Trends in health research ethics in the Philippines during the American Colonial Period (1898‐1946)

Research involving human participants has been conducted in the Philippines since the beginning of the Spanish colonial period. Such studies are expected to adhere to internationally accepted ethical guidelines. This paper discusses trends in clinical research ethics in the Philippines during the American colonial period (1898‐1946). Specifically, studies were assessed on: 1) their observance of ethical protocols, including review; 2) identification of inclusion and exclusion criteria in the selection of participants; 3) use of vulnerable subjects; and 4) practice of the informed consent process. Only the informed consent process had a significant logistic correlation with progression of years. Recruitment of vulnerable groups was common during this period; children and prisoners were the most common participants. Trends in medical ethics in the Philippines reflected those in the United States prior to the publication of the Nuremberg Code, which served as a milestone in the protection of human welfare in clinical research.     

Research participation and the right to withdraw

Most ethics committees which review research protocols insist that potential research participants reserve unconditional or absolute 'right' of withdrawal at any time and without giving any reason. In this paper, I examine what consent means for research participation and a sense of commitment in relation to this right to withdraw. I suggest that, once consent has been given (and here I am excluding incompetent minors and adults), participants should not necessarily have unconditional or absolute rights to withdraw. This does not imply that there should be a complete absence of rights, or, indeed, an abandonment of the right to withdraw. The point of this paper is to show that the supposed unconditional or absolute nature of these rights may be self-defeating and so fail to respect the autonomy of participants. In addition, and on a more positive note, I suggest that, attaching certain conditions on the right to withdraw, may better respect the autonomy of these participants by underlining the idea that autonomy is more than mere whim or indifference to the fate of others. On the contrary, research staff are currently unable to 'push' participants, who may merely have logistical difficulties unrelated to the research itself, but who really want to stay the course, for fear of coercing them. Furthermore, researchers now try to 'screen out' people they think may be unreliable to protect the science of the study and so groups at risk of dropping out may be unfairly denied access to research treatments. I conclude that on-going negotiation between the relevant parties could be on balance the only truly acceptable way forward but concede certain important limitations to take into account.     

Informed Consent in Health Research: Challenges and Barriers in Low‐and Middle‐Income Countries with Specific Reference to Nepal

Obtaining ‘informed consent’ from every individual participant involved in health research is a mandatory ethical practice. Informed consent is a process whereby potential participants are genuinely informed about their role, risk and rights before they are enrolled in the study. Thus, ethics committees in most countries require ‘informed consent form’ as part of an ethics application which is reviewed before granting research ethics approval. Despite a significant increase in health research activity in low‐and middle‐income countries (LMICs) in recent years, only limited work has been done to address ethical concerns. Most ethics committees in LMICs lack the authority and/or the capacity to monitor research in the field. This is important since not all research, particularly in LMICs region, complies with ethical principles, sometimes this is inadvertently or due to a lack of awareness of their importance in assuring proper research governance. With several examples from Nepal, this paper reflects on the steps required to obtain informed consents and highlights some of the major challenges and barriers to seeking informed consent from research participants. At the end of this paper, we also offer some recommendations around how can we can promote and implement optimal informed consent taking process. We believe that paper is useful for researchers and members of ethical review boards in highlighting key issues around informed consent.     

On the Alleged Right to Participate in High‐Risk Research

Reigning regulatory frameworks for biomedical research impose on researchers and research ethics committees an obligation to protect research participants from risks that are unnecessary, disproportionate to potential research benefits, and non‐minimized. Where the research has no potential to produce results of direct benefit to the subjects and the subjects are unable to give consent, these requirements are strengthened by an additional condition, that risks should not exceed a certain minimal threshold. In this article, I address the question of whether there should be limits of permissible risks in non‐therapeutic research involving competent and healthy subjects. Some commentators argue that competent and informed individuals should have a right to participate even in extremely risky research and that research ethics committees should never reject studies because they are too dangerous. To use David Shaw's expression, competent volunteers should have ‘a right to participate in high‐risk research’. I argue that this idea is ill‐founded, as it does not take into account the social mission and complex collaborative nature of research practice as well as the inequity of power between researchers and subjects. Imposition of limits on permissible risks for healthy volunteers is justified by the need to protect research enterprise and the need to protect the weaker party, namely the subjects. Also, I suggest that the best way to set boundaries on research risks is to leave the judgment of risk acceptability to research ethics committees.     

