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Writing an Ethics Application

  • Gabriel B. ReedyEmail author
  • Jill S. Sanko
Chapter

Abstract

Ethical research practice should be the aim of all simulation researchers. However, this intention does not always translate into the successful completion of an ethics application. In this chapter, we discuss considerations for conducting ethical research in simulation, and the relationship between these principles and the requirements for ethical approval. We will also give practical advice about the common requirements of ethics panels and institutional review boards (IRBs), to enable you to proceed as smoothly as possible through the process of gaining ethical approval for your simulation study.

Keywords

Ethics Study protocol Ethical practice Ethical review Research ethics committees Human subjects Institutional review board (IRB) Institutional review board Consent Responsible researcher 

References

  1. 1.
    World Medical Association. World medical association declaration of helsinki: ethical principles for medical research involving human subjects. JAMA. 2013;310(20):2191–4.  https://doi.org/10.1001/jama.2013.281053.CrossRefGoogle Scholar
  2. 2.
    Resnik DB. What is ethics in research and why is it important? [Internet]. 2015. Available from: https://www.niehs.nih.gov/research/resources/bioethics/whatis/index.cfm
  3. 3.
    Maggio LA, Artino Jr AR, Picho K, Driessen EW. Are you sure you want to do that? Fostering the responsible conduct of medical edu- cation research. Acad Med. 2017.  https://doi.org/10.1097/ACM.0000000000001805.
  4. 4.
    Miles SH. The Hippocratic Oath and the ethics of medicine. Oxford: Oxford University Press; 2004.Google Scholar
  5. 5.
    Eva KW. Research ethics requirements for medical education. Med Educ. 2009;43:194–5.  https://doi.org/10.1111/j.1365-2923.2008.03285.x.CrossRefPubMedGoogle Scholar
  6. 6.
    ten Cate O. Why the ethics of medical education research differs from that of medical research. Med Educ. 2009;43:608–10.  https://doi.org/10.1111/j.1365-2923.2009.03385.x.CrossRefPubMedGoogle Scholar
  7. 7.
    The Belmont Report. Belmont report: ethical principles and guidelines for the protection of human subjects of research. 1979; Report of the national commission for the protection of human subjects of biomedical and behavioral research.Google Scholar
  8. 8.
    Pugsley L, Dornan T. Using a sledgehammer to crack a nut: clinical ethics review and medical education research projects. Med Educ. 2007;41:726–8.  https://doi.org/10.1111/j.1365-2923.2007.02805.x.CrossRefPubMedGoogle Scholar
  9. 9.
    Boileau O, Patenaude J, St-Onge C. Twelve tips to avoid ethical pitfalls when recruiting students as subjects in medical education research. Med Teach. 2018;40(1):20–5.  https://doi.org/10.1080/0142159X.2017.1357805.CrossRefPubMedGoogle Scholar

Additional Resources

  1. Collaborative Institutional Training Initiative (CITI) certification. https://about.citiprogram.org/en/homepage/.
  2. Family Educational Rights and Privacy Act (FERPA). https://www2.ed.gov/policy/gen/guid/fpco/ferpa/index.html.
  3. General Data Protection Regulation (GDPR). https://eugdpr.org.
  4. Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule and Research. https://privacyruleandresearch.nih.gov/clin_research.asp.
  5. The Belmont Report. https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html. ∗The Belmont Report is one of the leading publications on the ethics of healthcare research. This report helped to establish the fundamental principles we follow as healthcare researchers including: (a) respect for persons, (b) protection of autonomy, and (c) informed consent.
  6. United Kingdom National Health Service (NHS) Health Research Authority (HRA) Guidance on the General Data Protection Regulation. https://www.hra.nhs.uk/hra-guidance-general-data-protection-regulation/.

Copyright information

© Springer Nature Switzerland AG 2019

Authors and Affiliations

  1. 1.Faculty of Life Sciences and MedicineKing’s College LondonLondonUK
  2. 2.School of Nursing and Health StudiesUniversity of MiamiCoral GablesUSA

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