In lieu of an abstract, here is a brief excerpt of the content:594 Feminist Studies 41, no. 3. © 2015 by Feminist Studies, Inc. Liberty Walther Barnes and Christin L. Munsch The Paradoxical Privilege of Men and Masculinity in Institutional Review Boards In the 1939 Hollywood classic The Wizard of Oz, the great wizard admonishes Dorothy and her friends to “pay no attention to that man behind the curtain.” Dorothy and company turn to see a man standing before a (...) large control panel operating the smoke, holographic image, and voice of the great wizard. Realizing he has been discovered, the man gives up manipulating the switches and the nebulous wizard vanishes.1 Hegemonic masculinity is analogous to the “all-powerful” wizard.2 In order to maintain its grandeur, power, and mystique, the mechanics of masculine ideology—as well as the social actors who participate in its reproduction —must be kept hidden.3 A crucial aim of feminist research is to 1. The Wizard of Oz, directed by Victor Fleming (Culver City, CA: Metro-Goldwyn -Mayer, 1939). 2. See R. W. Connell, Masculinities: Knowledge, Power and Social Change (Berkeley : University of California Press, 1995); R. W. Connell and James W. Messerschmidt, “Hegemonic Masculinity: Rethinking the Concept,” Gender & Society 19 (2005): 829–61; Michael Kaufman, “Me, Feminism, and Men’s Contradictory Experiences of Power,” in Theorizing Masculinities, ed. Harry Brod and Michael Kaufman (Thousand Oaks, CA: Sage Publications, 1994), 142– 63; and Michael S. Kimmel, “Masculinity as Homophobia: Fear, Shame, and Silence in the Construction of Gender Identity” in Brod and Kaufman, Theorizing Masculinities, 119–42. 3. Michael Flood and Bob Pease, “Undoing Men’s Privilege and Advancing Gender Equality in Public Sector Institutions,” Policy and Society 24, no. 4 (2005): 119–38; Allan G. Johnson, The Gender Knot: Unraveling Liberty Walther Barnes and Christin L. Munsch 595 pull back the curtain on men’s lives and masculine institutions in order to demystify socially constructed masculinities, particularly in their most powerful forms. As early feminist scholars note, male privilege renders women’s lives invisible.4 But male privilege renders aspects of men’s lives invisible, too. In this article we highlight how institutional review boards (IRBs) in universities and hospitals erect barriers to research that render particular aspects of men’s lives invisible. We draw on our experiences of submitting ten applications for a series of methodologically diverse studies of masculinity to eight IRBs. First, we argue that, despite their original function of protecting subordinated groups, IRBs are gendered institutions in which members base their decisions on culturally dominant, normative images of women and men. We show how this results in the stringent protection of male research participants, the safeguarding of participants’ personal masculinity, and the shielding of men’s lives from social inquiry. Second, we argue that IRBs are gendering institutions. Our experiences reveal how the privileging and protection of masculinity results in mandatory protocol modifications that idealize hegemonic masculinity. These modifications require researcher-participant interactions that socialize men to engage in gender “appropriate” behavior and reify gendered expectations. Third, our experiences reveal the ways in which IRBs protect the institution itself and privilege the universities, hospitals, and (predominantly male) medical doctors they represent. Consequently, the ways they reproduce social inequality remain impervious to academic inquiry. IRBS AS GENDERED AND GENDERING INSTITUTIONS Every university and hospital in the United States where human research is conducted houses a human research protections program, or IRB, to oversee academic research. Universities with hospitals typically our Patriarchal Legacy (Philadelphia, PA: Temple University Press, 1997); Michael Kimmel, Guyland: The Perilous World Where Boys Become Men (New York: Harper Collins, 2008). 4. Simone de Beauvoir, The Second Sex, trans. Howard M. Parshley (New York: Knopf, 1951); Sandra Harding, The Science Question in Feminism (Ithaca, NY: Cornell University Press, 1986); Dorothy E. Smith, “Women’s Perspective as a Radical Critique of Sociology,” in Feminist Perspectives on Social Research, ed. Sharlene N. Hesse-Biber and Michelle L. Yaiser (New York: Oxford University Press, 2004), 84–96. 596 Liberty Walther Barnes and Christin L. Munsch maintain two types of IRB committees: a social-behavioral committee that oversees studies in the social sciences, and a biomedical committee to supervise clinical drug trials, experimental medical treatments, and tissue and blood research. The duty of the... (shrink)

Reviews : Robyn Eckersley, Environmentalism and Political Theory: Toward an Ecocentric Approach ; Robert E. Goodin, Green Political Theory ; Peter Hay and Robyn Eckersley, Ecopolitical Theory: Essaysfrom Australia, ; Peter Hay, Robyn Eckersley and Geoff Holloway Environmental Politics in Australia and New Zealand ; Drew Hutton, Green Politics in Australia ; Michael Muetzelfeldt, Society, State and Politics in Australia.

