Ethics review of social, behavioral, and economic research: where should we go from here?

It is not unusual for researchers to complain about institutional review board (IRB) oversight, but social scientists have a unique set of objections to the work of ethics committees. In an effort to better understand the problems associated with ethics review of social, behavioral, and economic sciences (SBES) research, this article examinees 3 different aspects of research ethics committees: (a) the composition of review boards; (b) the guidelines used by these boards to review SBES--and in particular, behavioral health--research; and (c) the actual deliberations of IRBs. The article concludes with recommendations for changes in the review process and with suggestions for filling the gaps in knowledge about the way IRBs work.     

Dealing with the long-term social implications of research

Biomedical and behavioral research may affect strongly held social values and thereby create significant controversy over whether such research should be permitted in the first place. Institutional review boards (IRBs) responsible for protecting the rights and welfare of participants in research are sometimes faced with review of protocols that have significant implications for social policy and the potential for negative social consequences. Although IRB members often raise concerns about potential long-term social implications in protocol review, federal regulations strongly discourage IRBs from considering them in their decisions. Yet IRBs often do consider the social implications of research protocols and sometimes create significant delays in initiating or even prevent such research. The social implications of research are important topics for public scrutiny and professional discussion. This article examines the reasons that the federal regulations preclude IRBs from assessing the social risks of research, and examines alternative approaches that have been used with varying success by national advisory groups to provide such guidance. The article concludes with recommendations for characteristics of a national advisory group that could successfully fulfill this need, including sustainability, independence, diverse and relevant expertise, and public transparency.     

Utilitarianism and the Ethics of Professional Psychologists

Evidence exists that behavioral and social science researchers have been frustrated with regulations and institutional review boards (IRBs) from the 1970s through today. Making matters worse, many human participants protection instruction programs—now mandated by IRBs—offer inadequate reasons why researchers should comply with regulations and IRBs. Promoting compliance either for its own sake or to avoid penalties is contrary to the developmental aims of moral education and may be ineffective in fostering the responsible conduct of research. This article explores the concept of professional virtue and argues that compliance is capable of becoming a professional virtue like scientific honesty. This requires, however, that regulatory and IRB demands contribute to human well-being and to the aims of research as a profession and that researchers, therefore, internalize the norms that underlie regulatory and IRB demands. This, in turn, requires a series of changes in the way society develops, promulgates, and enforces regulatory and IRB rules. The challenge is, simply put, to embed compliance into the world of living morality.     

Conflict and Convergence: The Ethics Review of Action Research

The article is based on the author’s experience as an administrator of three primarily social science institutional review boards (IRBs) to which researchers presented research protocols that purported to be minimal risk studies of teacher practice where the “teacher–researcher” was the “research subject.” Recently, educational, social, and behavioral science researchers encounter many problems with regard to their methodologies and the oversight mandate of the IRBs. There is a divergence between the IRB’s role and assumed bio-clinical predisposition and the ability of behavioral and social science researchers to have their research methodologies and research understood and appreciated by IRB members. The article explores some of the dilemmas confronting IRB members and administrators in the review and administration of the action research protocols, particularly those that involve vulnerable populations and which, from the practitioner–researcher’s perspective, focus on the practitioner–researcher as the object of the research.     

The Emergence of Clinical Research Ethics Consultation: Insights From a National Collaborative

The increasing complexity of human subjects research and its oversight has prompted researchers, as well as institutional review boards (IRBs), to have a forum in which to discuss challenging or novel ethical issues not fully addressed by regulations. Research ethics consultation (REC) services provide such a forum. In this article, we rely on the experiences of a national Research Ethics Consultation Collaborative that collected more than 350 research ethics consultations in a repository and published 18 challenging cases with accompanying ethical commentaries to highlight four contexts in which REC can be a valuable resource. REC assists: 1) investigators before and after the regulatory review; 2) investigators, IRBs, and other research administrators facing challenging and novel ethical issues; 3) IRBs and investigators with the increasing challenges of informed consent and risk/benefit analysis; and 4) in providing flexible and collaborative assistance to overcome study hurdles, mediate conflicts within a team, or directly engage with research participants. Institutions that have established, or plan to establish, REC services should work to raise the visibility of their service and engage in open communication with existing clinical ethics consult services as well as the IRB. While the IRB system remains the foundation for the ethical review of research, REC can be a valuable service for investigators, regulators, and research participants aligned with the goal of supporting ethical research.     

