Do I need to prepare an informed consent process if my project qualifies for Administrative Review (i.e., exempt status)?
In general, yes. Regardless of the review category, the IRB is responsible for ensuring that basic ethical principles (functionalized in the regulations) are abided by in all research. While the exempt designation means that a project does not require review by the convened IRB or by Subcommittee Review procedures, it does not mean that it is exempt from the sound ethical principles set forth in the Ethical Principles and Guidelines for the Protection of Human Subjects of Research (a.k.a., The Belmont Report) (i.e., respect for persons, beneficence, and justice). The expectation that the informed consent of research participants be obtained is based upon the Belmont principle of respect for persons. Obtaining the informed consent of participants is required in most circumstances. In short, simply qualifying for Administrative Review does not determine whether consent or documentation of consent can be waived. NIU policies allow for some flexibility in the inclusion of the required elem
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