In lieu of an abstract, here is a brief excerpt of the content:Reviewed by:Charles S. Peirce: Selected Writings on Semiotics 1894–1912 ed. by Francesco BellucciCornelis de WaalEdited by Francesco BellucciCharles S. Peirce: Selected Writings on Semiotics 1894–1912 Berlin: De Gruyter, 2020; no index.With Francesco Bellucci's Charles S. Peirce: Selected Writings on Semiotics 1894–1912 and the Peirceana series, which Bellucci co-edits with Ahti-Veikko Pietarinen, the center of gravity in Peirce studies has dramatically shifted to Europe. The powerhouses of old, such as (...) the Peirce Edition Project at Indiana University and the Institute for Studies in Pragmaticism at Texas Tech University, appear pretty much dead in the water. And this new center of gravity is by no means limited to secondary literature. Bellucci's edition of Peirce's writings on semiotics and Pietarinen's multi-volume Logic of the Future present us with well-thought-out and responsibly edited volumes of primary literature that will leave their mark on Peirce scholarship for decades to come. And there are other volumes on the way.Bellucci's volume spans almost two decades of Peirce's life—a period during which Peirce had retreated to Milford, Pennsylvania, spending most of his time with his pen on paper. The main purpose of Bellucci's volume is to give us better access to material that has not yet been published—material that is, as Bellucci contends, "essential to understand Peirce's views about signs, their classification, and the relations between semiotics and logical inquiry" (p.1).In line with this, Bellucci starts off where the Writings break off. The last volume of the Writings, which appeared well over a decade ago, ends midway 1892, and Bellucci's volume opens with the sixth chapter of Peirce's 1894 logic book How to Reason, "The Essence of Reasoning." Bellucci thereby skips the second chapter of that same logic book, even though it deals directly with the question "What is a Sign?" He does this on the ground that that chapter is already published in the second [End Page 265] volume of The Essential Peirce (p.3). Bellucci's Selected Writings on Semiotics is thus best considered a professional tool aimed at filling gaps in the literature for Peirce scholars who are already familiar with, or knowledgeable of, what is already out there. Making these texts available is especially important since the manuscripts they are based on are not widely accessible and are in various states of disarray.Each text in Bellucci's volume comes with a (sometimes-extensive) editorial note that is largely bibliographical and, like the Writings, explains which manuscript sheets constitute the text by supplementing the Robin Catalogue designation with the page reference system devised by the Institute for Studies in Pragmaticism. The headnote is followed by explanatory annotations, emendations, and alterations, not unlike the system used for the Writings. In this way the reader can easily ascertain where Bellucci made corrections to the original text and what changes Peirce made himself when he was in the process of writing. Putting the apparatus immediately following each text is a much better choice than hiding everything in the back of the volume, as was done in the Writings. Given the nature of this edition, however, it would have been better to have the editorial note precede the text, as is done, for instance in The Essential Peirce, rather than follow it (or use two notes), as that would have made it easier for the reader to position the text within Peirce's oeuvre before beginning to read it (for instance, by reading "What is a Sign?" before starting "The Essence of Reasoning").Bellucci's Selected Writings on Semiotics includes eighteen selections in total, each of which is described briefly in the volume's Introduction with a rationale for including it. As with the Writings, titles not given by Peirce are printed in italic square brackets. At times a more forceful editorial hand in establishing the titles themselves would have been helpful. Selection 10, for instance, "The Basis of Pragmaticism," suggests that it would include two pieces already found in The Essential Peirce, namely "The Basis of Pragmaticism in Phaneroscopy," and "The Basis of Pragmaticism in the... (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Reviewed by:Ethnography as Christian Theology and Ethics ed. by Christian Scharen and Anna Marie VigenJohn KiessEthnography as Christian Theology and Ethics Edited by Christian Scharen and Anna Marie Vigen New York: Continuum, 2011. 304 pp. $29.95Over the past decade, an increasing number of Christian theologians and ethicists have turned to ethnographic methodologies in order to attend more closely to the complexities of lived faith and the bodily character of (...) theological knowledge. For those wishing to get a glimpse of what this looks like in practice, what its implications might be for theology and ethics, and how one might set off and do it oneself, this book is an excellent introduction.Editors Christian Scharen and Aana Marie Vigen organize the book into three parts. The first part orients readers to the use of ethnography in cultural anthropology and reviews the recent “ethnographic turn” in Christian theology and ethics. This is followed by a brief survey of theological critiques of social science and a defense of ethnography against these critiques. Scharen and Vigen argue that the use of ethnography, far from compromising the integrity of theology, has the potential to renew and enrich the discipline through the incorporation of long-overlooked forms of local wisdom. As a method attuned to practical, often noncognitive forms of knowledge, ethnography can help scholars move away from an exclusive focus on texts to a deeper consideration of the theological and ethical claims “embedded and embodied” in the lives and practices of everyday communities (xxii). [End Page 190]Naturally, the best argument for such an approach is exemplification. The second part of the book presents an impressive collection of ethnographic work from contexts as diverse as Chicago, Atlanta, Oregon, Chiapas, Nairobi, and Gulu. Contributors employ ethnography to compare pastoral leadership in two African American churches, track grassroots dissent on the issue of contraception among women living with HIV/AIDS, and reimagine the debate on physician-assisted suicide from the perspective of the poor and disabled. Particularly effective are Vicini’s exploration of the liturgical response of local churches to the legacy of violence in Chiapas and Whitmore’s critical examination of his own place as a white researcher in Northern Uganda, which makes hauntingly transparent the ethical complexities of the research process itself.The final part of the book offers a more practical how-to guide for those looking to do ethnography, covering such issues as institutional review board approval, interview methodology, and accountability to research subjects. This part, like the rest of the book, will be a gift for graduate students facing down a dissertation proposal or scholars contemplating the use of ethnography in their work. Admirably reflexive, vigilantly attentive to issues of power and privilege, and articulate about the ways that research can be a form of discipleship, one can only hope this book will succeed in its aim of encouraging other scholars to “go and do likewise.”Those who have already incorporated ethnographic techniques in their scholarship or who are looking for a fuller articulation of the relation between ethnography, ethics, and theology may find themselves less satisfied with the book. Its treatment of existing options (virtue ethics, Catholic social ethics) and thinkers (David Ford, Stanley Hauerwas, and John Milbank) is thin, and a number of key figures in the broader story of the ethnographic turn in theology (Karl Barth, Dietrich Bonhoeffer, and Hans Frei) are conspicuously missing. Their absence is felt particularly strongly in the unanswered questions the volume provokes, including how to account for God’s difference when appeals to experience become primary (Barth), and how to avoid positivism when appeals to the “reality” of the church become the point of departure for ecclesiology (Bonhoeffer).Such provocations, however, are reminders that we are still at the very early stages of the ethnographic turn in Christian theology and ethics. If this volume is any indication, the future of this exciting intersection of thought and practice looks very promising indeed. [End Page 191]John KiessLoyola University MarylandCopyright © 2013 Society of Christian Ethics... (shrink)