Designing humans: A human rights approach

Advances in genomic technologies such as CRISPR‐Cas9, mitochondrial replacement techniques, and in vitro gametogenesis may soon give us more precise and efficient tools to have children with certain traits such as beauty, intelligence, and athleticism. In this paper, I propose a new approach to the ethics of reproductive genetic engineering, a human rights approach. This approach relies on two claims that have certain, independent plausibility: (a) human beings have equal moral status, and (b) human beings have human rights to the fundamental conditions for pursuing a good life. I first argue that the human rights approach gives us a lower bound of when reproductive genetic engineering would be permissible. I then compare this approach with other approaches such as the libertarian, perfectionist, and life worth living approaches. Against these approaches, I argue that the human rights approach offers a novel, and more plausible, way of assessing the ethics of reproductive genetic engineering.     

Research ethics education for community-engaged research: a review and research agenda

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.     

The problem of abortion: essentially contested concepts and moral autonomy

When one thinks about the ethics of abortion, one inevitably thinks about rights, since it is in terms of the concept of rights that much of the debate has been conducted. This is true of overtly feminist as well as non-feminist accounts. Indeed, some early feminist writers--Judith Jarvis Thomson and Mary Ann Warren, for example--employ a model of rights that is indistinguishable, or virtually indistinguishable, from that of their non-feminist counterparts. However, more recent feminist writers have developed a different understanding of 'a woman's right to choose.' In this paper, I will begin by outlining the non-feminist debate over the moral permissibility of abortion. I will suggest that this debate is irresolvable, since at its heart is an 'essentially contested concept', that of personhood. I will then consider the way in which some feminist writers have attempted to reconceive the terms of the abortion debate and suggest an expanded account of women's right to abortion, drawing on the work of Susan Sherwin. Finally, I will argue that there is a further element to a 'woman's right to choose' that expands on and provides a conceptual link between feminist and non-feminist understanding of abortion.     

Human Research Ethics Committees: Examining their Roles and Practices

considerable time and resources are invested in the ethics review process. We present qualitative data on how human research ethics committee members and health researchers perceive the role and function of the committee. The findings are based on interviews with 34 Australian ethics committee members and 54 health researchers. Although all participants agreed that the primary role of the ethics committee was to protect participants, there was disagreement regarding the additional roles undertaken by committees. Of particular concern were the perceptions from some ethics committee members and researchers that ethics committees were working to protect the institution's interests, as well as being overprotective toward research participants. This has the potential to lead to poor relations and mistrust between ethics committees and researchers.     

A moderate Buddhist animal research ethics

Though there is a burgeoning interest in applied Buddhist ethics, Buddhist animal research ethics remains an underdeveloped area. In this paper I will explore how some central Buddhist ethical considerations can usefully engage our use of other animals (henceforth, animals) in science. As the scientific use of animals is broad, I will narrow my focus to laboratory science. I will show that, though a Buddhist abolitionism would not be unmotivated, it is possible to reject it. While doing so, it will be important to resist emphasizing elements of Buddhist thought that merely provide reasons to adopt the dominant ethical framework governing laboratory animal research ethics, known as the 3Rs. Though I will suggest how a Buddhist animal research ethics can sometimes permit the use of animals in harmful research, it will also require ethical constraints that resonate with some of the more progressive elements in ‘Western’ bioethics.     

Study bystanders and ethical treatment of study participants—A proof of concept

The ethics of research on human subjects is often construed as a fine balance between the interests of patients in need of novel health interventions, and those of study participants who should remain safe in the process. But there is a third group in the mix. Some people belong to neither category, yet research can affect or jeopardize them. Call such people “bystanders.” This article shows that thinking about bystander protection can question whether there is an upper limit on the risks that studies may legitimately visit upon their participants. Thus, thinking about appropriate bystander protection can shed light on the appropriate protection of study participants. Core research ethics, which focuses on the latter, must consider the former as well.     

