scholarly journals Negotiating the Ethical Conduct of Educational Research in an Institutional Review Board Space: Perspectives from a University in Ethiopia

2019 ◽  
Vol 5 (1) ◽  
Author(s):  
Ashenafi Alemu
Keyword(s):  
Research Ethics ◽  
Educational Research ◽  
Ethical Issues ◽  
Behavioral Science ◽  
Institutional Review Board ◽  
Ethical Review ◽  
National Guidelines ◽  
African Countries ◽  
Institutional Review ◽  
Éthique De La Recherche

Some international researchers assume that there is a lack of ethical review of research in many countries of the Global South. However, numerous African countries have recently introduced local and national research ethics guidelines. This article unpacks how ethical reviews of research in education are negotiated in a higher education institution in Ethiopia. It employs a critical analytical lens to challenge some of the assumptions of Beaty’s (2010) Institutional Review Board (IRB) stakeholder model. The article begins with a discussion of the limitations inherent in the IRB model. Critical analyses of institutional documents and non-confidential, off-the-shelf IRB minutes are also conducted. The analysis shows that researchers within the medical and health sciences disciplines have well established organizational engagement when it comes to handling issues related to research ethics. However, the limited representation of the educational and social and behavioral science disciplines remains a challenge. Furthermore, ethical issues in conducting educational research are hardly addressed in the national guidelines for granting research ethics approval. This results in further marginalisation of the contributions of educational research to knowledge production. Certains chercheurs internationaux présument un manque de suivi éthique de la recherche dans plusieurs pays du Sud. Cependant, de nombreux pays d’Afrique ont récemment mis en place des recommandations au niveau local et national en ce qui concerne l’éthique de la recherche. Le présent article analyse comment le suivi éthique de la recherche en sciences de l’éducation est mené dans un établissement d’enseignement supérieur en Ethiopie. Adoptant un point de vue analytique critique, il remet en question certains présupposés du modèle de l’Institutional Review Board (IRB – comité d’éthique de la recherche) de Beaty (2010) basé sur la théorie des parties prenantes. L’article commence par considérer les limites du modèle de l’Institutional Review Board. Des analyses critiques sont également menées à partir de documents institutionnels et de comptes-rendus disponibles et non confidentiels de réunions de l’Institutional Review Board. Cette recherche démontre que les chercheurs en médecine et sciences de la santé ont des positions clairement établies et propres aux organismes auxquels ils appartiennent, qui leur permettent de faire face aux questions d’éthique de la recherche. Cependant, la sous-représentation des sciences de l’éducation, des sciences sociales et des sciences comportementales demeure problématique. De plus, les questions éthiques qui se posent dans la recherche en sciences de l’éducation sont à peine abordées dans les directives nationales qui permettent d’obtenir l’approbation du comité d’éthique de la recherche. Cela a pour conséquence d’éloigner un peu plus les contributions de la recherche en sciences de l’éducation de la production du savoir.

scholarly journals Ethics in Research

Management ◽  
2013 ◽  
Author(s):  
Edward Wray-Bliss
Keyword(s):  
Research Ethics ◽  
Business School ◽  
Ethical Issues ◽  
Significant Proportion ◽  
Research Process ◽  
Ethical Review ◽  
Management Research ◽  
Research Practices ◽  
Organization Studies ◽  
Institutional Review

