Subjects in studies on humans are used as a means of conducting the research and achieving whatever good would justify putting them at risk. Accordingly, consent must normally be obtained before subjects are exposed to any substantial risks to their welfare. Bystanders are also often put at risk, but they are not used as a means. Accordingly—or so I argue—consent is more often unnecessary before bystanders are exposed to similar substantial risks to their welfare.

Interventions performed on a pregnant woman's body can affect the fetus in multiple ways. Such effects can be harmful to beneficial to the fetus. Unfortunately, the effects of new drugs and compoun...

ABSTRACT A complex problem exists about how to promote the best interests of children as a group through research while protecting the rights and welfare of individual research subjects. The Nuremberg Code forbids studies without consent, eliminating most children as subjects, and the Declaration of Helsinki disallows non-therapeutic research on non-consenting subjects. Both codes are unreasonably restrictive. Another approach is represented by the Council for the International Organizations of Medical Science, the U.S. Federal (...) class='Hi'>Research Guidelines, and many other national policies. They allow research ethics committees or institutional review boards to authorize studies with acceptable balances of likely benefits and harms, but neither clarify how to balance them nor explain the meaning of pivotal concepts, like “minimal risk.” Paths to the improvement of balancing or consequentialist approaches include improving standardizing of risk assessment, rejecting crude utilitarianism, identifying and justifying normative or moral judg-ments, and acknowledging extra-regulatory thresholds and deontological or non-negotiable duties to children. (shrink)

Empirical research has discovered that experimental subjects in ultimatum bargaining situations generally fail to play the decision-theoretic optimum strategy, and instead play something between that strategy and a fair split. In evolutionary dynamics, fair division and nearly fair division strategies often go to fixation and weakly dominated strategies can do quite well. Computer simulations were done using three different ultimatum bargaining games as determinates of fitness. (1) No tendency toward the elimination of weakly dominated strategies was observed, with (...) or without mutation. (2) Strategies making fair demands had sizable basins of attraction. (3) In a system where five different demands can be made, demands closest to (approximately) 91% had the largest basins of attraction. (4) If the strategies have thresholds for acceptable demands, rather than individuated responses to each demand, the apparent optimum demand may be quite low: 64% for one set of trials. (shrink)

Risk–benefit assessment is a routine requirement for research ethics committees that review and oversee biomedical research with human subjects. Nevertheless, it remains unclear how to weigh and balance risks to research participants against the social benefits that flow from generating biomedical knowledge. In this article, we address the question of whether there are any reasonable criteria for defining the limit of permissible risks to individuals who provide informed consent for research participation. We argue against any (...) a priori limit to permissible research risks. However, attention to the uncertainty of potential social benefit that can be derived from any particular study warrants caution in exposing prospective research participants to a substantial likelihood of serious harm. (shrink)

The federal regulations that govern biomedical research, most notably those enshrined in the Common Rule, are a product of their time. Born in the aftermath of wartime atrocities committed by Nazi doctors, and influenced by domestic research scandals like the Willowbrook and Tuskegee studies, the regulations express a protectionist ethos aimed at safeguarding subjects of human experimentation from the potential harms of research participation. Requirements for informed consent, risk minimization, equitable subject selection, and peer review of (...) proposed research rest on the presumption that the research enterprise owes subjects a duty of protection. (shrink)

Federal policies on human subjects research have performed a near‐about face. In the 1970s, policies were motivated chiefly by a belief that subjects needed protection from the harms and risks of research. Now the driving concern is that patients, and the populations they represent, need access to the benefits of research.

Unequal treatment of human research subjects is a significant ethical concern, because justice in research involving human subjects requires equal protection of rights and equal protection from harm and exploitation. Disputes sometimes arise concerning the issue of unequal treatment of research subjects. Allegedly unequal treatment occurs when subjects are treated differently and there is a genuine dispute concerning the appropriateness of equal treatment. Patently unequal treatment occurs when subjects are treated differently (...) and there is not a genuine dispute about the appropriateness of equal treatment. Allegedly unequal treatment will probably always occur in research with human subjects due to disagreements about fundamental questions of justice. The best way to deal with allegedly unequal treatment is to promote honest and open discussions of the issues at stake. Research regulations can help to minimize patently unequal treatment by providing rules for investigators, ethical review boards, institutions, and sponsors to follow. However, patently unequal treatment may still occur because the regulations are subject to interpretation. Federal agencies have provided interpretive guidance that can help promote consistent review and oversight of human subjects research. Additional direction may be needed on topics that are not adequately covered by current guidance or regulations. International guidelines can help promote equal treatment of human subjects around the globe. While minor variations in the treatment of research subjects should be tolerated and even welcomed, major ones (i.e. those that significantly impact human rights or welfare) should be avoided or minimized. (shrink)

This paper discusses how to deal with research that threatens to cause harm to society—in particular, whether and in what cases bans and moratoria are appropriate. First, it asks what normative resources philosophy of science may draw on to answer such questions. In an effort to presuppose only resources acknowledgeable across different comprehensive worldviews, it is claimed that the aim of credibility provides a good basis for normative reflection. A close analysis reveals an inner tension inherent in the (...) pursuit of credibility, referred to as the paradox of credibility: Although the aim of credibility involves the goal of being trusted, the immediate pursuit of the goal of being trusted as much as possible can run counter to and undermine the pursuit of credibility. From this inner tension, considerations are derived on what it means to uncompromisingly strive for trustworthiness. When applied to the problem of harmful research, it becomes apparent that it is important to distinguish between different types of cases. Some cases allow science to prevent harm while relinquishing credibility in the associated research area. In contrast, other cases demand preserving subject-specific scientific credibility in order to manage potential harm. (shrink)

