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Consensus standards for introductory e-learning courses in human participants research ethics
  1. John R Williams1,
  2. Dominique Sprumont2,
  3. Marie Hirtle3,
  4. Clement Adebamowo4,5,6,
  5. Paul Braunschweiger7,
  6. Susan Bull8,
  7. Christian Burri9,
  8. Marek Czarkowski10,
  9. Chien Te Fan11,
  10. Caroline Franck12,
  11. Eugenjius Gefenas13,
  12. Antoine Geissbuhler14,
  13. Ingrid Klingmann15,
  14. Bocar Kouyaté16,
  15. Jean-Pierre Kraehenbhul17,
  16. Mariana Kruger18,
  17. Keymanthri Moodley19,
  18. Francine Ntoumi20,
  19. Thomas Nyirenda21,
  20. Alexander Pym22,
  21. Henry Silverman23,
  22. Sara Tenorio24
  1. 1Department of Medicine, University of Ottawa, Ottawa, ON, Canada
  2. 2Institut de droit de la santé, Université de Neuchâtel, Neuchâtel, Switzerland
  3. 3Biotika, Montreal, Quebec, Canada
  4. 4Institute of Human Virology, Abuja, Nigeria
  5. 5West African Bioethics Training Program, Ibadan, Nigeria
  6. 6University of Maryland, Baltimore, Maryland, USA
  7. 7Office of Research Education, Miller School of Medicine, University of Miami, Miami, Florida, USA
  8. 8Centre for Tropical Medicine, University of Oxford, Oxford, UK
  9. 9Department of Medicines Research, Swiss Tropical & Public Health Institute, University of Basel, Basel, Switzerland
  10. 10Department of Internal Diseases and Endocrinology, Warsaw Medical University, Warsaw, Poland
  11. 11Institute of Law for Science and Technology, National Tsing Hua University, Hsinchu City, Taiwan
  12. 12AfricaBuild, Department Radiologie, Serv. Informatique médicale, Université de Genève, Geneva, Switzerland
  13. 13Department of Medical History and Ethics, Medical Faculty of Vilnius University, Vilnius, Lithuania
  14. 14Department of Radiologie, Serv. Informatique médicale, Université de Genève, Geneva, Switzerland
  15. 15European Forum for Good Clinical Practice, Brussels, Belgium
  16. 16Centre National de Recherche et de Formation sur le Paludisme, Ouagadougou, Burkina Faso
  17. 17HSeT Foundation, Epalinges, Switzerland
  18. 18Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, University of Stellenbosch, Tygerberg, South Africa
  19. 19Bioethics Unit, Centre for Medical Ethics and Law, University of Stellenbosch, Tygerberg, South Africa
  20. 20Congolese Foundation for Medical Research, Brazzaville, Republic of Congo
  21. 21European and Developing Countries Clinical Trials Partnership, Tygerberg, South Africa
  22. 22KwaZulu-Natal Research Institute for TB and HIV, Nelson R. Mandela School of Medicine, Durban, South Africa
  23. 23Global Ethics Education Initiative, University of Maryland Medical Center, Baltimore, Maryland, USA
  24. 24Office of International Research Ethics, FHI360, Durham, North Carolina, USA
  1. Correspondence to Professor John R Williams, Department of Medicine, University of Ottawa, 825 Grenon Avenue, Unit 19, Ottawa, ON, Canada K2B 6G1; jrewms{at}yahoo.com

Abstract

This paper reports the results of a workshop held in January 2013 to begin the process of establishing standards for e-learning programmes in the ethics of research involving human participants that could serve as the basis of their evaluation by individuals and groups who want to use, recommend or accredit such programmes. The standards that were drafted at the workshop cover the following topics: designer/provider qualifications, learning goals, learning objectives, content, methods, assessment of participants and assessment of the course. The authors invite comments on the draft standards and eventual endorsement of a final version by all stakeholders.

  • Education/Programs
  • Policy Guidelines/Inst. Review Boards/Review Cttes.
  • Research Ethics

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