Research ethics committees: a regional approach

Guidelines for Institutional Review Boards (IRBs) or research ethics committees exist at national and international levels. These guidelines are based on ethical principles and establish an internationally acceptable standard for the review and conduct of medical research. Having attained a multinational consensus about what these fundamental guidelines should be, IRBs are left to interpret the guidelines and devise their own means of implementing them. Individual and community values bear on the interpretation of the guidelines so different IRBs attain different levels of effectiveness. In the Caribbean and Pan American regions there are few IRBs. Obstacles to the establishment and function of IRBs are exacerbated in developing regions like these by differences in language, literacy, and local value systems; education, administrative expertise, facilities, and access to information are also limited. A regional IRB network might facilitate more uniform ethical review in developing countries, and simplify IRB procedures. This revised version was published online in August 2006 with corrections to the Cover Date.     

Institutional Review Boards and Professional Counseling Research

Institutional review boards (IRBs) are responsible for regulating and safeguarding research with human participants in academic institutions in the United States. The authors explore (a) the historical impetus for IRBs, (b) the ethical values and principles as core components of the review process, and (c) the American Counseling Association's (2005) standards for ethical research. In many ways, IRB review and counseling research are complementary, yet some challenges and obstacles unique to counseling research also exist and are elaborated in the article. Implications for counselors initiating research projects and suggestions for implementation are provided.     

A plea for pragmatism in clinical research ethics

Pragmatism is a distinctive approach to clinical research ethics that can guide bioethicists and members of institutional review boards (IRBs) as they struggle to balance the competing values of promoting medical research and protecting human subjects participating in it. After defining our understanding of pragmatism in the setting of clinical research ethics, we show how a pragmatic approach can provide guidance not only for the day-to-day functioning of the IRB, but also for evaluation of policy standards, such as the one that addresses acceptable risks for healthy children in clinical research trials. We also show how pragmatic considerations might influence the debate about the use of deception in clinical research. Finally, we show how a pragmatic approach, by regarding the promotion of human research and the protection of human subjects as equally important values, helps to break down the false dichotomy between science and ethics in clinical research.     

Is compliance a professional virtue of researchers? Reflections on promoting the responsible conduct of research

Evidence exists that behavioral and social science researchers have been frustrated with regulations and institutional review boards (IRBs) from the 1970s through today. Making matters worse, many human participants protection instruction programs--now mandated by IRBs--offer inadequate reasons why researchers should comply with regulations and IRBs. Promoting compliance either for its own sake or to avoid penalties is contrary to the developmental aims of moral education and may be ineffective in fostering the responsible conduct of research. This article explores the concept of professional virtue and argues that compliance is capable of becoming a professional virtue like scientific honesty. This requires, however, that regulatory and IRB demands contribute to human well-being and to the aims of research as a profession and that researchers, therefore, internalize the norms that underlie regulatory and IRB demands. This, in turn, requires a series of changes in the way society develops, promulgates, and enforces regulatory and IRB rules. The challenge is, simply put, to embed compliance into the world of living morality.     

Contextual Challenges in South Africa: The Role of a Research Ethics Committee

This article parallels a debate similar to the one in Canada and elsewhere where researchers whose work involves humans now operate under a single ethics policy, with a strong biomedical emphasis. The institution of research ethics committees for humanities and social sciences in South Africa are relatively recent, posing unique challenges to researchers and academicians. These factors contribute to the complexity of conducting ethically sound research in the humanities and social sciences. The article explores this specific context and how a research ethics committee in the humanities and social sciences can meet the challenge of the unique South African context.     

Human Participants in Engineering Research: Notes from a Fledgling Ethics Committee

