Belmont in Europe: A Mostly Indirect Influence.

This paper traces the reception of the Belmont Report in Europe and its influence on the development of European research ethics thinking and European research ethics systems. It is very difficult to trace a clear, linear reception history because it is difficult to disentangle the influence of the Report from the influence of concurrent developments, such as the 1975 revision of the World Medical Association Declaration of Helsinki and the requirement for research ethics review in the Vancouver Group's 1978 "Uniform Requirements for Manuscript Submission." The Report's insistence that the focus of research ethics should be the rights and interests of the individual research subject, and the use of an ethical framework and not ethical theory as the basis of analysis and justification of recommendations, were nevertheless very important for the development of research ethics. The divergence between Europe and the US in the governance of non-biomedical research can at least partly be explained by the absence of strong drivers for the introduction of research ethics committees outside of biomedicine in Europe, and by the ability of non-biomedical researchers to mobilize effectively against the introduction of such committees.

Revisiting the Distinction and the Connection Between Research and Practice.

The Belmont Report addresses the distinction between practice and research as guidance for which activities should be evaluated prospectively by a research ethics committee. This essay argues that the distinction between clinical practice and clinical research has a more fundamental significance for understanding the ethics of clinical research. After discussing the important connections between clinical research and clinical practice, the essay examines in detail ethically significant differences between these two sorts of activities. This sets the stage for a critique of clinical equipoise, widely regarded as a fundamental principle of clinical research ethics.

Conducting reproductive research during a new childhood cancer diagnosis: ethical considerations and impact on participants.

PURPOSE: Research among adults shows benefits and low perceived burden of engaging in behavioral research. However, questions remain regarding the ethics of conducting behavioral research in pediatric populations during sensitive situations, including during a new life-threatening diagnosis or at end-of-life. We examined reactions to participating in a behavioral reproductive research study among male adolescents newly diagnosed with cancer and their parents, as a step towards optimizing fertility preservation utilization in a population where future infertility is common. METHODS: Pediatric literature regarding the ethics of behavioral research was reviewed. In our pilot, forty-four participants (19 mothers, 11 fathers, 14 male adolescents newly diagnosed with cancer) from 20 families completed demographic questionnaires and a fertility preservation decision tool developed by the study team. Qualitative interviews exploring the impact of study participation were subsequently conducted. Verbatim transcripts were coded for thematic content using the constant comparison method. RESULTS: Literature review showed positive reactions to research participation among youth/caregivers. In our pilot study, 89% (n = 17) of mothers, 64% (n = 7) of fathers, and 71% (n = 10) of adolescents reported at least one benefit of participating. Eleven percent (n = 2) of mothers, 36% (n = 4) of fathers, and 29% (n = 4) of adolescents said they were not affected; none of the participants reported a negative effect. CONCLUSION: Consistent with prior literature, our study suggests behavioral reproductive research prior to cancer treatment can offer direct benefits to participants and society, without increasing burden. These findings will inform future interventions to improve long-term psychosocial and reproductive outcomes for youth with cancer.

Overcoming a primary barrier to practice-based research: Access to an institutional review board (IRB) for independent ethics review.

Practice-based research is an important means of bridging the gap between the science and practice of psychotherapy. Unfortunately, numerous barriers exist for clinicians who want to conduct research in practice settings. One specific barrier that has received minimal attention in the literature-lack of access to institutional review board (IRB) oversight for independent ethics review-can impede the ability to carry out and disseminate research projects. This article identifies reasons that practice-based researchers may want to seek IRB review even when not required, reviews the pros and cons of a range of strategies that some practice-based researchers have used to try and address lack of access to an IRB, and describes a novel solution for this problem: the creation of the Behavioral Health Research Collective IRB, a nonprofit IRB whose mission is to provide ethical oversight to practice-based researchers. The authors describe their experiences of developing and running the Behavioral Health Research Collective IRB, with the intent of providing a model for other professionals to create similar mechanisms for supporting practice-based research. (PsycINFO Database Record

Ethics Regulation in Social Computing Research: Examining the Role of Institutional Review Boards.

