Education of research ethics for clinical investigators with Moodle tool

BMC Medical Ethics

Tapani Keränen²  Kirsi Luoto⁴  Ville Leinonen¹  Mari Matveinen⁴  Arja Halkoaho³ 

[1] Institute of Clinical Medicine University of Eastern Finland, Kuopio, Finland;Department of Neurology, Kanta-Häme Central Hospital, Hämeenlinna, Finland;Research Ethics Committee/Science Service Center, Kuopio University Hospital, P.O BOX 100, Kuopio FI-70029 KYS, Finland;Science Service Center, Kuopio University Hospital, P.O BOX 100, Kuopio FI-70029, KYS, Finland

关键词: Legislation;    Web learning;    Research ethics;    Bioethics;   

Others  :  799623
DOI  :  10.1186/1472-6939-14-53

 received in 2013-09-16, accepted in 2013-12-10,  发布年份 2013

【 摘 要 】

Background

In clinical research scientific, legal as well as ethical aspects are important. It is well known that clinical investigators at university hospitals have to undertake their PhD-studies alongside their daily work and reconciling work and study can be challenging. The aim of this project was to create a web based course in clinical research bioethics (5 credits) and to examine whether the method is suitable for teaching bioethics. The course comprised of six modules: an initial examination (to assess knowledge in bioethics), information on research legislation, obtaining permissions from authorities, writing an essay on research ethics, preparing one’s own study protocol, and a final exam. All assignments were designed with an idea of supporting students to reflect on their learning with their own research.

Methods

57 PhD-students (medical, nursing and dental sciences) enrolled and 46 completed the course. Course evaluation was done using a questionnaire. The response rate was 78%. Data were analyzed using quantitative methods and qualitative content analysis.

Results

The course was viewed as useful and technically easy to perform. Students were pleased with the guidance offered. Personal feedback from teachers about students’ own performance was seen advantageous and helped them to appreciate how these aspects could be applied their own studies. The course was also considered valuable for future research projects.

Conclusions

Ethical issues and legislation of clinical research can be understood more easily when students can reflect the principles upon their own research project. Web based teaching environment is a feasible learning method for clinical investigators.

【 授权许可】

   
2013 Halkoaho et al.; licensee BioMed Central Ltd.

【 参考文献 】

• [1]WMA: Declaration of Helsinki. 2013. http://www.wma.net/en/30publications/10policies/b3/ webcite read 12.12.2013
• [2]Steneck NH: Research ethics. Global research integrity training. Science 2013, 340:552-553.
• [3]Medical Research Act. http://www.finlex.fi/en/laki/kaannokset/1999/en19990488?search[type] = pika&search[pika] = medical%20research webcite, read 20082013
• [4]Veerus P, Lexchin J, Hemminki E: Legislative regulation and ethical governance of medical research in different European Union countries. J Med Ethics 2012. doi:10.1136/medethics-2012-101282
• [5]Olson LE: Developing a framework for assessing responsible conduct of research education programs. Sci Eng Ethics 2010, 1:185-200.
• [6]Barnes BE, Friedman CP, Rosenberg JL, Russell J, Beedle A, Levine AS: Creating an infrastructure for training in the responsible conduct of research: The University of Pittsburgh’s experience. Acad Med 2006, 81:119-127.
• [7]Braunschweiger P, Goodman KW: The CITI program: an international online resource for education in human subjects protection and the responsible conduct of research. Acad Med 2007, 82:861-864.
• [8]DuBois JM, Dueker JM, Anderson EE, Campbell J: The development and assessment of an NIH-funded research ethics training program. Acad Med 2008, 83:596-603.
• [9]Williams JR, Sprumont D, Hirtle M, Adebamowo C, Braunschweiger P, Bull S, Burri C, Czarkowski M, Fan CT, Franck C, Gefenas E, Geissbuhler A, Klingmann I, Kouyaté B, Kraehenbhul J-P, Kruger M, Moodley K, Ntoumi F, Nyirenda T, Pym A, Silverman H, Tenorio S: Consensus standards for introductory e-learning courses in human participants research ethics. J Med Ethics 2013. doi:10.1136/medethics-2013-101572
• [10]Mijaljica G: Medical ethics, bioethics and research ethics education perspectives in South East Europe in graduate medical education. Sci Eng Ethics 2011., 23doi:10.1007/s11948-013-9432-9
• [11]Carrese JA, McDonald EL, Moon M, Taylor HA, Khaira K, Beach MC, Hughes MT: Everyday ethics in internal medicine resident clinic: An opportunity to teach. Med Educ 2011, 45:712-721.
• [12]Kalichman MW: Responding to challenges in educating for the responsible conduct of research. Acad Med 2007, 82:870-875.
• [13]Kuusisto H, Virkki M, Wuolijoki E, Keränen T: Hospital training program increases awareness of Good Clinical Practice (GCP). Contemp Clin Trials 2011, 32:339-341.
• [14]Carley S, Mackway-Jones K: Developing a virtual learning course in emergency medicine for F2 doctors. Emerg Med J 2007, 24:525-528.
• [15]Seluakumaran K, Jusof F, Ismail R, Husain R: Integrating an open-source course management system (Moodle) into the teaching of a first-year medical physiology course: A case study. Adv Physiol Educ 2011, 35:369-377.
• [16]Carvalho A, Areal N, Silva J: Students’ Perceptions of blackboard and moodle in a Portuguese university. Br J Educ Technol 2011, 42:824-841.
• [17]Defta CL: Security issues in e-learning platforms. WJET 2011, 3:13-167.
• [18]Aggarwal R, Gupte N, Kass N, Taylor H, Ali J, Bhan A, Aggarwal A, Sisson SD, Kanchanaraksa S, McKenzie-White J, McGready J, Miotti P, Bollinger RC: A comparison of online versus on-site training in health research methodology: a randomized study. BMC Med Educ 2011, 17(11):37.
• [19]Malterud K: Qualitative research: Standards, challenges, and guidelines. Lancet 2001, 358:483-488.
• [20]Elo S, Kyngäs H: The qualitative content analysis process. J Adv Nurs 2007, 62:107-115.
• [21]Ellaway R, Masters K: 2.AMEE Guide 32: e-Learning in medical education Part 1: Learning, teaching and assessment. Med Teach 2008, 30:455-473.
• [22]Nunez JC, Cerezo R, Bernardo A, Rosario P, Valle A, Fernandez E, Suarez N: Implementation of training programmes in self-regulated learning strategies in Moodle format: Results of an experience in higher education. Psicothema 2011, 23:274-281.