Experimental design is one aspect of a scientific method. A well-designed, properly conducted experiment aims to control variables in order to isolate and manipulate causal effects and thereby maximize internal validity, support causal inferences, and guarantee reliable results. Traditionally employed in the natural sciences, experimental design has become an important part of research in the social and behavioral sciences. Experimental methods are also endorsed as the most reliable guides to policy effectiveness. Through a discussion of some of the central concepts (...) associated with experimental design, including controlled variation and randomization, this chapter will provide a summary of key ethical issues that tend to arise in experimental contexts. In addition, by exploring assumptions about the nature of causation and by analyzing features of causal relationships, systems, and inferences in social contexts, this chapter will summarize the ways in which experimental design can undermine the integrity of not only social and behavioral research but policies implemented on the basis of such research. (shrink)

It is now typical for human subjects research to be regulated by review by an independent research ethics committee in most jurisdictions. However it is common for countries to opt to only compulsorily regulate medical research while leaving some or all non-medical research either unregulated or only regulated on a voluntary basis. In this paper I will argue, using regulation in the UK as an example, that it is difficult to justify this sharp distinction in practices. While I won’t come (...) to any definitive conclusions in this paper as to whether research ought to be regulated compulsorily I will suggest that we would be better to regulate all research, albeit perhaps with a lighter touch than the present UK system if we want to prevent some highly risky research avoiding appropriate regulation. I will examine several arguments to defend making such a distinction; that medical professionals have special moral duties, that medical research has a higher magnitude/frequency of risks and that regulating non-medical research constitutes the inappropriate imposition of the medical model onto non-medical research. Having critiqued these objections I will then discuss the advantages of harmonizing the regulation of research and conclude that there is not a good reason to treat medical and non-medical research as fundamentally different in kind. (shrink)

The aim of the present article is to contribute empirically derived knowledge about Swedish researchers’ experience of ethical problems, conflicts and dilemmas in their research practice in relation to the ethical vetting legislation and procedure. The study has been carried out using the critical incident technique, with researchers from various disciplines providing examples from their own research practice of problems relating to research ethics. The analysis of the researchers’ responses indicates three phenomena, partly in line with similar studies in other (...) countries: the law of ethical vetting puts limits on the relevant research ethical questions; it is not possible to anticipate all questions of research ethics; and there are consequences to the fact that the boards for ethical vetting ignore problems that fall outside the law. (shrink)

W ostatniej dekadzie można zaobserwować postępującą w naukach społecznych kodyfikację i instytucjonalizację etyki badań. Powstaje coraz więcej kodeksów etycznych, które standaryzują zasady etycznego prowadzenia badań oraz komisji etycznych kontrolujących projekty badawcze. Za kodyfikacją oraz instytucjonalizacją etyki naukowych badań społecznych stoi między innymi przekonanie, że kodeksy i komisje etyczne znacząco przyczynią się do etycznego postępowania badaczek i ochronią podmioty zaangażowane w badania, szczególnie ich uczestników, przed krzywdą. W artykule argumentuję, że to nie wystarczy, gdyż zarówno osoby prowadzące badania, jak i komisje (...) etyczne powinny kierować się w swoich decyzjach etycznych wyobraźnią moralną. (shrink)

This article is a response to the challenge with which Zachary Schrag concluded his article, ‘The case against ethics review in social sciences’ − that ‘the burden of proof for its continuation rests on its defenders’ (Schrag, 2011). This article acknowledges that there is substance in the charges he lays against some reviews of social sciences and that these are of sufficient quantity and seriousness to justify his challenge. Instead of favouring abandonment of ethical review of social sciences, the author (...) of this article draws upon his experience as Research Ethics Officer for Social Sciences and Law in a research intensive UK university to identify the sources of some of the problems and suggest potential remedies. These start with reviewing the warrant for ethical review as the basis for understanding reviewer’s role concerning the core ethical issues of rigour, respect and responsibility in the proposed research. This response concludes by considering the implications of a warrant for enhancing trust between scientists and the public as the context in which ethical review is only one component in a number of ethical strategies designed to promote ethical mindfulness as integral to social science research. (shrink)