The parallel rise of pervasive data collection platforms and computational methods for collecting, analyzing, and drawing inferences from large quantities of user data has advanced social computing research, investigating digital traces to understand mediated behaviors of individuals, groups, and societies. At the same time, methods employed to access these data have raised questions about ethical research practices. This article provides insights into U.S. institutional review boards' (IRBs) attitudes and practices regulating social computing research. Through descriptive and inferential analysis of survey data from staff at 59 IRBs at research universities, we examine how IRBs evaluate the growing variety of studies using pervasive digital data. Findings unpack the difficulties IRB staff face evaluating increasingly technical research proposals while highlighting the belief in their ability to surmount these difficulties. They also indicate a lack of consensus among IRB staff about what should be reviewed and a willingness to work closely with researchers.

The Significance of Benefit Perceptions for the Ethics of HIV Research Involving Adolescents in Kenya.

Assessment of benefits is traditionally regarded as crucial to the ethical evaluation of research involving human participants. We conducted focus group discussions (FGDs) with health and other professionals engaged with adolescents, caregivers/parents, and adolescents in Siaya County, Kenya, to solicit opinions about appropriate ways of conducting HIV research with adolescents. Our data revealed that many focus group participants have a profoundly positive conception of participation in health research, including studies conferring seemingly few benefits. In this article, we identify and analyze five different but interrelated types of benefits as perceived by Kenyan adolescent and adult stakeholders in HIV research, and discuss their ethical significance. Our findings suggest that future empirical and conceptual research should concentrate on factors that may trigger researcher obligations to improve benefit perceptions among research participants.

Parental Perceptions About Informed Consent/Assent in Pediatric Research in Jordan.

The informed consent/assent process during enrollment in pediatric research is integral to protecting children from possible harm. Here we explored parents' perceptions about the informed consent/assent process in Jordan. Therefore, focus group interviews were conducted that focused on the importance of consent/assent, the quality of the information provided during consent process, and the parents' perceptions toward written/verbal informed consent. Content thematic analysis approach was adopted in the transcription and translation processes of the interviews. The majority of parents have an ethically acceptable understanding of many of the aspects related to consent/assent; however, some views were not consistent with the proper conduct of research. For example, some parents believed that informed consent is not required for questionnaire studies. Discrepancies were also noted regarding the appropriate age of a child's assent. Some parents would force their child to participate. Thus, the development of Jordanian, culturally sensitive pediatric research guidelines is required.

Health Research Ethics: Between Ethics Codes and Culture.

This article is meant to describe and analyze some of the ethical difficulties encountered in a pilot research on treatment decisions of patients with chronic viral hepatitis C infection in Romania. It departs from an overview of the main ethics codes, and it shows that social health research on patients falls in between institutional codes of ethics. Furthermore, the article moves on to analyze so-called "important moments" of empirical research, such as the implementation of the ethical protocol, dealing with informal payments and with information on shady actions, as well as requests of information from interviewed patients and deciding when and if to breach confidentiality. In an attempt to evaluate the ad hoc solutions found in the field, the concluding remarks discuss these issues at the threshold of theory and practice.

Rethinking the Belmont Report?

This article reflects on the relevance and applicability of the Belmont Report nearly four decades after its original publication. In an exploration of criticisms that have been raised in response to the report and of significant changes that have occurred within the context of biomedical research, five primary themes arise. These themes include the increasingly vague boundary between research and practice, unique harms to communities that are not addressed by the principle of respect for persons, and how growing complexity and commodification in research have shed light on the importance of transparency. The repercussions of Belmont's emphasis on the protection of vulnerable populations is also explored, as is the relationship between the report's ethical principles and their applications. It is concluded that while the Belmont Report was an impressive response to the ethical issues of its day, the field of research ethics involving human subjects may have outgrown it.

Ethical considerations for sleep intervention in organizational psychology research.

Over the past several years, interest into the role of sleep in the workplace has grown. The theoretical shift from research questions examining sleep as an outcome to placing sleep as the independent variable has increased experimental approaches to manipulating sleep in organizational studies. This is an exciting trend that is likely to continue in the organizational sciences. However, sleep experimentation can also pose special challenges for organizational researchers unaccustomed to sleep science. In this commentary, I discuss five ethical considerations of conducting negative sleep interventions in organizational psychology research. I also provide recommendations for organizational researchers-or even other researchers in disciplines outside of sleep science-who wish to implement sleep interventions in their studies.

