There are two critical steps in determining whether a medical experiment involving human subjects can be conducted in an ethical manner: assessing risks and potential benefits and obtaining potential subjects’ informed consent. Although an extensive literature on both of these aspects exists, virtually nothing has been written about human experimentation for which the objective is not to prevent, cure, or mitigate a disease or condition, but to enhance human capabilities. One exception is a 2004 article (...) by Rebecca Dresser on preimplantation genetic modification — one of the most controversial enhancement technologies — in which she states, “Under existing research ethics principles, it would be unethical for investigators to perform modifications exposing embryos expected to develop into healthy children to significant risk in exchange for a possible physical or mental enhancement.” But Dresser does not explain why such an experiment would be unethical under existing principles, and her conclusion is not self-evident. (shrink)

This paper explores ethical considerations for active studies of circumcision, i.e., the amputation of the foreskin, in the form of a case study of three major trials performed in African countries in the early 2000s. The paper outlines the function of the foreskin and method and history of its amputation as well as its current use in attempting to combat the global AIDS crisis. These trials are then interrogated in accordance with the Declaration of Helsinki. In particular, the irreversible nature (...) of amputation is given great consideration. The case studies are found to have serious failures in terms of the modern iteration of the Declaration of Helsinki. This paper calls for extreme scrutiny in accordance with international norms relating to the ethical treatment of human subjects in a research context of studies of circumcision if and when they are proposed again. (shrink)

Experts from different disciplines offer novel ideas for improving research oversight and protection of human subjects.

The experimental method is designed to secure the reliable attribution of causal relationships by means of controlled comparison across conditions. Doing so, however, depends upon the reduction of uncertainties and inconsistencies in the process of comparison; and this poses particularly significant challenges for the behavioral and social sciences because they work with human subjects, whose malleability and complexity often interact in unexpected ways with experimental manipulations, thus resulting in unpredictable behavior. Drawing on the Science and Technology Studies perspective (...) and one of our authors’ experiences in experimental work, this paper examines how experimental social scientists manage to establish objectivity and standardization in the face of vagaries arising from working with human subjects. In identifying experimental researchers’ solutions to this challenge, we draw on methodological discussions among applied social scientists as naturally occurring data, through which we show how some seemingly mundane practices play essential roles in extracting patterns out of otherwise unpredictable behaviors in the lab. Closely examining such strategies, we reveal the inherent instabilities in the experimental method when adopted in the social sciences and discuss their methodological implications. In conclusion, we make tentative suggestions for escaping the kinds of methodological impasses which we have identified. (shrink)

Visual recording of human subjects is commonly used in biomedical disciplines for clinical, research, legal, academic and even personal purposes. Guidelines on practice standards of biomedical recording have been issued by certain health authorities, associations and journals, but none of the literature discusses this from an Islamic perspective. This article begins with a discussion on the general rules associated with visual recording in Islam, followed by modesty issues in biomedical recording and issues of informed consent and confidentiality. In (...) order to be deemed ethical from the Islamic perspective, all the aforementioned criteria must conform to, or not contradict, Islamic teaching. (shrink)

A collaborative team of environmental sociologists, community psychologists, religious studies scholars, environmental studies/science researchers and engineers has been working together to design and implement new training in research ethics, culture and community-based approaches for place-based communities and cultural groups. The training is designed for short and semester-long graduate courses at several universities in the northeastern US. The team received a 3 year grant from the US National Science Foundation’s Ethics Education in Science and Engineering in 2010. This manuscript details the (...) curriculum topics developed that incorporate ethical principles, particularly for group protections/benefits within the field practices of environmental/engineering researchers. (shrink)

There are growing discontinuities between the research practices of data science and established tools of research ethics regulation. Some of the core commitments of existing research ethics regulations, such as the distinction between research and practice, cannot be cleanly exported from biomedical research to data science research. Such discontinuities have led some data science practitioners and researchers to move toward rejecting ethics regulations outright. These shifts occur at the same time as a proposal for major revisions to the Common Rule—the (...) primary regulation governing human-subjects research in the USA—is under consideration for the first time in decades. We contextualize these revisions in long-running complaints about regulation of social science research and argue data science should be understood as continuous with social sciences in this regard. The proposed regulations are more flexible and scalable to the methods of non-biomedical research, yet problematically largely exclude data science methods from human-subjects regulation, particularly uses of public datasets. The ethical frameworks for Big Data research are highly contested and in flux, and the potential harms of data science research are unpredictable. We examine several contentious cases of research harms in data science, including the 2014 Facebook emotional contagion study and the 2016 use of geographical data techniques to identify the pseudonymous artist Banksy. To address disputes about application of human-subjects research ethics in data science, critical data studies should offer a historically nuanced theory of “data subjectivity” responsive to the epistemic methods, harms and benefits of data science and commerce. (shrink)

