Annotated Bibliography (2009-2014)
Alahmad, Ghiath, Mohammad Al-Jumah, and Kris Dierickx. Review of national research ethics regulations and guidelines in Middle Eastern Arab countries, BMC Medical Ethics, 2012; 13: 34
Research ethics guidelines are essential for conducting medical research. Recently, numerous attempts have been made to establish national clinical research documents in the countries of the Middle East. This article analyzes these documents.
Thirteen Arab countries in the Middle East were explored for available national codes, regulations, and guidelines concerning research ethics, and 10 documents from eight countries were found. We studied these documents, considering the ethical principles stated in the Declaration of Helsinki, the Council for International Organizations of Medical Sciences (CIOMS) guidelines, and the International Conference of Harmonization - Guidelines for Good Clinical Practice (ICH-GCP). Our paper comprises a complete list of protections, such as confidentiality, informed consent, ethics committees, and others.
This study found different levels and kinds of research ethics regulations and guidelines in the countries examined. Two groups can be distinguished: the countries in the first group have one or more research ethics regulations or guidelines, while the countries in the second group have not yet established any. Most of the documents showed various degrees of deficiencies in regard to ethical protection. The majority of the documents that were examined refer to one or more international documents on biomedical research ethics.
Anderson, Emily E., Stephanie Solomon, Elizabeth Heitman, James M. DuBois, Celia B. Fisher, Rhonda G. Kost, Mary Ellen Lawless, Cornelia Ramsey, Bonnie Jones, Alice Ammerman, Lainie Friedman Ross. Research Ethics Education for Community-Engaged Research: A Review and Research Agenda, Journal of Empirical Research on Human Research Ethics, Apr 2012; 7(2) pp: 3–19.
Community engagement is increasingly becoming an integral part of research. “Community-engaged research” (CEnR) introduces new stakeholders as well as unique challenges to the protection of participants and the integrity of the research process. We—a group of representatives of CTSA-funded institutions and others who share expertise in research ethics and CEnR—have identified gaps in the literature regarding (1) ethical issues unique to CEnR; (2) the particular instructional needs of academic investigators, community research partners, and IRB members; and (3) best practices for teaching research ethics. This paper presents what we know, as well as what we still need to learn, in order to develop quality research ethics educational materials tailored to the full range of stakeholder groups in CenR
Brody, Baruch A.. Intellectual Property, State Sovereignty, and Biotechnology, Kennedy Institute of Ethics Journal, 20(1), 51-73. The Johns Hopkins University Press. http://muse.jhu.edu.revproxy.brown.edu/journals/kennedy_institute_of_ethics_journal/v020/20.1.brody.html
The issue of biopiracy has attracted considerable attention in recent years. The Convention on Biological Diversity adopted a principle of state sovereignty over biological resources and the genetic information contained within those resources to address this issue. It is argued that this principle has not been adequately justified and that there are other solutions to the issue of biopiracy, based on different theories of justice, that deserve greater consideration. These alternatives include the common heritage of mankind principle and the global commons principle.
Brody, Howard. Chauncey Leake and the Development of Bioethics in America, Kennedy Institute of Ethics Journal, v. 24.1 (2014) pp:73-95.
Chauncey D. Leake (1896–1978) occupies a unique place in the history of American bioethics. A pharmacologist, he was largely an autodidact in both history and philosophy, and believed that ethics should ideally be taught to medical students by those with philosophical training. After pioneering work on medical ethics during the 1920s, he helped to lay the groundwork for important centers for bioethics and medical humanities at two institutions where he worked, the University of California-San Francisco and the University of Texas Medical Branch-Galveston. Understanding Leake’s role in American bioethics requires navigating a number of paradoxes—why he was described respectfully in his time but largely forgotten today; how in the 1920s he could write forward-looking pieces that anticipated many of the themes taken up by bioethics a half-century later, yet played largely a reactionary role when the new bioethics actually arrived; and why he advocated turning to philosophy and philosophers for a proper understanding of ethics, yet appeared often to misunderstand philosophical ethics.
Diehm, Christian. Darwin and Deep Ecology, Ethics & the Environment, 19(1), pp:73-93. http://muse.jhu.edu.revproxy.brown.edu/journals/ethics_and_the_environment/v019/19.1.diehm.html
This essay explores connections between Charles Darwin’s thinking and the writings of theorists in the deep ecology movement. It begins by placing Darwin’s thought in the context of Western attempts to reject teleological descriptions of nature. It then shows that while some authors cite Darwin’s naturalistic view of human origins as a positive contribution to deep ecological thought, the fact that his work also helped eliminate teleological explanations of natural phenomena is problematic for non-anthropocentric environmental ethics. Because of this, the argument is made that the significance of Darwin’s work for deep ecology theorists is not simply that it views humans as a part of nature, but that it asserts a basic continuity between humans and other living things. The essay concludes by suggesting that an outlook grounded in a Darwinian sense of continuity does not necessarily issue in a strictly bio-centric understanding of nature’s value.
Doorn, Neelke, Responsibility Ascriptions in Technology Development and Engineering: Three Perspectives, Science and Engineering Ethics, Mar 2012; 18(1) pp: 69–90.
In the last decades increasing attention is paid to the topic of responsibility in technology development and engineering. The discussion of this topic is often guided by questions related to liability and blameworthiness. Recent discussions in engineering ethics call for a reconsideration of the traditional quest for responsibility. Rather than on alleged wrongdoing and blaming, the focus should shift to more socially responsible engineering, some authors argue. The present paper aims at exploring the different approaches to responsibility in order to see which one is most appropriate to apply to engineering and technology development. Using the example of the development of a new sewage water treatment technology, the paper shows how different approaches for ascribing responsibilities have different implications for engineering practice in general, and R&D or technological design in particular. It was found that there was a tension between the demands that follow from these different approaches, most notably between efficacy and fairness. Although the consequentialist approach with its efficacy criterion turned out to be most powerful, it was also shown that the fairness of responsibility ascriptions should somehow be taken into account. It is proposed to look for alternative, more procedural ways to approach the fairness of responsibility ascriptions.
