In his absorbing book Art as Performance, David Davies argues that artworks should be identified, not with artistic products such as paintings or novels, but instead with the artistic actions or processes that produced such items. Such a view had an earlier incarnation in Currie’s widely criticized “action type hypothesis”, but Davies argues that it is instead action tokens rather than types with which artworks should be identified. This rich and complex work repays the closest study in spite of some (...) basic objections to be raised concerning Davies’s central concept of an action token. (shrink)

In India, judicial review is not a static phenomenon. It has ensured that the Constitution is the supreme law of the land, and in situations when a law impinges on the rights and the liberties of citizens, it can be pruned or made void. This is a collection of scholarly essays demonstrating the different facets of judicial review based on the vast area of comparative constitutional law. Importantly, it honours the body of work of Upendra Baxi, legal scholar and author, (...) whose contributions have shaped our understanding of legal jurisprudence and expanded the scope of social transformation in India. This volume recognizes his role as an Indian jurist. Various constitutional law experts come together to reflect on his expositions on the role of the apex court, judicial activism, accountability of judiciary, laws on surrogacy and adultery and so on. (shrink)

Objective: To examine the current ethical review process of ethics committees in a non-pharmacological trial from the perspective of a clinical investigator.Design: Prospective collection of data at the Study Centre of the German Surgical Society on the duration, costs and administrative effort of the ERP of a randomised controlled multicentre surgical INSECT Trial between November 2003 and May 2005.Setting: Germany.Participants: 18 ethics committees, including the ethics committee handling the primary approval, responsible overall for 32 clinical sites throughout Germany. 8 (...) ethics committees were located at university medical schools and 10 at medical chambers. Duration was measured as days between submission and receipt of final approval, costs in euros and administrative effort by calculation of the product of the total number of different types of documents and the mean number of copies required .Results: The duration of the ERP ranged from 1 to 176 days. The median duration was 26 days at MSUs compared with 34 days at medical chambers. The total cost was €2947. 1 of 8 ethics committees at universities and 8 of 10 at medical chambers charged a median fee of €162 . The administrative effort for primary approval was 30. Four ethics committees required a higher administrative effort for secondary approval .Conclusion: The ERP for non-pharmacological multicentre trials in Germany needs improvement. The administrative process has to be standardised: the application forms and the number and content of the documents required should be identical or at least similar. The fees charged vary considerably and are obviously too high for committees located at medical chambers. However, the duration of the ERP was, with some exceptions, excellent. A centralised ethics committee in Germany for multicentre trials such as the INSECT Trial can simplify the ERP for clinical investigators in and outside the country. (shrink)

The current paper discusses the peer review process in journals that publish research papers purveying new science and understandings. Different aspects of peer review including the selection of reviewers, the review process and the decision policy of editor are discussed in details. Here, the pros and cons of different conventional methods of review processes are mentioned. Finally, a suggestion is presented for the review process of scientific papers.

In this response, the Australian Health Ethics Committee (AHEC) indicates that it shares, and has strategies in place to address, the majority of the concerns identified by Susan Dodds. AHEC believes it is too early to assess the full impact of the National Statement on Ethical Conduct in Research Involving Humans (1999) or to call for a major review of the ethics committee process. While some Human Research Ethics Committees (HRECs) are over-stretched, the system is not on the verge (...) of collapse. (shrink)

ABSTRACT The ethical review process is an important component of contemporary health research worldwide. Sudan started an ethical review process rather late in comparison with other countries. In this study, we evaluate the structure and functions of existing ethics review committees. We also explore the knowledge and attitudes of Sudanese researchers toward the ethical review process and their experience with existing ethics review committees. There are four ethics review committees in the country; these committees have no institutional (...) regulations to govern their functions. Furthermore, Sudan also lacks national guidelines. Ethical reviews are carried out primarily for studies seeking international funding and are almost always governed by the funding agencies’ requirements. Nearly half of respondents (46.3%) knew about the existence of research ethics committees in Sudan. Researchers reported a variety of experiences with the ethical review process; most of them were unable to define ‘ethics committee’. (shrink)

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. (shrink)

Review of Hattich, F. (2004): 'Quantum Processes. A Whiteheadian Inter pretation of Quantum Field Theory'. Agenda Verlag, Munster. ISBN 3-89688-204-X (Euro 29.90; pbk).