The article rejects various attempts to negate the subjectivity of human embryo, formulated among others in the Polish debate entitled 'Stem cells - life for life?' and organised by the Ministry of Scientific Research and Information Technology in 2003 and 2004. The Author thinks that the proposal to treat a human embryo as a deceased donor of organs, is wrong both in the field of embryology and philosophical anthropology. It is also wrong to question the subjectivity of (...) class='Hi'>human embryo using various criteria of growth (developed nervous system, brain, consciousness, participation in the life of society and looking after one's own interests). For these criteria do not define humanity but describe human being in various phases of expressions of his/her human nature. That is why it is not acceptable to make the right to life conditional on the stage and degree of the actualization of humanity. Furthermore, one cannot justify the deprivation of the subjectivity of human embryo because of medical progress and the so-called good of humankind. The acceleration of progress cannot be done at the cost of life of some group of human beings. (shrink)

An engaging, compelling and disturbing confrontation with evil...a book that will be transformative in its call for individual and collective moral responsibility." - Michael A. Grodin, M.D., Professor and Director, Project on Medicine and the Holocaust, Elie Wiesel Center for Judaic Studies, Boston University Human Subjects Research after the Holocaust challenges you to confront the misguided medical ethics of the Third Reich personally, and to apply the lessons learned to contemporary human subjects research. While it is (...) comforting to believe that Nazi physicians, nurses, and bioscientists were either incompetent, mad, or few in number, they were, in fact, the best in the world at the time, and the vast majority participated in the government program of "applied biology." They were not coerced to behave as they did-they enthusiastically exploited widely accepted eugenic theories to design horrendous medical experiments, gas chambers and euthanasia programs, which ultimately led to mass murder in the concentration camps. Americans provided financial support for their research, modeled their medical education and research after the Germans, and continued to perform unethical human subjects research even after the Nuremberg Doctors' Trial. The German Medical Association apologized in 2012 for the behavior of its physicians during the Third Reich. By examining the medical crimes of human subjects researchers during the Third Reich, you will naturally examine your own behavior and that of your colleagues, and perhaps ask yourself "If the best physicians and bioscientists of the early 20th century could do evil while believing they were doing good, can I be certain that I will never do the same?" · Presents relatively unknown aspects of human subjects research during the Third Reich · Reveals surprising relationships between German and American human subjects research · Dispels myths about Nazi human subjects research · Compels introspection and self-examination by today's medical and research practitioners · Addresses contemporary bioethical issues affecting vulnerable populations · Brings together experts in the history of medicine during the Third Reich and thoughtful new voices. (shrink)

Over the past 5 years, a series of articles in leading American newspapers has revealed the extent to which the conduct of clinical trials may be affected by inducements offered by corporate research sponsors and accepted by some unscrupulous physicians. The cases described were disturbing. They involved physicians engaged in excessive “enrollment activities” in exchange for money. Some of these physicians perpetrated fraud, falsifying their recruitment records in order to increase their profits. Others ignored exclusion criteria designed to ensure the (...) safety of subjects and the validity of research results, referring their patients to research investigating treatments for conditions from which they did not suffer. One of the articles reports that physicians focusing exclusively on commercial research regularly divulge annual incomes upwards of $1,000,000 with profits in excess of $300,000. Two physicians accumulated well over $10,000,000 through clinical trials activities in less than a decade. (shrink)

Like all policies, contemporary human research policies are the product of their history. The scandals and traumas motivating their creation — the Nazi doctors trials, Tuskegee, the Milgram experiment on obedience — however different in their particulars, all share a common narrative: a scientist, pursuing valued social ends, runs roughshod over the personal interests of disadvantaged human subjects. From the Nuremberg code through the latest revisions of the Declaration of Helsinki, research ethics policies have sought to erect (...) a sphere of protection around the latter.As a consequence of this history, all major policies start with a well-rehearsed model of human investigations. Clinical research is viewed as an encounter between investigators and volunteers. The clinical investigator is given certain duties. The human volunteer has certain moral entitlements. What is ethically at stake in human investigations inheres in the nature and quality of the interactions between investigators and volunteers. These interactions involve an asymmetry because the investigator has privileged knowledge and influence. (shrink)