Fisher, Celia B., Erika L. Harrington. Ethics in Prevention Science Involving Genetic Testing, Prevention Science. Jun 2013; 14(3) pp: 310–318
The Human Genome Project and rapid technological advances in genomics have begun to enrich prevention science’s contributions to understanding the role of genetic factors in the etiology, onset and escalation of mental disorders, allowing for more precise descriptions of the interplay between genetic and non-genetic influences. Understanding ethical challenges associated with the integration of genetic data into prevention science has not kept pace with the rapid increase in the collection and storage of genetic data and dissemination of research results. This article discusses ethical issues associated with (1) decisions to withhold or disclose personal genetic information to participants; (2) implications of recruitment and data collection methods that may reveal genetic information of family members; and the (3) nature and timing of informed consent. These issues are presented within the contexts of adult and pediatric research, longitudinal studies, and use of biobanks for storage of genetic materials. Recommendations for research ethics decision-making are provided. The article concludes with a section on justice and research burdens and the unique ethical responsibilities of prevention scientists to ensure the new genomic science protects the informational rights of participants, their families and communities
Pollock, Kristian. Procedure versus process: ethical paradigms and the conduct of qualitative research, BMC Medical Ethics. 2012; 13: 25.
Research is fundamental to improving the quality of health care. The need for regulation of research is clear. However, the bureaucratic complexity of research governance has raised concerns that the regulatory mechanisms intended to protect participants now threaten to undermine or stifle the research enterprise, especially as this relates to sensitive topics and hard to reach groups.Much criticism of research governance has focused on long delays in obtaining ethical approvals, restrictions imposed on study conduct, and the inappropriateness of evaluating qualitative studies within the methodological and risk assessment frameworks applied to biomedical and clinical research. Less attention has been given to the different epistemologies underlying biomedical and qualitative investigation. The bioethical framework underpinning current regulatory structures is fundamentally at odds with the practice of emergent, negotiated micro-ethics required in qualitative research. The complex and shifting nature of real world settings delivers unanticipated ethical issues and (occasionally) genuine dilemmas which go beyond easy or formulaic ‘procedural’ resolution. This is not to say that qualitative studies are ‘unethical’ but that their ethical nature can only be safeguarded through the practice of ‘micro-ethics’ based on the judgement and integrity of researchers in the field. This paper considers the implications of contrasting ethical paradigms for the conduct of qualitative research and the value of ‘empirical ethics’ as a means of liberating qualitative (and other) research from an outmoded and unduly restrictive research governance framework based on abstract prinicipalism, divorced from real world contexts and values.
Hammami, Muhammad M, Yussuf Al-Jawarneh, Muhammad B Hammami, and Mohammad Al Qadire. Information disclosure in clinical informed consent: “reasonable” patient’s perception of norm in high-context communication culture, BMC Medical Ethics. 2014; 15: 3.
The current doctrine of informed consent for clinical care has been developed in cultures characterized by low-context communication and monitoring-style coping. There are scarce empirical data on patients’ norm perception of information disclosure in other cultures.
We surveyed 470 adults who were planning to undergo or had recently undergone a written informed consent-requiring procedure in a tertiary healthcare hospital in Saudi Arabia. Perceptions of norm and current practice were explored using a 5-point Likert scale (1=strongly agree with disclosure) and 30 information items in 7 domains: practitioners’ details, benefits, risks, complications’ management, available alternatives, procedure’s description, and post-procedure’s issues.
Lizza, John P.(2014) Potentiality: Metaphysical and Bioethical Dimensions. Baltimore, The Johns Hopkins University Press
What is the moral status of humans lacking the potential for consciousness? The concept of potentiality often tips the scales in life-and-death medical decisions. Some argue that all human embryos have the potential to develop characteristics—such as consciousness, intellect, and will—that we normally associate with personhood. Individuals with total brain failure or in a persistent vegetative state are thought to lack the potential for consciousness or any other mental function. Or do they? In Potentiality John Lizza gathers classic articles alongside newly commissioned chapters from leading thinkers who analyze the nature of potentiality in bioethics, a concept central to a number of important debates. The contributors illustrate how considerations of potentiality and potential persons complicate the analysis of the moral consideration of persons at the beginning and end of life. A number of works explicitly uncover the Aristotelian background of the concept, while others explore philosophical issues about persons, dispositions, and possibility. The common assumption that potentiality is intrinsic to whatever has the potentiality is challenged by a relational view of persons, an extrinsic account of dispositions, and attention to how extrinsic factors affect realistic possibilities. Although potentiality has figured prominently in bioethical literature, it has not received a great deal of logical, semantic, and metaphysical analysis in contemporary philosophical literature. This collection will bring these thorny philosophical issues to the fore. Incorporating cutting-edge research on the topic of potentiality, this thought-provoking collection will interest bioethicists, philosophers, health care professionals, attorneys engaged in medical and health issues, and hospital and governmental committees who advise on policy and law concerning issues at the beginning and end of life.