ABSTRACT The ethical review process is an important component of contemporary health research worldwide. Sudan started an ethical review process rather late in comparison with other countries. In this study, we evaluate the structure and functions of existing ethics review committees. We also explore the knowledge and attitudes of Sudanese researchers toward the ethical review process and their experience with existing ethics review committees. There are four ethics review committees in the country; these committees have no institutional (...) regulations to govern their functions. Furthermore, Sudan also lacks national guidelines. Ethical reviews are carried out primarily for studies seeking international funding and are almost always governed by the funding agencies’ requirements. Nearly half of respondents (46.3%) knew about the existence of research ethics committees in Sudan. Researchers reported a variety of experiences with the ethical review process; most of them were unable to define ‘ethics committee’. (shrink)

Ethics review processes are frequently perceived as extending from codes and protocols rooted in biomedical disciplines. As a result, many researchers in the humanities and social sciences (HASS) find these processes to be misaligned, if not outrightly obstructive to their research. This leads some scholars to advocate against HASS participation in institutional review processes as they currently stand, or in their entirety. While ethics review processes can present a challenge to HASS researchers, these are not insurmountable and, in fact, present (...) opportunities for ethics review boards (ERBs) to mediate their practices to better attend to the concerns of the HASS disciplines. By highlighting the potential value of the ethics review process in recognising the nuances and specificity across different forms of research, this article explores the generative possibilities of greater collaboration between HASS researchers and ERBs. Remaining cognisant of the epistemic and methodological differences that mark different disciplinary formations in turn will benefit the ethical conduct of all researchers. (shrink)

Objectives: To review the performance of research ethics committees in Spain in assessing multicentre clinical trial drug protocols, and to evaluate if they would comply with the requirements of the new EU Directive to be implemented by May 2004.Design and setting: Prospective study of applications of MCT submitted to RECs.Main measurements: Protocol related features and evaluation process dynamics.Results: 187 applications to be performed in 114 centres, were reviewed by 62 RECs. RECs had a median number of 14 members, of (...) which three were lay members. All applications were approved except four which were however approved by the other RECs involved. The median times from submission to approval and from submission to reception at the sponsor’s offices were 48 and 62 days, respectively. In 55% of all applications approved, 41 RECs raised 307 queries, 40% of these were protocol related issues, and 38% related to the patients’ information sheets. RECs charging an evaluation fee in advance and applications with no queries raised were statistically significantly associated with shorter evaluation times. However, there is a gap of at least 1.5 weeks between the date of the meeting and the reception of the approval letter in the sponsor’s office.Conclusions: Evaluating MCT protocols by RECs is a time consuming process. Needing 1.5 weeks for communicating the decision taken by RECs to the sponsor suggests serious administrative shortcomings within most RECs. By significantly reducing the time for communication of their decisions, the majority of RECs would comply with the Directive requirement of a maximum 60 day period for the assessment of MCT. (shrink)

Summary: Edward Lanphier and colleagues contend that human germline editing is an unethical technology because it could have unpredictable effects on future generations. In our view, such misgivings do not justify their proposed moratorium.

A review of the literature and ethnographic data from Australia, Canada, New Zealand, the United States, and the United Kingdom on the research ethics review process suggest that moral panics can become triggers for punctuated equilibrium in the review process at both the macro and microlevel, albeit with significantly different levels of magnitude and impact. These data suggest that neither the development of the ethics review process nor the process itself proceeds gradually, but both are characterized (...) by periodic major shifts evoked by particular events or situations that result in varying levels of moral panic. One way to deal with this moral panic is to increase the regulation of research and the depth or intensity of the scrutiny of applications under ethics review. Moral panics at the macrolevel influence those at the microlevel and, if the moral panic evoked at the local or microlevel is not satisfactorily resolved, it will evoke action at a higher level. Understanding the evolution of research ethics review processes from this perspective might help make actions by ethics committees and policy makers more understandable and help explain why attention to research ethics are heightened at particular points in time. It may also provide a basis for developing recommendations for adaptations to the ethics review process and policy at both the local and macrolevel. (shrink)