In August 2019, the fifth international congress of the 'International Association for the Study of the Philosophy of Edith Stein' (IASPES) took place at the University of Cologne. Of the 57 papers presented at this prominent conference prepared and chaired by the historian and theologian Harm Klueting, 54 were accepted for publication in revised versions. Professor Klueting was able to add three other contributions -- among them by the director of the Research Institute of the German Province of (...) the Carmelites at Bamberg, the historian and theologian Edeltraud Klueting, who acts as co-editor. The congress volume, published only a little more than a year after the congress despite significant constraints due to the Corona pandemic, contains 29 contributions in English, 21 in German, and seven in Spanish or French on the subjects 'Biographical questions', 'Edith Stein and thinkers of the past', 'Edith Stein and other contemporary thinkers', 'Anthropology -- Women and men', 'Philosophy -- phenomenology and Christian philosophy', 'Society and politics', 'Theology and spirituality', and 'Experiences with Edith Stein'. (shrink)

In a recent paper Edwards, Kirchin, and Huxtable have argued that research ethics committees (RECs) are often wrongfully paternalistic in their approach to medical research. They argue that it should be left to competent potential research subjects to make judgments about the acceptability of harms and benefits relating to research, and that this is not a legitimate role for any REC. They allow an exception to their overall antipaternalism, however, in that they think RECs should (...) have the power to prohibit the use of financial inducements to recruit research subjects into trials. In this paper it is argued that these claims are unjustified and implausible. A sketch is provided of an alternative model of the role of the REC as an expert body making judgments about the acceptability of research proposals through a consensual weighing of different moral considerations. (shrink)

When may a physician enroll a patient in clinical research? An adequate answer to this question requires clarification of trust-based obligations of the state and the physician-researcher respectively to the patient-subject. The state relies on the voluntarism of patient-subjects to advance the public interest in science. Accordingly, it is obligated to protect the agent-neutral interests of patient-subjects through promulgating standards that secure these interests. Component analysis is the only comprehensive and systematic specification of regulatory standards for benefit- (...) class='Hi'>harm evaluation by research ethics committees (RECs). Clinical equipoise, a standard in component analysis, ensures the treatment arms of a randomised control trial are consistent with competent medical care. It thus serves to protect agent-neutral welfare interests of the patient-subject. But REC review occurs prior to enrolment, highlighting the independent responsibility of the physician-researcher to protect the agent-relative welfare interests of the patient-subject. In a novel interpretation of the duty of care, we argue for a “clinical judgment principle” which requires the physician-researcher to exercise judgment in the interests of the patient-subject taking into account evidence on treatments and the patient-subject‘s circumstances. (shrink)

Ethical challenges to certain aspects of research on human subjects are not uncommon; examples include challenges to first-in-human trials (Chapman in J Clin Res Bioethics 2(4):1–8, 2011), certain placebo controlled trials (Anderson in J Med Philos 31:65–81, 2006; Anderson and Kimmelman in Kennedy Inst Ethics J 20(1):75–98, 2010) and “sham” surgery (Macklin in N Engl J Med 341:992–996, 1999). To date, however, there are few challenges to research when the subjects are competent and the research (...) is more than minimal risk with no promise of direct benefit. The principal reason given for allowing research that is more than minimal risk without benefit is that we should respect the autonomy of competent subjects. I argue that though the moral intuitions informing respect for autonomy are sound, there is another set of intuitions regarding what we take to be just treatment of another when one agent knowingly causes or allows suffering on another agent. I argue that concerns generated by commutative justice serve as limitations on permissible research. I highlight our intuitions informing this notion of justice by appealing to work done on theodicy; what counts as a morally sufficient reason for God to allow suffering in humans is applicable also to the researcher-subject relationship. I conclude that all human subjects who are exposed to more than minimal risk research should enjoy the same actual protections (e.g., subpart D) as those given subjects who cannot consent. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Protecting Human Research SubjectsThe Office for Protection from Research RisksJoan Paine Porter (bio)The office for Protection from Research Risks (OPRR), located within the National Institutes of Health, has two divisions: Human Subject Protections and Animal Welfare. This article will address the overall responsibilities and current projects relating to human subject protections.OPRR implements the Department of Health and Human Services' (HHS) regulations for the protection of human (...) subjects (45 CFR 46 (1991)). These regulations fulfill the responsibilities set forth in the Public Health Service (PHS) Act with regard to institutional review boards (IRB) and other protections for human subjects involved in biomedical and behavioral research conducted or supported by HHS. The PHS Act also mandates a program to clarify ethical issues in biomedical research involving human subjects and to address violations of the rights of human subjects of research (P.L. 99-158 (1985)).OPRR staff negotiate assurances of compliance with institutions conducting Federally-supported research involving human subjects. The assurances describe the policies and procedures each institution will follow to fulfill the requirements of the regulations, including specific IRB composition and functions.In addition, OPRR cosponsors with the Food and Drug Administration and awardee institutions a series of regional workshops that address human subject protections issues. These are attended by IRB members, institutional officials, research investigators, and others involved with human subject protections.Current ActivitiesNumerous activities are underway in OPRR. The following describes only a few of the initiatives and studies aimed at helping develop policies and procedures to protect human subjects of research."Points to Consider" DocumentsOPRR is currently working with the National Center for Human Genome Research (NCHGR) to develop a "points to consider" document for IRBs and others involved in large genetic pedigree studies. Many questions have emerged [End Page 279] on topics such as how subjects should be recruited, with whom information should be shared about others in the family, social risks of disclosure in employment and insurance, the circumstances and timing of informing subjects about study results, and involvement of children. OPRR and NCHGR hope to assemble a group this fall to review and refine the points that are now being developed jointly. A conference in South Carolina organized by the American Association for Advancement in the Sciences entitled "Project on the Ethical and Legal Implications of Genetic Testing," helped generate advice, and identified some of the more controversial issues in design and conduct of genetic research that involves large groups of family members.Another "points to consider" effort concerns enrollment of women and minorities in research. The PHS has established a policy that members of these groups must be included in research projects unless there are valid scientific justifications for their exclusion which can be made on a project by project basis (ADAMHA/NIH Policy 1990; NIH/ADAMHA Policy 1990). OPRR has commissioned several scholarly papers to help in developing "points to consider" for IRBs as they balance issues of equitable selection of subjects and protection of these selected individuals. Concerns about enrolling women of childbearing age in research that may be harmful to a fetus, and liability issues frequently dominate discussion in this area. The papers will address ethical, legal, and statistical aspects of enrollment of minorities and women as well as provide a description of various practices and roles of IRBs in addressing goals of fair selection of participants and appropriate protections.OPRR is also working with the PHS Panel on Women, Adolescents and Children to produce a document, also in the form of "points to consider" guidance, concerning enrollment of children who are wards of the state in HIV-related research. Subpart D of the regulations for the protection of human subjects (45 CFR 46) specifically addresses research involving children who are wards of the state, including the special protections that must be provided. State and local officials who have authority to enroll foster care children in research have indicated a desire to obtain advice in this area.The IRB GuidebookA major project that is now being completed under contract to the Poynter Center at Indiana University is the IRB Guidebook. It will revise and expand the current IRB Guidebook produced in the 1980s... (shrink)

