Step-By-Step Guide For Researchers

1. Before beginning a proposal, the researcher should know the definitions of research and human subject.

This tool from NIH can also help determine if the project qualifies as human subjects research as does this federal chart (Chart 1). If the research meets the definitions of human subjects and research, the researcher must submit the project for IRB review. Go to the Frequently Asked Questions to learn more. 

2. The researcher should complete a Collaborative Institutional Training Initiative (CITI) for ethics in research. Follow these Steps to CITI certification.

Student researchers must submit valid CITI certificates for both themselves and their faculty advisor (for "Social Research" or "Biomedical Research").

3. The researcher should check the SEU IRB Proposal Types Flowchart to determine which Application to submit (Exempt, Expedited, or Full Board Review).

For Exempt projects, see these federal charts (Charts 2-10) to check that the research meets the proper criteria. Then submit the IRB Exempt Application.

If the project does not qualify as Exempt, or if it is unclear, submit the IRB Expedited & Full Board Review Application. 

All supporting documentation (recruitment, consent, data collection measures, CITIs, etc.) can be uploaded at the bottom of the online applications. 

4. The researcher should use this IRB Submission Checklist to cross-check materials  before submission and avoid delays in approval.

5. The IRB determines the level of review required for the project.

The IRB Administrator will do an initial review of the materials and will email the researcher if the IRB needs corrections, clarifications, or missing information. After corrections are submitted, the project will be designated Exempt, Expedited, or Full Board Review based on the level of potential risk to participants.

6. The IRB reviews the proposal.

The proposal is assigned to IRB faculty reviewers who then check for the level of risk to subjects, focusing on certain parts of the application as required by federal regulations.

7. Faculty reviewers may approve the proposal, or request revisions.

If faculty reviewers decide the research protocols are thorough and sufficient, the researcher will receive an IRB Approval Letter signed by the IRB Chair. At that point, research may begin.

If faculty reviewers decide the proposal needs revisions, the IRB Administrator will email the researcher a Revisions Request Letter that will specify the requested changes. Researchers will follow the directions in the letter, highlighting any changes in the original documents before re-submission. The word REVISED must be included in the names of all re-submitted files. Revised documents will be sent as email attachments to IRB@stedwards.edu.

8. The IRB reviews the protocol again after revisions are received.

The IRB may then approve the project OR request further revisions as needed.

It is also possible that the IRB will grant Conditional Approval, meaning approval is contingent upon minor changes or additional required documentation that can be submitted later. These conditions would be explained in a Conditional Approval Letter.

9. The researcher receives an official IRB Approval Letter.

Approval for the research project expires one year after the date stated on the letter.

10. The researcher adds the IRB Protocol ID to relevant documentation (for Expedited or Full Board Review).

For non-exempt research, the Protocol ID needs to be added to the Consent Form and Recruitment documents before research begins. The researcher will also refer to this number in the subject line of all future communication with the IRB.

If the research is Exempt, there will be no Protocol ID number and those sections may be deleted.

11. If the researcher needs to make changes to the project while the research is in progress, they must submit an IRB Modifications Application.

12. If the research was designated Full Board Review, and data collection will extend beyond one (1) year, the researcher must submit an IRB Continuing Review Application at least 14 days before the study's expiration date.

If IRB approval expires, the researcher must suspend data collection until a new IRB Approval Letter is received with a date extension.

13. The researcher must securely store all research data and relevant documentation for a minimum of three (3) years after study completion, as required by law.

14. For planning purposes, review the information below regarding IRB approximate timelines. 

• Exempt: Reviewed by the IRB Chair and the IRB Administrator only. Researchers should plan between 10-14 days for approval.
• Expedited: Two IRB faculty reviewers are assigned. Researchers should plan between 14-21 days for approval.
• Full Board Review: These studies are reviewed by all voting IRB members, approximately 15 faculty. The Full Board only meets once a month during the school year and not at all during the summer. Researchers might have to wait 4-6 weeks to receive feedback. Check the Full Board Meeting Dates here. Researchers with Full Board proposals must submit AT LEAST fourteen (14) days in advance of a regularly scheduled meeting. In most cases, the researcher will receive IRB feedback shortly after the IRB meeting.