Consensus standards for introductory e-learning courses in human participants research ethics

John R Williams; Dominique Sprumont; Marie Hirtle; Clement Adebamowo; Paul Braunschweiger; Susan Bull; Christian Burri; Marek Czarkowski; Chien Te Fan; Caroline Franck; Eugenjius Gefenas; Antoine Geissbuhler; Ingrid Klingmann; Bocar Kouyaté; Jean-Pierre Kraehenbhul; Mariana Kruger; Keymanthri Moodley; Francine Ntoumi; Thomas Nyirenda; Alexander Pym; Henry Silverman; Sara Tenorio

doi:10.1136/medethics-2013-101572

Consensus standards for introductory e-learning courses in human participants research ethics

J Med Ethics. 2014 Jun;40(6):426-8. doi: 10.1136/medethics-2013-101572. Epub 2013 Aug 19.

Authors

John R Williams¹, Dominique Sprumont², Marie Hirtle³, Clement Adebamowo⁴, Paul Braunschweiger⁵, Susan Bull⁶, Christian Burri⁷, Marek Czarkowski⁸, Chien Te Fan⁹, Caroline Franck¹⁰, Eugenjius Gefenas¹¹, Antoine Geissbuhler¹², Ingrid Klingmann¹³, Bocar Kouyaté¹⁴, Jean-Pierre Kraehenbhul¹⁵, Mariana Kruger¹⁶, Keymanthri Moodley¹⁷, Francine Ntoumi¹⁸, Thomas Nyirenda¹⁹, Alexander Pym²⁰, Henry Silverman²¹, Sara Tenorio²²

Affiliations

¹ Department of Medicine, University of Ottawa, Ottawa, ON, Canada.
² Institut de droit de la santé, Université de Neuchâtel, Neuchâtel, Switzerland.
³ Biotika, Montreal, Quebec, Canada.
⁴ Institute of Human Virology, Abuja, Nigeria West African Bioethics Training Program, Ibadan, Nigeria University of Maryland, Baltimore, Maryland, USA.
⁵ Office of Research Education, Miller School of Medicine, University of Miami, Miami, Florida, USA.
⁶ Centre for Tropical Medicine, University of Oxford, Oxford, UK.
⁷ Department of Medicines Research, Swiss Tropical & Public Health Institute, University of Basel, Basel, Switzerland.
⁸ Department of Internal Diseases and Endocrinology, Warsaw Medical University, Warsaw, Poland.
⁹ Institute of Law for Science and Technology, National Tsing Hua University, Hsinchu City, Taiwan.
¹⁰ AfricaBuild, Department Radiologie, Serv. Informatique médicale, Université de Genève, Geneva, Switzerland.
¹¹ Department of Medical History and Ethics, Medical Faculty of Vilnius University, Vilnius, Lithuania.
¹² Department of Radiologie, Serv. Informatique médicale, Université de Genève, Geneva, Switzerland.
¹³ European Forum for Good Clinical Practice, Brussels, Belgium.
¹⁴ Centre National de Recherche et de Formation sur le Paludisme, Ouagadougou, Burkina Faso.
¹⁵ HSeT Foundation, Epalinges, Switzerland.
¹⁶ Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, University of Stellenbosch, Tygerberg, South Africa.
¹⁷ Bioethics Unit, Centre for Medical Ethics and Law, University of Stellenbosch, Tygerberg, South Africa.
¹⁸ Congolese Foundation for Medical Research, Brazzaville, Republic of Congo.
¹⁹ European and Developing Countries Clinical Trials Partnership, Tygerberg, South Africa.
²⁰ KwaZulu-Natal Research Institute for TB and HIV, Nelson R. Mandela School of Medicine, Durban, South Africa.
²¹ Global Ethics Education Initiative, University of Maryland Medical Center, Baltimore, Maryland, USA.
²² Office of International Research Ethics, FHI360, Durham, North Carolina, USA.

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.

Keywords: Education/Programs; Policy Guidelines/Inst. Review Boards/Review Cttes.; Research Ethics.

Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Consensus Development Conferences as Topic*
Ethics, Research / education*
Human Experimentation / standards
Humans
Online Systems / standards*

Grants and funding

R25 TW007091/TW/FIC NIH HHS/United States