Background Informed consent is often cited as the “cornerstone” of research ethics. Its intent is that participants enter research voluntarily, with an understanding of what their participation entails. Despite agreement on the necessity to obtain informed consent in research, opinions vary on the threshold of disclosure necessary and the best method to obtain consent. We aimed to investigate Australian researchers’ views on, and their experiences with, obtaining informed consent. Methods Semi-structured interviews were conducted with 23 researchers from NSW institutions, working (...) in various fields of research. Interviews were analysed and coded to identify themes. Results Researchers reported that consent involved information disclosure, understanding and a voluntary decision. They emphasised the variability of consent interactions, which were dependent on potential participants’ abilities and interests, study complexity and context. All researchers reported providing written information to potential participants, yet questioned the readability and utility of this information. The majority reported using signed consent forms to ‘operationalise’ consent and reported little awareness of, and lack of support in implementing more dynamic informed consent procedures, such as verbal informed consent, that was fit for the purposes of their studies. Views on Human Research Ethics Committees varied. Some reported inconsistent, arduous inputs on the information form and consent process. Others expressed reliance on HRECs for guidance, viewing them as institutional safeguards. Conclusions This study highlights the importance of transparent relationships, both between researchers and participants, and between researchers and HRECs. Where the relationship with study participants was reported as more robust, researchers felt that they were better able to ensure participants made better, more informed decisions. Where the relationship with HRECs was reported as more robust, researchers were more likely to view them as institutional safeguards, rather than as bureaucratic hindrances. Conscientious and mindful researchers are paramount to ensuring the procedure accommodates individual requirements. This study advocates that when designing ethical informed consent practices, researchers should be integrated as autonomous players with a positive input on the process, rather than, in the worst case, predatory recruiters to be curtailed by information forms and oversight. (shrink)

In this article we describe our approach to understanding wrongdoing in medical research and practice, which involves the statistical analysis of coded data from a large set of published cases. We focus on understanding the environmental factors that predict the kind and the severity of wrongdoing in medicine. Through review of empirical and theoretical literature, consultation with experts, the application of criminological theory, and ongoing analysis of our first 60 cases, we hypothesize that 10 contextual features of the medical environment (...) (including financial rewards, oversight failures, and patients belonging to vulnerable groups) may contribute to professional wrongdoing. We define each variable, examine data supporting our hypothesis, and present a brief case synopsis from our study that illustrates the potential influence of the variable. Finally, we discuss limitations of the resulting framework and directions for future research. (shrink)

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)

Imagine a study in which HIV-infected pregnant women are given antiretroviral treatment to determine how effectively it will prevent HIV transmission during childbirth. Each mother’s involvement in this study ends with the birth of her child, at which time her access to antiretrovirals provided by the study also ceases. At the outset of the study, the investigator and sponsor agree that after the child’s birth, they will refer mothers who require treatment for their HIV to a national program that provides (...) antiretroviral treatment and care. Assuming the Institutional Review Board raises no objections to this plan, should the research team consider their ethical obligations to participants fulfilled? If the investigator and sponsor were to consult the Common Rule, they would find little to suggest that there are any further ethical issues to address. (shrink)

A growing proportion of clinical research funded by pharmaceutical companies, high-income country research agencies, and not-for-profit funders is conducted in low- and middle-income settings. Disparities in wealth and access to healthcare between the populations where new interventions are often tested and those where many of them are ultimately marketed raise concerns about exploitation. This chapter examines several ethical requirements frequently advanced as mechanisms for protecting research subjects in underserved communities from exploitation and evaluates the effectiveness of those mechanisms as responses (...) to exploitation worries. It goes on to highlight where the conceptual frameworks relied upon by research ethicists must be improved if we are to fully understand the nature of the moral claims and obligations that arise in research conducted in underserved communities. (shrink)

Ethical oversight of clinical research is one of the primary means of ensuring that human subjects are protected from the natural bias of researchers and research institutions in favor of experimentation. At a minimum, effective oversight should ensure that risks are minimized and reasonable in relation to anticipated benefits, protect vulnerable subjects from potential coercion or undue influence, ensure full and informed consent, and promote the equitable distribution of the risks and benefits of research. Because these assessments often involve value (...) judgments for which there are no agreed-upon objective standards, we rely on deliberative procedures thought to have the greatest likelihood of producing the right or best outcomes. Concerns about the potential for improperly functioning IRBs to waste scarce human and institutional resources and impede biomedical progress have motivated a surge in empirical research assessing their procedures and outcomes. Yet within this literature, there has been minimal attention paid to the social scientific evidence regarding how individuals and deliberating groups make decisions, nor how those data might inform IRB practice. This essay seeks to fill that gap, locating recent empirical data on IRB composition and process within the context of data regarding what I call “deliberative pathologies,” or instances when deliberation fails to live up to one or more aspect of the deliberative ideal because of systematic biases in the ways participants interact. The paper goes on to make evidence-based recommendations to reduce the vulnerability of IRB deliberations to the kinds of pathologies discussed and indicate directions for future research. (shrink)

