular ethical issues identified by this review. For example, parties other than RECs may be more capable of ensuring that national research priority-setting processes are not exclusively donor-driven or that proposed research helps reduce health disparities.
The responsibilities of other stakeholders such as research institutions, funders and policymakers to address the ethical issues raised in this paper need to be investigated. Discussions relating to high-income country regulatory constructs and normative frameworks were dominant. This perhaps, in part, reflects the developing nature of ethics and regulatory oversight capacities in many LMICs. The review had two main limitations.
First, it is possible that the search strategy failed to identify some relevant literature because that literature used terms for HPSR that are uncommon and were not picked up by the search strategy. For example, while our search returned very little guidance with respect to the specific challenge of minimizing the risk of diminishing intrinsic motivation during health incentive research, there is literature addressing intrinsic motivation that may have been returned with more specific search terms related to behavioral research.
Given that the range of HPSR ethics issues described in the literature were not known prior to the search, it was not possible to ensure that all issues around which one might want guidance were included in the search terms. Our search strategy was, however, reviewed by health systems researchers, ethics experts and information specialists prior to implementation. Second, the coding process was performed by two single coders who each coded a subset of the documents, rather than by two coders who each thematically analyzed all documents.
This scoping review constitutes the most comprehensive report of the HPSR ethics literature to-date. Given that it presents an overview of the ethical issues that arise during HPSR and the available guidance on these issues, it can serve as a rich resource for researchers, RECs, research institutions, professional associations and funders.
We are grateful to Dr Nhan Tran, Dr Abha Saxena, Dr Sassy Molyneux and anonymous referees for their valuable comments on previous versions of this review and its methods. We thank Peggy Gross for assistance with search strategy development and Danielle Edwards for supporting literature screening and coding. The views expressed are those of the authors alone and do not necessarily reflect the views or policy of the World Health Organization.
Conflict of interest statement. None declared. Box 1. Examples of approaches encompassed by HPSR. QI usually has a more internal or bottom up perspective addressing what kind of approaches actors within the organization themselves can utilize to improve quality of care Hoffman et al. The aim of QI is typically to improve a system or organization as a means to improving individual outcomes.
Thus, the focus is on system functioning rather than the individual. Comparative effectiveness research CER aims to compare one treatment for a condition or health service against another to determine what works best for different individuals Vaida Operational research aims to solve operational issues that arise in health programs and organizations Remme Implementation research aims to systematically identify how best to deliver health interventions and services in real-world contexts Peters et al. It is closely related to operations research, but its focus is usually broader than a specific program or organization.
Health services research examines healthcare at the organizational level e. It aims to improve the delivery of health services and has multiple sub-disciplines that include but are not limited to the four listed above Hoffman et al. Determining what protections must be in place to reduce the individual and collective risks of HPSR studies.
Determining what constitutes an acceptable balance of risks and benefits amongst various participants involved in and affected by HPSR. Determining how risks to groups, health systems and individuals patients, health system staff etc. Determining how HPSR should be structured to help reduce health disparities between and within countries. Determining whether fair subject selection in HPSR entails giving some degree of priority to working with vulnerable and disadvantaged populations and, if so, to what degree.
Determining who is owed ancillary care in HPSR studies and what addressing systemic health needs might entail. Determining whether it is ethical to test interventions in HPSR that are unlikely to be sustainable. Determining what features of HPSR are relevant to decisions about whether and what type s of ethics and regulatory review may be required. Oxford University Press is a department of the University of Oxford. It furthers the University's objective of excellence in research, scholarship, and education by publishing worldwide. Sign In or Create an Account.
Sign In. Advanced Search. Article Navigation. Close mobile search navigation Article Navigation. Volume Article Contents. Characteristics of relevant literature. Ethical issues in HPSR. Ethics of health policy and systems research: a scoping review of the literature Bridget Pratt. Oxford Academic. Google Scholar. Amy Paul. Adnan A Hyder. Joseph Ali. Article history. Cite Citation. Permissions Icon Permissions. Abstract Health policy and systems research HPSR is increasingly funded and undertaken as part of health system strengthening efforts worldwide.