Guidelines for Community-based Ethics Review of Children’s Science Fair Projects

Low-level community based ethics committees staffed by teachers, parents and community representatives can readily review children’s science fair projects subject to the revision of two core assumptions currently governing children’s Science Fairs. The first part of the paper recasts the New Zealand Royal Society guidelines from its primary emphasis on risk to a new assumption, without benefit there can be no risk. Equally, this revision gives more prominence to the participant information sheet, allowing it to act as a quasi application form which provides ethical transparency between student researchers, participants and a community based ethics committee. A second core assumption, more accurately labeled a cult of originality, produces a random, open-ended array of student topics taking ethics review beyond the confidence level of most community based ethics review committees. This paper reins in Science Fair coordinators recommending they make community level ethics review more manageable by providing a list of preapproved topics for those students wanting to conduct research involving human participants. These revised assumptions create a workable division of labour. Teachers’ preapproved topics involving human participants are more likely to be low risk, permitting community level ethics review to focus primarily on two aspects of the minimization of harm: first, for all participants, especially those with diminished autonomy, and second, for the child researchers themselves, as some participants may be unknown to the student. These revised assumptions make science and ethics more accessible to public education thus demonstrating how Science Fairs can lead students and the community into better understanding the role and function that ethics has in all scientific research human participants. Martin Tolich chaired New Zealand’s National Health Ethics committee, the multi-region ethics committee.     

The ubiquity of deception and the ethics of deceptive research

Does the fact that deception is widely practised – even though there is a general prohibition against deception – provide insight into the ethics of deceptive methods in research, especially for social‐behavioral research? I answer in the affirmative. The ubiquity of deception argument, as I will call it, points to the need for a concrete and nuanced understanding of the variety of deceptive practices, and thus promises an alternative route of analysis for why some deception may be permissible in social‐behavioral research. As an alternative argument it also promises to break the stalemate that emerges in debates on the ethics of deceptive methods in social‐behavioral research. In the current paper I (1) motivate and articulate the ubiquity argument in order to clarify the significance of ubiquity and discharge some initial objections. Then, on the recommendations of the ubiquity argument, I (2) highlight the importance of interpersonal relationships for understanding the ethics of deception. Following this insight I (3) provide an analysis of several features of the researcher‐participant relationship relevant to the understanding of the ethics of deception in research. I then (4) conclude the argument with some recommendations for the ethical use of deceptive methods in social‐behavioral research.     

Post‐trial obligations in the Declaration of Helsinki 2013: classification,reconstruction and interpretation

The general aim of this article is to give a critical interpretation of post‐trial obligations towards individual research participants in the Declaration of Helsinki 2013. Transitioning research participants to the appropriate health care when a research study ends is a global problem. The publication of a new version of the Declaration of Helsinki is a great opportunity to discuss it. In my view, the Declaration of Helsinki 2013 identifies at least two clearly different types of post‐trial obligations, specifically, access to care after research and access to information after research. The agents entitled to receive post‐trial access are the individual participants in research studies. The Declaration identifies the sponsors, researchers and host country governments as the main agents responsible for complying with the post‐trial obligations mentioned above. To justify this interpretation of post‐trial obligations, I first introduce a classification of post‐trial obligations and illustrate its application with examples from post‐trial ethics literature. I then make a brief reconstruction of the formulations of post‐trial obligations of the Declaration of Helsinki from 2000 to 2008 to correlate the changes with some of the most salient ethical arguments. Finally I advance a critical interpretation of the latest formulation of post‐trial obligations. I defend the view that paragraph 34 of ‘Post‐trial provisions’ is an improved formulation by comparison with earlier versions, especially for identifying responsible agents and abandoning ambiguous ‘fair benefit’ language. However, I criticize the disappearance of ‘access to other appropriate care’ present in the Declaration since 2004 and the narrow scope given to obligations of access to information after research.     

Module one: introduction to research ethics

This module will introduce you to the ethical concepts underlying applied ethical decision-making in the area of research involving human participants. We will also learn what the issues are that people involved in research on research ethics are concerned with. Ethics without an understanding of historical and legal context makes arguably little sense. It is for this reason that this module will begin with a brief history of research ethics and ends with a brief overview of the relevant national and international guidelines pertaining to ethical issues in research involving human participants.     