Peer review of manuscripts for biomedical journals has become a subject of intense ethical debate. One of the most contentious issues is whether or not peer review should be anonymous. This study aimed to generate a rich, empirically-grounded understanding of the values held by journal editors and peer reviewers with a view to informing journal policy. Qualitative methods were used to carry out an inductive analysis of biomedical reviewers’ and editors’ values. Data was derived from in-depth, open-ended interviews with journal (...) editors and peer reviewers. Data was “read for” themes relevant to reviewer anonymisation and interactions among editors, reviewers, and authors. Editors and peer reviewers provided three arguments that would support a more open and interactive peer-review process. First, a number of participants emphasised the importance of not only ensuring the scientific quality of published research but also nurturing their colleagues and supporting their communities. Second, many spoke about the ongoing moral responsibilities that reviewers and editors felt toward authors. Finally, participants spoke at length about their enjoyment of social interactions and of the value of collective, rather than isolated, reasoning processes. Whether or not journal editors decide to allow anonymous review , the values of editors and reviewers need to be seriously addressed in codes of publication ethics, in the management of biomedical journals, and in the establishment of journal policies. (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)

Medical and public health research includes surveys, interviews, and biospecimens — techniques that do not present substantial risks to subjects. Consequently, this research is exempt from regulation under the Federal Common Rule. Nevertheless, at many institutions, exempt research is frequently subject to the same regulatory process that is required for non-exempt research, requiring the consumption of time and resources for review by Institutional Review Board members or staff. The federal government has indicated an intention to reform and centralize this (...) system, but has not yet specified the form that it will use instead. By examining the policies of the top 50 research institutions, this article assesses institutional practices surrounding exempt research, quantifies the extent of exempt-research review requirements, documents a problem of “over-compliance,” and makes recommendations for reform. (shrink)

BackgroundDespite rapid growth of the scientific literature, no consensus guidelines have emerged to define the optimal criteria for editors to grade submitted manuscripts. The purpose of this project was to assess the peer reviewer metrics currently used in the surgical literature to evaluate original manuscript submissions.MethodsManuscript grading forms for 14 of the highest circulation general surgery-related journals were evaluated for content, including the type and number of quantitative and qualitative questions asked of peer reviewers. Reviewer grading forms for the seven (...) surgical journals with the higher impact factors were compared to the seven surgical journals with lower impact factors using Fisher’s exact tests.ResultsImpact factors of the studied journals ranged from 1.73 to 8.57, with a median impact factor of 4.26 in the higher group and 2.81 in the lower group. The content of the grading forms was found to vary considerably. Relatively few journals asked reviewers to grade specific components of a manuscript. Higher impact factor journal manuscript grading forms more frequently addressed statistical analysis, ethical considerations, and conflict of interest. In contrast, lower impact factor journals more commonly requested reviewers to make qualitative assessments of novelty/originality, scientific validity, and scientific importance.ConclusionSubstantial variation exists in the grading criteria used to evaluate original manuscripts submitted to the surgical literature for peer review, with differential emphasis placed on certain criteria correlated to journal impact factors. (shrink)

Most public and non-profit organisations that fund health research provide the majority of their funding in the form of grants. The calls for grant applications are often untargeted, such that a wide variety of applications may compete for the same funding. The grant review process therefore plays a critical role in determining how limited research resources are allocated. Despite this, little attention has been paid to whether grant review criteria align with widely endorsed ethical criteria for allocating health research (...) resources. Here, we analyse the criteria and processes that ten of the largest public and non-profit research funders use to choose between competing grant applications. Our data suggest that research funders rarely instruct reviewers to consider disease burden or to prioritise research for sicker or more disadvantaged populations, and typically only include scientists in the review processes. This is liable to undermine efforts to link research funding to health needs. (shrink)

Rooted in altruism theory, the purpose of the double-blind academic journal peer-review process is to: assess the quality of scientific research, minimize the potential for nepotism, and; advance the standards of research through high-quality, constructive feedback. However, considering the limited, if any, public recognition and monetary incentives that referees receive for reviewing manuscripts, academics are often reluctant to squander their limited time toward peer reviewing manuscripts. If they do accept such invitations, referees, at times, do not invest (...) the appropriate time needed and, as a result, scantily review manuscripts, which adversely affects the quality of the review. In addition, given that authors’ identities are not blind to journal editors, there is the potential for bias toward well-established academics from highly-ranked institutions. As a result of these issues, the aims of the academic journal review process are currently not being fulfilled. To rectify these issues, several recommendations, namely: single-blind the editors, pay reviewers, standardize the review process, increase the acceptance standards at academic conferences, and provide constructive feedback, are offered. (shrink)