Ethics committees enjoy both a long history and a strong presence in Anglophone countries, although simultaneously their functioning provokes debate in the social research community. In this paper, I analyse selected contested issues that revolve around three questions: 1) Who do ethics committees protect, and who should they? 2) Should ethics committees protect all research participants in the same way? 3) When can ethics committees intervene in the methodology of the research project under review? Analysing these disputes is important since (...) it may help to improve the functioning of ethics committees for social research in Poland. Their number has increased significantly in the last decade, but this has not been accompanied by a broader reflection on either their functioning or the concerns associated with this kind of control. (shrink)

Research Ethics Boards (REBs) at universities are chaired and staffed by researchers who serve to enforce codes of ethics by scrutinizing research proposals. Yet there is widespread dissatisfaction with the REB approval process. This article examines the sources of that dissatisfaction, the place for codes of ethics in the conducting of research, the evidence for risk to research participants as the basis for those codes, and the effectiveness of REBs in protecting research participants. We offer suggestions for how REB chairs, (...) members, and researchers can improve the REB approval process so that it is fair and responsive. (shrink)

Background:Africa is increasingly becoming an important region for health research, mainly due to its heavy burden of disease, socioeconomic challenges, and inadequate health facilities. Regulatory...

Ethics regulation for human-subject research has been established for about 20 years in Brazil. However, compliance with this regulation is controversial for non-biomedical sciences, particularly for human and social sciences, the source of a recent debate at the National Commission for Research Ethics. We hypothesized that for these fields, formal requirements for compliance with HSR regulation in graduate programs, responsible for the greatest share of Brazilian science, would be small in number. We analyzed institutional documents from 171 graduate programs at (...) six prestigious Brazilian universities in São Paulo and Rio de Janeiro, the states that fund most of the science conducted in Brazil. Among these programs, 149 were in HSS. The results suggest that non-compliance with standard regulation seems to be the rule in most of these programs. The data may reflect not only a resistance from scientists in these fields to comply with standard regulations for ethics in HSR but also a disciplinary tradition that seems prevalent when it comes to research ethics in HSR. However, recent encounters between Brazilian biomedical and non-biomedical scientists for debates over ethics in HSR point to a changing culture in the approach to research ethics in the country. (shrink)

Ethics review committees have become a common institution in English-speaking research communities, and are now increasingly being adopted in a variety of research environments. In light of existing debates on the aptness of ethics review boards for assessing research work in the social sciences, this article investigates the ways in which researchers navigate issues of research ethics in the absence of a formal review procedure or of an ethics review board. Through the analysis of qualitative and quantitative data, the article (...) questions the overall utility of ethics review boards. Highlighting the importance of space for sharing, the authors argue for the development of a new type of structure that takes into account researchers’ ‘ethos of responsibility’ as an adequate ethical compass for research in the social sciences. (shrink)

A growing body of literature critical of ethics review boards has drawn attention to the processes used to determine the ethical merit of research. Citing criticism on the bureaucratic nature of ethics review processes, this literature provides a useful provocation for (re)considering how the ethics review might be enacted. Much of this criticism focuses on how ethics review boards _deliberate,_ with particular attention given to the lack of transparency and opportunities for researcher recourse that characterise ethics review processes. Centered specifically (...) on the conduct of ethics review boards convened within university settings, this paper draws on these inherent criticisms to consider the ways that ethics review boards might enact more communicative and deliberative practices. Outlining a set of principles against which ethics review boards might establish strategies for engaging with researchers and research communities, this paper draws attention to how _Deliberative communication_, _Engagement with researchers_ and the _Distribution of responsibility_ for the ethics review might be enacted in the day-to-day practice of the university human ethics review board. This paper develops these themes via a conceptual lens derived from Habermas’ (The theory of communicative action. Volume 1: Reason and the rationalization of society, 1984 ) articulation of ‘communicative action’ and Fraser’s (Social Text, 25(26), 56–80, 1990 ) consideration of ‘strong publics’ to cast consideration of the role that human ethics review boards might play in supporting university research cultures. _Deliberative communication_, _Engagement with researchers_ and the _Distribution of responsibility_ provide useful conceptual prompts for considering how ethics review boards might undertake their work. (shrink)

This article responds directly to an article published in Research Ethics in 2011 where Schrag argued against ethics review for social science and humanities research. He argued that review committees offer solutions in search of a problem, impose silly restrictions and apply inappropriate principles. He suggests that review committees typically lack appropriate expertise and argued that the process harms the innocent. This article refutes these claims and offers a case study of the ethical review process at Queen Mary University of (...) London (QMUL) to offer counter claims. The discussion highlights the way in which the QMUL process is sensitized to the challenges posed by social science and humanities research and is a process that, rather than focusing upon avoiding harm, emphasizes notions of care to both participants and researchers. (shrink)