For the past half-century, issues relating to the ethical conduct of human research have focused largely on the domain of medical, and more recently social–psychological research. The modern regime of applied ethics, emerging as it has from the Nuremberg trials and certain other historical antecedents, applies the key principles of: autonomy, respect for persons, beneficence, non-maleficence, and justice to human beings who enter trials of experimental drugs and devices (Martensen in J Hist Med Allied Sci 56(2):168–175, 2001). Institutions such as Institutional Review Boards (in the U.S.) and Ethics Committees (in Europe and elsewhere) oversee most governmentally-funded medical research around the world, in more than a hundred nations that are signers of the Declaration of Helsinki (World Medical Association 2008). Increasingly, research outside of medicine has been recognized to pose potential risks to human subjects of experiments. Ethics committees now operate in the US, Canada, the U.K. and Australia to oversee all governmental-funded research, and in other jurisdictions, the range of research covered by such committees is expanding. Social science, anthropology, and other fields are falling under more clear directives to conduct a formal ethical review for basic research involving human participants (Federman et al. in Responsible research: a systems approach to protecting research participants. National Academies Press, Washington, 2003, p. 36). The legal and institutional response for protecting human subjects in the course of developing non-medical technologies, engineering, and design is currently vague, but some universities are establishing ethics committees to oversee their human subjects research even where the experiments involved are non-medical and not technically covered by the Declaration of Helsinki. In The Netherlands, as in most of Europe, Asia, Latin America, or Africa, no laws mandate an ethical review of non-medical research. Yet, nearly 2 years ago we launched a pilot ethics committee at our technical university and began soliciting our colleagues to submit their studies for review. In the past year, we have become officially recognized as a human subjects ethics committee for our university and we are beginning the process of requiring all studies using human subjects to apply for our approval. In this article, we consider some of the special problems relating to protecting human participants in a technology context, and discuss some of our experiences and insights about reviewing human subjects research at a technical university, concluding: that not less than in medical studies, human participants used in technology research benefit from ethical committees’ reviews, practical requirements for publications, grants, and avoiding legal liability are also served by such committees, and ethics committees in such contexts have many similarities to, but certain other special foci than medical ethics committees. We believe that this experience, and these observations, are helpful for those seeking to establish such committees in technology research contexts, and for framing the particular issues that may arise in such contexts for the benefit of researchers, and nascent committees seeking to establish their own procedures.     

The Importance of Ethical Appraisal in Social Science Research: Reviewing a Faculty of Humanities’ Research Ethics Committee

Research Ethics Committees (RECs) or Institutional Review Boards (IRBs) are rapidly becoming indispensable mechanisms in the overall workings of university institutions. In fact, the ethical dimension is an important aspect of research governance processes present in institutions of higher learning. However, it is often deemed that research in the social sciences do not require ethical appraisal or clearance, because of the alleged absence of harm in conducting such research. This is an erroneous and dangerous assumption given that research in social sciences poses various and complex dilemmas related to ethics. The article aims to gauge the importance of ethical appraisal at a particular institution of higher learning’s Faculty of Humanities. This is done by scrutinising its defunct REC, and the views that Heads of Departments of the Faculty have of ethics in research and the need for ethical appraisal by this REC. Finally, some suggestions are made to proceed to review and restructure the current REC with the ultimate objective to make it functional again. It was found that the development and discussion around ethics in research and ethical appraisal are part of a much needed thrust to sensitise the entire Faculty and the institution on the widespread beneficial repercussions of ethical awareness in research and beyond.     

The need for marital violence prevention efforts: A behavioral—cognitive secondary prevention program for engaged and newly married couples

The purpose of this paper is threefold: (a) to review research indicating that prevention efforts are needed for marital violence; (b) to present the rationale for a prevention approach derived from a behavioral—cognitive, social learning perspective; and (c) to describe a new behavioral—cognitive secondary prevention program that we are developing for engaged and newly married couples at risk for marital violence. Given these goals, we first present data demonstrating that physical aggression is often introduced early in a relationship and is likely to continue without intervention. After reviewing questions about the efficacy of marital violence treatment programs, we propose that prevention is a potentially important means of reducing and eliminating relationship violence. We then review behavioral—cognitive models of marital violence and the empirical data supporting these models. Based upon this review, we introduce a new behavioral—cognitive program (PREP/SAVE) designed to prevent relationship violence. Finally, we briefly present our pilot work and planned research on the efficacy of PREP/SAVE, along with some issues for consideration by future researchers.     

The Ghana Experience

This article featuring Ghana constitutes one of five articles in a collection of essays on local capacity-building in research ethics by graduates from the University of Toronto’s Joint Centre for Bioethics MHSc in Bioethics, International Stream programme funded by the Fogarty International Center for Advanced Study in the Health Sciences (FIC). Although there are no national ethical guidelines in Ghana, eight research ethics committees have been established in the country, with a number of them obtaining Federal Wide Assurances (FWA) from the United States Office for Human Research Protections (OHRP).However, the existing ethics committees cannot match the volume of work to be done, especially in light of the increase of research activities in the country. This calls for the need to train more people in research ethics to fill that gap and provide continuing education to members of research ethics committees in the country.     

Transcultural discussion in bioethics drawn from research experience in China: building up a theoretical and methodological framework for further research cooperation

My article discusses bioethics in transcultural context and builds on an experience of conducting research in China in partnership with Chinese scholars and institutions. Key points are about the creation of ethical committees and their prerogatives, the regulation of experimenting in human and animal, and of donating and transplanting organs. Ethical issues are approached according to an anthropological reading. Three transversal lines for further research are suggested: global/local ethical governance applied to research ethics; implications of transnationalizing and delocalizing research practices with regards to governance; theoretical positioning--conceptual pluralism versus pragmatic pluralism--following actual confrontation to transcultural variations in research ethics. Moreover, this work claims for conceptualizing and implementing an ethics in context while assessing intangible (non-relative) principles based on knowledge production and a global patrimony.     