Institutional Review Boards and their federal overseers protect human subjects, but this vital work is often dysfunctional despite their conscientious efforts. A cardinal, but unrecognized, explanation is that IRBs are performing a specific function – the management of risk – using a flawed theoretical and practical approach. At the time of the IRB system’s creation, risk management theory emphasized the suppression of risk. Since then, scholars of governance, studying the experience of business and government, have learned that we must (...) distinguish pure from opportunity risks. Pure risks should be suppressed. Some opportunity risks, in contrast, must be accepted if the institution is to meet its goals. Contemporary theory shows how institutions may make these decisions wisely. It also shows how a sound organizational understanding of risk, a proper locus of responsibility, and appropriate institutional oversight all contribute to effective risk management. We can apply this general theory, developed in other contexts, to the problems of the IRB system. Doing so provides a unifying explanation for IRBs’ disparate dysfunctions by spotlighting five related deficiencies in IRB theory and structure. These deficiencies are inability to focus on greater risks, loss of balanced theory, inaccessibility to guidance from senior leadership, unbalanced federal oversight, and inflexibility. These flaws are deeply rooted in the system, and superficial reform cannot resolve them. Congress should overhaul the system to meet contemporary standards of risk management; this would benefit subjects, scientists, and the public that needs the fruits of research. (shrink)