Marsh, V. M., D. K. Kamuya, M. J. Parker, C. S. Molyneux. Working with Concepts: The Role of Community in International Collaborative Biomedical Research, Public Health Ethics, Apr 2011; 4(1),pp: 26–39
The importance of communities in strengthening the ethics of international collaborative research is increasingly highlighted, but there has been much debate about the meaning of the term ‘community’ and its specific normative contribution. We argue that ‘community’ is a contingent concept that plays an important normative role in research through the existence of morally significant interplay between notions of community and individuality. We draw on experience of community engagement in rural Kenya to illustrate two aspects of this interplay: (i) that taking individual informed consent seriously involves understanding and addressing the influence of communities in which individuals’ lives are embedded; (ii) that individual participation can generate risks and benefits for communities as part of the wider implications of research. We further argue that the contingent nature of a community means that defining boundaries is generally a normative process itself, with ethical implications. Community engagement supports the enactment of normative roles; building mutual understanding and trust between researchers and community members have been important goals in Kilifi, requiring a broad range of approaches. Ethical dilemmas are continuously generated as part of these engagement activities, including the risks of perverse outcomes related to existing social relations in communities and conditions of ‘half knowing’ intrinsic to processes of developing new understandings.
Munung, Nchangwi Syntia, Godfrey B Tangwa, Chi Primus Che, Laurent Vidal, and Odile Ouwe-Missi-Oukem-Boyer. Are students kidding with health research ethics? The case of HIV/AIDS research in Cameroon, BMC Medical Ethics, 2012; 13: 12
Universities in Cameroon are playing an active part in HIV/AIDS research and much of this research is carried out by students, usually for the purpose of a dissertation/thesis. Student theses/dissertations present research findings in a much more comprehensive manner and have been described as the stepping-stone of a budding scientist’s potential in becoming an independent researcher. It is therefore important to verify how students handle issues of research ethics.
Nisbet, Matthew C, Declan Fahy. Bioethics in popular science: evaluating the media impact of The Immortal Life of Henrietta Lacks on the biobank debate, BMC Medical Ethics, 2013; 14: 10.
The global expansion of biobanks has led to a range of bioethical concerns related to consent, privacy, control, ownership, and disclosure. As an opportunity to engage broader audiences on these concerns, bioethicists have welcomed the commercial success of Rebecca Skloot’s 2010 bestselling book The Immortal Life of Henrietta Lacks. To assess the impact of the book on discussion within the media and popular culture more generally, we systematically analyzed the ethics-related themes emphasized in reviews and articles about the book, and in interviews and profiles of Skloot. We conducted a content analysis of a population of relevant English-language articles and transcripts (n
125) produced by news organizations and publications in the U.S., Canada, Great Britain/Ireland, and Australia/New Zealand. We scored each article for the emphasis and appearance of 9 ethics-related themes. These were informed consent, welfare of the vulnerable, compensation, scientific progress, control/access, accountability/oversight, privacy, public education, and advocacy.
The informed consent theme dominated media discussion, with almost 39.2 percent of articles/transcripts featuring the theme as a major focus and 44.8 percent emphasizing the theme as a minor focus. Other prominent themes and frames of reference focused on the welfare of the vulnerable (18.4 percent major emphasis; 36.0 percent minor emphasis), and donor compensation (19.2 percent major; 52.8 percent minor). Ethical themes that comprised a second tier of prominence included those of scientific progress, control/access, and accountability/oversight. The least prominent themes were privacy, public education, and advocacy.The book has been praised as an opportunity to elevate media discussion of bioethics, but such claims should be re-considered. The relatively narrow focus on informed consent in the media discussion generated by Skloot’s book may limit the ability of ethicists and advocates to elevate attention to donor control, compensation, patenting, privacy, and other ethical issues. Still, ethicists should view the book and a pending major TV film translation as opportunities to highlight through media outreach, consultation exercises and public forums a broader range of bioethical concerns that would otherwise be under-emphasized in news coverage. Such efforts, however, need to be carefully planned and evaluated
Resnik, David B. Human Health and the Environment: In Harmony or in Conflict? Health Care Analysis Sep 2009; 17(3) pp: 261–276.
Health policy frameworks usually construe environmental protection and human health as harmonious values. Policies that protect the environment, such as pollution control and pesticide regulation, also benefit human health. In recent years, however, it has become apparent that promoting human health sometimes undermines environmental protection. Some actions, policies, or technologies that reduce human morbidity, mortality, and disease can have detrimental effects on the environment. Since human health and environmental protection are sometimes at odds, political leaders, citizens, and government officials need a way to mediate and resolve conflicts between these values. Unfortunately, few approaches to applied bioethics have the conceptual tools to do accomplish this task. Theories of health care ethics have little to say about the environment, and theories of environmental ethics don't say much about human health. In this essay, I defend an approach to ethical decision-making that gives policy-makers some tools for balancing promotion of human health and protection of the environment.
Ries, Nola M, Jane LeGrandeur, Timothy Caulfield. Handling ethical, legal and social issues in birth cohort studies involving genetic research: responses from studies in six countries, BMC Medical Ethics. 2010; 11: 4.
Research involving minors has been the subject of much ethical debate. The growing number of longitudinal, pediatric studies that involve genetic research present even more complex challenges to ensure appropriate protection of children and families as research participants. Long-term studies with a genetic component involve collection, retention and use of biological samples and personal information over many years. Cohort studies may be established to study specific conditions (e.g. autism, asthma) or may have a broad aim to research a range of factors that influence the health and development of children. Studies are increasingly intended to serve as research platforms by providing access to data and biological samples to researchers over many years. This study examines how six birth cohort studies in North America and Europe that involve genetic research handle key ethical, legal and social (ELS) issues: recruitment, especially .parental authority to include a child in research; initial parental consent and subsequent assent and/or consent from the maturing child; withdrawal; confidentiality and sample/data protection; handling sensitive information; and disclosure of results.