When compared to a number of other areas of the social sciences—sociology and anthropology being perhaps the best examples—discussions and debates around research ethics in the field of management are quite limited, both in number and scope. This is likely the consequence of a number of interrelated factors. It may speak to issues of the constitution of management faculty, the frequent separation of the business school from other parts of the university, or the historic construction of what is considered to be the role of the business school and management research in society. For whatever other reasons it has occurred, one of the factors must be the relatively homogenous nature of the field of management and organization studies—a field dominated by positivist research and a broadly functionalist, managerial orientation. In any field of inquiry largely constituted by conventional epistemological and ontological approaches, assumptions about “normal science” emerge and the impetus to question and debate, or indeed to defend, the ethics of normalized research practices is diminished. For many, the field of research ethics in management remains a formal process of compliance, requiring little discussion or reflection; it is a process of following a predefined code and satisfying the ethical review committee or institutional review board of one’s institution. Understood thus, ethics in management research is seen as something akin to a hurdle to be overcome by requisite form filling at the start of a research project. This is a limited—and limiting—understanding of ethical issues in management research. As the contributions cited in this bibliography attest, issues of ethics span the entire research process—from conception, through execution, to publication, and beyond. Assumptions regarding the purpose and value of research constitute an ethical warrant, legitimizing the very conduct of research in the first place. Additionally, the constitution of the management academy itself and its process of publication, citation, and review raises a number of ethical issues and concerns. Finally, management scholarship that draws on explicitly critical theoretical traditions and nonpositivist or antipositivist research approaches has heightened the questioning of conventional research practices and assumptions—generating critiques and some defenses of research ethics in management. This article maps out a significant proportion of the work and resources in the management academy that engage with such issues and debates.

scholarly journals Institutional Review Board (IRB): its role and responsibility in making research ethical

2014 ◽  
Vol 5 (1) ◽  
pp. 5-10 ◽  
Author(s):  
Abu Sadat Mohammad Nurunnabi
Keyword(s):  
Institutional Review Board ◽  
Educational Activity ◽  
Systemic Review ◽  
Ethical Review ◽  
Institutional Research ◽  
Journal Articles ◽  
Research Strategies ◽  
Ethical Research ◽  
Roles And Responsibilities ◽  
Institutional Review

This is a review article prepared as a part of the assignment in the educational activity and training on research ethics titled “Ethical and Regulatory Aspects of Clinical Research” arranged by the Bangladesh Bioethics Society (BBS), Dhaka, Bangladesh, in collaboration with the Department of Bioethics of National Institutes of Health (NIH), Bethesda, Maryland, USA, through video conferencing between September 25 and November 13 of 2013. The search was confined to ‘Google’, ‘HINARI’ and ‘PubMed’ published articles. Besides, some guidelines on roles and responsibilities of Institutional Review Board (IRB) were taken into consideration. Key words used for searching were ‘institutional review board’, ‘ethical review committee’ and ‘ethical research’. A total of 18 journal articles and some guidelines were selected for this writing. The systemic review from the databases revealed some important discussions on research, ethical research, roles and responsibilities of IRB/ERC and its challenges, and national/institutional research strategies. DOI: http://dx.doi.org/10.3329/bioethics.v5i1.18442 Bangladesh Journal of Bioethics 2014 Vol.5(1): 5-10

scholarly journals 489 TWT-101: a phase 1 study of the novel HPK1 inhibitor CFI-402411 in patients with advanced cancer

2021 ◽  
Vol 9 (Suppl 3) ◽  
pp. A519-A519
Author(s):  
Omid Hamid ◽  
Johanna Bendell ◽  
Siqing Fu ◽  
Kyriakos Papadopoulos ◽  
Judy Wang ◽  
...  
Keyword(s):  
T Cells ◽  
T Cell ◽  
Research Ethics ◽  
Potent Inhibitor ◽  
Phase 1 ◽  
Institutional Review Board ◽  
Institutional Review ◽  
Research Ethics Board ◽  
Grade 3 ◽  
Advanced Tumors