Welcome to the 23rd volume 2nd issue of Cumhuriyet Theology Journal which left behind 22 years of academic publication journey. It is important to carry out valuable scientific studies in academic life as well as to reach a wide audience. Our journal has achieved great progress in both national and interna-tional academic publication. Today, almost all scientific knowledge can be reached through online access. The researchs in the field of religious studies in Turkey deserves to reach all the world beyond (...) the boundaries of the libraries. Cumhuriyet Theology Journal has gained a very rapid acceleration in the last five years by meeting the international publication criteria with its format and publication principles and has managed to attract the attention of the scientific world. The Isnad Citation Style developed within our journal and workshops con-ducted under the leadership of our journal are examples of the Theology Field Journals. We are pleased to announce two important news in this issue. The first is that the 2nd Edition of the Isnad Citation System is available to you, and the second is the addition of the Arabic language option to our journal. In 23rd volume 2nd issue two Arabic articles were published for the first time. Our journal now has been indexed by various international indexes: TURKISH NATIONAL DATABASE Social Sciences and Humanities Database (Accept-ed: 13/11/2015) The European Reference Index for the Humanities and the Social Sciences (Accepted: 25/03/2016) ATLA RDB©: ATLA Religion Database© (Indexing and Abstracting Start: 20/05/2016) BROWZINE Academic Journal Collections (Accepted: 07/07/2016) J-GATE: E-Journal Gateway (Accepted: 07/07/2016) ROAD: Directory Of Open Access Scholarly Resources (Accepted: 24/08/2016) DOAJ: Directory of Open Access Journals (Accepted: 02/09/2016) MLA International Bibliography (Indexing and Abstracting Start: 14/06/2016) CEEOL: Central and Eastern European Online Library (Accepted: 06/10/2016) EBSCO Humanities International Index (Indexing and Abstracting Start: 07/01/2016) EBSCO Humanities Source Ultimate Database (Indexing and Abstracting Start: 07/01/2016) PHILPAPERS: Bibliography of Philosophy (Accepted: 01/01/2016) ROOT INDEXING: Journal Abstracting and Indexing (Accepted: 12/02/2017) ESCI: Emerging Sources Citation Index (Indexing and Abstracting Start: 01/01/2016) ProQuest Central (Accepted: 15/01/2017, 21/1) ProQuest Turkey Database (Accepted: 15/01/2017, 21/1) Index Islamicus (Indexing and Abstracting Start: 13/12/2017) Scopus (S.Date: 01/01/2016; Accepted: 23/01/2018) Moreover, we have also announced the preliminary review form and the review form for the blind review process. We examine Turkish and English titles, summaries, and keywords to make sure that they correspond to the field’s terminology. Furthermore, we require proper nouns and concepts/terms to be written in the reference style of TDV Ency-clopaedia of Islam. We also particularly require for the articles to use the Isnad Citation Style. To improve the academic quality of the journal, we have also checked the article up for plagiarism. The articles that are marked with a result above %15 are returned to the authors with a plagiarism report. It might be right to note here that we have been getting more attention from scholar-ly world day by day with our mission and standards. The journal has received 73 articles between July 1- Sptember 15, 2019 from the academic world. All articles went through the pre-review process to check the referencing and transliteration style before testing them using a plagiarism checker. We then have forwarded the articles that successfully passed the plagiarism check to our reviewers. Following this process, we have been able to offer to you 40 articles, a bookreview and a symposium review at two our issues. We are delighted to offer you the various ranges of themes and topics with this new issue. We sincerely thank the contributors for their submission, the editorial and review board, and particularly to the assistant editors, Dr. Adem Çiftci, Dr. Fatma Kurttekin, Res. Asst. Maruf Cakır, Res. Asst. Alper Ay, Res. Asst. Esma Güneş, Res. Asst. Bayram Ün-ce, Res. Asst. Sena Kaplan, Res. Asst. Gülistan Aktaş, Res. Asst. Hamit Demir Res. Asst. Merve Yetim, Res. Asst. Rukiye Göğen, Res. Asst. Ömer Faruk Özbek, Res. Asst. Salime Bera Kemikli, Res. Asst. Naim Yaman, Res. Asst. Sema Tombul, Res. Asst. Nurgül Akdoğan, Res. Asst. Ayşe Mine Akar, Res. Asst. İlknur Bahadır and the editors of the language review-process Prof. Dr. Ömer Faruk Yavuz, Dr. Miyase Yavuz Altıntaş, Zeynep Yucedoğru, Dr. Zuhal Ağılkaya Şahin, Dr. Metin Güven and Dr. Kenan Tekin. For the next issue, which will be published on June 15, 2020 we announce the ac-ceptance of the articles from Jenuary 1 to March 15 by our editorial board. We wish you convenience in your studies. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Reviewed by:Women, Ethics, and Inequality in US Healthcare: “To Count among the Living” by Aana Marie Vigen, and: New Feminist Christianity: Many Voices, Many Views ed. by Mary E. Hunt and Diann L. NeuKelly Denton-BorhaugWomen, Ethics, and Inequality in US Healthcare: “To Count among the Living” By Aana Marie Vigen NEW YORK: PALGRAVE MACMILLAN, 2011. 304 PP. $31.11New Feminist Christianity: Many Voices, Many Views Edited by Mary E. Hunt (...) and Diann L. Neu WOODSTOCK, VT: SKYLIGHT PATHS, 2010. 384 PP. $24.99In this age of the Supreme Court Hobby Lobby decision, which declared that corporation owners’ religious commitments could provide a basis for denial of their employees’ critical reproductive health insurance benefits (with particular impact on the lives of women), ethical investigation of medical sociology, theology, and the realities of women’s lives is more important than ever. Originally released in 2006, Aana Marie Vigen’s Women, Ethics, and Inequality in US Healthcare makes important headway through these complex waters. And for this volume in the Palgrave Macmillan Series on Black Religion / Womanist Thought / Social Justice, editors Dwight N. Hopkins [End Page 202] and Linda E. Thomas set forth the goal to “pioneer conceptual work and boundary-pushing effort engaging Black Religion or Womanist thought, and social justice” (xiv).Rereleased in paperback in 2011 with a new preface, Vigen’s updated health statistics reveal how racial-ethnic minorities “continue to be overrepresented among the ranks of the uninsured and/or of those living in poverty” (xliii). Her project is to better understand what enables and perpetuates this inequitable distribution and oppression, and to suggest methods of redress and reform. But in order to accomplish any of this, society in general and especially those with socioeconomic power—including administrative leaders in health care, medical providers, and ethicists—need to listen much more deeply to the stories of those who are most vulnerable and are being most negatively affected by current health care systems and practices. For Vigen, this meant a decision to focus on in-depth interviews with eight black and Latina women with breast cancer, in addition to six health care providers.With this method, Vigen pursues a very ambitious goal to, as she puts it, “begin a conversation among several distinct dialogue partners: medical sociology, biomedical ethics, ethnography, theology, and feminist social ethics” (5). She uses a “reflexive” practice, striving for openness to the new insights and ideas that emerged from this creative, multidisciplinary encounter. However, even before launching her interviews, her analysis of the process to seek approval from the Institutional Research Board illustrates the “clash of cultures” she would encounter, as she writes, “one cannot take for granted that others will share the view that women of color are able to speak truth in their own right and out of their own experiences—without comparison to others—about human personhood, dignity, and adequate healthcare quality” (107). It is to Vigen’s credit that she remained undeterred; if anything, the struggle she encountered with powerful leaders helped to confirm and focus the value of this work: not to tell every story, “but to tell a few with care and attention to detail” (108).Vigen’s ethnographical method makes it possible for her to illuminate and address not only stark inequities but also much subtler dynamics of racism combined with socioeconomic discrimination. Along the way, she illustrates a wide variety of experiences of oppression. In contrast to the experience of white patients, these female patients of color tended to be sent to the accounting/financing office before being allowed to see the doctor (144). Though white patients may express strong emotions in medical settings, some women of color felt pressured to reassure white doctors that they could be rational and not overly emotional (141). Socioeconomic and racial discrimination often reinforced one another in these settings. Perhaps most alarming, Vigen notes, the white care providers she interviewed seemed to be very unconscious of [End Page 203] their own racial identity and its role in medical care encounters (165). Her final chapter concludes with a series of immensely practical ethical mandates that would help alter these oppressive patterns. Clergy, students of ethics, and anyone... (shrink)