Problems in peer review, the backbone of maintaining high standards in scientific publishing, have led to wide spread discontent within the scientific community. Training in the peer review process and a simpler format to assist in decision making are possible courses to improve and expedite the process of peer review and scientific publishing. The authors discuss problems in the peer review process focusing on challenges related to major revisions and reviewer's wish list of experiments; this leads to (...) the loss of time and money. Major revisions rarely lead to significant improvements, while simultaneously delay the dissemination of knowledge. The authors propose simple solutions including training peer reviewers to improve the peer review system. (shrink)

As pressure to publish increases in the academic nursing world, journal submission numbers and rejection rates are soaring. The review process is crucial to journals in publishing high quality, cutting‐edge knowledge development, and to authors in preparing their papers to a high quality to enable the nursing world to benefit from developments in knowledge that affect nursing practice and patient outcomes and the development of the discipline. This paper does not intend to contribute to the debate regarding the ethics (...) of reviewing, but rather seeks to explore notions of how the quality of the reviewing process can be enhanced to benefit authors, the reviewers, and the state of nursing knowledge. Furthermore, a call is made to editors to devise strategies for aiding reviewers to attain higher validity and reliability within the reviewing process by establishing clear standards and expectations and to ensure published work is judged against industry norms for quality. (shrink)

People with lived experience are individuals who have first-hand experience of the medical condition being considered. The value of including the viewpoints of people with lived experience in health policy, health care, and health care and systems research has been recognized at many levels, including by funding agencies. However, there is little guidance or established best practices on how to include non-academic reviewers in the grant review process. Here we describe our approach to the inclusion of people with lived (...) experience in every stage of the grant review process. After a budget was created for a specific call, a steering committee was created. This group included researchers, people with lived experience, and health systems administrators. This group developed and issued the call. After receiving proposals, stage one was scientific review by researchers. Grants were ranked by this score and a short list then reviewed by people with lived experience as stage two. Finally, for stage three, the Steering Committee convened and achieved consensus based on information drawn from stages one and two. Our approach to engage people with lived experience in the grant review process was positively reviewed by everyone involved, as it allowed for patient perspectives to be truly integrated. However, it does lengthen the review process. The proposed model offers further practical insight into including people with lived experience in the review process. (shrink)

People with lived experience are individuals who have first-hand experience of the medical condition being considered. The value of including the viewpoints of people with lived experience in health policy, health care, and health care and systems research has been recognized at many levels, including by funding agencies. However, there is little guidance or established best practices on how to include non-academic reviewers in the grant review process. Here we describe our approach to the inclusion of people with lived (...) experience in every stage of the grant review process. After a budget was created for a specific call, a steering committee was created. This group included researchers, people with lived experience, and health systems administrators. This group developed and issued the call. After receiving proposals, stage one was scientific review by researchers. Grants were ranked by this score and a short list then reviewed by people with lived experience as stage two. Finally, for stage three, the Steering Committee convened and achieved consensus based on information drawn from stages one and two. Our approach to engage people with lived experience in the grant review process was positively reviewed by everyone involved, as it allowed for patient perspectives to be truly integrated. However, it does lengthen the review process. The proposed model offers further practical insight into including people with lived experience in the review process. (shrink)

Few studies in sub-Saharan Africa evaluate Institutional Review Boards (IRBs) capacity. The study aims to explore the composition of IRBs, training, and challenges experienced in the ethics review processes by members of research institutions and universities in Addis Ababa, Ethiopia. Our findings indicate that most IRBs members were trained on research ethics and good clinical practice. However, majority perceived the trainings as basic. IRB members faced several challenges including: investigators wanting rapid review; time pressure; investigators not following checklists; limited expertise (...) in reviewing clinical trials, studies on genetics, and traditional medicine; lack of IRB offices for administrative work; competing tasks; limited staffing and the lack of a standardized review system. There is need for advanced training on research ethics to meet the evolving research needs. In addition, investments in IRBs are needed in terms of funding, and physical and human resources in Addis Ababa and Ethiopia in general. (shrink)