Developing countries , ethics , ethical guidance , health policy and systems research , research ethics committee , scoping review. Figure 1. View large Download slide. Table 3. Box 2. Priority areas for the development of HPSR ethics guidance. Evaluating international research ethics capacity development: an empirical approach. Search ADS. Ethical and regulatory issues of pragmatic cluster randomized trials in contemporary health systems. Busting the bureaucracy: lessons from research governance in primary care. Ethical review of health systems research: vulnerability and the need for philosophy in research ethics.
Building the field of health policy and systems research: an agenda for action. Guidelines for local research ethics committees: distinguishing between patient and population research in the Multicentre Research Project. Does clinical equipoise apply to cluster randomized trials in health research. Addressing the theoretical, practical and ethical challenges inherent in prospective health policy analysis. Why we should not seek individual informed consent for participation in health services research.
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An ethics framework for a learning health care system: a departure from traditional research ethics and clinical ethics.
Ethical principles and approaches to health systems governance research: conceptual and methodological implications. What is the role and authority of gatekeepers in cluster randomized trials in health research. Impact of institutional review board practice variation on observational health services research.
Ethical review of health systems research in low-and middle-income countries: research—treatment distinction and intercultural issues.
Note that this argument, more than any of the others, provides a rationale for ethical standards specific to researcher-subject relations that maintain higher standards than is expected of general interactions. In this approach, the consequences of an action determine its merit, not the intent or motivation that lie behind it. Contact us Submission enquiries: bmcmedethics biomedcentral. Google Scholar Ottinger G. Bayer, who received his doctorate in political science from the University of Chicago, is an associate for policy studies at the Hastings Center in New York.
The treating physician as active gatekeeper in the recruitment of research subjects. Conflicting notions of research ethics: the mutually challenging traditions of social scientists and medical researchers.
Researcher-decision-maker partnerships in health services research: practical challenges, guiding principles. So you want to conduct a cluster randomized controlled trial? Ethical considerations related to participation and partnership: an investigation of stakeholders' perceptions of an action-research project on user fee removal for the poorest in Burkina Faso.
Are distinctive ethical principles required for cluster randomized controlled trials? Ethical issues in implementation research: a discussion of the problems in achieving informed consent. The ethics of health systems research in low-and middle-income countries: a call to action. Ethical review of health systems research in low-and middle-income countries: a conceptual exploration.
Infectious Diseases Society of America. Grinding to a halt: the effects of the increasing regulatory burden on research and quality improvement efforts. Institute of Medicine. Are ethics committees retarding the improvement of health services in Australia? Quality, safety, and Institutional Review Boards: navigating ethics and oversight in applied health systems research. Resituating the principle of equipoise: justice and access to care in non-ideal conditions. Improving ethical review of research involving incentives for health promotion.
A conceptual model for the translation of bioethics research and scholarship. Reflections on applying for NHS ethical approval and governance in a climate of rapid change: prioritising process over principles. When is informed consent required in cluster randomized trials in health research. Who is the research subject in cluster randomized trials in health research. Enabling our instruments: accommodation, universal design, and access to participation in research. Ethical challenges in cluster randomized controlled trials: experiences from public health interventions in Africa and Asia.
How variability in the Institutional Review Board review process affects minimal-risk multisite health services research. Ethics, regulation, and comparative effectiveness research: time for a change. Health systems research and the Gadchiroli debate: a plea for universal and equitable ethics. Connecting health systems research ethics to a broader health equity agenda.
Applying a global justice lens to health systems research ethics: an initial exploration. Research in support of health systems transformation in South Africa: the experience of the centre for health policy. Building the field of health policy and systems research: framing the questions. How ethical is ethical research? Recruiting marginalized, vulnerable groups into health services research. Ethics review of multisite studies: the difficult case of community-based Indigenous health research. Variability in research ethics review of cluster randomized trials: a scenario-based survey in three countries.
Ethical and policy issues in cluster randomized trials: rationale and design of a mixed methods research study. The Ottawa Statement on the ethical design and conduct of cluster randomised trials: precis for researchers and research ethics committees. Quality improvement in general practice: enabling general practitioners to judge ethical dilemmas.
The ethical review of health care quality improvement initiatives: findings from the field. Unintended consequences of incentive provision for behaviour change and maintenance around childbirth. Ethical review of health service research in the UK: implications for nursing. Patient-centered outcomes research: early evidence from a burgeoning field. Van Teijlingen. Clinical governance and research ethics as barriers to UK low-risk population-based health research?