This paper explores that the topic of ethics dumping, its causes and potential remedies. In ED, the weaknesses or gaps in ethics policies and systems of lower income countries are intentionally exploited for intellectual or financial gains through research and publishing by higher income countries with a more stringent or complex ethical infrastructure in which such research and publishing practices would not be permitted. Several examples are provided. Possible ED needs to be evaluated before research takes place, and detected prior (...) to publication as an academic paper, because it might lead to a collaborative effort between a wealthier country with restrictive ethical policies and a less wealthy country with more permissive policies. Consequently, if that collaboration ultimately results in an academic paper, there are ethical ramifications of ED to scholarly communication. Institutional review board approval is central to avoid ED-based collaborations. Blind trust and goodwill alone cannot eliminate the exploitation of indigenous or “vulnerable” populations’ intellect and resources. Combining community-based participatory research using clear codes of research conduct and a simple but robust verification system in academic publishing may reduce the risks of ED-based research from being published. (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)

The quality of a research study application sends a distinct signal to the institutional review board (IRB) about the skills, capacities, preparation, communication, experience, and resources of its authors. However, efforts to research and define IRB application quality have been insufficient. Inattention to the quality of an IRB application is consequential because the application precedes IRB review, and perceptions of quality between the two may be interrelated and interdependent. Without a clear understanding of quality, IRBs do not (...) know how to define quality and researchers do not know how to achieve quality. This position has not been systematically studied to date, and future research could provide much-needed empirical validation. This paper lays the conceptual groundwork for future investigation into what constitutes quality in an IRB application. It includes a landscape review of multidisciplinary research on quality, as well as a discussion of quality frameworks analogous to research with human participants that exist in the published literature. It also examines the background and significance of federal research regulations, regulatory burdens, researchers’ regulatory literacy, and the roles and responsibilities of IRB professionals within this ecosystem. (shrink)

This book is a small handbook designed to give Institutional Review Board (IRB) members the information they need to protect the rights and welfare of research subjects in a way that is both effective and efficient. The chapters of this book are short and to the point. Topic-specific chapters list the criteria IRB members should use to determine how to vote on specific kinds of studies and offer practical advice on what IRB members should do before and during (...) full-committee meetings. (shrink)

BackgroundInstitutional review boards (IRBs) are formally designated to review, approve, and monitor biomedical research. They are responsible for ensuring that researchers comply with the ethical guidelines concerning human research participants. Given that IRBs might face different obstacles that cause delays in their processes or conflicts with investigators, this study aims to report the functions, roles, resources, and review process of IRBs in Saudi Arabia.MethodThis was a cross-sectional self-reported survey conducted from March 2021 to March 2022. The survey (...) was sent to 53 IRB chairpersons and the administration directors (or secretary) across the country through email after receiving verbal consent. The validated survey consisted of eight aspects: (a) organizational aspects, (b) membership and educational training, (c) submission arrangements and materials, (d) minutes, (e) review procedures, (f) communicating a decision, (g) continuing review, and (h) research ethics committee (REC) resources. A total of 200 points indicated optimal IRB functions.ResultsTwenty-six IRBs across Saudi Arabia responded to the survey. Overall, the IRBs in this study scored a total of 150/200 of the points on the self-assessment tool. Relatively newer IRBs (established less than ten years ago) conducted meetings at least once in a month, had annual funding, had more balanced gender representation, tended to score higher than older IRBs. The organizational aspect score was the lowest among all items in the survey (14.3 score difference, p-value < 0.01). The average turnaround time for expedited research from proposal submission to final decision was 7 days, while it was 20.5 days for the full committee review.ConclusionSaudi IRBs performed generally well. However, there is room for focused improvement with respect to extra resources and organizational issues that require closer evaluation and guidance from the regulatory bodies. (shrink)

As we rapidly approach the 50th year of the much‐celebrated ‘cognitive revolution’, it is worth reflecting on its widespread impact on individual disciplines and areas of multidisciplinary endeavour. Of specific concern in this paper is the example of the influence of cognitivism's equation of mind and computer in education. Within education, this paper focuses on a particular area of concern to which both mind and computer are simultaneously central: educational technology. It examines the profound and lasting effect of cognitive science (...) on our understandings of the educational potential of information and communication technologies, and further argues that recent and multiple ‘signs of discontent’, ‘crises’ and even ‘failures’ in cognitive science and psychology should result in changes in these understandings. It concludes by suggesting new directions that educational technology research might take in the light of this crisis of cognitivsm. (shrink)