Sampson, Deborah A., Dennis Caldwell, Andre D. Taylor, Jacquelyn Y. Taylor. Blending Genetics and Sociocultural Historical Inquiry: Ethics, Culture, and Human Subjects Protection in International Cross Cultural Research, Yale Journal of Biology and Medicine. Mar 2013; 86(1) pp: 89–98
In this paper, we examine the implementation and difficulties when conducting genetics research in a rural, traditional West African culture within the frame of the United States’ grounded research ethics. Research challenges are highlighted by Western researchers following U.S. Institutional Review Board (IRB) guidelines and practices in a non-Western country. IRB concepts are culture bound in Western ideals that may not have synchronicity and compatibility with non-Western cultures. Differences in sociocultural norms, traditions, language, and geography were influencing factors that can affect application of IRB principles. Suggestions for change are offered, which will potentially aid researchers considering application of IRB requirements when conducting research in non-Westernized, non-industrialized countries.
Sly, Peter D., Brenda Eskenazi Jenny Pronczuk, Radim Šrám, Fernando Diaz-Barriga, Diego Gonzalez Machin, David O. Carpenter, Simona Surdu, and Eric M. Meslin. Ethical Issues in Measuring Biomarkers in Children’s Environmental Health, Environmental Health Perspectives, Aug 2009; 117(8)pp: 1185–1190.
Background: Studying the impact of environmental exposures is important in children because they are more vulnerable to adverse effects on growth, development, and health. Assessing exposure in children is difficult, and measuring biomarkers is potentially useful. Research measuring biomarkers in children raises a number of ethical issues, some of which relate to children as research subjects and some of which are specific to biomarker research. Objective: As an international group with experience in pediatric research, biomarkers, and the ethics of research in children, we highlight the ethical issues of undertaking biomarker research in children in these environments. Discussion: Significant issues include undertaking research in vulnerable communities, especially in developing countries; managing community expectations; obtaining appropriate consent to conduct the research; the potential conflicts of obtaining permission from an ethics review board in an economically developed country to perform research in a community that may have different cultural values; returning research results to participants and communities when the researchers are uncertain of how to interpret the results; and the conflicting ethical obligations of maintaining participant confidentiality when information about harm or illegal activities mandate reporting to authorities. Conclusion: None of these challenges are insurmountable and all deserve discussion. Pediatric biomarker research is necessary for advancing child health.
Stephens, Piers H.G.. Pragmatic Environmentalism: Towards a Rhetoric of Eco-Justice by Shane J. Ralston (review), Ethics & the Environment, 19(1), pp:123-131
Thus wrote an exasperated William James in The Meaning of Truth in 1910, attempting to refute the persistent misunderstanding of classical American pragmatism as being some form of reductive and technocratic epistemological capitalism. A century on and the misunderstandings rather depressingly continue in new contexts, most notably environmental philosophy, and we must ask “Why?” I suspect that this question has several interconnected answers: the popular non-philosophical associations of the word “pragmatism”; the mistaken tendency to equate pragmatism with runaway subjectivism; poorly informed impressions of the pragmatist criteria of “success” [End Page 123] and “workability”; and the misguided common assumptions, popularized in early environmental ethics work, that pragmatist schemes have no room for noninstrumental values (Leiss 1972; Rolston 1989; Hargrove 1989). The last of these continues despite scholarly refutations (Weston 1992; Minteer 2001; McDonald 2004; Stephens 2009 and 2012), and it is possible that a deeper reason for this obdurate resistance to pragmatist persuasion may lie in the philosophical history of persuasiveness itself. For as Shane Ralston observes in this book’s introduction, there is an intimate relationship between pragmatism and rhetoric, one which clashed with emergent Platonic ideas of truth during the very birth pangs of Western philosophy and may thus have led both to “a philosophical prejudice that rhetorical persuasion is inferior to philosophical logic” (xiv) and a related awareness that “the democratic spirit of rhetoric and its moorings in commonsense, everyday experience make it especially compatible with pragmatism” (xiv). Thus the mistaken tendency to equate philosophical pragmatism with the crassly opportunistic or the crudely populist, and the persistent failure to register pragmatist philosophy’s subtleties may well both have their roots in antique rivalries—Plato’s contrast of truth to mere popular opinion and his related condemnation of the Sophist rhetoricians. Ralston’s response to this problem is first to sensibly orientate his pragmatism to the philosophically sophisticated end of the spectrum and then employ it to enrich contemporary theory of rhetoric. He then attempts to demonstrate the potential of the new pragmatic rhetoric in a series of studies of particular areas of environ-mentalist contestation.
Strech, Daniel, Samia Hurst, and Marion Danis. The Role of Ethics Committees and Ethics Consultation in Allocation Decisions: A 4-Stage Process, Medical Care. Sep 2010; 48(9) pp: 821–826. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3622545/
Background: Decisions about the allocation and rationing of medical interventions likely occur in all health care systems worldwide. So far very little attention has been given to the question of what role ethics consultation and ethics committees could or should play in questions of allocation at the hospital level. Objectives and Methods:This article argues for the need for ethics consultation
Sumathipala, Athula, Aamir Jafarey, Leonardo D. De Castro, Aasim Ahmad, Darryl Marcer, Sandya Srinivasan, Nandini Kumar, Sisira Siribaddana, Sleman Sutaryo, Anant Bhan, Dananjaya Waidyaratne, Sriyakanthi Beneragama, Chandrani Jayasekera, Sarath Edirisingha and Chesmal Siriwardhana. Ethical Issues in Post-Disaster Clinical Interventions and Research: A Developing World Perspective. Key Findings from a Drafting and Consensus Generation Meeting of the Working Group on Disaster Research and Ethics (WGDRE) Asian Bioethics Review, 2007, 2(2), pp: 124-14. http://muse.jhu.edu.revproxy.brown.edu/journals/asian_bioethics_review/v002/2.2.sumathipala.html
Disasters, natural or man-made, can occur virtually anytime and anywhere in the world. They bring mass destruction and loss of human lives. The effects of a disaster can be amplified many times in resource poor settings, especially in developing countries. In a post-disaster period, many clinical interventions and a lot of research takes place which focuses on the disaster-affected populations. While many of these interventions and research are conducted in the hour of need, some, unfortunately, are opportunistic. While many of these activities happen in accordance with internationally accepted ethical and other regulations, many of them violate ethical norms, and disaster-affected populations end up being exploited. Also, many ethical regulations are culturally inappropriate for the setting where research is taking place. In the aftermath of the 2004 tsunami, a group of Sri Lankan and international academics and researchers observed these irregularities and formed a group to counter the exploitation of vulnerable populations, especially in developing countries. The Working Group on Disaster Research and Ethics (WGDRE) was formed in 2007 and has produced a set of ethical guidelines applicable to post-disaster research focusing on the developing world perspective.