The somewhat disturbing success of bioethics as a discipline is probably due to the unique nature of its subject matter. Indeed what is it that happens when scientific interest, with its particular resources and language, turns toward the study of the human body? Can this body be instrumentalized like any other object, or do the sciences have to give way here before a taboo subject? Have the sciences not, without their knowing it, taken on an unprecedented signification? The truly (...) prodigious growth of new fields of biological knowledge has thrust biology into the public arena. Extending more than ever beyond the status of narrowly scientific knowledge, these new fields have taken on a mythological and normative character in the social imagination. (shrink)

Globalization and Human Subjectivity argues that Hegelian subjectivity could serve as a philosophical basis for a new conception of human subjectivity for the age of globalization. Why, then, does globalization demand a new conception of human subjectivity at all? What constitutes the Hegelian subjectivity such that it is not only relevant and but also necessary to the contemporary, postmodern context of globalization? This book largely addresses these two questions. Capitalist globalization, the context in which we find ourselves (...) today, strategically leads to the “death of the subject,” in the sense that it reduces human beings merely to consumers who, without critical subjectivity, simply succumb to the imperialism of a globalizing market. In this context, we are impelled to envision a new conception of human subjectivity for the age of globalization. This book explores Hegel’s view on human subjectivity as spiritual subjectivity, particularly presented in his Phenomenology of Spirit, which could function as a new anthropological vision about what it means to be authentically human in a globalizing world, that is, a sort of cosmopolitan citizen who is constantly universalizing oneself through self-transcending, self-determined ethico-political actions in solidarity with others to create a global community of co-existence and co-prosperity for all. (shrink)

The human subjects researchmodel is increasingly invoked in discussions ofethics for Internet research. Here we seek toquestion the widespread application of thismodel, critiquing it through the two themes ofspace and textual form. Drawing on ourexperience of a previous piece ofresearch, we highlightthe implications of re-considering thetextuality of the Internet in addition to thespatial metaphors that are more commonlydeployed to describe Internet activity. Weargue that the use of spatial metaphors indescriptions of the Internet has shaped theadoption of the (...) class='Hi'>human subjects research model.Whilst this model is appropriate in some areasof Internet research such as emailcommunication, we feel that researchers, whennavigating the complex terrain of Internetresearch ethics, need also to consider theInternet as cultural production of texts. (shrink)

Non-lethal weapons have become an increasingly important class of weapons. Creating these armaments requires examination of ethical issues in their research and development processes. Chief a...

The overlap and differences between the parallel regulatory systems for research create ample room for confusion and missteps, as discussed by Barbara Bierer and Mark Barnes in their report in this supplement. In practice, beyond the inherent differences in the two systems of regulations themselves, there are many issues that further complicate the application of these regulations. These include the variation in size of the institutions receiving PHS funding, the increased prevalence of multisite research, the allocation of research conduct and (...) oversight to external organizations, and the variability in assignment of human subject protection roles between the IRB and the institution. (shrink)

There have been serious controversies in the latter part of the 20th century about the roles and functions of scientific and medical research. In whose interests are medical and biomedical experiments conducted and what are the ethical implications of experimentation on subjects unable to give competent consent? From the decades following the Second World War and calls for the global banning of medical research to the cautious return to the notion that in controlled circumstances, medical research on human (...) subjects is in the best interest of the given individual and the broader population, this book addresses the key implications of experimentation on humans. This volume covers major ethical themes within biomedical research providing historical, philosophical, legal and policy reflections on the literature and specific issues in the field of research on human subjects. Focusing on special populations (the elderly, children, prisoners and the cognitively impaired) it represents the most up-to-date review of the special ethical and legal conflicts that arise with relation to experimentation on subjects from these groups. In the light of current initiatives for law reform pertaining to research ethics the world over, this volume provides a timely, comprehensive and provocative exploration of the field. The volume has been carefully organized to present important philosophical perspectives on organizing principles that should underlie any practical application. A forward-looking historical review of the regulatory regimes of principal jurisdictions, including of the legal controls already in place, provides the backdrop for future policy initiatives. Additionally, in the light of global restructuring of health care systems, several chapters have been devoted to epidemiological research and related issues. (shrink)

On November 14, 1996, an in-depth report on the recruiting and testing practices of Lilly Pharmaceuticals appeared in the Wall Street Journal. Laurie Cohen reported that most pharmaceutical companies had difficulty recruiting healthy subjects to participate in testing of “untried and potentially dangerous” drugs. These companies often had to pay subjects up to $250 a day to ensure adequate enrollment, and some even gave referral bonuses to doctors who sent potential subjects their way. Cohen then exposed how (...) Lilly was able to keep costs down: by recruiting homeless alcoholics to serve as research guinea pigs. “In many ways,” Cohen reported, “the practice is mutually beneficial. For Lilly, it is efficient and limits the risk that subjects will sue if harmed by an experiment or divulge particulars of a drug.” And the subjects “get several weeks or months of free room and board, and in interviews they express voluble gratitude for what they often call easy money.”. (shrink)