Human beings with diminished decision-making capacities are usually thought to require greater protections from the potential harms of research than fully autonomous persons. Animal subjects of research receive lesser protections than any human beings regardless of decision-making capacity. Paradoxically, however, it is precisely animals’ lack of some characteristic human capacities that is commonly invoked to justify using them for human purposes. In other words, for humans lesser capacities correspond to greater protections but for animals the opposite is (...) true. Without explicit justification, it is not clear why or whether this should be the case. Ethics regulations guiding human subject research include principles such as respect for persons—and related duties—that are required as a matter of justice while regulations guiding animal subject research attend only to highly circumscribed considerations of welfare. Further, the regulations guiding research on animals discount any consideration of animal welfare relative to comparable human welfare. This paper explores two of the most promising justifications for these differences␣between the two sets of regulations. The first potential justification points to lesser moral status for animals on the basis of their lesser capacities. The second potential justification relies on a claim about the permissibility of moral partiality as␣found in common morality. While neither potential justification is sufficient to justify the regulatory difference as it stands, there is possible common ground between supporters of some regulatory difference and those rejecting the current difference. (shrink)

The risks of harm to nonhuman primates, and the absence of benefits for them, are critically important to decisions about nonhuman primate research. Current guidelines for review and practice tend to be permissive for nonhuman primate research as long as minimal welfare requirements are fulfilled and human medical advances are anticipated. This situation is substantially different from human research, in which risks of harms to the individual subject are typically reduced to the extent feasible. A risk (...) threshold is needed for the justification of research on nonhuman primates, comparable to the way risk thresholds are set for vulnerable human subjects who cannot provide informed consent. Much of the laboratory research conducted today has inadequate standards, leading to common physical, psychological, and social harms. (shrink)

This paper examines the ethical difficulties of organ donation from living donors and the problem of causing harm to patients or research subjects at their request. Graham Greene explored morally similar questions in his novella, The Tenth Man.

Este ensayo presenta una panorámica general y un análisis de la visión que sustenta el empleo de los métodos cualitativos, incluyéndose su aplicación a la investigación en Administración. Bajo los planteamientos de un monismo metodológico, la aportación de conclusiones no generalizables y de subjetividad inherente de tales métodos se considera limitada; mientras que para los adherentes al constructivismo y al pluralismo, es de gran valía en la exploración de la profundidad de los fenómenos de estas disciplinas. En sí, prevalece en (...) el medio una falta de consensos incluso con respecto a qué son los métodos cualitativos y qué son las técnicas cualitativas de investigación, derivada del uso indistinto que dan algunos autores a esos términos; lo que aunado a la cantidad y diversidad de métodos cualitativos crea dificultades para comprender qué es en realidad la investigación cualitativa.This essay presents a general outlook and an analysis of the rationale behind the use of qualitative methods, including their being applied in research in Management. According to the views of methodological monism, the contribution of the conclusions which these methods yield, which are essentially subjective and not susceptible of being generalized, is considered too limited; while for advocates of constructivism and pluralism they are valuable in probing the depth of the phenomena of these disciplines. In fact, a lack of consensus prevails in these areas even in connection with what are qualitative methods and what are qualitative research techniques, associated to an indistinct use of these terms by some authors; which together with the number and diversity of qualitative methods makes it difficult to understand what actually is qualitative research. (shrink)

Specialist Sport Programs are an underexamined activity that combines the best features of two different contexts for adolescent development: a sporting program and a secondary school. A mixed-methods study was conducted to determine the influence of participation in SSPs on the educational outcomes of lower secondary students in Western Australia. The results demonstrated a significant improvement in specialist students' mean grade for Mathematics over the course of a year, while their mean grade for all other subjects, and their level (...) of engagement with school, remained stable over the same period of time. Semi-structured interviews were also conducted with key stakeholders. Overall, the participants felt that SSPs had a positive influence on students' engagement with school, and that this engagement had a positive impact on their academic achievement. Taken together, the results of this research suggest that there is a role for SSPs in promoting positive educational outcomes for lower secondary students attending public schools located in low SES areas. (shrink)

When science takes man as its subject, tensions arise between two values basic to Western society: freedom of scientific inquiry and protection of individual inviolability.... At the heart of this conflict lies an age-old question: When may a society, actively or by acquiescence, expose some of its members to harm in order to seek benefits for them, for others, or for society as a whole?

