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Completing the OneAegis Application

Access to OneAegis requires registration with your BYU credentials. Click the login button on the top right of this page, and see here for more account information.

OneAegis uses smart form logic: The New Study application is composed of a number of sections. Within some of these sections are “branching” questions which will trigger the display or repression of additional sections depending on they are answered.

To save information in the application, click the “Save For Later” button found at the bottom of the screen. You must click the save button; the information is not automatically saved.

Submissions Review Process

The IRB ensures that appropriate safeguards exist to protect the rights and welfare of research subjects (45 CFR 46.111).

The IRB will give proper consideration to:

  1. The risks to the subjects;
  2. The anticipated benefits to the subjects and others;
  3. The selection of subjects is equitable;
  4. The importance of the knowledge that may reasonably be expected to result;
  5. The informed consent process to be employed; and
  6. The confidentiality of data and privacy of subjects.

The IRB has the authority to approve, require modifications to secure approval, and disapprove all research activities overseen and conducted by the organizations. The IRB has the authority to suspend, place restrictions, or terminate approval of research activities that fall within its jurisdiction that are not being conducted in accordance with IRB requirements or that have been associated with serious harm to subjects. The IRB has the authority to observe or have a third party observe the consent process and/or the research if the IRB determines it to be indicated.

All projects that meet the federal definition of research with human subjects must be reviewed and approved, or receive an exempt determination, by an IRB prior to beginning the research. The IRB staff initially screens submissions to determine the completeness and the appropriate type of review. Submissions may be returned to the study team for changes before the review type is assigned. The review type may be reassessed at any time during the review process.

There are three types of review paths for an IRB application:

The Office for Human Research Protections [OHRP] provide decision charts to investigators and others to decide whether or not an activity involves human subjects and the appropriate review type.