In this paper, I discuss the ethical issues related to deception in human subject research in terms of honesty. First, I introduce the background and suggest the conception of honesty that understands it as involving respect for the right not to be deceived (RND). Next, I examine several ways to address the ethical issues of deceptive elements in the human subject research and show why they fail to adequately meet the demand of honesty. I focus on how to (...) make an honest research plan and examine after participation and before participation phases in turn. Then I conclude by suggesting possible strategies to minimizes dishonesty in human subject research. (shrink)

Small-scale research projects involving human subjects have been identified as being effective in developing critical appraisal skills in undergraduate students. In deciding whether to grant ethical approval to such projects, university research ethics committees must weigh the benefits of the research against the risk of harm or discomfort to the participants. As the learning objectives associated with student research can be met without the need for human subjects, the benefit associated with training new healthcare professionals cannot, (...) in itself, justify such risks. The outputs of research must be shared with the wider scientific community if it is to influence future practice. Our survey of 19 UK universities indicates that undergraduate dissertations associated with the disciplines of medicine, dentistry and pharmacy are not routinely retained in their library catalogues, thus closing a major avenue to the dissemination of their findings. If such research is unlikely to be published in a peer-reviewed journal, presented at a conference, or otherwise made available to other researchers, then the risks of harm, discomfort or inconvenience to participants are unlikely to be offset by societal benefits. Ethics committees should be satisfied that undergraduate research will be funnelled into further research that is likely to inform clinical practice before granting ethical approval. (shrink)

Although deceptive psychology experiments receive less attention than some forms of medical research, they pose similar moral challenges. These challenges mainly concern the use of human subjects and intentional deception. Psychologists provide an argument to justify this deception. But what is an essentially utilitarian argument too often includes faulty comparisons and dubious accounts of risks and benefits. Commentators in other areas of humansubject research might examine this argument and the assumptions behind it. Bioethics commentators seem especially well-positioned for (...) this task. (shrink)

Two years ago, the Journal of Law, Medicine & Ethics published volume 28, number 4, devoted to a symposium entitled Human Subjects Research and the Role of Institutional Review Boards - Conflicts and Challenges. I had the good fortune to be asked to serve as editor of that issue. In her introduction to the symposium, the then editor-in-chief of the journal, Ellen Wright Clayton, observed that the country is currently undergoing a major reexamination of how biomedical research is (...) conducted. While that reexamination has continued in the interim, some very recent events raise questions about the extent to which this will continue, at least in the short run, with equal vigor. The intervening years have witnessed a variety of new directions and events. The federal Office of Human Research Protections, directed by Dr. Greg Koski, who wrote a brief commentary for the last symposium,L has taken a new direction, strongly stressing the need for institutions and their institutional review boards ORBS) to engage in extensive educational and quality improvement efforts with both researchers and their own member. (shrink)

Nanomedicine is yielding new and improved treatments and diagnostics for a range of diseases and disorders. Nanomedicine applications incorporate materials and components with nanoscale dimensions where novel physiochemical properties emerge as a result of size-dependent phenomena and high surface-to-mass ratio. Nanotherapeutics and in vivo nanodiagnostics are a subset of nanomedicine products that enter the human body. These include drugs, biological products, implantable medical devices, and combination products that are designed to function in the body in ways unachievable at larger (...) scales. Nanotherapeutics andin vivonanodiagnostics incorporate materials that are engineered at the nanoscale to express novel properties that are medicinally useful. These nanomedicine applications can also contain nanomaterials that are biologically active, producing interactions that depend on biological triggers. Examples include nanoscale formulations of insoluble drugs to improve bioavailability and pharmacokinetics, drugs encapsulated in hollow nanoparticles with the ability to target and cross cellular and tissue membranes and to release their payload at a specific time or location, imaging agents that demonstrate novel optical properties to aid in locating micrometastases, and antimicrobial and drug-eluting components or coatings of implantable medical devices such as stents. (shrink)

