What This Document Is
This guide provides comprehensive information surrounding the crucial process of obtaining informed consent in research, specifically within the field of Human Factors Engineering. It’s designed as a resource for researchers navigating the ethical and regulatory requirements of studies involving human participants at Wright State University. It functions as an addendum to the university’s broader Institutional Review Board (IRB) guidelines.
Why This Document Matters
This resource is essential for anyone involved in conducting research with human subjects – students, faculty, and research staff within the HFE 734 course and beyond. It’s particularly valuable when initially designing a research study and drafting the necessary documentation for IRB review. Understanding the principles outlined here is vital for ensuring participant rights are protected and research is conducted ethically and in compliance with federal regulations, including those related to HIPAA. It will help you prepare for submitting your research proposals.
Common Limitations or Challenges
This guide focuses on the *structure* and *principles* of consent documentation. It does not provide pre-written consent forms ready for immediate use. While sample formats are referenced, they serve as templates requiring significant customization based on the specifics of your research. It also assumes a foundational understanding of research ethics and IRB processes; it’s not a substitute for formal training on these topics.
What This Document Provides
* A detailed overview of the core principles underpinning informed consent.
* A breakdown of the essential elements that *must* be included in a consent document.
* A suggested structure and outline for creating a clear and effective consent form.
* Specific guidance on composing cover letters to accompany consent forms.
* Appendix materials including standard consent form formats for different types of studies (biomedical and minimal risk).
* Information regarding HIPAA compliance and the handling of protected health information.
* A list of identifiers to be mindful of when dealing with sensitive data.