There is an alleged tension between undue inducement and exploitation in research trials. This paper considers claims that increasing the benefits to research subjects enrolled in international, externally-sponsored clinical trials should be avoided on the grounds that it may result in the undue inducement of research subjects. This article contributes to the debate about exploitation versus undue inducement by introducing an analysis of the available empirical research into research participants' motivations and the influence (...) of payments on research subjects' behaviour and risk assessment. Admittedly, the available research in this field is limited, but the research that has been conducted suggests that financial rewards do not distort research subjects' behaviour or blind them to the risks involved with research. Therefore, I conclude that research sponsors should prioritise the prevention of exploitation in international research by providing greater benefits to research participants. (edited). (shrink)

The Code of Federal Regulations permits harmful research on children who have not agreed to participate, but I will argue that it should be no more permissive of harmful research on such children than of harmful research on adults who have not agreed to participate. Of course, the Code permits harmful research on adults. Such research is not morally problematic, however, because adults must agree to participate. And, of course, the Code also permits beneficial (...) class='Hi'>research on children without needing their explicit agreement. This sort of research is also not problematic, this time because paternalism towards children may be justifiable. The moral problem at the center of this paper arises from the combination of two potential properties of pediatric research, first that it might be harmful and second that its subjects might not agree to participate. In Section 2 of this article I explain how the Code permits harmful research on non-agreeing children. Section 3 contains my argument that we should no more permit harmful research on non-agreeing children than on non-agreeing adults. In Section 4, I argue that my thesis does not presuppose that pediatric assent has the same moral force that adult consent does. In Section 5, I argue that the distinction between non-voluntary and involuntary research is irrelevant to my thesis. In Section 6, I rebut an objection based on the power of parental permission. In Section 7 I suggest how the Code of Federal Regulations might be changed. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:When Should “Riskier” Subjects Be Excluded from Research Participation?*Dave Wendler** (bio)AbstractThe exclusion of potential subjects based on increased risks is a common practice in human subjects research. However, there are no guidelines to ensure that this practice is conducted in a systematic and fair way. This gap in the literature and regulations is addressed by a specific account of a “condition on inclusion risks” (...) (CIR), a condition under which potential subjects should be excluded from research on the basis of increased risks. This account provides a general framework for assessing standard exclusions as well as more controversial ones such as the exclusion of pregnant women and women of childbearing potential from certain types of research.The exclusion of potential subjects on the basis of increased risks is a common and, in most instances, noncontroversial practice in human subjects research. Investigators routinely exclude potential subjects with reduced kidney function, bleeding disorders, and allergies to the drugs under investigation. Surprisingly, this use of exclusion criteria takes place in the absence of any explicit guidelines. In the present paper, I attempt to fill this gap in the literature and regulations by offering a specific account of the conditions under which potential subjects should be excluded from research on the basis of increased risk. This account serves two purposes.First, subjects who are excluded on the basis of increased risk are prevented from making their own enrollment decisions. Therefore, it is important to ensure, in spite of the broad range of potential subjects and the varied reasons for excluding them, that potential subjects are excluded in [End Page 307] a systematic and fair way. Second, certain instances of subject exclusion, most notably the exclusion of pregnant women and women of childbearing potential, raise more difficult issues. By providing a general framework for assessing the exclusion of potential subjects based on increased risks, the present analysis covers these cases as well and, thus, offers a solution to one of the thornier ethical dilemmas facing investigators and IRBs today.Briefly, I argue that standard exclusion practices suggest that whenever two groups of potential research subjects offer the same opportunity for scientific and individual benefit, but different levels of risk, the group that would introduce greater risks should be excluded. With this framework in place, I consider potential subjects, such as men and women of child-parenting potential, whose research participation introduces increased risks to third parties. I argue that the present approach is justified, not because it reduces harms to specific individuals, but because it reduces aggregate harms. Therefore, it should be applied to all riskier potential subjects regardless of who faces the risks in question. After defending this approach, I consider several objections.First, I argue that the present approach is not paternalistic; the exclusions it calls for are not justified by what is thought to be in the best interests of the individuals excluded. Rather, the argument is that these exclusions minimize the aggregate harm of human subjects research. In addition, the present approach does not violate the obligation of researchers to respect subject autonomy because it does not reduce the number of potential subjects who are given the opportunity to enroll in a particular protocol. Finally, the exclusions are consistent with reasonable side constraints on attaining the goals of research.“Riskier” SubjectsWhen it comes to evaluating risks, most guidelines on human subjects research stipulate simply that the risks entailed must be reasonable given the potential for benefit. The Australian National Health and Medical Research Council’s guidelines, for instance, require only that “the investigator... must be satisfied that the possible advantage to be gained from the work justifies any discomfort or risk involved” (ANMRC 1992, Clause 3). To determine whether the risks of a protocol are justified, one sums the risks of the various procedures in the protocol, whatever those procedures may be, and compares the result to the procedures’ potential for benefit. This evaluation of risks assumes that the aggregate risks of a [End Page 308] given protocol are fixed and thus will not help to determine whether and when the risks of particular protocols should be reduced by excluding riskier subjects. The United States Department of Health... (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)

Responsible research and innovation features the dialog of science “with society,” and research performed “for society,” i.e., for the benefit of the people. I focus on this latter, outcome-oriented notion of RRI and discuss two kinds of problems. The first one concerns options to anticipate the future course of science and technology. Such foresight knowledge seems necessary for subjecting research to demands of social and moral responsibility. However, predicting science and technology is widely considered impossible. The second (...) problem concerns moral evaluation. The benefit or harm produced by certain research and innovation achievements is often hard to estimate. Against this background of uncertainty in factual and moral assessment, I explore opportunities left for RRI. First, RRI should contribute to maintaining a wide range of approaches. Second, judgments about RRI should draw on zones of convergence among the variety of research approaches pursued. Third, decisions about implementing a technology should be revisable. Fourth, the more specific inclusion of demands from society should be reserved to technology development. Fifth, in many respects, the social compatibility of a new technology is due rather to the social context than the inherent features of the product. Favorable circumstances are transparency, representation of all relevant parties, and procedural fairness. As a result, some of the benefits and detriments of research and innovation can be identified without detailed knowledge of future findings. (shrink)

