IRB submissions

Before you submit anything in Mentor, you will need to determine if your study is human subject research that requires IRB review.

Information and Resources

• IRB Guidance: Determining if Your Project is Human Subject Research
• Self Certification Tool for Quality Improvement and not Human Subject Research Projects
• IRBWorksheet: Determination of Human Subject Research Form
• OHRP Quality Improvement Activities FAQs

If you have questions, you can always contact IRB staff.

Ascension Wisconsin uses the Ascension National electronic IRB (eIRB) submission and review system. All human research projects, Humanitarian Use Devices (HUDs) and expanded access to investigational products, including single patient use must be submitted through the eIRB.

Emergency Use requests do not need to be submitted through the eIRB, though they can be entered if the user has an account.

Request an eIRB Account

All study team members must have a user account before beginning a submission or being added to a protocol.

1) Complete CITI Training (see CITI Guide)

• Save a pdf copy of the completion certificate

2) Email the following to the Ascension WI IRB office at IRB@Ascension.org

• a current CV/resume
• CITI completion certificate

3) Request an eIRB account

• Go to the eIRB at https://eirb.ascension.org
• Select “Create Account” on the left hand side
• Compete the information requested then click "Register" on the lower right hand side

4) Within 48 hours, you will receive an email with your login information.

• When you reset the password, note that it must be: at least 8 characters, contain 3 out of 4 (Lower Case, Upper case, Numbers, Spec. character) and cannot contain any part of user ID, First name, Last name or employer name.

Information and Resources

• IRB SOPs & Guidance
• FAQs below

IRB Forms & Templates

You can access all IRB Forms and Templates here, including: 

• Protocol Template
• IRB application and submission forms
• Consent form templates 

All protocols approved by the IRB are required to submit a continuing report to extend the IRB approval period, this is often required annually.
Investigators must also submit a final report to notify the IRB when an approved study is completed.

Information and Resources

• IRB SOPs & Guidance
• You can access all IRB Forms and Templates here, including the Continuing Report Site Supplement form 

Research problems, incidents or new information that involves risk or harm must be promptly reported to the IRB.

Examples include unanticipated problems involving risks to subjects or others, significant protocol deviations, possible serious or continuous noncompliance, subject incarceration, unresolved subject complaints, unanticipated adverse device effects and FDA labeling changes or withdrawal from market.

Information and Resources

• Mentor User Guide
• IRB SOPs & Guidance

• Current State (0:55)
• System View Summary (1:55)
• Workflow Map (0:54)
• Study Workspace: Introduction (0:47), Study Workspace (7:54)
• Inbox:   Introduction (2:31), My Inbox (9:28)

Videos-Submissions 

• Creating and Submitting a New Protocol (5:48)
• Creating and submitting a Continuing Review (3:45)
• Creating a Modification (3:34)
• Submitting Reportable New Information (RNI) (3:19) 
• Responding to Clarifications Required (2:44)
• Responding to Modifications Required (1:59)

User Guides

• AWRI  Researcher eIRB Implementation Tips Reference Guide
• Ascension eIRB Researcher Quick Reference Guide

• eIRB Guidance: Populating the SmartForm at first CR/MOD
• eIRB Guidance: Local Site Supplement
• ACRI Guidance for Requesting Microsoft Office Application
• ACRI Guidance for eIRB Email Notifications Marked as Spam

eIRB SmartForm (IRB application pages)

• eIRB SmartForm Application Sections (all questions expanded)
• Guidance for Completing the SmartForms

Local Site Supplement Forms

• WI Local Site Supplemental Application- New Study (w/subject interaction/intervention) 
• WI Local Site Supplemental Application- HUD, New and Continuing Review

• AWRI eIRB IRB Member Tips Reference Guide
• AWRI eIRB IRB Member Presentation Handout
• IRB Member Training Recorded Session
• Ascension eIRB Member Quick Reference Guide

Additional IRB Specific Videos (also see above)

• Meetings Shortcut
• RNI Committee Review (1:45)
• Completing a Designated (non-committee) Review (2:00)

Do I need to submit my project to the IRB?

Studies that meet the definition of Human Subject Research (see below) must be submitted to the IRB and must receive IRB approval BEFORE any study activities take place.

The IRB must also make certain administrative determinations, like if the institution is engaged in conducting research. Review the section above “Is your project Human Subject Research?” for more information.

What is the definition of Human Subject Research?

Research is defined in the federal regulations as "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge".

When an FDA-regulated drug, device or biologic is involved, it is also defined as "any experiment that involves a test article and one or more human subjects."

A human subject is defined in the federal regulations as "a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information". When an FDA-regulated drug, device or biologic is involved, it is also defined as "an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy individual or a patient.”

Human subject research must meet both of those definitions.

This OHRP chart may assist you in determining whether your study meets the definition of human subject.