Research in the ranks: vulnerable subjects, coercible collaboration, and the hepatitis E vaccine trial in Nepal

Concern over the diminished autonomy of members of the armed forces has resulted in the classification of these groups as "vulnerable" in many international codes of research ethics, a designation that places the onus on researchers to provide special justification for the inclusion of these persons in research. This paper examines the application of these ethical requirements to a recent trial carried out by U.S. Army researchers among soldiers of the Royal Nepal Army (RNA) and concludes that the requirements to justify conducting research in this population were not met. Furthermore, noting the human rights abuses rampant in the RNA, it is appropriate to question the choice of this institution as both a partner and a subject pool for U.S. state-sponsored research. This case study raises another important ethical question about the vulnerability to coerced collaboration of groups or institutions. In response, I propose the idea of "institutional vulnerability" as an extension of the idea of individual "juridic vulnerability." The recent military and financial assistance that the RNA received from the U.S. Army, in light of their partnership in this biomedical research trial, constitutes an appropriate and revealing context in which to ground this discussion.     

Who are we when we are doing what we are doing?: the case for mindful embodiment in ethics case consultation

This paper explores the theory and practice of embodied epistemology or mindful embodiment in ethics case consultation. I argue that not only is this epistemology an ethical imperative to safeguard the integrity of this emerging profession, but that it has the potential to improve the quality of ethics consultation (EC). It also has implications for how ethics consultants are trained and how consultation services are organized. My viewpoint is informed by ethnographic research and by my experimental application of mindful embodiment to the development of an ethics consultation service. My argument proceeds in four phases. First I explore the notion of 'situatedness' in the bioethics literature, identifying gaps in the field's theories as they apply to EC. I then describe my theoretical approach to embodiment grounded in critical-interpretive medical anthropology and autoethnography. I use embodiment to refer to a moral epistemology grounded in the body, comprised of the interplay of physical, symbolic, intersubjective and political elements. Third, I describe how mindful embodiment can inform the role of the ethics consultant and the development of effective training techniques, vocabularies and processes for EC. I also discuss the benefits of this orientation, and the potential harms of ignoring the embodied dimensions of EC. My goals are to expose the fallacy of the 'theory-practice gap', to demonstrate how my own EC practice is deeply informed by this theoretical orientation, and to argue for a wider definition of what 'counts' as relevant theory for ethics consultation.     

What is wrong with ethics review,the impact on teaching anthropology,and how to fix it: results of an empirical study

There is no empirical evidence that ethics review protects anthropologists’ research participants, but there is ample evidence that it is stifling research agendas and reshaping how we teach anthropological research methods, entrenching a positivist, clinical model of what constitutes research. This paper examines the impact of ethics review on student research in Australia, based on interviews conducted at 14 Australian universities. The data clearly show that the risks posed by student research are minor, and vastly overestimated by ethics committees. To avoid problems with ethics committees, we shepherd students into undertaking low‐risk, and consequently low‐impact, research. Many departments are abandoning research‐led teaching altogether because of the obstacle of ethics review. One solution would be to locate ethics discussions in disciplines and departments, radically restructuring the encounter to reconceptualise it as collegial debate about ethics dilemmas rather than ‘ethics review’.     

Biomedical Enhancement and Social Development: A Conservative Techno‐Fix

Allen Buchanan has argued for a linking of the ethics of human enhancement to the ethics of development more generally. The promise of the ‘enhancement enterprise' is that it may help develop society, just as other technological advances have in the past. He proposes a framework of intellectual property rights, government action to ensure the poor can access the enhancements, an international organization to administer the diffusion of new enhancement technologies from the West to poor countries, and the diffusion within countries to the poorer populations. I take seriously his proposal of discussing biomedical enhancement in terms of the ethics of development. On these grounds of assessment, I argue that his proposal is politically conservative. To make the case, I distinguish conservatism in ethics from conservatism in politics; and I contextualize the proposal against the background of development economics and the neoliberal approach to development.