A Troubled Dance: Doing the Work of Research Ethics Review

The fast growing interest in the work of university ethics review boards is evident in the proliferation of research and literature in the area. This article focuses on a Research Ethics Board (REB) in the Canadian context. In-depth, open-ended interviews with REB members and findings from a qualitative study designed to examine the ethics review of school-based research are used to illustrate points raised in the paper. The author’s experiences as academic researcher, advisor to student researchers and a 3-year term as an REB member inform the discussion. Macro issues related to the general workings of the board (e.g., maintaining appropriate membership) and micro issues connected to individual REB members’ experiences of reviewing research applications are examined. The author’s goal is to contribute to a fastgrowing conversation related to the issues that influence university ethics review while drawing attention to the contribution that faculty members’ understandings of their work as REB members can make to that conversation.     

The Ethics of Counseling: A National Survey of Certified Counselors

National survey data were collected from 579 counselors certified by the National Board for Certified Counselors (NBCC). Participants indicated their beliefs about whether each of 88 behaviors was ethical and also the degree to which they were confident of their judgment about the behavior. Systematic patterns in responding emerged in regard to age, sex, primary work setting, and degree. Participants also indicated their evaluation of 16 sources of ethical information or guidance. Highest ratings were given to American Association for Counseling and Development (AACD; now the American Counseling Association [ACA]) Ethical Standards, AACD ethics committee, the Journal of Counseling & Development, state licensing boards, and colleagues. The lowest ratings were given to local ethics committees, published clinical and theoretical work, court decisions, state and federal laws, and agencies for which participants had worked.     

Response to Herman and Daniel

There is a growing body of literature on the research ethics review process, a process that can have important effects on the nature of research in contemporary times. Yet, many people know little about what the actual process entails once an application has been submitted for review. This lack of knowledge can affect researchers and committee members' responses to the review process. Based on ethnographic research on the ethics review process in 5 countries (Australia, Canada, New Zealand, the United States, and the United Kingdom) this article takes the reader through common aspects of the research ethics review process, including some of the kinds of narratives that influence decision making. Greater understanding of the nature of the review process and the narratives that often form the core of the process can help contextualize responses that researchers get from committees so they can better address them. It may also help committee members reflect on how these narratives influence their decision making and the responses they make to researchers.     

Are the Votes of Ethics Committees in Germany for the Protection of Clinical Study Trial Subjects “Sovereign Acts?”

A sudden paradigm shift has resulted in governmental measures that greatly impact the scope in which the ethics committees in Germany can perform their task of providing expert opinions for clinical research. The so-called “revaluation” of the Medical Device Law Deutsches Medizinproduktegesetz—MPG) is, in our opinion, not based on sound political and professional judgment. In accordance with the changed regulations, ethics committees are now seen as being sub-organs of the state medical associations or the medical faculties and are therefore official authorities. It follows that the votes of ethics committees are then “sovereign acts” or authoritative measures! However, equality and justice speak against this misleading conclusion and its resulting consequence that an ethics committee’s vote is a sovereign act. This has, in turn, resulted in the public ethics committees obtaining their long-sought goal of having a state-sanctioned monopoly. The private ethics committees are not recognized as being authoritative bodies, nor are they to be seen as such in the future (i.e. such a status has been denied the Freiburg Ethics Commission International (FEKI) in Baden-Württemberg). This political mistake must be corrected, otherwise, conducting clinical research will become increasingly difficult.     

Health Care Chaplains and their Role on Institutional Ethics Committees: An Australia Study

This paper presents the results of the largest Australian pastoral study concerning the perceptions of health care chaplains about their involvement on hospital research ethics committees (also known in some contexts as institutional ethics committees). Survey results from over 300 Australian health care chaplains indicated that nearly 90% of chaplains believed there was merit in chaplains serving on hospital research ethics committees, yet only a minority (22.7%) had ever participated on such committees. Data from in-depth interviews is also presented exploring the reasons for the lack of participation and the varying opinions regarding the role, appropriateness, and value of chaplains on ethics committees. Some implications of this study with respect to chaplaincy, hospital research ethics committees, health care institutions, ecclesiastical institutions, and government responsibilities are discussed.