Institutional Review Boards are confronted with new challenges in the face of expanding technologies while fulfll-ing their existing regulatory mandate to ensure that plans are in place to protect subjects and to inform them of risks and benefts of research participation. Existing regulations and guidance do not address the issue of incidental fndings , thus leaving awareness of the issue and the application of ethical principles to IRB judgment alone. In order to assure that researchers are aware of the (...) potential for IFs, IRBs must identify which studies are likely to identify IFs and establish what plans should be put into place prior to study initiation to assure the subjects are appropriately informed of the likelihood of IFs, how IFs will be communicated to subjects, and whether the burden of follow-up falls on the researchers or is the subject's responsibility. (shrink)

Background Institutional review board (IRB) expertise is necessarily limited by maintaining a manageable board size. IRBs are therefore permitted by regulation to rely on outside experts for review. However, little is known about whether, when, why, and how IRBs use outside experts.Methods We conducted a national survey of U.S. IRBs to characterize utilization of outside experts. Our study uses a descriptive, cross-sectional design to understand how IRBs engage with such experts and to identify areas where outside (...) expertise is most frequently requested.Results The survey response rate was 18.4%, with 55.4% of respondents reporting their institution’s IRB uses outside experts. Nearly all respondents who reported using outside experts indicated they do so less than once a month, but occasionally each year (95%). The most common method of identifying an outside expert was securing a previously known subject matter expert (83.3%). Most frequently, respondents sought consultation for scientific expertise not held by current members (69.6%). Almost all respondents whose IRBs had used outside experts reported an overall positive impact on the IRB review process (91.5%).Conclusions Just over half of the IRBs in our sample report use of outside experts; among them, outside experts were described as helpful, but their use was infrequent overall. Many IRBs report not relying on outside experts at all. This raises important questions about what type of engagement with outside experts should be viewed as optimal to promote the highest quality review. For example, few respondents sought assistance from a Community Advisory Board, which could address expertise gaps in community perspectives. Further exploration is needed to understand how to optimize IRB use of outside experts, including how to recognize when expertise is lacking, what barriers IRBs face in using outside experts, and perspectives on how outside expert review impacts IRB decision-making and review quality. (shrink)

As we rapidly approach the 50th year of the much‐celebrated ‘cognitive revolution’, it is worth reflecting on its widespread impact on individual disciplines and areas of multidisciplinary endeavour. Of specific concern in this paper is the example of the influence of cognitivism's equation of mind and computer in education. Within education, this paper focuses on a particular area of concern to which both mind and computer are simultaneously central: educational technology. It examines the profound and lasting effect of cognitive science (...) on our understandings of the educational potential of information and communication technologies, and further argues that recent and multiple ‘signs of discontent’, ‘crises’ and even ‘failures’ in cognitive science and psychology should result in changes in these understandings. It concludes by suggesting new directions that educational technology research might take in the light of this crisis of cognitivsm. (shrink)

Ethics committees like Institutional Review Boards and Research Ethics Committees are typically empowered to approve or reject proposed studies, typically conditional on certain conditions or revisions being met. While some have argued this power should be primarily a function of applying clear, codified requirements, most institutions and legal regimes allow discretion for IRBs to ethically evaluate studies, such as to ensure a favourable risk-benefit ratio, fair subject selection, adequate informed consent, and so forth. As a result, ethics committees typically (...) make moral demands on researchers: require them to act in a way the committee considers ethically right or appropriate. This paper argues that moral demands are legitimate only if publicly justifiable; and as a result, committee decisions are subject to a public justification requirement. Ethics committees can permissibly request for more information, changes to the research protocol or that the research is delayed or even stopped only if these demands are publicly justifiable. This latter claim is in turn justified on the basis that moral demands to φ are permissible only if we are in a position to know that the addressee ought to φ and that we are in a position to know a proposition only if it is publicly justifiable. This argument suggests that ethics committees must consciously and explicitly appeal to public reasons in their decision-making. In cases where public reasons cannot be offered, committees would not be permitted to reject a given study or make approval conditional on an amendment. (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)

With rapidly expanding technological capacity, research has outpaced the existing infrastructure of ethical and regulatory guidance. In the area of incidental findings, this is particularly true.The regulations under which most Institutional Review Boards operate were established over 25 years ago and have not been substantially altered in the intervening years. The technology available today that creates the opportunity for IFs was not conceived of, or considered, in the crafting of those regulations. Therefore, little guidance can be derived directly from (...) these regulations. Rather, aspects of existing ethical guidance and regulations can be adapted to assist IRBs and researchers in dealing with issues surrounding IFs. (shrink)

In medical research, patients are increasingly recognized with ‘lay knowledge’ but their views are poorly researched. The study objective was to investigate patients’ attitudes to medical research. This is in comparison to lay and expert members on ethical review boards, as their task is to evaluate the risk−benefits of research, which are ultimately grounded in attitudes and values. From focus-group interviews with patients suffering from chronic inflammatory diseases, a postal questionnaire was developed and sent to patient members of the (...) Swedish Rheumatism Association and to all ERB board members in Sweden. Response rates were 65 percent and the surveys were conducted in Jan−May 2011. Agreement across the groups included priority for medical research on diagnostic and early detection of disease. A key difference was expert and lay ERB members giving higher priority to basic research/research on lifestyle and prevention, whereas patients prioritized research on daily function. On this significant point, lay members did not share the opinion of this patient group, indicating that they may be poor representatives for patients’ views. These results call for further research: how can patient perspectives be included in ERB discussions and in what way should patients’ values influence the research agenda. (shrink)