BackgroundCFI-402411 is an orally available small molecule potent inhibitor of HPK1 (Hematopoietic progenitor kinase 1). T-cells are negatively-regulated at different junctures of cancer-immunity cycle by this regulatory kinase. HPK1, (also mitogen activated protein kinase kinase kinase kinase 1 (MAP4K1)) is a protein serine/threonine kinase predominantly expressed in hematopoietic cells. In T-cells, following T-cell receptor activation, HPK1 is recruited to the plasma membrane where it phosphorylates the adapter protein SH2 domain-containing leukocyte protein of 76 kDa (SLP-76), down-regulating signaling events required for T cell activation and proliferation. Selected for development based on its pharmacologic properties and preclinical activity in a variety of syngeneic cancer models and assays, with an IC50 = 4.0±1.3 nM, CFI-402411 is expected to relieve HPK1-mediated inhibition of T and B cells, facilitating an anti-tumor immune response.MethodsPhase 1, 3 + 3 design in patients. Patients have acceptable laboratory, other parameters for study entry. Single agent dose daily oral escalation cohort (A1) in advanced tumors, then dose expansion (A3) with biomarker backfill (A2) in select advanced tumors; combination with PD-1 Inhibitor (pembrolizumab) (B1, pembrolizumab eligible tumors with no prior grade >=3 related to CPI)) and expansion (B2, PD-1/PD-L1 naïve pembrolizumab eligible tumors). DLT defined as any grade >=3 toxicity in first cycle of therapy (21d cycles). Standard assessments for response per RECIST v1.1 or iRECIST. The starting dose level was 80mg.ResultsAt 10 June 2021 data is available for 12 patients from A1. Median age 61.5 years (range 33–73), 8 patients female, and 10 white. Diagnoses were pancreatic cancer, colorectal (3 pts), ovarian, basal cell, cholangiocarcinoma, sigmoid, salivary and breast cancer (1 pt). Six patients (50%) had 4 prior therapies, 1 patient (basal cell) had prior treatment with immune checkpoint inhibitor, pembrolizumab. Four doses studied: 80, 120, 180 and 270mg. TEAEs across all CTCAE grades, (in >2 patients) were diarrhea (6 patients), nausea (4 patients), dyspepsia (3 patients), fatigue (3 patients). No related grade 3–5 events, one immune related event (grade 1, weight loss). 3 grade 3 events all unrelated to study drug - pleural effusion, rash, thromboembolic event. Discontinuation due to disease progression was main reason (7 patients). PK and PD assessments will be updated at time of presentation.ConclusionsCFI-402411 is a potent inhibitor of HPK1 that is well tolerated with a manageable adverse event profile and dose escalations continue. Further safety and efficacy results will be presented at the meeting including additional cohorts if available.AcknowledgementsTreadwell Therapeutics thanks all sites, importantly their patients and their families.Trial RegistrationClinicalTrials.gov Identifier: NCT04521413Ethics ApprovalThis study obtained has obtained ethics approvals at multiple institutions globally including;USAWCG IRB - Western Institutional Review Board - MOD00002618 (Submission ID)IntegReview Institutional Review Board - N/AAdvarra Central IRB - SSU00130103IntegReview Institutional Review Board N/AAdvarra Central IRB - SSU00137751Advarra Central IRB - SSU00143275The University of Texas MD Anderson Cancer Center Institutional Review Board - 2020–0678 (IRB ID Number)Hong KongJoint Chinese University of Hong Kong - New Territories East Cluster Clinical Research Ethics Committee - 2020.367 (Ref Number)CanadaOntario Cancer Research Ethics Board - 3320 (Project ID)Health Research Ethics Board of Alberta, HREBA Cancer Committee - HREBA.CC-20–0504 (Ethics ID Number)South KoreaimCORE - Seoul National University Hospital Institutional Review Board - H-2012-094-1182 (IRB Number)National Cancer Institute Review Board - 2020–0525–0001 (Receipt Number)All participants gave informed consent before taking part in this clinical trial.

Ethical Issues in Social Influence Research

2015 ◽  
Author(s):  
Allan J. Kimmel
Keyword(s):  
Social Influence ◽  
Ethical Issues ◽  
Scientific Discipline ◽  
Ethical Review ◽  
Ethical Guidelines ◽  
Human Welfare ◽  
Ethical Decisions ◽  
Institutional Review ◽  
Ethical Review Process ◽  
Privacy And Confidentiality

Social influence researchers encounter a variety of ethical issues in the conduct of their investigations, including those involving deception, privacy, and confidentiality. Facing a growing array of ethical guidelines, governmental regulations, and institutional review, researchers are faced with decisions that often pit the search for scientific knowledge against human welfare. Ethical decisions pertaining to social influence research methodology can have an impact on research participants, organizations, the scientific discipline, and society in general. This chapter surveys ethical issues in the conduct of laboratory, field, online, and applied research; describes remedial efforts (e.g., debriefing) to mitigate adverse research effects; and considers the nature of the ethical review process.

