¶¥¼¶¹ú²úÊÓƵ

1. IRB review can be a lengthy process. 

Ideally, the researcher (also known as the "Principal Investigator" or PI) should plan 2-6 weeks in advance to receive IRB approval. See #15 for more specifics.

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

This  can help determine if the project qualifies as human subjects research, as does this  (Chart 1). If the research meets the definitions of human subjects and research, the researcher must submit the project for IRB review. All research that includes living, human subjects—including the use of secondary data with personally-identifiable information—requires IRB review.

Regarding secondary data, the IRB recognizes several datasets that do not require IRB approval, as they do not meet the federal definition of human subjects research. See this document for the full guidance and approved list.

3. The researcher is required to complete CITI training for ethics in research.

CITI certification requires a time commitment of several hours. Student researchers must submit valid CITI certificates for both themselves and their faculty advisor ("Social Research" or "Biomedical Research") as appropriate.

Follow this guide, , to sign up for the online courses.

4. After CITI certification, the researcher will prepare the supporting documentation for their IRB proposal.

Supporting documents include: recruitment wording, consent forms, copies of data collection measures, site permission letters, & CITI certificates. The IRB provides optional templates for some of the required documents, under the Templates tab. When preparing materials, use this to avoid delays in your proposal.

Supporting documents should be clearly written and free of grammar errors or typos. Student researchers who need assistance with a technical writing style should consult with their faculty advisor and allow proofreading of their materials. The SEU Writing Center is also available for appointments.

5. Once all documents are ready, the researcher will submit an online IRB Application.

Check the  to determine which application is most appropriate: Exempt, Expedited, or Full Board Review.

The online applications cannot be saved in progress, so downloadable, hard-copies are available for planning purposes under the Online Applications tab.

All supporting documents can be attached/uploaded to the bottom of the online applications. 

6. The IRB Chair determines the level of review required for the project.

The IRB Administrator will do an initial review of the proposal and will email the researcher if the IRB needs corrections, clarifications, or additional materials. The researcher will email individually corrected documents to IRB@stedwards.edu. The IRB Chair will then designate the project Exempt, Expedited, or Full Board Review based on the level of potential risk to participants. 

Student researchers are not eligible to conduct Full Board Review research. Students will modify their research protocols to minimize risk with help from their faculty advisors and the IRB.

7. The IRB reviews the proposal.

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

Relevant IRB policies referred to during the review process could include , , and considerations.

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

If faculty reviewers determine that the research protocols sufficiently minimize the risk to human subjects, 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 due to unclear or unmitigated risk factors, 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.

9. 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.

10. The researcher receives an official IRB Approval Letter.

Research approval extends for one year after the date stated on the letter.

11. 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. Those sections should state "IRB Exempt" research instead.

12. If the researcher needs to make changes to the project after IRB approval, they must submit an . 

All changes to the research protocols must be officially reviewed and approved by the IRB before implementing.

13. If the research was designated Full Board Review, and data collection will extend beyond one (1) year, the researcher must submit an 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 an extended approval date.

14. After the study concludes, the researcher is required by law to securely store all research data for a minimum of three (3) years.

The details of this long-term storage plan are required in the IRB Application. See the for more information.

SEU email and cloud servers such as Box & Google Drive are acceptable locations for secure, long-term storage of research data. Graduating SEU students can retain access to these databases by requesting an , which must be renewed yearly, or they may rely on their faculty advisor's SEU storage methods.

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

• Exempt Proposals: Reviewed by the IRB Chair and the IRB Administrator only. Researchers should plan between 10-14 days for approval.
• Expedited Proposals: Two IRB faculty reviewers are assigned. Researchers should plan between 14-28 days for approval.
• Full Board Review Proposals: 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. Full Board feedback could take between 4-6 weeks to receive. Check the Full Board Meeting Dates & Deadlines here. Researchers with Full Board proposals must submit as least fifteen (15) business days (M-F) in advance of a regularly scheduled meeting. In most cases, the researcher will receive IRB feedback the same day after the board meeting. Students are not eligible to conduct Full Board Review research. The faculty advisor must be the Principal Investigator (PI) for these type of projects.