Celem artykułu jest przedstawienie wyzwań i trudności, jakie mogą pojawić się w procesie oceny przez komisje etyczne projektów badawczych bazujących na jakościowych technikach gromadzenia danych uzyskiwanych od osób świadczących różnego rodzaju usługi seksualne. Badania te zwykle podlegają ocenie komisji etycznych ze względu na ryzyko krzywdy dla uczestników, którzy postrzegani są jako szczególnie „podatni na zranienie”. Jednocześnie ze względu na stygmatyzację społeczną, jaka wiąże się ze świadczeniem usług seksualnych, zarówno badacze, jak i osoby uczestniczące w badaniu i wchodzące w skład komisji (...) etycznych mogą mieć swoje wyobrażenia i oczekiwania co do tego, jak powinny przebiegać etyczne badania w tym obszarze. Odwołując się do doświadczeń badaczek anglosaskich, omówię, jak te oczekiwania oraz wymagania komisji etycznych zderzają się, stawiając badaczy przed koniecznością spełniania rozbieżnych czy wręcz sprzecznych oczekiwań różnych aktorów społecznych. Zaproponuję także, w jakim kierunku mógłby zmienić się sposób działania rodzimych komisji etycznych, aby proces uzyskiwania ich aprobaty był bardziej demokratyczny i otwarty na zróżnicowane potrzeby tak badaczy, jak i osób uczestniczących w badaniach. (shrink)

This paper aims to interrogate the potential and challenges in interdisciplinary working across disciplinary boundaries by examining a longitudinal partnership designed to research student experiences of digital technologies in undergraduate medicine established by the two authors. The paper is situated in current methodological trends including the changing value of replicability and evidence based methods and increases in qualitative and mixed methods studies in Medical Education, whilst education research has seen growing encouragement for randomised controlled trials and large-scale quantitative studies. A (...) critical analysis of the partnership interactions is framed by Holland’s positional and imagined identities, negotiated across ‘figured’ worlds and the concept of epistemic games that guide knowledge construction. We consider social, political and cultural challenges and how ‘in between’ sites of knowledge were established where the academic identity of each was shaped by engaging with the other and new theoretical, methodological and ethical understandings were co-constructed. The paper concludes that despite the on-going challenges, ‘bottom up’ partnerships can contribute to a growth in interdisciplinarity which might itself be understood as a boundary object. Interdisciplinarity necessitates improvisation and boundary crossing and can therefore always be considered a matter of negotiation, creativity and collaboration. (shrink)

In his article ‘The case against ethics review in the social sciences’, Schrag asserts that the social sciences should not be subject to ethical review. He recounts a number of examples where ethical review has seemingly failed. He further suggests some alternative models for dealing with ethical review in the social sciences. Finally, he concludes, and we concur, that there is a lack of empirical evidence as to the benefit of research ethics review.

There has been considerable debate around the ethical issues raised by data-driven technologies such as artificial intelligence. Ethical principles for the field have focused on the need to ensure...

This article aims to open a discussion on better ethical assurance for non-university research actors drawing on democratic norms. It derives from the author’s experience of a gap in ethical assurance for social science and humanities (SSH) research that takes place outside academia, for example within international organisations, public bodies, non-governmental organisations (NGOs) and by private entities. Many of these actors commission, conduct or sub-contract research activities involving human participants on a regular basis, an activity that often increases during times (...) of crisis where researchers in both the public and private sphere scramble to generate the new knowledge necessary to respond and prevent further harms. The ethical assurance frameworks for such research, while growing, remain limited. Discussion of research conducted by actors outside of university settings and their ethical assurance frameworks are both subjects under-interrogated within the literature. This paper seeks to open that discussion by presenting this broad non-university research context through the frame of research in crisis settings, where the ethical requirements of ‘do no harm’ and the ‘dual imperative’ possess an even heavier significance in research ethics. Furthermore, the global and diverse nature of crisis settings often gives rise to conversations concerning the positioning of the research actor and the need to empower the research participant. This paper presents an early vision of the non-university research actor and ethical assurance process based on the democratic norms of equality and inclusivity. (shrink)