Response

2000 ◽  
Vol 27 (1) ◽  
pp. 28-28
Author(s):  
David Wyatt Seal ◽  
Frederick R. Bloom ◽  
Anton M. Somlai
Keyword(s):  
Research Ethics ◽  
Applied Field ◽  
Ethical Dilemmas ◽  
Real Life ◽  
Field Research ◽  
Institutional Review Board ◽  
Board Governance ◽  
Practical Application ◽  
Multiple Strategies ◽  
Institutional Review

Lew Margolis’s commentary on our discussion of field dilemmas delineates the basic tenets of research ethics and presents the historical backdrop for Institutional Review Board governance of the conduct of scientific research. Margolis’s commentary also highlights two important points: (1) within broad boundaries, multiple strategies may exist for resolving ethical dilemmas, and (2) field judgments about the best strategy for resolving ethical dilemmas may sometimes appear less than optimal with hindsight. These emphases reinforce the critical need for continued dialogue about the practical application of research ethics in applied field settings. We further emphasize the importance of conducting this dialogue not only in community forums but in academic arenas. The professional expertise of field researchers often is derived from direct experience with or membership in the communities being studied. For academic discussion of research ethics to have real-life utility, it is essential that conceptual discussion be translated into discussion of these issues as they apply to real-life situations demanding real-life solutions. We invite others to continue this dialogue about the practical application of research ethics to dilemmas that have been encountered during the conduct of applied field research.

Ethical issues in phase I oncology research: a comparison of investigators and institutional review board chairpersons.

1992 ◽  
Vol 10 (11) ◽  
pp. 1810-1816 ◽  
Author(s):  
E Kodish ◽  
C Stocking ◽  
M J Ratain ◽  
A Kohrman ◽  
M Siegler
Keyword(s):  
Phase I ◽  
Ethical Issues ◽  
Institutional Review Board ◽  
Phase I Trials ◽  
Conducting Phase ◽  
Institutional Practice ◽  
Oncology Research ◽  
Institutional Review ◽  
Differences Of Opinion ◽  
Board Chairpersons

PURPOSE Phase I research trials assess the safety of agents never before administered to humans. In the field of oncology, this practice raises several important ethical questions. We examined the ethics of these trials by surveying phase I oncology investigators and institutional review board (IRB) chairpersons at major cancer research centers around the country. METHODS Questionnaires were mailed to 78 investigators and 47 chairpersons to obtain their views on the ethical propriety of conducting phase I oncology research, and on institutional practice regarding these trials. The response rate was 68% in each group. RESULTS The majority of each group reported that phase I oncology trials face no more scrutiny or resistance in their institution's IRB process than other research protocols. Nevertheless, IRB chairpersons were more likely than investigators to favor special procedural safeguards to protect subjects in phase I oncology trials. Nearly all respondents agreed that although actual medical benefit was very uncommon, most patients entered for a chance at a therapeutic effect. Investigators were more likely than chairpersons to report that patients obtained psychologic benefit from participation in phase I trials. CONCLUSION Although individual IRB chairpersons and oncology investigators may have important differences of opinion concerning the ethics of phase I trials, these disagreements do not represent a widespread area of ethical conflict in clinical research.

scholarly journals Negotiating Responsibility for Navigating Ethical Issues in Qualitative Research: A Review of Miller, Birch, Mauthner, and Jessop’s (2012) Ethics in Qualitative Research, Second Edition

2015 ◽  
Author(s):  
Michelle McCarron
Keyword(s):  
Qualitative Research ◽  
Research Ethics ◽  
Ethical Issues ◽  
Ethics Committees ◽  
Institutional Review Boards ◽  
Research Ethics Committees ◽  
The United Kingdom ◽  
Institutional Review ◽  
Technological Advances ◽  
Research Ethics Boards