A national survey on researchers’ experiences with their institutional review boards (IRBs) is presented, focused exclusively on social and behavioral researchers. A wide range of experiences is apparent in the data, especially in terms of turnaround time for submitted protocols, incidence of data collection without prior IRB approval, and stated reasons for "going solo." Sixty-two percent felt that the turnaround time they typically experience is "reasonable," and 44% said they had not experienced long delays in obtaining approval. However, 48% of (...) respondents reported either conducting a project without IRB approval or modifying an existing project without IRB approval, with anticipated time for approval being the dominant reason offered for doing so. This adds a new dimension to the widely discussed "national IRB crisis" (e.g., Illinois White Paper, 2005). The article concludes with 2 preliminary recommendations for IRB reform. (shrink)

For decades, scholars in the social sciences and humanities have questioned the appropriateness and utility of prior review of their research by human subjects' ethics committees. This essay seeks to organize thematically some of their published complaints and to serve as a brief restatement of the major critiques of ethics review. In particular, it argues that 1) ethics committees impose silly restrictions, 2) ethics review is a solution in search of a problem, 3) ethics committees lack expertise, 4) ethics committees (...) apply inappropriate principles, 5) ethics review harms the innocent, and 6) better options exist. (shrink)

Institutional Review Boards can play vital roles in observing, monitoring, and responding to research integrity issues among researchers, yet many questions remain concerning whether, when, and in what ways these boards in fact adopt these roles. Increasingly, RI is being challenged due to many factors, yet the extent of violations, and institutional responses to these, remain unknown. As the amount and complexity of experiments on human participants, often funded by for-profit industry, mushrooms, scandals have occurred, posing dilemmas concerning how to (...) best oversee research to protect these participants from harm.For over 15 years, many institutions have been developing research compliance programs that monitor misconduct and conflict of interest, and may interact with IRBs. In 2002, the Institute of Medicine report, “Responsible Research: A Systems Approach to Protecting Research Participants,” called for increased assessment of the overall human research protections system, and oversight of research. (shrink)

Although well established in developed countries, Ethics review boards in the academia, and specifically for social and behavioral sciences (SBS) research, is a relatively new, and still a controversy inducing endeavor. This study explores the establishment and functioning of ERBs in Israeli academia, serving as a case study for the challenges and progress made in ensuring ethical research practices in non-medical related spheres. A purposeful sample of 46 participants was selected, comprising ERB current or past members and SBS researchers, who (...) each interacted extensively with ERB’s evaluation processes. The participants came from all eight research universities of Israel, as well as seven large public and private academic colleges. Open, semi structured In-depth interviews were conducted in order to facilitate a critical reflective stance among the various participants, exploring their experiences, behaviors and the meanings they assign to ERB processes. Our research revealed two major themes. The first is the developmental trajectories in the construction processes of ERBs in Israel, comprised of the following stages: Initiation, expansion, opposition, and acceptance and assimilation. The second was a typology of participation throughout the ERBs’ construction process. Inspired by Merton’s strain theory, this typology includes conformists, ritualists, ideologists, control-freaks, and insurgents. The findings expose a unique perspective into the initiation, establishment, and development of ERBs, which can shed light on the role of ERBs in general, as well as point out how resistance to ERBs, as well as the different reasons for championing them, affected not only ERBs form and their legitimacy, but also their interaction with researchers. (shrink)

In the world of research, compliance with research regulations is not the same as ethics, but it is closely related. One could say that compliance is how most societies with advanced research programs operationalize many ethical obligations. This paper reports on the development of the How I Think about Research questionnaire, which is an adaptation of the How I Think questionnaire that examines the use of cognitive distortions to justify antisocial behaviors. Such an adaptation was justified based on a review (...) of the literature on mechanisms of moral disengagement and self-serving biases, which are used by individuals with normal personalities in a variety of contexts, including research. The HIT-Res adapts all items to refer to matters of research compliance and integrity rather than antisocial behaviors. The HIT-Res was administered as part of a battery of tests to 300 researchers and trainees funded by the US National Institutes of Health. The HIT-Res demonstrated excellent reliability. Construct validity was established by the correlation of the HIT-Res with measures of moral disengagement, cynicism, and professional decision-making in research. The HIT-Res will enrich the set of assessment tools available to instructors in the responsible conduct of research and to researchers who seek to understand the factors that influence research integrity. (shrink)

Scholars and policymakers continue to struggle over the meaning of the word “vulnerable” in the context of research ethics. One major reason for the stymied discussions regarding vulnerable populations is that there is no clear distinction between accounts of research vulnerabilities that exist for certain populations and discussions of research vulnerabilities that require special regulations in the context of research ethics policies. I suggest an analytic process by which to ascertain whether particular vulnerable populations should be contenders for additional regulatory (...) protections. I apply this process to two vulnerable populations: the cognitively vulnerable and the economically vulnerable. I conclude that a subset of the cognitively vulnerable require extra protections while the economically vulnerable should be protected by implementing existing regulations more appropriately and rigorously. Unless or until the informed consent process is more adequately implemented and the distributive justice requirement of the Belmont Report is emphasized and operationalized, the economically disadvantaged will remain particularly vulnerable to the harm of exploitation in research. (shrink)