Results for 'Institutional Review Boards'

969 found
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  1.  36
    Institutional Review Board Use of Outside Experts: A National Survey.Kimberley Serpico, Vasiliki Rahimzadeh, Luke Gelinas, Lauren Hartsmith, Holly Fernandez Lynch & Emily E. Anderson - 2022 - AJOB Empirical Bioethics 13 (4):251-262.
    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 (...)
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  2.  21
    Defining institutional review board application quality: critical research gaps and future opportunities.Kimberley Serpico - 2024 - Research Ethics 20 (1):19-35.
    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 (...)
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  3.  23
    Institutional review boards: A flawed system of risk management.Simon N. Whitney - 2016 - Research Ethics 12 (4):182-200.
    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 (...)
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  4.  21
    Institutional review boards in Saudi Arabia: the first survey-based report on their functions and operations.Asim Khogeer, M. Zuheir AlKawi, Abeer Omar, Yasmin Altwaijri, Amani AlMeharish, Ammar Alkawi, Asma AlShahrani, Norah AlBedah & Areej AlFattani - 2023 - BMC Medical Ethics 24 (1):1-8.
    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 (...)
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  5.  57
    Institutional Review Board Approaches to the Incidental Findings Problem.Moira A. Keane - 2008 - Journal of Law, Medicine and Ethics 36 (2):352-355.
    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 (...)
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  6.  57
    Composition and capacity of Institutional Review Boards, and challenges experienced by members in ethics review processes in Addis Ababa, Ethiopia: An exploratory qualitative study.Yemisrach Zewdie Seralegne, Cynthia Khamala Wangamati, Rosemarie D. L. C. Bernabe, Bobbie Farsides, Abraham Aseffa & Martha Zewdie - 2022 - Developing World Bioethics 23 (1):50-58.
    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 (...)
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  7.  35
    Institutional review board: management and function.Elizabeth A. Bankert, Bruce G. Gordon, Elisa A. Hurley & Sharon P. Shriver (eds.) - 2022 - Burlington, Massachusetts: Jones & Bartlett Learning.
    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 (...)
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  8.  30
    Institutional Review Board (IRB): its role and responsibility in making research ethical.Abu Sadat Mohammad Nurunnabi - 2014 - Bangladesh Journal of Bioethics 5 (1):5-10.
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  9. Institutional Review Board assessment of risks and benefits associated with research.Ernest D. Prentice & Bruce G. Gordon - forthcoming - National Bioethics Advisory Commission 6705 Rockledge Drive, Suite 700, Bethesda, Maryland 20892-7979 Telephone: 301-402-4242• Fax: 301-480-6900• Website: Www. Bioethics. Gov.
     
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  10.  26
    Institutional Review Board: member handbook.Robert J. Amdur - 2021 - Burlington, Massachusetts: Jones & Bartlett Learning. Edited by Elizabeth A. Bankert.
    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 (...)
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  11.  23
    Institutional Review Board Oversight of Citizen Science Research Involving Human Subjects.David B. Resnik - 2019 - American Journal of Bioethics 19 (8):21-23.
    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...
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  12. Institutional Review Boards and Public Justification.Anantharaman Muralidharan & G. Owen Schaefer - 2022 - Ethical Theory and Moral Practice 26 (3):405-423.
    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 (...)
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  13. The institutional review board is an impediment to human research: the result is more animal-based research.Mark J. Rice - 2011 - Philosophy, Ethics, and Humanities in Medicine 6:12.
    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 (...)
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  14.  11
    Institutional Review Boards as an Instrument of Assessment: Research Involving Human Subjects in the U.S.Bradford H. Gray - 1978 - Science, Technology, and Human Values 3 (3):34-47.
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  15.  9
    Institutional Review Board Determinations.Bethany J. Spielman - forthcoming - Bioethics in Law.
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  16. The Institutional Review Board: Its Origins, Purpose, Function, and Future.C. R. McCarthy - 1998 - In David N. Weisstub (ed.), Research on human subjects: ethics, law, and social policy. Kidlington, Oxford, UK: Pergamon Press. pp. 301--317.
     