International health-related research on human subjects entails unique ethical responsibilities and difficulties. Often, these difficulties are augmented by the lack of a local ethical review infrastructure. In a recent cross-national study conducted by us, three critical components of ethical regulation were identified—external oversight, local oversight and subject involvement—and integrated into the study design. These three concepts are outlined and established as an important aspect of ensuring ethical coherence in the local context, particularly when reviews by the local institutional (...) review boards cannot practically be obtained. The three levels of ethical oversight identified are suggested to be the framework within which future field studies on human subjects are developed and a standard for maintaining ethical rigorousness in research on humans. (shrink)

The use of brain imaging technology as a common tool of research has spawned concern and debate over how investigators should respond to incidental fndings discovered in the course of research. In this article, we argue that investigators have an obligation to respond to incidental fndings in view of their entering into a professional relationship with research participants in which they are granted privileged access to private information with potential relevance to participants' health. We discuss the scope and limits of (...) this professional obligation to respond to incidental fndings, bearing in mind that the relationship between investigators and research participants differs fundamentally from the doctor-patient relationship. (shrink)

(2010). Ethical Rules for Human Subjects Research: A Case Where the “Is” Must Inform the “Ought”. The American Journal of Bioethics: Vol. 10, No. 6, pp. 14-15.

The natural epistemology of W. V. Quine has not been well understood. Critics argue that Quine's scientific approach to epistemology is circular and fails to be normative, yet these criticisms tend to be based on the very presuppositions concerning language, theory, and epistemology that Quine is at pains to reject or alter. ;Quine's views on the meaningfulness of language use imply a breakdown in the dichotomy between language as a theoretically neutral instrument and theory as the commitment to some subset (...) of the sentences allowed by a language. This breakdown, and the view of language which drives it, result in Quine's doctrine that speaking a language involves substantial theoretical commitments, and that inquiry must begin from within some ongoing theory of the world. That is, our epistemic practices, including epistemology itself, must be globally circular. The traditionally fundamental norm of linear propositional support, which drives the circularity objection, is thus seen as based in a misconception of language and theory. This not only explains Quine's lack of concern with the circularity of his view, but also illuminates the fundamental motivation for his general naturalism. ;Natural epistemology cannot be normative in the traditional sense of providing an independent ground for science. However, having accepted the "terminal parameter" of prediction as the test of theory, normativity becomes a matter of describing which procedures best promote predictively successful theory. Thus, epistemic norms emerge from science as hypotheses concerning the effectiveness of various methods in promoting predictively successful theory. Not only can natural epistemology prescribe and proscribe various epistemic practices, it offers the promise of an explanatory understanding of the strengths and weaknesses of those practices. Based on this understanding, natural epistemology further involves the improvement of current practices and the development of new ones. Crucial to this reconception of epistemology is the reconception of the knower as an adaptive organism employing the language/theory complex as an adaptive tool for interacting with the environment. ;The naturalism/anti-naturalism debate is advanced by acknowledging the substantial theoretical commitments implicit in the traditional view, and by examining Quine's reconception of language, theory, and the human knowing subject. (shrink)

In order to increase understanding of the ethical implications of biomedical, behavioral and clinical research, the Fogarty International Center, part of the United States National Institutes of Health, established an International Research Ethics Education and Curriculum Development Award to support programs in low- and middle-income countries. To develop research ethics expertise in Jordan, the University of California San Diego fellowship program in collaboration with Jordan University of Science and Technology provides courses that enable participants to develop skills in varied research (...) ethics topics, including research with human subjects. The program provides a master’s level curriculum, including practicum experiences. In this article we describe a practicum project to modify an existing introduction to human subjects research for a US audience to be linguistically and culturally appropriate to Arabic-speaking-Islamic communities. We also highlight key differences that guided the conversion of an English version to one that is in Arabic. And finally, as Institutional Review Boards follow the ethical principles of the Belmont Report in evaluating and approving biomedical and behavioral human subjects research proposals, we provide observations on the conformity of the three ethical principles of the Belmont Report with Islam. (shrink)

Over the past 40 years, a complex review and oversight system has grown within the United States and internationally to regulate the conduct of human subjects research. This system developed in response to revelations of abuses of human subjects in experiments such as those conducted in the Nazi concentration camps, the Tuskegee Study of Untreated Syphilis in the Negro Male, the Willowbrook Hepatitis Studies, and the studies described by Beecher in his 1966 article in the New (...) England Journal of Medicine. The oversight system is based on a foundation, first implemented by the U.S. Public Health Service in 1966 and by the U.S. Food and Drug Administration in 1971, of prior review and approval of a written experimental protocol by an independent committee. The World Medical Association articulated the ethical centrality of independent review in its 1975 revision of the Declaration of Helsinki, and the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research endorsed the requirement in its flagship Belmont Report. (shrink)