The following is the process for submitting an IRB proposal. Please contact the IRB Office with questions: IRB@stedwards.edu
1. Before beginning a proposal, the researcher should review the definitions of research and human subject.
This tool from NIH can also help determine if the project qualifies as human subjects research, as do these flow charts. If the research meets the definitions of human subjects and research, the researcher must submit the project for review by the IRB.
Go to the Frequently Asked Questions, Definitions subsection, to read more about the definitions.
If the project involves Scholarship of Teaching and Learning or a classroom project, please review the information in the Frequently Asked Questions, Faculty subsection.
2. All researchers involved with any human subjects research project must complete their Collaborative Institutional Training Initiative (CITI) ethics training.
Keep in mind that all human subjects research projects, including those that receive exempt review, require CITI certification.
Note: Student researchers must also request a copy of the up-to-date CITI certification from their faculty advisor.
3. The researcher determines whether or not their activity qualifies for exempt review using the charts available here, (charts 2-10). It the researcher believes that the project qualifies, they submit a Request for Exemption, linked here.
In addition to the Request for Exemption form, researchers also need to submit the research instrument, such as a survey or list of interview questions, and the CITI completion forms for all involved in the project.
4. If the project does not meet the criteria for exempt review, the researcher prepares an Expedited or Full Board IRB Proposal using the IRB Application Form.
In this step, the researcher completes the Application Form, which provides material needed for the IRB review. The researcher also prepares required documents to submit. Please note that every researcher must complete the form at this link as part of the IRB application. This IRB Application Checklist is available for researchers to use as a tool to check for completeness.
5. The researcher submits their Expedited or Full Board IRB Application Form and other required proposal materials via the
6. The IRB will determine the level of review required for the project.
The project may be given Expedited, Full Board, or Exempt status, based on the level of potential risk to participants. Read more about how the review levels and the types of risk terms are defined in the Frequently Asked Questions, Definitions and Research Subjects subsections.
7. The IRB reviews the proposal.
The IRB reviewers check for completeness, level of risk, and pay particular attention to certain parts of the application as required by federal regulations.
8. Reviewers may approve the proposal at this time or ask for revisions.
A researcher who receives a revision request will revise their previously submitted IRB Application Form. At the beginning of the document, the researcher will provide a summary of changes made, in response to the request for revision from the IRB. Researchers are asked to use track changes in Word, or otherwise highlight changes in the documents they submit in response to revision requests. Please also include the word Revised in names of all revised files, if applicable. These revised documents will be submitted by email to IRB@stedwards.edu.
9. After requested revisions are submitted, the IRB will review the protocol again.
Upon review of the revisions, the IRB may approve the project OR request further revisions as needed. It is also possible that the IRB will give approval conditional on some minor changes which would be listed in the approval letter.
10. When the proposal is approved, the researcher receives an approval letter, which expires after one year.
11. The researcher will add the protocol number, found in the approval letter, to their Informed Consent and Recruiting documents, and will also use this number in future communication with the IRB.
12. If the researcher needs to make changes to the project while the research is underway, they must submit a revision request to the IRB.
The Request for Revision of Personnel or Request for Continuing Review or Revision forms are available in the Forms and Template section of the IRB website.
13. If data collection will extend beyond 12 months, the researcher must submit a request for Continuing Review before the project ends.
Note that if IRB approval expires, the researcher must suspend data collection until a new IRB approval is in place.
14. When data collection has come to an end, the researcher must immediately submit a Study Closure Form.
15. The researcher retains documents such as informed consent and communication relevant to the project for a minimum of 3 years after completion.
For planning purposes, please review the below information about IRB review timelines.
*Expedited proposals: researchers should plan for roughly 20 business days to receive IRB feedback.
* Proposals that require full board review: Researchers may sometimes wait three-to-four weeks before the IRB meets to review. Since these are studies that pose a greater risk to participants, they are reviewed by all voting members. instead of by two reviewers, as is the case with expedited reviews. For projects that will require full board review, researchers must submit AT LEAST fourteen (14) days in advance of a regularly scheduled meeting- you can see Full Board Meeting Dates here. In most cases, the researcher will receive IRB feedback shortly after the IRB meeting.