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  17.  26
    Institutional Review Boards (IRBs) Render “Coercion as Subjection” Implausible.Theodore Bania, Glenn Martin & Ilene Wilets - 2019 - American Journal of Bioethics 19 (9):58-60.
    Volume 19, Issue 9, September 2019, Page 58-60.
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  18.  20
    The Institutional Review Board: An Evolving Ethics Committee.Stuart E. Lind - 1992 - Journal of Clinical Ethics 3 (4):278-282.
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  19.  37
    The stipulations of one institutional review board: a five year review.R. A. Sansone - 2004 - Journal of Medical Ethics 30 (3):308-310.
    Objectives: This study was designed to explore the prevalence and types of stipulations required of investigators by the institutional review board of one institution over a five year period.Design: Stipulations to research proposals were documented from the minutes of the IRB meetings.Setting: Community hospital.Participants: IRB submissions.Main measurements: Number and type of IRB stipulations.Results: Nineteen research submissions were approved without any stipulations. For the remainder, the majority of stipulations related to consent forms .Conclusions: Consent forms appear to be at (...)
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  20. Contrasting institutional review boards with institutional ethics committees.Leonard H. Glantz - 1984 - In Ronald E. Cranford & A. Edward Doudera (eds.), Institutional ethics committees and health care decision making. Ann Arbor, Mich.: Health Administration Press.
     
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  21.  48
    Rethinking Local Institutional Review Board (IRB) Review at State Health Departments: Implications for a Consolidated, Independent Public Health IRB.David Perlman - 2012 - Journal of Law, Medicine and Ethics 40 (4):997-1007.
    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 (...)
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  22. Institutional review boards and human subjects research.Ccco Occcccocccoc Occccccooccccc Coco Occ Coo - 1984 - Bioethics Reporter 1 (1).
     
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  23.  99
    Victor Frankenstein’s Institutional Review Board Proposal, 1790.Gary Harrison & William L. Gannon - 2015 - Science and Engineering Ethics 21 (5):1139-1157.
    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, (...)
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  24.  26
    Catholic Hospitals, Institutional Review Boards and Cooperation.Stephen Napier - 2011 - The National Catholic Bioethics Quarterly 11 (2):257-266.
    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 (...)
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  25.  27
    Institutional review boards lack the moral legitimacy to reinterpret subpart D.Robert M. Nelson - 2008 - American Journal of Bioethics 8 (4):37 – 39.
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  26.  22
    A Survey of University Institutional Review Boards: Characteristics, Policies, and Procedures.Gregory J. Hayes, Steven C. Hayes & Thane Dykstra - 1995 - IRB: Ethics & Human Research 17 (3):1.
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  27.  42
    Towards a balanced approach to identifying conflicts of interest faced by institutional review boards.Sharon Kaur & Sujata Balan - 2015 - Theoretical Medicine and Bioethics 36 (5):341-361.
    The welfare and protection of human subjects is critical to the integrity of clinical investigation and research. Institutional review boards were thus set up to be impartial reviewers of research protocols in clinical research. Their main role is to stand between the investigator and her human subjects in order to ensure that the welfare of human subjects are protected. While there is much literature on the conflicts of interest faced by investigators and researchers in clinical investigations, an (...)
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  28.  45
    Views of the process and content of ethical reviews of hiv vaccine trials among members of us institutional review boards and south african research ethics committees.Robert Klitzman - 2007 - Developing World Bioethics 8 (3):207-218.
    ABSTRACTGiven the ethical controversies concerning HIV vaccine trials , we aimed to understand through an exploratory study how members of institutional review boards in the United States and research ethics committees in South Africa view issues concerning the process and content of reviews of these studies. We mailed packets of 20 questionnaires to 12 US IRB chairs and administrators and seven REC chairs to distribute to their members. We received 113 questionnaires . In both countries, members tended (...)
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  29.  20
    Perceptions and Experiences of Community Members Serving on Institutional Review Boards: A Questionnaire Based Study.M. S. Kuyare, Padmaja A. Marathe, S. S. Kuyare & U. M. Thatte - 2015 - HEC Forum 27 (1):61-77.
    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 (...)
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  30. Ethical Imperialism: Institutional Review Boards and the Social Sciences, 1965–2009.[author unknown] - 2010
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  31.  29
    How do 66 European institutional review boards approve one protocol for an international prospective observational study on traumatic brain injury? Experiences from the CENTER-TBI study.Marjolein Timmers, Jeroen T. J. M. van Dijck, Roel P. J. van Wijk, Valerie Legrand, Ernest van Veen, Andrew I. R. Maas, David K. Menon, Giuseppe Citerio, Nino Stocchetti & Erwin J. O. Kompanje - 2020 - BMC Medical Ethics 21 (1):1-14.
    Background The European Union aims to optimize patient protection and efficiency of health-care research by harmonizing procedures across Member States. Nonetheless, further improvements are required to increase multicenter research efficiency. We investigated IRB procedures in a large prospective European multicenter study on traumatic brain injury, aiming to inform and stimulate initiatives to improve efficiency. Methods We reviewed relevant documents regarding IRB submission and IRB approval from European neurotrauma centers participating in the Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury. (...)
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  32. Editorial: The Institutional Review Board.R. Hauptman - 2008 - Journal of Information Ethics 17 (1):3.
     