Internet-based brain training games, citizen scientists, and big data: ethical issues in unprecedented virtual territories.

Internet brain training programs, where consumers serve as both subjects and funders of the research, represent the closest engagement many individuals have with neuroscience. Safeguards are needed to protect participants' privacy and the evolving scientific enterprise of big data.

Shock treatment: using immersive digital realism to restage and re-examine milgram's 'obedience to authority' research.

Attempts to revisit Milgram's 'Obedience to Authority' (OtA) paradigm present serious ethical challenges. In recent years new paradigms have been developed to circumvent these challenges but none involve using Milgram's own procedures and asking naïve participants to deliver the maximum level of shock. This was achieved in the present research by using Immersive Digital Realism (IDR) to revisit the OtA paradigm. IDR is a dramatic method that involves a director collaborating with professional actors to develop characters, the strategic withholding of contextual information, and immersion in a real-world environment. 14 actors took part in an IDR study in which they were assigned to conditions that restaged Milgrams's New Baseline ('Coronary') condition and four other variants. Post-experimental interviews also assessed participants' identification with Experimenter and Learner. Participants' behaviour closely resembled that observed in Milgram's original research. In particular, this was evidenced by (a) all being willing to administer shocks greater than 150 volts, (b) near-universal refusal to continue after being told by the Experimenter that "you have no other choice, you must continue" (Milgram's fourth prod and the one most resembling an order), and (c) a strong correlation between the maximum level of shock that participants administered and the mean maximum shock delivered in the corresponding variant in Milgram's own research. Consistent with an engaged follower account, relative identification with the Experimenter (vs. the Learner) was also a good predictor of the maximum shock that participants administered.

Ethical issues associated with the use of animal experimentation in behavioral neuroscience research.

This chapter briefly explores whether there are distinct characteristics in the field of Behavioral Neuroscience that demand specific ethical reflection. We argue that although the ethical issues in animal-based Behavioral Neuroscience are not necessarily distinct from those in other research disciplines using animal experimentation, this field of endeavor makes a number of specific, ethically relevant, questions more explicit and, as a result, may expose to discussion a series of ethical issues that have relevance beyond this field of science. We suggest that innovative research, by its very definition, demands out-of-the-box thinking. At the same time, standardization of animal models and test procedures for the sake of comparability across experiments inhibits the potential and willingness to leave well-established tracks of thinking, and leaves us wondering how open minded research is and whether it is the researcher's established perspective that drives the research rather than the research that drives the researcher's perspective. The chapter finishes by introducing subsequent chapters of this book volume on Ethical Issues in Behavioral Neuroscience.

The use of animal models in behavioural neuroscience research.

Animal models are used in experiments in the behavioural neurosciences that aim to contribute to the prevention and treatment of cognitive and affective disorders in human beings, such as anxiety and depression. Ironically, those animals that are likely to be the best models for psychopathology are also likely to be considered the ones that are most morally problematic to use, if it seems probable that (and if indeed they are initially selected as models because) they have experiences that are similar to human experiences that we have strong reasons to avoid causing, and indeed aim to alleviate (such as pain, anxiety or sadness). In this paper, against the background of contemporary discussions in animal ethics and the philosophy of animal minds, we discuss the views that it is morally permissible to use animals in these kinds of experiments, and that it is better to use less cognitively complex animals (such as zebrafish) than more complex animals (such as dogs). First, we criticise some justifications for the claim that human beings and more complex animals have higher moral status. We argue that contemporary approaches that attribute equal moral status to all beings that are capable of conscious strivings strivings (e.g. avoiding pain and anxiety; aiming to eat and play) are based on more plausible assumptions. Second, we argue that it is problematic to assume that less cognitively complex animals have a lesser sensory and emotional experience than more complex beings across the board. In specific cases, there might be good reasons to assume that more complex beings would be harmed more by a specific physical or environmental intervention, but it might also be that they sometimes are harmed less because of a better ability to cope. Determining whether a specific experiment is justified is therefore a complex issue. Our aim in this chapter is to stimulate further reflection on these common assumptions behind the use of animal models for psychopathologies. In order to be able to draw more definite conclusions, more research will have to be done on the influence of cognitive complexity on the experience of (human and non-human) animals.