Victor, Elizabeth and Laura Guidry-Grimes. The persistence of agency through social institutions and caring for future generations. International Journal of Feminist Approaches to Bioethics, 7(1), pp: 122-141. University of Toronto Press.
We argue that we have obligations to future people that are similar in kind to obligations we have to current people. Modifying Michael Bratman’s account, we argue that as planning agents we must plan for the future to act practically in the present. Because our autonomy and selfhood are relational by nature, those plans will involve building affiliative bonds and caring for others. We conclude by grounding responsibility to future others by the way we plan through our social institutions. Our account fills out the story of responsibility to future generations by referring only to ourselves, our practical identities, and practical reason.
Vries, Jantina de, Susan J Bull, Ogobara Doumbo,Muntaser Ibrahim, Odile Mercereau-Puijalon, Dominic Kwiatkowski, and Michael Parker. Ethical issues in human genomics research in developing countries, BMC Medical Ethics, 2011; 12: 5
Genome-wide association studies (GWAS) provide a powerful means of identifying genetic variants that play a role in common diseases. Such studies present important ethical challenges. An increasing number of GWAS is taking place in lower income countries and there is a pressing need to identify the particular ethical challenges arising in such contexts. In this paper, we draw upon the experiences of the MalariaGEN Consortium to identify specific ethical issues raised by such research in Africa, Asia and Oceania.
We explore ethical issues in three key areas: protecting the interests of research participants, regulation of international collaborative genomics research and protecting the interests of scientists in low income countries. With regard to participants, important challenges are raised about community consultation and consent. Genomics research raises ethical and governance issues about sample export and ownership, about the use of archived samples and about the complexity of reviewing such large international projects. In the context of protecting the interests of researchers in low income countries, we discuss aspects of data sharing and capacity building that need to be considered for sustainable and mutually beneficial collaborations.Many ethical issues are raised when genomics research is conducted on populations that are characterised by lower average income and literacy levels, such as the populations included in MalariaGEN. It is important that such issues are appropriately addressed in such research. Our experience suggests that the ethical issues in genomics research can best be identified, analysed and addressed where ethics is embedded in the design and implementation of such research projects.
Weijer, Charles, Jeremy M. Grimshaw, Martin P. Eccles, Andrew D. McRae, Angela White, Jamie C. Brehaut, Monica Taljaard and the Ottawa Ethics of Cluster Randomized Trials Consensus Group. The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials, PLoS Medicine. Nov 2012; 9(11): e1001346.
In cluster randomized trials (CRTs), the units of allocation, intervention, and outcome measurement may differ within a single trial. As a result of the unique design of CRTs, the interpretation of existing research ethics guidelines is complicated.The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials aims to provide researchers and research ethics committees (RECs) with detailed guidance on the ethical design, conduct, and review of CRTs.A five-year mixed methods research project explored the ethical challenges of CRTs. Empirical studies documented the reporting of ethical issues in published CRTs, interviewed experienced trialists, and surveyed trialists and REC chairs. The ethical issues identified were explored in a series of background papers that provided detailed ethical analyses and policy options, and a panel of experts using a systematic process developed a consensus statement. The Ottawa Statement sets out 15 recommendations for the ethical design and conduct of CRTs. The recommendations provide guidance on the justification of a cluster randomized design, the need for REC review, the identification of research participants, obtaining informed consent, the role of gatekeepers in protecting group interests, the assessment of benefits and harms, and the protection of vulnerable participants.
Weijer, Charles, Jeremy M Grimshaw, Monica Taljaard, Ariella Binik, Robert Boruch, Jamie C Brehaut, Allan Donner, Martin P Eccles, Antonio Gallo, Andrew D McRae, Raphael Saginur and Merrick Zwarenstein. Ethical issues posed by cluster randomized trials in health research, Trials. 2011; 12: 100.
The cluster randomized trial (CRT) is used increasingly in knowledge translation research, quality improvement research, community based intervention studies, public health research, and research in developing countries. However, cluster trials raise difficult ethical issues that challenge researchers, research ethics committees, regulators, and sponsors as they seek to fulfill responsibly their respective roles. Our project will provide a systematic analysis of the ethics of cluster trials. Here we have outlined a series of six areas of inquiry that must be addressed if the cluster trial is to be set on a firm ethical foundation:
1. Who is a research subject?
2. From whom, how, and when must informed consent be obtained?
3. Does clinical equipoise apply to CRTs?
4. How do we determine if the benefits outweigh the risks of CRTs?
5. How ought vulnerable groups be protected in CRTs?
6. Who are gatekeepers and what are their responsibilities?
Subsequent papers in this series will address each of these areas, clarifying the ethical issues at stake and, where possible, arguing for a preferred solution. Our hope is that these papers will serve as the basis for the creation of international ethical guidelines for the design and conduct of cluster randomized trials.
