Visual research methods like photography and digital storytelling are increasingly used in health and social sciences research as participatory approaches that benefit participants, researchers, and audiences. Visual methods involve a number of additional ethical considerations such as using identifiable content and ownership of creative outputs. As such, ethics committees should use different assessment frameworks to consider research protocols with visual methods. Here, we outline the limitations of ethics committees in assessing projects with a visual focus and highlight the sparse knowledge (...) on how researchers respond when they encounter ethical challenges in the practice of visual research. We propose a situated approach in relation to visual methodologies that encompasses a negotiated, flexible approach, given that ethical issues usually emerge in relation to the specific contexts of individual research projects. Drawing on available literature and two case studies, we identify and reflect on nuanced ethical implications in visual research, like tensions between aesthetics and research validity. The case studies highlight strategies developed in-situ to address the challenges two researchers encountered when using visual research methods, illustrating that some practice implications are not necessarily addressed using established ethical clearance procedures. A situated approach can ensure that visual research remains ethical, engaging, and rigorous. (shrink)

Visual research methods like photography and digital storytelling are increasingly used in health and social sciences research as participatory approaches that benefit participants, researchers, and audiences. Visual methods involve a number of additional ethical considerations such as using identifiable content and ownership of creative outputs. As such, ethics committees should use different assessment frameworks to consider research protocols with visual methods. Here, we outline the limitations of ethics committees in assessing projects with a visual focus and highlight the sparse knowledge (...) on how researchers respond when they encounter ethical challenges in the practice of visual research. We propose a situated approach in relation to visual methodologies that encompasses a negotiated, flexible approach, given that ethical issues usually emerge in relation to the specific contexts of individual research projects. Drawing on available literature and two case studies, we identify and reflect on nuanced ethical implications in visual research, like tensions between aesthetics and research validity. The case studies highlight strategies developed in-situ to address the challenges two researchers encountered when using visual research methods, illustrating that some practice implications are not necessarily addressed using established ethical clearance procedures. A situated approach can ensure that visual research remains ethical, engaging, and rigorous. (shrink)

Few would argue with the idea that nursing research should be conducted ethically yet obtaining ethical approval is considered by many to have become unnecessarily burdensome. This brief article investigates the idea that there might be a relationship between the level of perceived burdensomeness of the research ethics application process on the one hand and the character of the nurse‐researcher on the other. Given that nurses are required to be other‐regarding, a nurse who undertakes research primarily for self‐regarding reasons would (...) seem to be acting in ways inconsistent with the aims of nursing as set out in nursing codes. It is suggested that the self‐regarding nurse‐researcher may find the ethics application process more burdensome than the other‐regarding nurse‐researcher who, it is further suggested, is engaged with nursing research as a practice in the technical sense in which that term has been developed by the philosopher Alasdair MacIntyre. (shrink)

Background: The Declaration of Helsinki prohibits the publication of articles that do not meet defined ethical standards for reporting of research ethics board approval and informed consent. Despite this prohibition and a call to highlight the deficiency for the reader, articles with potential ethical shortcomings continue to be published.Objective: To determine what proportion of articles in major medical journals lack statements confirming REB approval and informed consent, and whether accompanying commentary alerts readers to this deficiency.Design: Retrospective, observational study.Setting: Online review (...) of five major medical journals.Population: All clinical research articles published online between 1 January 2005 and 31 December 2006 in the BMJ, Lancet, Annals of Internal Medicine, JAMA and the New England Journal of Medicine.Measurements: Statement of REB approval and informed consent.Results: Of 1780 articles reviewed, 1133 met inclusion criteria , 36 articles lacked a statement of REB approval, 62 lacked disclosure of informed consent and 15 articles lacked both. Articles that did not state REB approval were associated with not stating informed consent . There were no editorial comments to alert readers to the lack of either REB approval or informed consent statements associated with any of the deficient articles.Conclusions: Articles that lack explicit statements of REB approval and informed consent are infrequent but continue to be published in major medical journals without editorial statements to alert the reader to this deficiency. (shrink)

Vulnerability is one of the least examined concepts in research ethics. Vulnerability was linked in the Belmont Report to questions of justice in the selection of subjects. Regulations and policy documents regarding the ethical conduct of research have focused on vulnerability in terms of limitations of the capacity to provide informed consent. Other interpretations of vulnerability have emphasized unequal power relationships between politically and economically disadvantaged groups and investigators or sponsors. So many groups are now considered to be vulnerable in (...) the context of research, particularly international research, that the concept has lost force. In addition, classifying groups as vulnerable not only stereotypes them, but also may not reliably protect many individuals from harm. Certain individuals require ongoing protections of the kind already established in law and regulation, but attention must also be focused on characteristics of the research protocol and environment that present ethical challenges. (shrink)

