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 conducting a project with living human subjects must complete and submit their Collaborative Institutional Training Initiative (CITI) ethics certificate. Step-by-step instructions to CITI certification are provided to SEU-affiliated researchers.
Student researchers must also request an up-to-date CITI certificate from their faculty advisor and submit to the IRB.
3. The researcher determines whether or not their study qualifies for Exempt Review using these charts (Charts 2-10). If the researcher believes that the project qualifies, they complete an online IRB Application for Research Exemption.
Within the application, CITI certificates for all researchers can be uploaded, plus any supporting materials as required based on the Exemption Charts (i.e. surveys or list of interview questions.) More guidance on IRB supporting documentation is provided at the bottom of the online application.
4. If the project does not meet the criteria for Exempt Review, the researcher prepares an IRB Application for Expedited or Full Board Review instead.
In this application, the researcher provides more extensive details about the project. The researcher also prepares required supporting documentation. All documentation is then attached to the IRB Online Submission Form. The IRB Application Checklist is a helpful resource to ensure completeness.
5. 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.
6. 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.
7. Reviewers may approve the proposal at this time or ask for revisions.
A researcher who receives a Revisions Request Letter will also receive a copy of their Application in Microsoft Word format, along with specific instructions on how/what needs revision. At the beginning of the Application, the researcher will provide a summary of changes made, in response to the specific revisions required from the IRB. Researchers will highlight any changes in the documents before resubmission and include the word REVISED in names of all revised files. These revised documents will be submitted by email to IRB@stedwards.edu.
8. After requested revisions are submitted, the IRB will review the protocol again.
After receiving 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.
9. When the proposal is approved, the researcher receives an IRB Approval Letter, which expires after one year.
10. The researcher will add the IRB Protocol ID number to their Consent Form and Recruitment documents, and will also use this number in future communication with the IRB.
11. If the researcher needs to make changes to the project while the research is in progress, they must submit an IRB Application for Revisions or Continuing Review.
12. If data collection will extend beyond 12 months, the researcher must submit an IRB Application for Revisions or Continuing Review before the project ends.
If IRB approval expires, the researcher must suspend data collection until a new IRB Approval Letter is received, extending the approval date.
13. The researcher retains documents such as the Consent Form 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: Two faculty reviewers will be assigned. Researchers should plan between 7-21 business days to receive IRB approval.
*Full Board Review proposals: Researchers may sometimes wait three-to-four weeks before the IRB committee meets to review. Since these are studies that pose a greater risk to participants, they are reviewed by all voting members. For projects that will require Full Board Review, researchers must submit AT LEAST fourteen (14) days in advance of a regularly scheduled meeting. Check the Full Board Meeting Dates here. In most cases, the researcher will receive IRB feedback shortly after the IRB meeting.