The National Institutes of Health (NIH) invests over $37 billion per year in support of research to improve human health. All research funded by NIH that involves human subjects is subject to regulatory oversight, requiring institutions to staff and manage Institutional Review Boards (IRBs). IRB members, chairs, and the many associated human subjects protections oversight professionals who support the work of the IRB must navigate complex federal regulations issued by multiple agencies. This book is the industry standard reference work (...) for the research oversight community, providing comprehensive, understandable interpretations of the regulations, clear descriptions of the ethical principles on which the regulations are based, and practical best-practices guidelines for effectively implementing regulatory oversight. (shrink)

BackgroundInstitutional Review Boards (IRBs) play a vital role in safeguarding the rights and interests of both research participants and researchers. However, China initiated the establishment of its own IRB system relatively late in comparison to international standards. Despite commendable progress, there is a pressing need to strengthen the organizational capacity building of Chinese IRBs. Hence, this study aims to analyze the key factors driving the enhancement of organizational capacity within these committees.MethodThe cross-sectional survey for this research was conducted from (...) July 2020 to January 2022. Following the statistical grouping based on the "2020 China Health Statistical Yearbook", a systematic investigation of IRBs in various provinces of China was carried out. In-depth interviews and questionnaire surveys were conducted with the chairpersons and administrative executives (or secretaries) of highly cooperative IRBs. Subsequently, data were collected from 107 IRBs. Qualitative Comparative Analysis (QCA) was employed as the method to analyze the factors influencing the organizational capacity of medical ethics committees and explore the diverse combinations of these factors.ResultsThrough a singular necessary condition analysis, the variable "protection of rights and interests" emerges as a critical factor contributing to the robust construction of Institutional Review Boards Institutional Review Boards (IRBs). Conversely, the variables of "lack of member ability, absence of review process, and deficiency in the supervision mechanism" collectively constitute a sufficient condition leading to weaker IRB construction. The state analysis uncovers three interpretation modes: member ability-oriented (M1), system process-oriented mode (M2), and resource system-oriented mode (M3).ConclusionsThe results of this study are effectively explicable using the "Triangular Force" model proposed for the hypothesis of IRBs' organizational capacity, which provides a solid foundation for the development of organizational capabilities in IRBs. To enhance the organizational capacity of IRBs in China, it is imperative to elevate the competence of committee members and strengthen team development. This can be achieved by establishing a comprehensive regulatory framework and refining procedural protocols. Moreover, clarifying the organizational structure and optimizing resource allocation are essential steps in bolstering the overall organizational capabilities of these committees. (shrink)

Researchers seeking to engage in projects related to Tribal communities and their citizens, lands, and non-human relatives are responsible for understanding and abiding by each Tribal nation’s research laws and review processes. Few studies, however, have described the many diverse forms of Tribal research review systems across the United States (US). This study provides one of the most comprehensive examinations of research review processes administered by Tribal Research Review Boards (TRRBs) in the US. Through a systematic (...) analysis, we consider TRRBs’ online presence, online documentation, and themes across documents, for five entity types: Tribal nations and Tribal consortiums, Tribal colleges and universities, Tribal health organizations, Indian Health Services, and other Tribal organizations. Results include an assessment of online presence for 98 potential TRRBs, identification of 118 publicly available online documents, and analysis of 41 themes across four document types: Tribal research codes and TRRBs’ guidelines, applications, and post-approval documents. Altogether, this research provides a macro-level analysis of the most common types of TRRBs in the US in an effort to increase researchers’ understanding of these important processes as they prepare to ethically engage Tribal communities in research. These results aim to empower Tribal decision makers as they align their TRRBs’ online visibility and documentation with community priorities and strengthen their protections for the rights and wellbeing of their citizens and community. Ultimately, by expanding our knowledge of TRRBs across the US, this contribution seeks to uphold Tribal sovereignty in research and promote ethical approaches to research with Indigenous communities. (shrink)

In their target article, “The Rise of Citizen Science in Health and Biomedical Research,” Andrea Wiggins and John Wilbanks (2019) summarize some of the emerging ethical issues related to citizen sc...

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)

Confucius in the Technology Realm is a ground-breaking new approach to the dynamic world of Education Technology. In this work, the author has decided to soften on structure and focus on art - to take a philosophical approach to the planning and management of the chaotic and ever-changing realm of Educational Technology - what would Confucius think about Ed Tech? But while providing a method of inquiry for philosophical guidance, the book is also meant to reinforce the ethereal concepts (...) with real-world, Ed Tech examples. The ultimate objectives of impacting student learning and achievement and mastery of philosophical self-discipline becomes one and the same - thus, the Tao of Education Technology may be seen as Confucius' viewpoint, helping identify the path to transcending the organization's people, policies, and processes to attain a state where the whole is greater than the sum of its parts - where the education technology infrastructure and operational support structure are ingrained and embodied within the organization as a whole. (shrink)

