- New
-
Topics
- All Categories
- Metaphysics and Epistemology
- Value Theory
- Science, Logic, and Mathematics
- Science, Logic, and Mathematics
- Logic and Philosophy of Logic
- Philosophy of Biology
- Philosophy of Cognitive Science
- Philosophy of Computing and Information
- Philosophy of Mathematics
- Philosophy of Physical Science
- Philosophy of Social Science
- Philosophy of Probability
- General Philosophy of Science
- Philosophy of Science, Misc
- History of Western Philosophy
- Philosophical Traditions
- Philosophy, Misc
- Other Academic Areas
- Journals
- Submit material
- More
Shortcomings of protocols of drug trials in relation to sponsorship as identified by Research Ethics Committees: analysis of comments raised during ethical review
BMC Medical Ethics 15 (1):83 (2014)
Abstract
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 trialsLinks
PhilArchive
External links
(no proxy)
Setup an account with your affiliations in order to access resources via your University's proxy server
Through your library
- Sign in / register and customize your OpenURL resolver
- Configure custom resolver
My notes
Similar books and articles
Participants’ awareness of ethical compliance, safety and protection during participation in pharmaceutical industry clinical trials: a controlled survey.Gerardo González-Saldivar, René Rodríguez-Gutiérrez, Jose Luis Viramontes-Madrid, Alejandro Salcido-Montenegro, Neri Alejandro Álvarez-Villalobos, Victoria González-Nava & José Gerardo González-González - 2019 - BMC Medical Ethics 20 (1):2.
The effect of study type on research ethics committees’ queries in medical studies.Saara M. Happo, Arja Halkoaho, Soili M. Lehto & Tapani Keränen - 2017 - Research Ethics 13 (3-4):115-127.
Performance of research ethics committees in Spain. A prospective study of 100 applications for clinical trial protocols on medicines.R. Dal-Re, J. Espada & R. Ortega - 1999 - Journal of Medical Ethics 25 (3):268-273.
Evaluating the work of ethical review committees: an observation and a suggestion.T. Harding & M. Ummel - 1989 - Journal of Medical Ethics 15 (4):191-194.
Clinical trials: two neglected ethical issues.A. Herxheimer - 1993 - Journal of Medical Ethics 19 (4):211-218.
The activity of French Research Ethics Committees and characteristics of biomedical research protocols involving humans: a retrospective cohort study. [REVIEW]Evelyne Decullier, Véronique Lhéritier & François Chapuis - 2005 - BMC Medical Ethics 6 (1):1-10.
Multicentre trials review process by research ethics committees in Spain: where do they stand before implementing the new European regulation?R. Dal-Re - 2005 - Journal of Medical Ethics 31 (6):344-350.
Surveying the Indian research ethics committee response to the COVID‐19 pandemic.Yashashri C. Shetty, Sudha Ramalingam, Paresh Koli, Karthikeyan Shanmugam & Rajmohan Seetharaman - forthcoming - Developing World Bioethics.
Are investigators’ access to trial data and rights to publish restricted and are potential trial participants informed about this? A comparison of trial protocols and informed consent materials.Peter C. Gøtzsche, Karsten J. Jørgensen, Mikkel Marquardsen, Michelle C. Ogden & Asger S. Paludan-Müller - 2021 - BMC Medical Ethics 22 (1):1-7.
Assessing the detection, reporting and investigation of adverse events in clinical trial protocols implemented in Cameroon: a documentary review of clinical trial protocols.Akoh Walter Ebile, Jerome Ateudjieu, Martin Ndinakie Yakum, Marceline Ngounoue Djuidje & Pierre Watcho - 2015 - BMC Medical Ethics 16 (1):1-9.
Analytics
Added to PP
2014-12-14
Downloads
44 (#351,290)
6 months
17 (#204,512)
2014-12-14
Downloads
44 (#351,290)
6 months
17 (#204,512)
Historical graph of downloads
Citations of this work
What are the most common reasons for return of ethics submissions? An audit of an Australian health service ethics committee.Caitlin Brandenburg, Sarah Thorning & Carine Ruthenberg - 2021 - Research Ethics 17 (3):346-358.
Evidence-Based Guidelines for Low-Risk Ethics Applicants: A Qualitative Analysis of the Most Frequent Feedback Made by Human Research Ethics Proposal Reviewers.Sarven S. McLinton, Sarah N. Menz, Bernard Guerin & Elspeth McInnes - forthcoming - Journal of Academic Ethics:1-24.
The effect of study type on research ethics committees’ queries in medical studies.Saara M. Happo, Arja Halkoaho, Soili M. Lehto & Tapani Keränen - 2017 - Research Ethics 13 (3-4):115-127.
References found in this work
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.
Consistency in decision making by research ethics committees: a controlled comparison.E. Angell, A. J. Sutton, K. Windridge & M. Dixon-Woods - 2006 - Journal of Medical Ethics 32 (11):662-664.
Clinical research projects at a German medical faculty: follow-up from ethical approval to publication and citation by others.A. Blumle, G. Antes, M. Schumacher, H. Just & E. von Elm - 2008 - Journal of Medical Ethics 34 (9):e20-e20.
Responses by four Local Research Ethics Committees to submitted proposals.G. Kent - 1999 - Journal of Medical Ethics 25 (3):274-277.
Terminating clinical trials without sufficient subjects.Lianne Damen, Frans van Agt, Theo de Boo & Frans Huysmans - 2012 - Journal of Medical Ethics 38 (7):413-416.
PhilPapers logo by Andrea Andrews and Meghan Driscoll.
This site uses cookies and Google Analytics (see our terms & conditions for details regarding the privacy implications). Use of this site is subject to terms & conditions.
All rights reserved by The PhilPapers Foundation
Server: philpapers-web-6686886f5-5pqs9 uwo