Ethics in Qualitative Research (Miller, Birch Mauthner, & Jessop, 2012), now in its second edition, uses a feminist framework to present a variety of issues pertinent to qualitative researchers. Topics include traditional challenges for qualitative researchers (e.g., access to potential participants, informed consent, overlapping roles), as well as those that have garnered more attention in recent years, particularly with regard to uses and consequences of technological advances in research. The book is critical of committees whose function it is to review proposed research and grant research ethics approval (e.g., University Research Ethics Committees [URECs], Research Ethics Boards [REBs], and Institutional Review Boards [IRBs]). The authors of this book are situated within the United Kingdom. The editors take the position that ethics oversight by the researchers themselves is preferable and that such boards and committees are not well equipped to review qualitative research. A rebuttal to this position is presented within this review. Ethics in Qualitative Research provides a good overview of ethical issues that researchers face and is effective in merging theory with practice. It would be strengthened by avoiding the debate over URECs or by offering concrete suggestions for how URECs can improve their reviews of qualitative research.

scholarly journals Challenges and Best Practices in Ethical Review of Human and Organizational Factors Studies in Health Technology: a Synthesis of Testimonies

2020 ◽  
Vol 29 (01) ◽  
pp. 058-070
Author(s):  
Linda W. Peute ◽  
Valentina Lichtner ◽  
Melissa T. Baysari ◽  
Maria Hägglund ◽  
Juell Homco ◽  
...  
Keyword(s):  
Best Practices ◽  
Ethical Issues ◽  
Organizational Factors ◽  
Health Technology ◽  
The United States ◽  
Ethical Review ◽  
Human Beings ◽  
Institutional Review ◽  
Study Designs ◽  
Human And Organizational Factors

Summary Objective: Human and Organizational Factors (HOF) studies in health technology involve human beings and thus require Institutional Review Board (IRB) approval. Yet HOF studies have specific constraints and methods that may not fit standard regulations and IRB practices. Gaining IRB approval may pose difficulties for HOF researchers. This paper aims to provide a first overview of HOF study challenges to get IRB review by exploring differences and best practices across different countries. Methods: HOF researchers were contacted by email to provide a testimony about their experience with IRB review and approval. Testimonies were thematically analyzed and synthesized to identify and discuss shared themes. Results: Researchers from seven European countries, Argentina, Canada, Australia, and the United States answered the call. Four themes emerged that indicate shared challenges in legislation, IRB inefficiencies and inconsistencies, general regulation and costs, and lack of HOF study knowledge by IRB members. We propose a model for IRB review of HOF studies based on best practices. Conclusion: International criteria are needed that define low and high-risk HOF studies, to allow identification of studies that can undergo an expedited (or exempted) process from those that need full IRB review. Enhancing IRB processes in such a way would be beneficial to the conduct of HOF studies. Greater knowledge and promotion of HOF methods and evidence-based HOF study designs may support the evolving discipline. Based on these insights, training and guidance to IRB members may be developed to support them in ensuring that appropriate ethical issues for HOF studies are considered.

Qualitative research ethics on the spot

2015 ◽  
Vol 23 (4) ◽  
pp. 455-464 ◽  
Author(s):  
Christine Øye ◽  
Nelli Øvre Sørensen ◽  
Stinne Glasdam
Keyword(s):  
Qualitative Research ◽  
Informed Consent ◽  
Research Ethics ◽  
Ethical Issues ◽  
Ethical Dilemmas ◽  
Institutional Review Boards ◽  
Ethical Guidelines ◽  
Ethical Considerations ◽  
Institutional Review ◽  
Review Boards

Background: The increase in medical ethical regulations and bureaucracy handled by institutional review boards and healthcare institutions puts the researchers using qualitative methods in a challenging position. Method: Based on three different cases from three different research studies, the article explores and discusses research ethical dilemmas. Objectives and ethical considerations: First, and especially, the article addresses the challenges for gatekeepers who influence the informant’s decisions to participate in research. Second, the article addresses the challenges in following research ethical guidelines related to informed consent and doing no harm. Third, the article argues for the importance of having research ethical guidelines and review boards to question and discuss the possible ethical dilemmas that occur in qualitative research. Discussion and conclusion: Research ethics must be understood in qualitative research as relational, situational, and emerging. That is, that focus on ethical issues and dilemmas has to be paid attention on the spot and not only at the desktop.

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