Writing an Ethics Application
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.
KeywordsEthics Study protocol Ethical practice Ethical review Research ethics committees Human subjects Institutional review board (IRB) Institutional review board Consent Responsible researcher
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- Collaborative Institutional Training Initiative (CITI) certification. https://about.citiprogram.org/en/homepage/.
- Family Educational Rights and Privacy Act (FERPA). https://www2.ed.gov/policy/gen/guid/fpco/ferpa/index.html.
- General Data Protection Regulation (GDPR). https://eugdpr.org.
- Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule and Research. https://privacyruleandresearch.nih.gov/clin_research.asp.
- Research Ethics Timeline (1939 – present). https://www.niehs.nih.gov/research/resources/bioethics/timeline/index.cfm.
- 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.
- 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/.