Throughout the world, research ethics committees are relied on to prevent unethical research and protect research subjects. Given that reliance, the composition of committees and the manner in which decisions are arrived at by committee members is of critical importance. There have been Instances in which an inadequate review process has resulted in serious harm to research subjects. Deficient committee review was identified as one of the factors In a study in New Zealand (...) which resulted in the suffering and death of many women diagnosed with carcinoma in situ. (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)

This paper addresses the growing concern over violation of research ethics in marketing, in particular rights of human subjects in fieldwork, notably the right to informed consent; right to privacy and confidentiality; and right not to be deceived or harmed as a result of participation in a research. The paper highlights the interaction of the three main parties involved in most marketing research: the sponsoring organization (client or user), researcher, and participant in the survey, focusing on (...) researcher’s ethical responsibilities in interacting with human subjects in surveys. The paper stresses the importance of ethical integrity in marketing research and emphasizes the need to establish a universal model for regulatory requirements and well institutionalized practice of ethical research. (shrink)

The clinical trial is the major investigational tool of clinical medicine. Two recent reports highlight the fact that the most often quoted mechanisms for the protection of research subjects, viz., research ethics board review and eligibility criteria, are insufficient to achieve this end. In this paper, we argue that the prime mechanism for the protection of persons in clinical trials should be the clinical judgement of the physician-investigator. The clinical investigator has a duty to protect subjects (...) from both harm and undue risk. It is argued that the clinical investigator has a duty to screen for, and exclude, potential research subjects who may be unduly vulnerable to the risks of a particular clinical trial. In order to fulfill this obligation, the investigator should personally screen each potential research subject at the time of accrual. In larger trials in which this is not feasible, this task could be delegated to another appropriately qualified health care professional, with the principal investigator retaining personal responsibility. To reinforce and make explicit this legal and moral duty, we propose that the investigator sign a statement, appended to each subject's consent form, to attest that this duty has been responsibly discharged. (shrink)

Mandatory reporting laws, which vary slightly from state to state, require reporting by helping professionals when there is reasonable cause to suspect child abuse. Institutional Review Boards (IRBs) require researchers to warn subjects of this duty to report, which may have a chilling effect on subject rapport and candor. Certificates of confidentiality, in conjunction with other precautions, may reduce some barriers to valid research. Attempts to resolve problems created by reporting laws must produce the most valid research, (...) while minimizing harm and distress to research participants, their families, and the researcher and meeting local and federal legal requirements. (shrink)

Koplin and Wilkinson (K&W) argue for the sociological claim that many believe (1) that the moral uncertainty argument provides significant moral reasons against farming human–pig chimaeras for their organs (henceforth, ‘farming for organs’) but (2) that there no are significant moral reasons against farming non-chimeric pigs for food (henceforth, ‘farming for food’). And yet, K&W argue for the ethical claim, that if the moral uncertainty argument provides significant moral reasons against farming for organs then there are similar moral reasons against (...) farming for food. The moral uncertainty argument appears to be an application of what I have called ‘the moral status framework’ to farming for organs.1–3 According to the moral status framework, human–animal chimaera research should be evaluated as to its risk of (1) enhancing the moral status of an animal to that of a normal human while (2) continuing to treat the animal as animals are usually treated in biomedical research.4 In status-enhancing research, ‘sacrificing the fundamental interests of the chimeric research subject as they would have been sacrificed in any other animal research is the moral equivalent of sacrificing the fundamental interests of a fully functional adult human being. On all but the most extreme animal rights views, this makes status-enhancing research much worse than other biomedical research on animals, and on any plausible view, makes it absolutely unacceptable’.5 K&W similarly say that, according to the moral uncertainty argument, ‘It would be gravely wrong to treat humans the same way we do animal …. (shrink)

Net‐risk pediatric research encompasses interventions and studies that pose risks and do not offer a compensating potential for clinical benefit. These interventions and studies are central to efforts to improve pediatric clinical care. Yet critics argue that it is unethical to expose children to research risks for the benefit of unrelated others. While a number of ethical justifications have been proposed, none have received widespread acceptance. This leaves funders with uncertainty over whether they should support and institutional review (...) boards with uncertainty over whether they should approve net‐risk pediatric research. To try to answer these questions, this article describes a justification that I previously proposed and considers two objections to it. This analysis reveals that the opportunity to contribute to a valuable project can justify exposing children to risks even though some trials turn out to be valueless and others turn out to be harmful. It follows that, to protect pediatric participants, institutional review boards need to assess whether trials have the potential to collect socially valuable information and whether they are likely to enroll and retain a sufficient number of participants. (shrink)

Offering cash payments to research subjects is a common recruiting method but there is significant debate about whether and in what amount such payments are appropriate. This paper is concerned with exploitation and whether there should be a lower limit on the amount researchers can pay their subjects. When subjects participate in research as a way to make money, fairness requires that researchers pay them a fair wage. This call for the establishment of a lower (...) limit meets resistance in two places: (1) denial that the payments offered by researchers are wages for participation; and (2) concern about undue inducement. This paper critically examines these arguments for and against a lower limit. It shows that the need for a lower limit cannot be avoided by adopting a non-wage payment model and that concerns about undue inducement are unjustified in all trials except those that present greater than minimal risk. This analysis suggests the following compromise position: there should be an unconditional lower limit on payment amounts so that researchers cannot offer less than a fair wage, and when researchers cannot satisfy this limit because fairness requires a problematically large payment, then researchers should offer no payment at all. (shrink)