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  33.  80
    A comparison of journal instructions regarding institutional review board approval and conflict-of-interest disclosure between 1995 and 2005.Anne Rowan-Legg, Charles Weijer, J. Gao & C. Fernandez - 2009 - Journal of Medical Ethics 35 (1):74-78.
    OBJECTIVES: To compare 2005 and 1995 ethics guidelines from journal editors to authors regarding requirements for institutional review board (IRB) approval and conflict-of-interest (COI) disclosure. DESIGN: A descriptive study of the ethics guidelines published in 103 English-language biomedical journals listed in the Abridged Index Medicus in 1995 and 2005. Each journal was reviewed by the principal author and one of four independent reviewers. RESULTS: During the period, the proportion of journals requiring IRB approval increased from 42% (95% CI (...)
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  34. Ten Questions Institutional Review Boards Should Ask When Reviewing International Clinical Research Protocols.Daniel W. Fitzgerald, Angela Wasunna & Jean William Pape - 2003 - IRB: Ethics & Human Research 25 (2):14.
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  35.  47
    An open letter to institutional review boards considering northfield laboratories' polyheme® trial.Ken Kipnis, Nancy M. P. King & Robert M. Nelson - 2006 - American Journal of Bioethics 6 (3):18 – 21.
    At the time of this writing, a widely publicized, waived-consent trial is underway. Sponsored by Northfield Laboratories, Inc. (Evanston, IL) the trial is intended to evaluate the emergency use of PolyHeme®, an oxygen-carrying resuscitative fluid that might prevent deaths from uncontrolled bleeding. The protocol allows patients in hemorrhagic shock to be randomized between PolyHeme® and saline in the field and, still without consent, randomized between PolyHeme® and blood after arrival at an emergency department. The Federal regulations that govern the waiver (...)
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  36. Bureaucracies of mass deception : institutional review boards and the ethics of ethnographic research.with Raymond G. Devries - 2008 - In Charles L. Bosk (ed.), What would you do?: juggling bioethics and ethnography. Chicago: University of Chicago Press.
     