Institutional Review Boards have substantial power and authority over research with human subjects, and in turn, their decisions have substantial implications for those subjects, investigators, and the public at large. However, there is little transparency about IRB processes and decisions. This article provides the first comprehensive taxonomy of what transparency means for IRBs — answering the questions “to whom, about what, and by what mechanisms?” It also explains why the status quo of nontransparency is problematic, and presents arguments for greater (...) transparency from the perspective of a variety of stakeholders. IRB transparency will make boards more accountable, improve the quality of their decision-making, facilitate consistency in board decisions, permit empirical study of IRBs, promote research efficiency, and advance trust in the research enterprise, among a variety of other benefits. Regulators should promote IRB transparency, IRBs themselves should commit to sharing as much information as they can within the confines of confidentiality requirements, and investigators can endeavor to take matters into their own hands by sharing IRB correspondence and IRB-approved protocols and consent materials. (shrink)

Research Ethics Committees or Institutional Review Boards 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. (shrink)

I argue that the increase in identification of human subjects as potentially vulnerable provides evidence for a transition in human research practice analogous to changes that have occurred in implementation of environmental policy. More specifically, the increasing identification of subjects as vulnerable corresponds to de facto acceptance of what has been called “the precautionary principle” in environmental policy.

Background: Authors are required to describe in their manuscripts ethical approval from an appropriate committee and how consent was obtained from participants when research involves human participants.Objective: To assess the reporting of these protections for several study designs in general medical journals.Design: A consecutive series of research papers published in the Annals of Internal Medicine, BMJ, JAMA, Lancet and The New England Journal of Medicine between February and May 2003 were reviewed for the reporting of ethical approval and patient consent. (...) Ethical approval, name of approving committee, type of consent, data source and whether the study used data collected as part of a study reported elsewhere were recorded. Differences in failure to report approval and consent by study design, journal and vulnerable study population were evaluated using multivariable logistic regression.Results: Ethical approval and consent were not mentioned in 31% and 47% of manuscripts, respectively. 88 papers failed to report both approval and consent. Failure to mention ethical approval or consent was significantly more likely in all study designs than in randomised controlled trials . Failure to mention approval was most common in the BMJ and was significantly more likely than in The New England Journal of Medicine. Failure to mention consent was most common in the BMJ and was significantly more likely than in all other journals. No significant differences in approval or consent were found when comparing studies of vulnerable and non-vulnerable participants.Conclusion: The reporting of ethical approval and consent in RCTs has improved, but journals are less good at reporting this information for other study designs. Journals should publish this information for all research on human participants. (shrink)

BackgroundCountries are increasingly devoting significant resources to creating or strengthening research ethics committees, but there has been insufficient attention to assessing whether these committees are actually improving the protection of human research participants.DiscussionResearch ethics committees face numerous obstacles to achieving their goal of improving research participant protection. These include the inherently amorphous nature of ethics review, the tendency of regulatory systems to encourage a focus on form over substance, financial and resource constraints, and conflicts of interest. Auditing and accreditation programs (...) can improve the quality of ethics review by encouraging the development of standardized policies and procedures, promoting a common base of knowledge, and enhancing the status of research ethics committees within their own institutions. However, these mechanisms focus largely on questions of structure and process and are therefore incapable of answering many critical questions about ethics committees' actual impact on research practices.The first step in determining whether research ethics committees are achieving their intended function is to identify what prospective research participants and their communities hope to get out of the ethics review process. Answers to this question can help guide the development of effective outcomes assessment measures. It is also important to determine whether research ethics committees' guidance to investigators is actually being followed. Finally, the information developed through outcomes assessment must be disseminated to key decision-makers and incorporated into practice. This article offers concrete suggestions for achieving these goals.ConclusionOutcomes assessment of research ethics committees should address the following questions: First, does research ethics committee review improve participants' understanding of the risks and potential benefits of studies? Second, does the process affect prospective participants' decisions about whether to participate in research? Third, does it change participants' subjective experiences in studies or their attitudes about research? Fourth, does it reduce the riskiness of research? Fifth, does it result in more research responsive to the local community's self-identified needs? Sixth, is research ethics committees' guidance to researchers actually being followed? (shrink)