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IRB Prologue and General Policies

Prologue

The following is an online guide presenting the reasons and processes for the protection of human subjects in research at UW – Eau Claire. This guide is written in the spirit of U. S. Department of Health and Human Services (HHS) Code of Federal Regulations (45 CFR 46), describing our local application of the federal regulations.

These UW-Eau Claire policies and procedures have been established to protect the rights and welfare of human subjects utilized in research projects. Safeguarding human subjects is a critical step in the research process in order to protect not only the subject, but also the investigator, the sponsor, and the institution. In accordance with federal, state, and University regulations, these policies and procedures are implemented by the Institutional Review Board for the Protection of Human Subjects (IRB). The IRB follows specific federal definitions for research (a systematic investigation designed to contribute to generalizable knowledge) and human subject (a living individual about whom an investigator obtains identifiable private information or data through interaction) as outlined in  45 CFR 46.102.

General Policies

Any research project that involves human subjects conducted by UW-Eau Claire faculty, staff, or students must be reviewed and approved by the UW-Eau Claire IRB before any data is collected. During the review process, the IRB asks the following questions:

  1. Will the rights and welfare of subjects be adequately protected?
  2. Will subjects be placed at risk? If so, will any risks be outweighed by the benefits to the subject and the knowledge to be gained from the study?
  3. Will legally effective and ethically appropriate informed consent be secured from subjects?
  4. Will the protocol meet all standards established by the federal government and University guidelines, including those pertaining to special populations such as minors, pregnant women, and prisoners?
  5. Is the research scientifically sound such that valid conclusions can be reached?

The above questions are written in the spirit of 45 CFR 46.111.

Next: Three Types of Review

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