The Ottawa Statement on the ethical design and conduct of cluster randomized trials. A voluntary privacy standard for health services and policy research: legal, ethical and social policy issues in the Canadian context. Challenge of research ethics committees to the nature of operations research. World Health Organization. New ethical challenges to mental health services research in the era of community-based care. Biomedical research is defined to encompass basic, translational and clinical research.
Basic research aims to generate new knowledge about the underlying foundations physiological and psychological of disease, without any particular application or use in view WHO Translational research aims to harness knowledge from basic research to produce interventions for the prevention, detection, diagnosis and treatment of disease; it lies at the intersection of basic and clinical research Woolf The following risks are common in HPSR using participatory action research methods: social discord, social harms such as stigma individual or group and financial harms Hunt et al.
The following risks are common in HPSR testing incentive interventions: decreases in intrinsic motivation and well-being, negative impact on relationships, widening of health disparities i. If an intervention is found to be effective and appropriate efforts to sustain it are not made, then study participants may experience harm in certain contexts.
Hill further notes that donors often contract out HPSR studies. The pressure of deadlines makes it more difficult for contractors to provide skills transfer to local personnel in research design and data analysis. Questions on how to quantify the best interests of a group remain, but this is a problem for all decisions concerning cluster interventions, whether in a trial or not. A waiver of consent means that the REC removes the requirement to obtain informed consent, whereas an alteration of consent means that the committee permits changes to or removal of some of the standard elements of disclosure in the informed consent—for example, to maintain blinding in the case of a behavioural intervention Weijer et al.
The local de facto standard is the standard of care set by what physicians in a locality actually do in practice London The local de jure standard is the standard of care that is set, not by what physicians in the locality actually do, but by the judgement of medical experts in the host country as to what diagnostic and therapeutic practices have proved most effective against the illness in question, under the present material conditions London The duty of rescue is derived from a moral principle affirming that we ought to help people who are in need and whom no one else is well-situated to help, provided that we can do so without our incurring serious sacrifice or risk Belsky and Richardson According to this model, researchers may be obligated by special duties to provide ancillary care for certain health needs that fall within the scope of entrustment.
It should be noted that this ethical framework applies to a ll learning health care activities, both those that might be classified as research and those that would not be, because Faden et al. Brody and Miller argue against that contention. All rights reserved. For permissions, please e-mail: journals. Issue Section:. Download all figures. View Metrics. Email alerts New issue alert. Advance article alerts. Article activity alert. JEL classification alert. Receive exclusive offers and updates from Oxford Academic. More on this topic Rethinking collaboration: developing a learning platform to address under-five mortality in Mpumalanga province, South Africa.
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The cost of not breastfeeding: global results from a new tool. Individuals who are the intended recipients of experimental or control intervention Individuals who are the target of experimental or control interventions that manipulate their environment Individuals with whom investigator interacts for purpose of collecting data about that individual Individuals about whom investigator obtains identifiable, private information. Fox and Tulsky , Kass and Pronovost Fox and Tulsky , Tapp et al. Platt WHO Cassell and Young Hakama et al. Only some CER can ethically proceed without informed consent, i.
Improvements in health systems, Provision of health services, Health worker capacity building. Consulting members of clusters, Local advisory committees, Community representatives, Focus groups, Citizens juries Thinking through possible consequences with multiple stakeholders, including fieldworkers.
Daly and Rosenfeld Molyneux et al. Opportunity costs to participants for time spent participating. Social or financial harm : Implement no fault policies. Kass and Pronovost WHO Opportunity costs to participants: no specific guidance identified. Decreasing intrinsic motivation: no specific guidance identified. Buse Lange Thomson et al. Hill Hunt et al. Cost to healthcare system: no specific guidance identified.
Distortion of local markets: no specific guidance identified. Widening of health inequities: no specific guidance identified. Socio-political instability: no specific guidance identified. The reconstruction of these stories, along with analysis of reference publications on the subject, helps illustrate what bioethicists themselves understand about their practices and field of knowledge. Likewise, I have analyzed how bioethics appeared as a discipline devoid of the religious content present at its inception as a field of inquiry and, with the exception of studies by feminist authors, with no gender perspective.