Wendler, David and Emily Abdoler. Does it Matter Whether Investigators Intend to Benefit Research Subjects? Kennedy Institute of Ethics Journal, 20(4), Dec 2010, pp: 353-370
There has been long-standing, albeit largely implicit, debate over whether investigator intentions are relevant to the ethical appropriateness of clinical research. Some commentators argue that whether investigators intend to collect generalizable knowledge or to benefit subjects is central to the ethics of clinical research. Others do not even mention investigator intentions when evaluating what makes clinical research ethical. To shed light on this debate, the present paper considers the reasons why investigator intentions might be ethically relevant. This analysis reveals that investigator intentions are related to, but distinct from three ethical requirements: whether subjects understand that they are contributing to a project to help others, whether the included interventions have an appropriate risk/benefit ratio, and whether subjects’ interests are adequately protected. Provided these three requirements are satisfied, the ethical appropriateness of clinical research does not depend on what intentions investigators have in conducting it.
Wiesemann, Claudia, Susanne Ude-Koeller,Gernot H. G. Sinnecker,and Ute Thyen. Ethical principles and recommendations for the medical management of differences of sex development (DSD)/intersex in children and adolescents, European Journal of Pediatrics. Jun 2010; 169(6): 671–679
The medical management of differences of sex development (DSD)/intersex in early childhood has been criticized by patients’ advocates as well as bioethicists from an ethical point of view. Some call for a moratorium of any feminizing or masculinizing operations before the age of consent except for medical emergencies. No exhaustive ethical guidelines have been published until now. In particular, the role of the parents as legal representatives of the child is controversial. In the article, we develop, discuss, and present ethical principles and recommendations for the medical management of intersex/DSD in children and adolescents. We specify three basic ethical principles that have to be respected and substantiate them. The article includes a critical discussion of the best interest of the child and of family privacy. The argumentation draws upon recommendations by the working group “Bioethics and Intersex” within the German Network DSD/Intersex, which are presented in detail. Unlike other recommendations with regard to intersex, these guidelines represent a comprehensive view of the perspectives of clinicians, patients, and their families.
Up to 2008
Module One Materials: Cases for Class Exercises
Bengston, D., Schermann, M., Moua, M., & Lee, T. 2008. Listening to Neglected Voices: Hmong and Public Lands in Minnesota and Wisconsin. Society and Natural Resources 21, 876-890.
Bento, S., Hardy, E., & Duarte Osis, M. 2008. Process for obtaining informed consent: women’s opinions. Developing World Bioethics 8, 197-206.
Hall, A. 2002. What the Navajo Culture Teaches About Informed Consent. HEC Forum 14, 241-246.
Helgesson, G., Ludvigsson, J., & Stolt, U. 2005. How to handle informed consent in longitudinal studies when participants have a limited understanding of the study. Journal of Medical Ethics 31, 670-673.
King, M. & Faasili, U. 1999. Community-based management of subsistence fisheries in Samoa. Fisheries Management and Ecology 6, 133-144.
Marsh, H. & Kenchinton, R. 2004. The role of ethics in experimental marine biology and ecology. Journal of Experimental Marine Biology and Ecology 300, 5-14.
McCaulet, L. Beltran, M., Phillips, J., Lasarev, M., & Sticker, D. 2001. The Oregon Migrant Farmworker Community: An Evolving Model for Participatory Research. Environmental Health Perspectives 109, 449-455.
Mukadasi, B. & Nabalegwa, M. 2007. Gender mainstreaming and community participation in plant resource conservation in Buzaya County, Kamuli District, Uganda. African Journal of Ecology 45 Suppl. 1, 7-12.
Singer, E. & Couper, M. Do incentives exert undue influence on survey participation? Experimental Evidence. Journal of Empirical Research on Human Research Ethics 3, 49-56.
Schmidt, C. 2001. Indi-gene-ous Conflicts. Environmental Health Perspectives 109, A216-A219.
Module One Materials: Assigned Readings
Appelbaum, P., Lidz, C., & Klitman, R. 2009. Voluntariness of consent to research: a conceptual model. Hastings Center Report 39, 30-39.
Engels, Johannes M. M., Hannes Dempewolf, and Victoria Henson-Apollonio. 2011. “Ethical Considerations in Agro-biodiversity Research, Collecting, and Use,” Journal of Agricultural and Environmental Ethics 24:107–126.
Guthan, J. 2008: Bringing good food to others: investigating the subjects of alternative food practice. Cultural Geographies 15, 425–41.
Harding, Anna, Barbara Harper, Dave Stone, et al. 2012. "Conducting Research with Tribal Communities: Sovereignty, Ethics, and Data-Sharing Issues" [Commentary], Environmental Health Perspectives 120(1): 6-10.
Matthew, D. 2008. Race, religion, and informed consent: lessons from social science. Journal of Law Med Ethics 36(1), 150-74.
Morrow, David. R., Robert E Kopp and Michael Oppenheimer. Toward ethical norms and institutions for climate engineering research. Environ. Res. Lett. 4 (2009) 045106 (8pp).
The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1979). The Belmont Report. Ethical Principles and Guidelines for the Protection of Human Subjects of Research.
Schrag, B. 2006. Research with groups: group rights, group consent, and collaborative research. Science and Engineering Ethics 12, 511-521.
Smith, L. 1998. Concept analysis: cultural competence. Journal of Cultural Diversity 5, 4-10.
Thering, S. 2011. A Methodology for a Scholarship of Transdisciplinary Action Research in the Design Professions: Lessons from Indian Country. Landscape Journal, 01.01.11 , Project Muse.
Module Two Materials: Case Studies
Kuletz, V. 2002. The movement for environmental justice in the Pacific Islands. The Environmental Justice Reader 2002, 125-142.
Lowe, J. & Shaw, T. 2009. After Katrina: racial regimes and human development barriers in the Gulf Coast region. American Quarterly 61, 803-827.
Module Two Materials: Class Readings
Davis, S. & Reid, R. 1999. Practicing participatory research in American Indian communities. American Journal of Clinical Nutrition 69, 755-759.