A number of unique problems plague human research protection efforts at United States State and Territorial Departments of Health. The first problem is related to the number of Institutional Review Boards operated by and Federalwide Assurances held by DOHs. The lack of these two essential regulatory human research protection program mechanisms points to a possible inadequacy of infrastructure at DOHs for protecting human subjects. The second and third problems are related to the use and interpretation of research protection laws and (...) regulations at DOHs. Parsing public health activities into research or practice can be vexing and likely produces variability in how individual DOHs make the determination between research and practice and the outcomes of such decisions for the same or similar projects. A related problem is that DOH or Institutional Review Board officials might misclassify public health practice activities as research, which can have costly, adverse consequences. (shrink)

Though rapid collection of big data is ubiquitous across domains, from industry settings to academic contexts, the ethics of big data collection and research are contested. A nexus of data ethics issues is the concept of creep, or repurposing of data for other applications or research beyond the conditions of original collection. Data creep has proven controversial and has prompted concerns about the scope of ethical oversight. Institutional review boards offer little guidance regarding big data, and problematic research can still (...) meet ethical standards. While ethics seem concrete through institutional deployment, I frame ethics as produced. Informed by my ethnographic research at a large public university in the U.S., I explore ethics through two models: ethics as institutional procedures and ethics as acts and intentions. The university where I conducted fieldwork is the development grounds for a predictive model that uses student data to anticipate academic success. While students consent to data collection, the circumstances of consent and the degree to which they are informed are not so apparent, as many data are a product of creep. Drawing from interviews and participant observation with administrators, data scientists, developers, and students, I examine data ethics, from a larger institutional model to everyday enactments related to data creep. After demonstrating the limits of such models, I propose a remodeling of ethics that draws on recent works on data, justice, and refusal to pose generative questions for rethinking ethics in institutional contexts. (shrink)

Published in 2014, the Facebook “emotional contagion” study prompted widespread discussions about the ethics of manipulating social media content. By and large, researchers focused on the lack of corporate institutional review boards and informed consent procedures, missing the crux of what upset people about both the study and Facebook’s underlying practices. This essay examines the reactions that unfolded, arguing the public’s growing discomfort with “big data” fueled the anger. To address these concerns, we need to start imagining a socio-technical approach (...) to ethics that does not differentiate between corporate and research practices. (shrink)

Proposed changes to the Common Rule are proffered to save almost 7,000 reviews annually and consequently vast amounts of investigator and IRB-member time. However, the proposed changes have been subject to criticism. While some have lauded the changes as being imperfect, but nevertheless as improvements, others have contended that ‘neither the scientific community nor the public can be confident that improved practices will emerge from the regulatory changes mandated by the NPRM.’ In the present article, I discuss an important aspect (...) that has been overlooked: the question of whether benefits will emerge is demonstrably empirical, yet data upon which to draw conclusions are conspicuous by their absence. This is thrown into sharp relief when we consider the current environment in which health research is increasingly focused on providing evidence of need or benefit, where there is greater emphasis on evidence-based practice, and when we have the nascent field of implementation science. (shrink)

Experience has shown that the application of ethical guidelines developed for research in developed countries to research in developing countries can be, and often is, impractical and raises a number of contentious issues. Various attempts have been made to provide guidelines more appropriate to the developing world context; however, to date these efforts have been dominated by the fields of bioscience, medical research and nutrition. There is very little advice available for those seeking to undertake collaborative social science or natural (...) science research in developing countries and what is there tends to be held within disparate sources. Charting the development of a set of ethics documentation for future use by the Ecosystem Services for Poverty Alleviation (ESPA) programme research community, this paper outlines past and present attitudes towards ethics procedures amongst this community and suggests ways in which ethics procedures might be made more relevant and user-friendly to researchers working in this area. (shrink)

Zachary Schrag would like to put the burden of proof for continuation of research ethics review in the Social Sciences on those who advocate for research ethics committees (RECs), and asks that we take the concerns that he raises seriously. I separate his concerns into a principled issue and a number of pragmatic issues. The principled issue concerns the justification for having research ethics committees; the pragmatic issues concern questions such as the effectiveness of review and the expertise of the (...) committee members. I argue that RECs can be justified by their role in improving ethical practice and in reducing wrongs done to research participants. I propose a model of review for doing this, which I think would also address the pragmatic issues raised. I then offer an account of where the UK ethics review system is now and suggest three steps which could improve social science ethics review in the UK and move it in a perhaps more desirable direction. (shrink)