The first objective of this article is to demonstrate that ethics committee members can learn a great deal from a forensic analysis of two classic psychology studies: Zimbardo’s Stanford Prison Study and Milgram’s Obedience Study. Rather than using hindsight to retrospectively eradicate the harm in these studies, the article uses a prospective minimization of harm technique. Milgram attempted to be ethical by trying to protect his subjects through debriefing and a follow-up survey. He could have done more, (...) however, by carrying out what ethics committees routinely insist on today for those researching sensitive topics. The establishment of counselling supports to identify harm to participants would have minimized additional harm. Were these in place, or in Zimbardo’s case had the Stanford Ethics Committee properly identified Zimbardo’s conflict of interest – he was both a principal investigator and the prison warden – how much harm could have been minimized? The second aim is to examine how some qualitative authors routinely demonize these classic studies. It might appear that there are too few cases of unethical qualitative research to justify such an examination; however, this article identifies a number of recent examples of ethically dubious qualitative research. This would suggest that qualitative research should examine its own ethics before poaching from psychology. (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)

This essay analyzesexploitation in biomedical research in terms ofthree basic elements: harm, disrespect, orinjustice. There are also degrees ofexploitation, ranging from highly exploitationto minimally exploitation. Althoughexploitation is prima facie wrongful,some exploitative research studies are morallyjustified, all things considered. The reasonan exploitative study can still be ethical isthat other moral considerations, such as theautonomy of the research subject or the socialbenefits of research, may sometimes justifystudies that are minimally exploitative. Calling a research project exploitative doesnot (...) end the debate about the merits of thestudy but invites one to ask additionalquestions about how the study is exploitative,and whether the study is justifiablenevertheless. (shrink)

During the Third Reich, state‐sponsored violence was linked to scientific research on many levels. Prisoners were used as involuntary subjects for medical experiments, and body parts from victims were used in anatomy and neuropathology on a massive scale. In many cases, such specimens remained in scientific collections and were used until long after the war. International bioethics, for a long time, had little to say on the issue. Since the late 1980s, with a renewed interest in the Holocaust (...) and other Nazi crimes, a consensus has increasingly taken hold that research on human tissues and body parts from the Nazi era is inadmissible, and that such specimens should be removed from scientific collections and buried. The question of what to do with scientific data obtained from these sources has not received adequate attention, however, and remains unsolved. This paper traces the history of debates about the ethical implications of using human tissue or body parts from the Nazi period for scientific purposes, primarily in the fields of anatomy and neuropathology. It also examines how this issue, from after the war until today, influenced the establishment of legal and bioethical norms on the use of human remains from morally tainted sources, with a particular emphasis on Germany and Austria. It is argued that the use of such specimens and of data derived from them is unethical not only because of potential harms to posthumous rights of the victims, but also because such use constitutes a moral harm to society at large. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Women and Health Research:A Report from the Institute of MedicineAnna C. Mastroianni (bio), Ruth Faden (bio), and Daniel Federman (bio)In recent years, claims have been made by segments of the research community and by women's health advocacy groups that clinical research practices and policies have not benefitted women's health to the same extent as men's health. Central to these claims has been an assertion that women (...) have been inadequately represented as subjects of clinical studies and that as a result neither health conditions unique to women—e.g., menopause—nor women's manifestations of health problems affecting both sexes—e.g., heart disease—have been investigated sufficiently.The scientific community, including federal agencies that sponsor and regulate clinical studies, is increasingly responsive to these claims and is taking steps to raise the level of women's participation in clinical studies. Controversy and concern have surrounded these actions, however. Two of the claims that have been made are: (1) that women are more difficult to study than men because of their cyclical hormonal changes; and (2) that conducting gender-specific subgroup analyses would increase the size of study populations, raise the cost of studies, and thereby reduce the number of studies that could be performed with the limited resources available. In addition, controversy over the inclusion of women of childbearing potential and pregnant women has been particularly salient. Concerns have been expressed about avoiding potential harm to existing or potential fetuses and about the possible legal and financial ramifications of such harm. A further concern involves the perceived difficulties in enrolling women in studies and retaining them for the duration of the studies.Against this backdrop, the Office of Research on Women's Health at the National Institutes of Health (NIH) asked the Institute of Medicine (IOM) in October 1992 to establish the Committee on the Ethical and Legal Issues Relating to the Inclusion of Women in Clinical Studies. The Committee's charge was to: (1) consider the ethical and legal implications of including women, particularly pregnant women and women of childbearing potential, in clinical studies; (2) examine known instances of litigation regarding injuries to research subjects [End Page 55] and describe existing legal liabilities and protections; and (3) provide practical advice on these issues for consideration by NIH, institutional review boards (IRBs), and clinical investigators.The 16 Committee members came from diverse backgrounds: bioethics, law, epidemiology and biostatistics, public health policy, obstetrics and gynecology, clinical research, pharmaceutical development, social and behavioral sciences, and clinical evaluative sciences.1 Chaired by two of the authors of this article, Ruth Faden and Daniel Federman, and coordinated by the third, IOM Study Director Anna Mastroianni, the Committee met five times over a fourteen-month period, convened a one-and-one-half day invitational workshop, and commissioned several background papers. The Committee's deliberations were complicated by the announcement of new federal policies late in its term. Specifically, the Food and Drug Administration (FDA) issued guidelines (FDA 1993) to replace its 1977 guidelines, which prohibited the inclusion of women of childbearing potential in early phases of most clinical drug trials. In addition, Congress passed the NIH Revitalization Act of 1993 (P.L. 103-43), which contains provisions mandating the inclusion of women and racial and ethnic minorities in NIH-sponsored clinical research. In February 1994, the IOM Committee publicly issued its final report and recommendations, Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, publishing the workshop presentations and commissioned papers in a separate volume.Deliberations of the CommitteeA number of issues arose at the outset as the Committee considered its charge. A few members initially believed that verification of the underrepresentation of women relative to men in clinical studies as a whole was a prerequisite to providing policy recommendations. Others believed that such an examination would be an important contribution to the knowledge base, but that it was not necessary for addressing the Committee's charge. As summarized in the Committee's report, the Committee's research indicated that firm conclusions about the relative underrepresentation of women could not be drawn from the available data because of the lack of systematic information... (shrink)