All these viewpoints have influenced the development of bioethics as a discipline in Ibero-American contexts, particularly in Latin America, where various authors are currently attempting to provide an epistemological framework appropriate for bioethics in the region Garrafa, ; Tealdi, ; Luna, Salles, These actors use a disciplinary language that appears neutral, based both on developments in biomedicine and in human and social sciences.
It is a discourse that, like religious thinking, demonstrates the abuses of science, the commercialization of the human and the social disintegration produced by modernity Borrillo, In this regard, some authors argue that bioethics is a place where the forces of contemporary biopower can be seen Fassin, Memmi, ; Rose, ; Fassin, 15 maio The relationship between bioethics, biopower and biopolitics has not been analyzed in this article and remains to be studied in the future.
I believe that this overview provides a contribution to the field of Ibero-American bioethics, which tends to refer to the context of the United States as a homogenous foundational site, and can also help consolidate a field of sociological studies of bioethics. As De Vries says, we need to advance from sociology within bioethics towards a sociology of bioethics.
Revisiting the argument from fetal potential. Philosophy, Ethics, and Humanities in Medicine , v. Acceso en: 10 sep. A critique of arguments supporting disability avoidance. In defense of bioethics. Stem cell rethoric and the pragmatics of naming. The American Journal of Bioethics, v. Histoire Politique , v. Acceso en: 12 feb. What it takes to defend deceptive placebo use. Kennedy Institute of Ethics Journal , v. Gaceta Sanitaria , v. The fallacy of the principle of procreative beneficence. Bioethics , v. Bioethics and politics: a values analysis of the mission of the center for practical bioethics.
The American Journal of Bioethics , v. Paris: Dalloz. Intellectual property and biotechnology: the European debate. Religion and the secularization of bioethics. The Hastings Center Report , v. Bioethics as a discipline. The Hastings Center Studies , v. The birth of tragedy in pediatrics: a phronetic conception of bioethics. Nursing Ethics , v. Human cloning laws, human dignity and the poverty of the policy making dialogue. BMC Medical Ethics , v. The ethics of patenting human embryonic stem cells. Is there a constitutional right to preconception sex selection?
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The Hastings Center Series in Ethics. Free Preview cover Ethics, The Social Sciences, and Policy Analysis Interpretive Social Science and Policy Analysis. Ethics, The Social Sciences, and Policy Analysis (The Hastings Center Series in Ethics) [Sidney Callahan, Bruce Jennings] on rapyzure.tk *FREE* shipping.
The foundations of bioethics. New York: Oxford University Press. Archives des sciences sociales des religions , n. Le gouvernement des corps. Feminist bioethics : at the center, on the margins. The ethics of everyday practice in primary medical care: responding to social health inequities. Origin myths in bioethics: constructing sources, motives and reason in bioethic s. Universitas Humanas , v. Acceso en: 24 feb. Madrid: Dickinson. The body, emotions and intentions: challenges of preconception arrangements for health care providers.
Canadian Medical Association Journal , v. Paris: Albin Michel. Ponencia presentada en Colloque Les discours officiels sur les recherches embryonnaires en Europe. Paris, 21 maio Words count how interest in stem cells has made the embryo available : a look at the French law of bioethics. Producciones religiosas de la Modernidad. In: Mallimaci, Fortunato Ed.
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Configurations , v. Ethics and politics. Daniel Callahan and bioethics: where the best arguments take him. Acceso en: 9 ago. He also emphasized the notion that people should not expect science to tell them how to live their lives. Durkheim's theories are considered by some sociologists to be even more applicable today than they were at the time he formulated them Turner His primary contribution to sociology was his stance on social solidarity, social roles, and the division of labor.
Morality and the connection between science and society also influenced Durkeim's work on professional ethics. Durkheim touted the importance of moral education on everyday life and emphasized its inclusion in the study of sociology. Marx, Weber, and Durkheim may have developed their theories in a different academic era, but they continue to influence and impact the field of sociology today. Works by Weber and Durkheim were the precursors to those by Robert Merton, the first sociologist to win the National Medal of Science and the founder of the sociology of science.
