Switch to: Citations

Add references

You must login to add references.
  1. How do we know that research ethics committees are really working? The neglected role of outcomes assessment in research ethics review.Carl H. Coleman & Marie-Charlotte Bouësseau - 2008 - BMC Medical Ethics 9 (1):6-.
    BackgroundCountries are increasingly devoting significant resources to creating or strengthening research ethics committees, but there has been insufficient attention to assessing whether these committees are actually improving the protection of human research participants.DiscussionResearch ethics committees face numerous obstacles to achieving their goal of improving research participant protection. These include the inherently amorphous nature of ethics review, the tendency of regulatory systems to encourage a focus on form over substance, financial and resource constraints, and conflicts of interest. Auditing and accreditation programs (...)
    Download  
     
    Export citation  
     
    Bookmark   33 citations  
  • Opening Closed Doors: Promoting IRB Transparency.Holly Fernandez Lynch - 2018 - Journal of Law, Medicine and Ethics 46 (1):145-158.
    Institutional Review Boards have substantial power and authority over research with human subjects, and in turn, their decisions have substantial implications for those subjects, investigators, and the public at large. However, there is little transparency about IRB processes and decisions. This article provides the first comprehensive taxonomy of what transparency means for IRBs — answering the questions “to whom, about what, and by what mechanisms?” It also explains why the status quo of nontransparency is problematic, and presents arguments for greater (...)
    Download  
     
    Export citation  
     
    Bookmark   10 citations  
  • The introduction of research ethics review procedures at a university in South Africa: review outcomes of a social science research ethics committee.Simeon E. H. Davies - 2020 - Research Ethics 16 (1-2):1-26.
    The research ethics committee is a key element of university administration and has gained increasing importance as a review mechanism for those institutions that wish to conduct responsible...
    Download  
     
    Export citation  
     
    Bookmark   6 citations  
  • Improving the process of research ethics review.Jeffrey Nyeboer & Stacey A. Page - 2017 - Research Integrity and Peer Review 2 (1).
    BackgroundResearch Ethics Boards, or Institutional Review Boards, protect the safety and welfare of human research participants. These bodies are responsible for providing an independent evaluation of proposed research studies, ultimately ensuring that the research does not proceed unless standards and regulations are met.Main bodyConcurrent with the growing volume of human participant research, the workload and responsibilities of Research Ethics Boards (REBs) have continued to increase. Dissatisfaction with the review process, particularly the time interval from submission to decision, is common within (...)
    Download  
     
    Export citation  
     
    Bookmark   8 citations  
  • Do research ethics committees identify process errors in applications for ethical approval?E. Angell & M. Dixon-Woods - 2009 - Journal of Medical Ethics 35 (2):130-132.
    We analysed research ethics committee (REC) letters. We found that RECs frequently identify process errors in applications from researchers that are not deemed “favourable” at first review. Errors include procedural violations (identified in 74% of all applications), missing information (68%), slip-ups (44%) and discrepancies (25%). Important questions arise about why the level of error identified by RECs is so high, and about how errors of different types should be handled.
    Download  
     
    Export citation  
     
    Bookmark   14 citations  
  • Ethical dilemmas in research in relation to ethical review: An empirical study.Gunnel Colnerud - 2014 - Research Ethics 10 (4):238-253.
    The aim of the present article is to contribute empirically derived knowledge about Swedish researchers’ experience of ethical problems, conflicts and dilemmas in their research practice in relation to the ethical vetting legislation and procedure. The study has been carried out using the critical incident technique, with researchers from various disciplines providing examples from their own research practice of problems relating to research ethics. The analysis of the researchers’ responses indicates three phenomena, partly in line with similar studies in other (...)
    Download  
     
    Export citation  
     
    Bookmark   8 citations  
  • The high costs of getting ethical and site-specific approvals for multi-centre research.Nicholas Graves, Brett G. Mitchell, Anne Gardner, Katie Page, Lisa Hall, Alison Farrington, Carla Shield, Megan J. Campbell & Adrian G. Barnett - 2016 - Research Integrity and Peer Review 1 (1).
    BackgroundMulti-centre studies generally cost more than single-centre studies because of larger sample sizes and the need for multiple ethical approvals. Multi-centre studies include clinical trials, clinical quality registries, observational studies and implementation studies. We examined the costs of two large Australian multi-centre studies in obtaining ethical and site-specific approvals.MethodsWe collected data on staff time spent on approvals and expressed the overall cost as a percent of the total budget.ResultsThe total costs of gaining approval were 38 % of the budget for (...)
    Download  
     
    Export citation  
     
    Bookmark   5 citations  
  • Shortcomings of protocols of drug trials in relation to sponsorship as identified by Research Ethics Committees: analysis of comments raised during ethical review.Marlies van Lent, Gerard A. Rongen & Henk J. Out - 2014 - BMC Medical Ethics 15 (1):83.
    Submission of study protocols to research ethics committees constitutes one of the earliest stages at which planned trials are documented in detail. Previous studies have investigated the amendments requested from researchers by RECs, but the type of issues raised during REC review have not been compared by sponsor type. The objective of this study was to identify recurring shortcomings in protocols of drug trials based on REC comments and to assess whether these were more common among industry-sponsored or non-industry trials.
    Download  
     
    Export citation  
     
    Bookmark   3 citations  
  • The research ethics review process and ethics review narratives.Maureen H. Fitzgerald, Paul A. Phillips & Elisa Yule - 2006 - Ethics and Behavior 16 (4):377 – 395.
    There is a growing body of literature on the research ethics review process, a process that can have important effects on the nature of research in contemporary times. Yet, many people know little about what the actual process entails once an application has been submitted for review. This lack of knowledge can affect researchers and committee members' responses to the review process. Based on ethnographic research on the ethics review process in 5 countries (Australia, Canada, New Zealand, the United States, (...)
    Download  
     
    Export citation  
     
    Bookmark   4 citations  
  • The effect of study type on research ethics committees’ queries in medical studies.Saara M. Happo, Arja Halkoaho, Soili M. Lehto & Tapani Keränen - 2016 - Research Ethics 13 (3-4):115-127.
    Background:Medical research involving human subjects must be evaluated by a research ethics committee before a study is initiated. However, knowledge of REC decision processes, particularly in relation to evaluating the risk–benefit balance in various study types, appears scant.Methods:The study protocols and records of a Finnish university hospital REC were surveyed for a time span of 5 years. All study procedures in each study plan were examined, and the studies were divided into clinical drug trials, clinical trials with medical devices, studies (...)
    Download  
     
    Export citation  
     
    Bookmark   1 citation  
  • What changes are there in decisions by the Wits Human Research Ethics Committee and in process errors by research applicants between 2003 and 2015? [REVIEW]Peter Cleaton-Jones - 2016 - South African Journal of Bioethics and Law 9 (2):66-68.
    Objective. A retrospective examination of numbers of applications, decision rates, and process errors in 2015 was done for comparison with earlier studies to understand current ethics secretariat workload. Methods. In December 2015 information from committee minutes of all the meetings in 2015 was collected to quantify change in application numbers and process errors. Statistical analysis used SAS for Windows. Statistical significance was set at p<0.05. Results. There were 809 new general research applications considered in 2015. Monthly approvals at first evaluation (...)
    Download  
     
    Export citation  
     
    Bookmark   2 citations