Gbadegesin, S. & Wendler, D. 2006. Protecting communities in health research from exploitation. Bioethics 20, 248-253.
King, P. 1992. The dangers of difference. Hastings Center Report 22, 35-38.
Minkler, M. 2004. Ethical challenges for the ‘outside’ researcher in community-based participatory research. Heath Education Behavior 31, 684-697.
Panikkar, B. & Brugge, D. 2007. The ethical issues in uranium mining research in the Najavo Nation. Accountability in Research 14, 121-153.
Thomas, S. & Crouse, S. 1992. The Tuskegee legacy. Hastings Center Report 22, 38.
Module Two Material: Optional Class Reading
Gruber, J. Key Principles of Community-Based Natural Resource Management: A Synthesis and Interpretation of Identified Effective Approaches for Managing the Commons Environmental Management (2010) 45:52–66.
Israel, B., Schultz, A., Parker, E., & Becker, A. 1998. Review of community-based research: assessing partnership approaches to improve public health. Annual Review of Public Heath 19, 173-202.
Thiollent, Michel. Action Research and Participatory Research. International Journal of Action Research, 7(2), 2011: 160-174.
Module Three Materials: Case Studies
Almany, G., Hamilton, R., Williamson, D., Evans, R., Jones, G., Matawai, M., Potuku, T., Rhodes, K., Russ, G. & Sawynok, B. 2010. Research partnerships with local communities: two case studies from Papua New Guinea and Australia. Coral Reefs 29, 567-576.
Brooks, Jeremy, Kerry A. Waylenb, and Monique Borgerhoff Mulder. 2012. How national context, project design, and local community characteristics influence success in community-based conservation projects. c,dPNAS, vol. 109, no. 5.
Castleden, H. 2009. ‘Hishuk Tsawak’ (everything is one/connected): A Huu-ay-aht worldview for seeing forestry in British Columbia, Canada. Society and Natural Resources 22, 789-804.
Chen, P., Diaz, N., Lucas, G., & Rosenthal, M. 2010. Dissemination of results in community-based participatory research. American Journal of Preventative Medicine 39, 372-378.
Davis, S. & Reid, R. 1999. Practicing participatory research in American Indian communities. American Journal of Clinical Nutrition 69, 755-759.
Flint, G., Luloff, A., & Finley, J. 2008. Where is ‘community’ in community-based forestry? Society and Natural Resources 21, 526-537.
Kendrick, A. & Manseau, M. 2008. Representing traditional knowledge: resource management and Inuit knowledge of barren-ground caribou. Society and Natural Resources 21, 404-418.
Prokopy, L. 2008. Ethical concerns in researching collaborative natural resource management. Society and Natural Resources 21, 258-265.
Quandt, S., Arcury, T. & Pell, A. 2001. Something for everyone? A community and academic partnership to address farmworker pesticide exposure in North Carolina. Environmental Health Perspectives 109, 435-441.
St. Martin, Kevin, and Madeleine Hall-Arber. 2008. “Creating a Place for "Community" in New England Fisheries,” Human Ecology Review 15(2):161-17.
Schell, L., Ravenscroft, J., Cole, M., Jacobs, A., Newman, J. & Akwesasne Task Force on the Environment. 2005. Health sisparities and toxicant exposure of Akwesasne Mohawk young adults: a partnership approach to research. Environmental Health Perspectives 113.
Sibongile Masuku Van Damme, L. & Meskell, L. 2009. Producing conservation and community in South Africa. Ethics, Place & Environment 12, 69-89.
Module Three Materials: Assigned Readings
Arquette, M., Cole, M., Cook, K., LaFrance, B., Peters, M., Ransom, J., Sargent, E., Smoke, V. Stairs, A. 2002. Holistic risk-based environmental decision-making: a native perspective. Environmental Health Perspectives 110, 259-264.
Charles, J. & Menzie, C. 1998. Identifying Southeast Asian immigrant populations in Massachusetts at risk from eating contaminated shellfish. Journal of Environmental Management 51, 161-171.
Coburn, J. 2002. Combining community-based research and local knowledge to confront asthma and subsistence-fishing hazards in Greenpoint/Williamsburg, Brooklyn, New York. Environmental Health Perspectives 110, 241-248.
Flint, C., Luloff, A., & Finley, J. 2008. Where is ‘community’ in community-based forestry? Society and Natural Resources 21, 526-537.
Gibbs, M. 2001. Toward a strategy for undertaking cross-cultural collaborative research. Society and Natural Resources 14, 673-687.
Kimmerer, R. 2000. Native knowledge for native ecosystems. Journal of Forestry 98, 4-9.
Léger, A. 2005. Intellectual property rights in Mexico: do they play a role? World Development 33, 1865-1879.
Menzie, C. & Butler, C. 2006. Understanding ecological knowledge. Traditional Ecological Knowledge and Natural Resource Management 2006, 4-10.
Quigley, D. 2006. A review of improved ethical practices in environmental and public health research: case examples from native communities. Health Education and Behavior 33, 130-147.
Sharp, R. & Foster, M. 2002. Community involvement in the ethical review of genetic research: lessons from American Indian and Alaska Native populations. Environmental Health Perspectives 110, 145-148.
Sze, Julie. 2002. Asian American activism for environmental justice. Peace Review 16, 149-156.
Module Three Materials: Assigned Readings (Optional)
The Akwesasne Research Advisory Committee. The Good Mind Research Protocol. Akwesasne Notes New Series 2, 94-9.
Kimmerer, R. 2002. Weaving traditional ecological knowledge into biological education: a call to action. BioScience 52, 432-438.
MacQueen, K., McLellan, E., Metzger, D., & Kegeles, S. 2001. What is community? An evidence-based definition for participatory public health. American Journal of Public Health 91, 1929-1938.