Merton's focus was on the functional analysis of social structures, and he discounted subjective dispositions, such a motives and aims. Things Merton is best known for are coining the terms " self-fulfilling prophecy ," "deviant behavior," and implementing the focus group concept in a research setting.
The first attempt to promote international cooperation and professionalize the field of sociology can be seen in the formation of the International de Sociologie by Rene Worm in In a number of well-known sociologists across the United States met to create an entity to promote the professionalization of the field of sociology. This organization was called the American Sociological Society and later evolved into what is known today as the American Sociological Association. It includes an introduction, a preamble, five general principles, and specific ethical standards.
Rules and procedures for handling and investigating complaints are also noted. As time went on, more organizations such as the International Sociological Association were formed to support sociologists and advance knowledge about this field of study.
Like ASA, these entities have also developed and established codes of ethics for their membership to follow. ISA, an organization founded in , drafted its own code of ethics and the current version was approved by their Executive Committee in the fall of New and exciting research opportunities often bring unforeseen scenarios, many of which revolve around the sociologist's relationship with subjects.
Dilemmas involving the applicability of informed consent , the use of deception, and the protection of privacy and confidentiality are common in social science research. A conflict between the desire to protect human subjects and the goal of obtaining data may not be easy to rectify even if guidelines are followed. Research misconduct and authorship violations are also concerns that face social scientists. Abuses vary in severity and may encompass plagiarism, data fabrication, and falsification of data and results.
The ethical dilemmas encountered in sociology are not unique. As science and technology become intertwined further with society, these ethical questions will become even more complex. Problems that occurred during the s and s, such as the thalidomide drug tests and the Tuskegee syphilis study — emphasized the fallibility and injustices of scientific research and added momentum to appeals for more regulations and guidelines.
Scientific investigations, especially those in biomedicine, often are considered high-risk and life-threatening, but the social sciences also have encountered less obvious but not necessarily less dangerous situations. One case that is discussed frequently in social science circles is Stanley Milgram 's work on obedience to authority in Milgram found that a majority of the individuals participating in this series of studies were willing to administer what they believed to be harmful electrical shocks to their victims.
Laud Humphreys's tearoom trade in also sparked controversy. Humphreys studied homosexual encounters in a St. Louis park restroom without revealing the true nature and intention of his research. Philip Zimbardo's Stanford prison experiment in is another example of an infraction that sent up red flags to those involved in protecting human subjects Sieber Zimbardo's study, which ended early due to concerns about its effects on the subjects, used role playing to determine what happens when good people are put in an environment that fosters evil.
Informed consent is a key component of human subjects research, but it can be controversial in disciplines such as sociology. Regulations require that in most cases informed consent be obtained before research can commence, but consent often is seen as an unrealistic obstacle in the social sciences. Research conducted by social scientists often involve the use of ethnographic methods, the collection of oral histories, and survey procedures, which do not readily lend themselves to the written informed consent process.
Obtaining written consent may be problematic for researchers working in situations where language and cultural differences pose as a barrier. This may occur in situations where the individuals are illiterate or merely speak a different language. Some cultures consider the signing of a document taboo or an act reserved for certain situations such as the signing of legal documents. Evidence also indicates that subjects who sign consent forms, like those who participated in Milgram's study, do not always comprehend the full extent of the project Mitchell Many social science initiatives include individuals involved in illegal activities where anonymity is essential.
In these situations the informed consent document may compromise confidentiality by being the only link to the subject. Steps taken to protect the privacy of the subject and ensure the confidentiality of the data may instill a false sense of security in the researcher and the subjects. A researcher may code identifiers, destroy data after project completion, use pseudonyms to mask identity, and avoid gathering personal information altogether in an attempt to provide protection.
These measures are not infallible, and violations are evident in numerous cases. Sociologist Arthur Vidich and anthropologist Joseph Bensman conducted a study of small town life and assigned the pseudonym "Springdale" to the upstate New York community. It didn't take long for the community's true identity to be revealed, which caused Vidich's and Bensman's research practices to be called into question. Other infractions have involved the subpoena of data, as in the case of Rik Scarce, who underwent days of incarceration for refusing to release his field notes Scarce Even with protections in place the subject's privacy and confidentiality may be at risk.
All researchers wrestle with similar issues of research misconduct.