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  37.  58
    How US institutional review boards decide when researchers need to translate studies.Robert Klitzman - 2014 - Journal of Medical Ethics 40 (3):193-197.
    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 (...)
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  38. Internet research ethics and the institutional review board: current practices and issues.Elizabeth A. Buchanan & Charles M. Ess - 2009 - Acm Sigcas Computers and Society 39 (3):43-49.
    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.
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  39.  1
    Nonscientific Members of Institutional Review Boards.Joshua Cedric A. Gundayao, Julia Patrick Engkasan & Sharon Kaur - forthcoming - Asian Bioethics Review:1-16.
    Given ICH-GCP’s role in shaping IRB standards in most jurisdictions, clarifying the function and definition of nonscientific members is crucial. ICH-GCP 3.2.1 requires a nonscientific member but its definition focuses on who they are not rather than who they are, creating ambiguity and varied interpretations. This paper reviews the idea of nonscientific members of the IRB to understand their definitions and roles based on current literature. This is because, despite the ICH-GCP’s mandate, recent research is scarce. Our review identifies (...)
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  40.  14
    5 The Impact of Institutional Review Boards on Research.Bradford Gray & Robert A. Cooke - 1980 - Hastings Center Report 10 (1):36-41.
  41. First do no harm: Institutional Review Boards and behavioral health research.R. De Vries, Deborah De Bruin & Andrew Goodgame - 2004 - Ethics and Behavior 14 (3):351-368.
  42.  31
    Ethical Imperialism: Institutional Review Boards and the Social Sciences, 1965–2009 by Zachary M. Schrag.Sara R. Jordan - 2011 - The National Catholic Bioethics Quarterly 11 (4):814-817.
  43.  17
    Operational Characteristics of Institutional Review Boards in the United States.Genevieve L. Nesom, Iraklis Petrof & Tyler M. Moore - forthcoming - AJOB Empirical Bioethics:1-11.
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  44.  45
    A qualitative study of institutional review board members' experience reviewing research proposals using emergency exception from informed consent.K. B. McClure, N. M. Delorio, T. A. Schmidt, G. Chiodo & P. Gorman - 2007 - Journal of Medical Ethics 33 (5):289-293.
    Background: Emergency exception to informed consent regulation was introduced to provide a venue to perform research on subjects in emergency situations before obtaining informed consent. For a study to proceed, institutional review boards need to determine if the regulations have been met.Aim: To determine IRB members’ experience reviewing research protocols using emergency exception to informed consent.Methods: This qualitative research used semistructured telephone interviews of 10 selected IRB members from around the US in the fall of 2003. IRB (...)
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  45.  8
    Ethics and Citizen Participation in the uBiome Institutional Review Board Debate: Some Reflections on Social and Normative Analyses.Lorenzo Del Savio - 2018 - In Hauke Riesch, Nathan Emmerich & Steven Wainwright (eds.), Philosophies and Sociologies of Bioethics: Crossing the Divides. Dordrecht, Netherlands: Springer. pp. 65-75.
    uBiome offers a gut bacteria sequencing service to consumers to entice data donation. It aims to establish a genomic repository for microbiomics. In 2013, some bloggers worried that uBiome operations had not received any Institutional Review Board ethics approval. uBiome co-founders Richman and Apte replied by effectively arguing that crony research agencies hamper innovation by requiring cumbersome for-fee IRBs to so-called “citizen science” projects. The debate soon ascended from ethics to appropriate institutional design for research and innovation. (...)
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  46.  8
    Continuous improvement of the institutional review board at one completely online university: a transferable framework.Tara J. Lehan - 2020 - Perspectives: Policy and Practice in Higher Education 24 (4):131-135.
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  47.  23
    A commentary on Dr. Kennedy's perception of the impact of Institutional Review Boards on cancer research.Herman Wigodsky - 1984 - Journal of Bioethics 5 (1):33-40.
    The Institutional Review Board is a committee of the institution responsible for carrying out the institution's responsibilities for the protection of human research subjects. Since it is a local committee, most of the complaints about the IRB can be resolved locally provided it is borne in mind that the IRB is the champion not only of the human research subject but also of the investigator. National or regional cooperative research protocols present problems that are not insurmountable.
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  48.  81
    The evaluation of the risks and benefits of phase II cancer clinical trials by institutional review board (IRB) members: a case study.H. E. M. van Luijn - 2006 - Journal of Medical Ethics 32 (3):170-176.
    Objectives: There are indications that institutional review board members do not find it easy to assess the risks and benefits in medical experiments, although this is their principal duty. This study examined how IRB members assessed the risk/benefit ratio of a specific phase II breast cancer clinical trial.Participants and methods: The trial was evaluated by means of a questionnaire administered to 43 members of IRBs at six academic hospitals and specialised cancer centres in the Netherlands. The questionnaire addressed: (...)
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  49.  11
    Analysis of factors influencing the organizational capacity of Institutional Review Boards In China: a crisp-set Qualitative Comparative Analysis based on 107 cases.Chanjuan Liu, Bojing Liu, Shuwen Shi & Lu Lu - 2023 - BMC Medical Ethics 24 (1):1-11.
    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 (...)
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  50.  54
    Ethical international research on human subjects research in the absence of local institutional review boards.S. B. Bhat - 2006 - Journal of Medical Ethics 32 (9):535-536.
    International health-related research on human subjects entails unique ethical responsibilities and difficulties. Often, these difficulties are augmented by the lack of a local ethical review infrastructure. In a recent cross-national study conducted by us, three critical components of ethical regulation were identified—external oversight, local oversight and subject involvement—and integrated into the study design. These three concepts are outlined and established as an important aspect of ensuring ethical coherence in the local context, particularly when reviews by the local institutional (...)
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