All research which involves human subjects and which is conducted under the auspices of Augsburg University by its faculty, staff, or students is subject to Augsburg policy guidelines and IRB review.
In conformity with Federal Regulations and Augsburg policy, there are three separate avenues for review of research involving human subjects. The review status refers to the number of reviewers of each proposal, not the timing of the review.
Definition of minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests (46.102.i)
Full and Expedited Review. Proposals use the same IRB Application Form. Care should be given to early planning and rigorous scholarship when preparing an IRB Application. Step-by-step instructions and checklists within the application form must be followed scrupulously or the applicant risks rejection by the IRB.
Full IRB Review. Research involving more than minimal risk to the subject requires review by the full IRB using risk/benefit analysis. In general, research requiring Full review places the subject at greater than minimal risk. Full review means that the research protocol is read, discussed and voted upon by the full IRB. Most research using children or vulnerable populations requires review by the full IRB.
Expedited Review. Research involving no more than minimal risk and in which the only involvement of subjects will be in one or more of the categories defined by Federal Policy 46.110 requires review by the Chair and selected members of the IRB. See page ii of the IRB Full/Expedited form for eligibility criteria.
Exempt Review. Research of minimal or no risk as defined by Federal Policy 46.101b requires review by the IRB Chair only. In general, research which does not propose to disrupt or manipulate the normal life experiences of subjects, incorporate any form of intrusive procedures or sensitive topics, or involve deception will be exempt from full IRB review. Projects that involve more than very minimal risk and those that include any degree of deception do not qualify for Exempt status. Research involving children can be considered Exempt if: “research conducted in established or commonly accepted educational settings, involving normal educational practices… (2) involving the use of survey procedures, interview procedures or observation of public behavior [45 cfr 46.101(b)(2)].” See the IRB Exempt Review Application Form for eligibility criteria.
Please see application forms at the application forms page.
Important Note: Each applicant should submit one electronic copy of their application in PDF format to the chair for all 3 types of review. Student proposals must have an accompanying email from the faculty advisor sent to the IRB chair. The emails serve as an electronic signature.
Submissions are accepted on an on-going basis For Expedited and Exempt review. Allow three weeks for an initial decision on a proposal submitted for Expedited and Exempt review.
Submissions For FULL REVIEW are due by 12:00 p.m. on the due date per the schedule on the Application Deadline Page. Late submissions will be considered for the following meeting. Allow four weeks for an initial decision on a proposal submitted for Full review.
Revision of Proposals: Revisions to proposals which have been submitted and reviewed that require some additions or corrections should be completed as soon as possible.
Any questions regarding whether a particular study requires IRB approval should be directed to the current IRB Chair. Final determination will be made by the IRB Chair. Noncompliance with the policies and requirements of the IRB may lead to disciplinary action.
Guidelines for submission: Send an electronic copy of proposal to email@example.com.