Informed consent is crucial in research, but potential participants may not all speak the same language, posing questions that have not been examined concerning decisions by institutional review boards and research ethics committees’ about the need for researchers to translate consent forms and other study materials. Sixty US IRBs were contacted, and leaders from 34 and an additional 12 members and administrators were interviewed. IRBs face a range of problems about translation of informed consent documents, questionnaires and manuals—what, when (...) and how to translate , why to do so and how to decide. Difficulties can arise about translation of specific words and of broader cultural concepts regarding processes of informed consent and research, especially in the developing world. In these decisions, IRBs weigh the need for autonomy and justice against practical concerns about costs to researchers. At times IRBs may have to compromise between these competing goals. These data, the first to examine when and how IRBs/RECs require researchers to translate materials, thus highlight a range of problems with which these committees struggle, suggesting a need for further normative and empirical investigation of these domains, and consideration of guidelines to help IRBs deal with these tensions. (shrink)

To show how the case of Mary Shelley’s Victor Frankenstein brings light to the ethical and moral issues raised in Institutional Review Board protocols, we nest an imaginary IRB proposal dated August 1790 by Victor Frankenstein within a discussion of the importance and function of the IRB. Considering the world of science as would have appeared in 1790 when Victor was a student at Ingolstadt, we offer a schematic overview of a fecund moment when advances in comparative anatomy, (...) medical experimentation and theories of life involving animalcules and animal electricity sparked intensive debates about the basic principles of life and the relationship between body and soul. Constructing an IRB application based upon myriad speculations circulating up to 1790, we imagine how Victor would have drawn upon his contemporaries’ scientific work to justify the feasibility of his project, as well as how he might have outlined the ethical implications of his plan to animate life from “dead” tissues. In Mary Shelley’s Frankenstein, Victor failed to consider his creature’s autonomy, vulnerability, and welfare. In this IRB proposal, we show Victor facing those issues of justice and emphasize how the novel can be an important component in courses or workshops on research ethics. Had Victor Frankenstein had to submit an IRB proposal tragedy may have been averted, for he would have been compelled to consider the consequences of his experiment and acknowledge, if not fulfill, his concomitant responsibilities to the creature that he abandoned and left to fend for itself. (shrink)

Biomedical research today can be generally classified as human-based or nonhuman animal-based, each with separate and distinct review boards that must approve research protocols. Researchers wishing to work with humans or human tissues have become frustrated by the required burdensome approval panel, the Institutional Review Board. However, scientists have found it is much easier to work with the animal-based research review board, the Institutional Animal Care and Use Committee. Consequently, animals are used for investigations even (...) when scientists believe these studies should be performed with humans or human tissue. This situation deserves attention from society and more specifically the animal protection and patient advocate communities, as neither patients nor animals are well served by the present situation. (shrink)

Volume 19, Issue 9, September 2019, Page 58-60.

A number of unique problems plague human research protection efforts at United States (U.S.) State and Territorial Departments of Health (DOHs) problems which might be ameliorated through a consolidated national or regional, independent, not-for-profit Institutional Review Board (IRB).

The Internet has been used as a place for and site of an array of research activities. From online ethnographies to public data sets and online surveys, researchers and research regulators have struggled with an array of ethical issues around the conduct of online research. This paper presents a discussion and findings from Buchanan and Ess's study on US-based institutional review boards and the state of internet research ethics.

This paper addresses a certain lacuna in moral theological reflec­tion. An institutional review board (IRB) reviews research on human subjects and so represents the institution’s ethical review mechanism for research. The author argues that if an IRB approves a research project that is immoral, it thereby implicates the institution in formal cooperation. The author also argues that numerous ethical concerns are created by current research enterprises—concerns that extend beyond the “usual suspects” of embryonic stem cell research and (...) research using cell lines of illicit origin. The author describes these more subtle issues and shows how IRBs at Catholic hospitals can navigate them. National Catholic Bioethics Quarterly 11.2 (Summer 2011): 257–266. (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)

The community representative plays a very important role in an institutional review board but there is sparse data about their understanding of their role in an IRB. This study was conducted to assess perceptions of community members serving on IRBs of one region in India. A validated questionnaire was administered to community members of IRBs in a prospective cross-sectional study. The questions related to demography, perceptions of their role in the IRB, experiences while serving on the IRBs, difficulties (...) faced by them, and suggestions to improve their contributions. Of the 56 IRBs contacted, all 15 of the public institutions shared details of their community members, while only 26 of the 41 IRBs of private institutions responded. When questioned about why they joined the IRB, one third of the respondents said either that there was “no specific reason” for joining or that they accepted the invitation to serve on the insistence of other members of the IRBs or the head of their institution. All except one felt that community members were needed for optimal functioning. Six participants said that they did not review informed consent documents, and 10 were unaware that their presence was vital for quorum to be met. Twenty-eight said they participated actively in meetings and did not feel intimidated by the presence of clinicians. Twelve reported difficulties in understanding medical terminologies in ICDs. Although the majority of participants were aware about their role in an IRB, some did not review important documents such as ICDs. Restricted participation by private hospital IRBs was a striking observation in our study. There is a need to define eligibility criteria and develop targeted training modules for community members to ensure their effective contribution to effective oversight of clinical research. (shrink)

The concepts of informed consent and surveillance of human research designed to protect human subjects is commendable. The regulations of the Institutional Review Board are having a major impact on clinical cancer research. There is greater administrative time needed of the investigator, the mechanisms of patient care have become cumbersome and some patients reject optional medical management that could be life saving. IRB regulations must be flexible to meet the needs of human subjects as well as those of (...) the clinical investigator. (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)