SEKESC-IRB Review Processes

Review Processes

The IRB ensures that appropriate safeguards exist to protect the rights and welfare of research subjects (45 CFR 46.111). In fulfilling these responsibilities, the IRB reviews all the research documents and activities that bear directly on the rights and welfare of the subjects of proposed research. The application or protocol, the consent/assent document(s), research equipment form, tests, surveys, questionnaires and similar measures, and recruitment documents are examples of documents that the IRB reviews.

Before any human subject is involved in research in relationship to this institution, the IRB will give proper considerations to:

1. The risks to the subjects;
2. The anticipated benefits to the subjects and others;
3. The importance of the knowledge that may reasonably be expected to result; and
4. The informed consent process to be employed.

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.

The Southeast Kansas Education Service Center fulfill their goals to protect human subjects and support the design and conduct of sound research by reviewing for approval IRB submissions: new applications, amendments to approved studies, and continuing reviews.

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 PI for changes before the review type is assigned. The review type may be reassessed at any time during the review process.

Determining whether your project is evaluation or research requiring an IRB can sometimes be confusing. For additional information in determining whether your project is evaluation or research requiring an IRB review, please see two helpful papers here: Taxonomy for Defining and Classifying UNICEF Research, Evaluation, & Studies, and Program Evaluation vs. Request. If you still have questions, please reach out to the IRB Chair at [email protected].