Few studies in sub-Saharan Africa evaluate Institutional Review Boards (IRBs) capacity. The study aims to explore the composition of IRBs, training, and challenges experienced in the ethics review processes by members of research institutions and universities in Addis Ababa, Ethiopia. Our findings indicate that most IRBs members were trained on research ethics and good clinical practice. However, majority perceived the trainings as basic. IRB members faced several challenges including: investigators wanting rapid review; time pressure; investigators not following checklists; limited expertise (...) in reviewing clinical trials, studies on genetics, and traditional medicine; lack of IRB offices for administrative work; competing tasks; limited staffing and the lack of a standardized review system. There is need for advanced training on research ethics to meet the evolving research needs. In addition, investments in IRBs are needed in terms of funding, and physical and human resources in Addis Ababa and Ethiopia in general. (shrink)

In 2006, United Nations Human Rights Council was tasked to establish a new human rights monitoring mechanism: Universal Periodic Review process. The objective of this process is to promote and protect the universality of all human rights issues and concerns via a dialogical peer review process. The primary aim of this investigation is to ask the following question: has this claim of promoting and protecting the universality of the human rights been met, or challenged, during state reviews (...) in the UPR process? The issue of polygamy has been selected as the focus for this investigation to be used, primarily, as a tool to undertake an in-depth analysis of the discussions held during state reviews in the review process. In addition, this paper will employ scholarly debates between universalism and cultural relativism, as well as the sophisticated and nuanced approaches that fall in between the polarised opposites, to analyse the discussions held on human rights during state reviews. Ultimately, the findings and discussion of this investigation will provide a unique and valuable insight to the work and operation of the UPR process, so far. (shrink)

Reviewer evaluations and recommendations for 853 manuscript submissions, over a span of 4 years, are analyzed for evidence of particularistic bias, reviewer agreement, and predictive validity for forecasting a published manuscript's citation impact. Attributes of the submitters, their affiliated institutions, and the reviewers have little consistent association with reviewers' recommendations or editorial decision outcomes. Furthermore, reviewers' recommendations demonstrate a reasonable degree of agreement. However, neither reviewers' evaluative ratings across five dimensions nor publication recommendations can predict the number of citations that (...) a published article subsequently receives. Strengths and limitations of various features of the manuscript review process, as well as the importance of monitoring the process for particularistic biases and evidence of predictive validity, are discussed. (shrink)

Research Ethics, Volume 18, Issue 1, Page 84-91, January 2022. The purpose of the traditional peer review process is to provide a more constructive and scientifically rigorous critical review of scholarly research that builds scientific rigor and validity within diverse academic disciplines. Peer review has received criticism as the demand for publications in a variety of competitive journals has significantly increased while the number of individuals who are both willing and qualified to conduct thorough reviews is significantly declining. The (...) purpose of this topic piece is to examine the overall efficacy of the peer review process and provide recommendations toward a more collaborative, transparent, and interdisciplinary communication process. (shrink)

BackgroundTo investigate the factors related to approval after review by an Institutional Review Board, the structure equation model was used to analyze the latent variables ‘investigators’, ‘vulnerability’ and ‘review process’ for 221 proposals submitted to our IRB.MethodsThe vulnerability factor included vulnerable cases, and studies that involved drug tests and genetic analyses. The principal investigator factor included the license level of the PI and whether they belonged to our institution. The review factor included administration time, total review time, and revision (...) frequency. The revision frequency and total review time influenced the efficiency of review.ResultsThe latent variable of reviewing was the most important factor mediating the PIs and vulnerability to IRB review approval. The local PIs moderated with genetic study and revision frequency had an impact on the review process and mediated non-approval.ConclusionsBetter guidance of the investigators and reviewers might improve the efficiency with which IRBs function. (shrink)

Most countries, including Botswana, have established Institutional Review Boards to provide oversight of research involving human beings. Although much has been published on the structure and function of IRBs around the world, there is less literature that empirically describes the perspectives of stakeholders in low- and middle-income country settings regarding IRB processes. In this study, we employed primarily quantitative methods to examine the perceptions of researchers at the University of Botswana about the review of research protocols by local IRBs. Data (...) were collected using a web-based survey. This was a preliminary effort to document some of the emerging experiences of researchers with ethics review in a context where both research and research oversight are relatively new. Findings from 85 researchers indicate that researchers recognized the need for an IRB to review all human research protocols, expressed the need for research ethics training, experienced hig... (shrink)