The government-sponsored Tuskegee syphilis study had a huge impact on U.S. research ethics and policy. Study investigators regarded subjects as “mere means” to their research ends, which led to a variety of ethical violations. Investigators used deception so that subjects would see participation as therapeutic — researchers promoted the therapeutic misconception because this advanced study objectives. The research would produce important information, and this justified lying to research subjects.Today we see this sort of (...) intentional deception as unjustified no matter how important a study might be. But what do we make of the claim that the syphilis study had value? As James Jones reported, its objectives were to test the prevailing views that syphilis affected blacks and whites differently, and that the disease was less harmful to blacks than whites. U.S. Public Health Service researchers and officials assumed the study had sufficient value to justify not only deceiving subjects, but also depriving them of safe and effective treatment. (shrink)

Although researchers generally take great care to ensure that human subjects do not suffer very serious harms from their involvement in research, the situation is different for nonhuman animal subjects. Significant progress has been made in reducing unnecessary animal suffering in research, yet researchers still inflict severe pain and distress on tens of thousands of animals every year for scientific purposes. Some bioethicists, scientists, and animal welfare advocates argue for placing an upper limit on the suffering (...) researchers may impose on animal subjects, with rare exceptions for research that promises critical social benefits. In this article, I argue against such an upper limit on harm on the grounds that researchers often can compensate animal subjects for their suffering, even severe and long-lasting suffering. If animal subjects receive adequate compensation for the harms they suffer, then there is no general limit on how much suffering researchers may impose on them for scientific purposes. (shrink)

This article argues that we could improve the design of research protocols by developing an awareness of and a responsiveness to the social contexts of all the actors in the research enterprise, including subjects, investigators, sponsors, and members of the community in which the research will be conducted. “Social context” refers to the settings in which the actors are situated, including, but not limited to, their social, economic, political, cultural, and technological features. The utility of thinking (...) about social contexts is introduced and exemplified by the presentation of a hypothetical case in which one central issue is limitation of the probability of injury to subjects by selection of individuals who are not expected to live long enough for the known risks of the study to become manifest as harms. Benefits of such considerations may include enhanced subject satisfaction and cooperation, community acceptance, and improved data quality, among other desirable consequences. (shrink)

This paper argues against paying people to participate in research. Volunteering to participate as a subject in a research program is not like taking a job. The main difference is to do with the risks inherent in research. Experimentation on human beings is, by definition, trying out something with an unknown consequence and exposes people to risks of harm which cannot be known in advance. This is the main reason for independent review by committee of (...) class='Hi'>research programs. It is based on a recognition that researchers are not always capable of putting the interests of their subjects ahead of their research objectives. It is not simply a matter of individual autonomy. Society has an obligation, prior to the protection of individual freedom and autonomy, to establish basic safeguards that are equitable in their operation. Any inducement for participating in research would add to the difficulty subjects have in adequately assessing the risks of participating in research. An acceptance of inducement to participate in research would further increase the inequity of research conducted on the impecunious for the benefit of the well‐off. (shrink)

In this issue of the Hastings Center Report, Amulya Mandava, Joseph Millum, and Benjamin E. Berkman revisit an old conundrum—whether to disclose incidental findings of misattributed parentage—in light of new developments in genomic sequencing that will make that conundrum both more complex and more common. While the authors’ defense of nondisclosure as the appropriate default action in genomic research aligns with prior thinking and practice, their exploration of philosophical foundations is refreshingly rigorous and developed. The final product of their (...) analysis—an applied taxonomy of the types of harms and benefits that can result from disclosure of misattributed parentage—is an important contribution to the literature on this subject and worthy of serious consideration by genomic researchers and bioethicists alike. Despite these virtues, I am struck by the authors’ deference to the traditional assumption that disclosure ethics can be adequately understood and appreciated within a purely consequentialist framework. (shrink)

Throughout the world, research ethics committees are relied on to prevent unethical research and protect research subjects. Given that reliance, the composition of committees and the manner in which decisions are arrived at by committee members is of critical importance. There have been Instances in which an inadequate review process has resulted in serious harm to research subjects. Deficient committee review was identified as one of the factors In a study in New Zealand (...) which resulted in the suffering and death of many women diagnosed with carcinoma in situ. (shrink)