Module Four: Case Studies
Douglass, Mike. 1992. "The Political Economy of Urban Poverty and Environmental Management in Asia: Access, Empowerment and Community Based Alternatives," Environment and Urbanization 4(2):9-32.Ha, Seong-Kyu. 2001. Developing a community-based approach to urban redevelopment. GeoJournal 53: 39–45.
Jacobson, Maxine, Kate Pruitt-Chapin, and Chris Rugeley. 2009. "Toward Reconstructing Poverty Knowledge: Addressing Food Insecurity through Grassroots Research Design and Implementation," Journal of Poverty 13:1-19.
Krasny, Marianne. 2001. "Participatory approaches to program development and engaging youth in research: The case of an inter-generational urban community gardening program," Journal of Extension 40(5)
Rishbeth, Clare. 2004. Ethno-cultural Representation in the Urban Landscape. Journal of Urban Design, Vol. 9, No. 3, 377-333.
Shandas, V.& W. Barry Messer. 2008. Fostering Green Communities Through Civic Engagement: Community-Based Environmental Stewardship in the Portland Area, Journal of the American Planning Association, 74:4, 408-418.
Svendson, Erika S., and Lindsay K. Campbell. 2008. "Urban ecological stewardship: Understanding the structure, function and network of community-based urban land management," Cities and the Environment 1(1):1-32.
Natural Resource Management
Howard, Johnathon Leigh. 2010. “Managing for justice in community-based water planning: a conceptual framework,” Environmental Conservation 37(3):356–363.
Larson, S. 2009. Communicating stakeholder priorities in the Great Barrier Reef region. Society and Natural Resources 22, 650-664.
Sibongile Masuku Van Damme, L. & Meskell, L. 2009. Producing conservation and community in South Africa. Ethics, Place & Environment 12, 69-89.
Corburn, Jason. 2002. "Combining Community-Based Research and Local Knowledge to Confront Asthma and subsistence-Fishing Hazards in Greenpoint/ Williamsburg, Brooklyn, New York," Environmental Health Perspectives 110(suppl 2): 241-248.
Cohen, Alison. Andrea Lopez, Nile Malloy and Rachel Morello-Frosch. Our Environment, Our Health : A Community-Based Participatory Environmental Health Survey in Richmond, California. Health Educ Behav 2012 39: 198.
Kegler, Michelle C; Lorraine Halinka Malcoe; Veronika Fedirko. Primary Prevention of Lead Poisoning in Rural Native American Children Behavioral Outcomes From a Community-Based Intervention in a Former Mining Region Fam Community Health 2010, Vol. 33, No. 1, pp. 32–43.
Engineering Case Studies
Anonymous. Blackburn Pedestrian Bridge and Walkway: community-based aspects Civil Engineering : Magazine of the South African Institution of Civil Engineering; Dec 2011; 19, 11;(see article on Blackboard site for pictures).
Garvin, Theresa., Tara K. McGee, Karen E. Smoyer-Tomic1, Emmanuel Ato Aubynn. Community- company relations in gold mining in Ghana. Journal of Environmental Management 90 (2009) 571-586.
Kraemer, Antonie. Whose forests, whose voices? Mining and community-based nature conservation in southeastern Madagascar. Conservation and Development, Vol. 7, Issue 25, November 2012.
Penningroth, S. M. Yarrow, A. Figueroa, R. Bowen, S. Delgado. Community-based Risk Assessment of Water Contamination from High Volume Horizontal Hydraulic Fracturing, New Solutions Vol. 23(1) 137-166, 2013.
Native American/Indiginous Studies
Carter, Jennifer, Protocols, particularities, and problematizing Indigenous ‘engagement’ in community-based environmental management in settled Australia The Geographical Journal, Vol. 176, No. 3, September 2010, pp. 199–213
Grimwood, B., Doubleday, N., Liubicic, G., Donaldson, S. Blangy, S., Nancy C. Engaged acclimatization: Towards responsible community-based participatory research in Nunavut. The Canadian Geographer / Le G´eographe canadien 2012, 56(2): 211–230
Kegler, Michelle C; Lorraine Halinka Malcoe; Veronika Fedirko. Primary Prevention of Lead Poisoning in Rural Native American Children Behavioral Outcomes From a Community-Based Intervention in a Former Mining Region Fam Community Health 2010, Vol. 33, No. 1, pp. 32–43
Zagozewski, Rebecca, Ian Judd-Henrey, Suzie Nilson, and Lalita Bharadwaj. 2011. "Perspectives on Past and Present Waste Disposal Practices: A Community-Based Participatory Research Project in Three Saskatchewan First Nations Communities," Environmental Health Insights 5:9‑20.
Gender and Environmental Research
Ardey, Samuel Nii. Codjoe & Lucy Kafui Atidoh and Virginia Burkett . Gender and occupational perspectives on adaptation to climate extremes in the Afram Plains of Ghana. Climatic Change (2012) 110:431–454.
Caizhen, Lu. Gender Issues in Water User Associations in China: A Case Study in Gansu Province, Rural Society, Volume 18, Number 3, December 2008.
Ibnou, Fatma Osman. Challenges and possibilities for achieving household food security in the Western Sudan region: the role of female farmer Food Sec. (2011) 3:215–231.
Module Four: Class Readings
Davenport, M., Leahy, J., Anderson, D., & Jakes, P. 2007. Building trust in natural resource management within local communities: a case study of the Midewin National Tallgrass Prairie. Environmental Management 39, 353-368.
Foster, D. 2009. Cultural humility and the importance of long-term relationships in international partnerships. Journal of Obstetric, Gynecologic, & Neonatal Nursing 38, 100-107.
MacIntyre, A. 1984. After virtue: a study in moral theory. University of Notre Dame Press: Notre Dame.