Certain researchers in the field of moral psychology, following Turiel, argue that children and adults in different cultures make a distinction between moral and conventional transgressions. One interpretation of the theory holds that moral transgressions elicit a signature moral response pattern while conventional transgressions elicit a signature conventional response pattern. Four dimensions distinguish the moral response pattern from the conventional response pattern. 1. HARM/JUSTICE/RIGHTS – Subjects justify the wrongness of moral transgressions by stating that they involve a victim (...) that is harmed, whose rights have been violated or who has been subject to an injustice. Conventional transgressions do not involve a victim that is harmed, whose rights have been violated or who has been subject to an injustice. 2. AUTHORITY – Subjects judge moral transgressions as wrong independent of structures of authority while the wrongness of conventional transgressions can be changed by an authority. 3. GENERALIZABILITY – Subjects judge moral transgressions as generalizably wrong, i.e., independent of time and place, while conventional transgressions’ wrongness depends on time and place. 4. SERIOUSNESS – Subjects judge moral transgressions as more seriously wrong than conventional transgressions. Others have criticized this view for a diversity of reasons. Relevant for our purposes is that, first, there appear to be cultural differences in what constitutes a moral transgression and second, it is unclear what the exact hypotheses are, surrounding this supposed moral/conventional distinction. I will present planned and ongoing experimental research that investigates two specific problems we encountered in the moral-conventional literature. First of all, we cannot draw reliable conclusions from previous work about the generalizability of the wrongness of different kinds of transgressions. In previous experiments, differences in time and place are often but not always confounded with a variety of other differences. For example, Huebner et al. ask participants if the depicted act would be OK for someone who lived elsewhere where everyone else did this. Moreover, when varying time and/or place, participants are likely to assume that other things differ as well. In our study, we vary time and/or place in a variety of scenarios in order to investigate what assumptions participants make when confronted with the generalizability question. Second, it is an open question as to what extent any transgression will universally elicit one of the two signature response patterns. In our study, we make use of existing differences in participants’ value hierarchy to test this. For one and the same scenario, we compare the response of participants for whom authority is an important value with the results of participants for whom authority is not an important value, in order to see if there are differences in the two groups’ response patterns. References: Haidt J., Koller S. & Dias M. 1993. Affect, culture and morality, or is it wrong to eat your dog? Journal of Personality and Social Psychology 65:613-628. Huebner B., Lee, J.L. & Hauser, M.D. 2010. The Moral-Conventional Distinction in Mature Moral Competence. Journal of Cognition and Culture 10: 1-26. Kelly D., Stich S., Haley K.J., Eng S.J. & Fessler D.M.T. 2007. Harm, Affect, and the Moral/Conventional Distinction. Mind & Language 22:117-131. Nichols S. 2004. Sentimental Rules: on the Natural Foundations of Moral Judgment. Oxford University Press. Stich S., Fessler, D.M.T. & Kelly D. 2009. On the Morality of Harm: A response to Sousa, Holbrook and Piazza. Cognition 113:93-97. Turiel E. 1983. The Development of Social Knowledge. Morality & Convention. Cambridge University Press. (shrink)

This paper discusses the use of the Milgram obedience experiments and the Tuskegee syphilis study in the bioethical literature. The two studies are presented and a variety of uses of them identified and discussed. It is argued that the use of these studies as paradigms of problematic research relies on a reduction of their complexity. What is discussed is thus often constructions of these studies that are closer to hypothetical examples than to the real studies.

Important advances in biomedical and behavioral research ethics have occurred over the past few decades, many of them centered on identifying and eliminating significant harms to human subjects of research. Comprehensive attention has not been paid to the totality of harms experienced by animal subjects, although scientific and moral progress require explicit appraisal of these harms. Science is a public good and the prioritizing within, conduct of, generation of, and application of research must soundly address (...) questions about which research is morally defensible and valuable enough to support through funding, publication, tenure, and promotion. Likewise, educational pathways of re-imagined science are critical. (shrink)

This paper aims to pay tribute to Figal’s comprehensive and innovative analysis of the artwork and beauty, while challenging both his realist position on the immediacy of meaning and his monist stance that reduces sublimity to beauty. To enquire into the origin of aesthetic feelings and sense, and thus, to break the hermeneutic circle, we first trace the origin of this reduction to the reception of Burke’s concept of the sublime by Mendelssohn and Kant. We then recur to Husserl and (...) Dufrenne to trace the origin of the sense of the feeling of sublimity in the realm of affectivity or sensuousness. This genesis takes place in passive experience, where we identify an excess of sensuous sense over categorial meaning that is constitutive of the affective sense that our bodily sensations give to hyletic material. It is argued that this sensuous excess evokes a sublime experience in the phenomenological sense, involving an affective and disruptive bodily experience and an endless process of sense formation. Affective or sensuous sense is thus an event that irreversibly affects the bodily surface. To elucidate this phenomenon, we draw on the theoretical framework of Breton and Bataille, positing it as a form-transgressive ‘convulsive’ sublime, which we then illustrate in the architectural works of Tschumi and Eisenman. In short, we have retrieved the origin of aesthetic experience and redefined the feeling of the sublime as a phenomenological ‘convulsive’ sublimity. (shrink)

At a White House ceremony in October 1995, the Advisory Committee on Human Radiation Experiments presented its Final Report to President Bill Clinton. The 925-page report and the over 2,000 pages of supplemental volumes summarized eighteen months of investigative research, debate, and deliberation on historical and contemporary issues in human subjects research. The Advisory Committee's efforts were aided by unprecedented support from the highest levels of the executive branch, including the heads of eight cabinet-level agencies and their (...) departments' resources. The presidentially appointed committee and its staff delved into long-forgotten Cold Warera government archives, listened to hours of public testimony, interviewed key players in the development of medical therapies and nuclear weapons, and studied ethical issues arising in today's research.In this article we focus on a critical, but narrowly defined, part of the Advisory Committee's Final Report: remedying harms or wrongs to subjects of human radiation experiments conducted or sponsored by the U.S. government between 1944 and 1974. (shrink)

This paper demonstrates how the UK’s Advertising Standards Authority governs advertising ethics with and on behalf of its members and stakeholders. Drawing on an archive of 310 non-commercial adjudication reports, we highlight the substantive norms and procedural mechanisms through which the ASA governs advertising complaints alleging offence and/or harm. Substantively, the ASA precludes potential normative transgressions by publishing, disseminating, consulting upon, and updating detailed codes of advertising conduct. Procedurally, the ASA adjudicates between allegations and justifications of offence and (...) class='Hi'>harm on a received complaint-by-complaint basis, often upon consequentialist grounds. Such consequentialism, we claim, has the effect of normalizing power imbalances between the ASA’s members, on the one hand, and wider stakeholders, on the other hand. The paper argues that, in the context of UK advertising, what Michel Foucault called the right ‘to be or not to be governed like that’ is enjoyed by relatively few subjects. Having demonstrated how UK advertising practices are governed, the paper closes with suggestions as to how they might be governed otherwise. (shrink)