Do I need to submit my quality improvement/assurance project to the IRB?

You do not need to submit quality improvement (QI) or assurance (QA) projects to the IRB if the project does not meet the definition of Human Subject Research (see above). However, it is sometimes difficult to determine whether or not the QI/QA project qualifies as human subject research.

Additionally, if you plan to share or publish the results of your QI project, many journals require an IRB determination letter stating that the project did not include human subject research.

Therefore, we strongly suggest that if you have any doubt or if you plan to publish the QI results, that you send your project to the IRB so they can make a QI determination BEFORE you begin the project.

The Ascension IRB has developed an online Self-Certification tool you can use to determine if your project qualifies as QI and does not require IRB review. For additional information, see “Is your project Human Subject Research?” section above.

I am developing case studies/series; do I need to submit my proposal to the IRB?

Most case studies or series do not require IRB review. Studies that use multiple case studies to draw conclusions that are applicable in a generalizable context, or to address a hypothesis, would meet the federal definition of human subject research and require review by the IRB office.

Even if you don’t need IRB review, you may still need to obtain a HIPAA authorization or HIPAA waiver for case studies. You can do this using the HIPAA Authorization Template or HIPAA authorization waiver request form in Mentor and submitting to the IRB. The IRB also serves as the HIPAA privacy board and grants HIPAA waivers for case studies.

If you want the IRB to determine whether your activity requires IRB review, you can complete the IRB Worksheet: Determination of Human Subject Research Form and submit it to the IRB for review, or you can contact the IRB staff for assistance.

I am not collecting any identifying information in my research project. Do I need to submit my proposal to the IRB for review?

Yes, if your research data collection involves accessing and viewing of identifiable information it is considered human subject research and would require IRB review, even if you do not record identifiers.

However, if your research project involves use of existing information collected from human participants (e.g., secondary datasets, existing biological samples), but there are no identifiers or links between identifiers and the data/samples, then the activity may not require IRB review.

If you want the IRB to determine whether your activity requires IRB review, you can complete the IRB Worksheet: Determination of Human Subject Research Form and submit it to the IRB for review, or you can contact the IRB staff for assistance.

What kinds of IRB review are there?

Types of IRB review include full board, expedited, and exempt review as well as administrative determinations.

• Full Board Review - Studies are reviewed by a fully-convened IRB committee. The Board discusses the study and makes a decision about the approval of the study. This type of review is carried out for studies greater than minimal risk to subjects or for minimal risk studies not qualifying for expedited review. Examples include studies about investigational new drugs or devices.
• Expedited Review - Studies are reviewed by a qualified member of the IRB. This member reviews the appropriate materials and consults with the PI if necessary to come to a decision about the approval of the study. This type of review is carried out for studies which involve minimal risk to subjects and fit into an expedited review category of research. Examples include studies that collect blood samples (of minimal amounts), survey research or chart review studies.
• Exempt Review - Studies are reviewed by a qualified member of the IRB. If a study fits into an exempt category of research outlined in the regulations and is low risk to subjects, the IRB will send a letter indicating the study qualifies for exemption will not need to go through expedited or full-committee review.
• Administrative Determinations - For projects that do not meet the definition of human subject research, the IRB may be required to make certain determinations. Examples of this include whether or not Ascension Wisconsin is engaged in conducting research or QI determinations.

What exactly does "exempt" mean?

"Exempt" is a kind of IRB review for certain human subject research that fits into exempt categories outlined in the federal regulations (at 45 CFR 46). In these specific cases, the IRB can determine the protocol as Exempt.

Exempt research is human subject research and the exempt status does not lessen the ethical obligations to subjects as articulated in the Belmont Report and in codes of professional conduct. Thus, depending on the circumstances, investigators performing exempt studies may need to make provisions to obtain informed consent, protect confidentiality, minimize risks, and address problems or complaints.

This OHRP chart may also assist you in determining whether your study qualifies for exempt review.

If my research qualifies as exempt, does this mean that I don't have to submit a protocol for review?

No. The Federal Regulations do make certain categories of research exempt from IRB review. However, it is Ascension Wisconsin's policy that the IRB office makes the determination about whether or not a project is exempt from IRB review.

In order to have a research project recognized as exempt, investigators will need to submit a Request for Exemption from IRB Review, along with other study related materials (e.g., consent forms, surveys, questionnaires, interview scripts/outlines, etc.). The IRB staff evaluates exemption requests and notifies investigators if their projects are eligible.

Exemption requests must be submitted through the Mentor eIRB system.

The significance of exempt status is that the research activity does not need to have continuing oversight by the IRB. However, if a change is made to the project, the investigator may need to consult with the IRB to determine if that change affects the eligibility of the research activity to continue to be exempt from IRB review and approval. The Researcher must also inform the IRB when the study is complete or terminated.

For additional information see the IRB SOP: Exemptions and the IRB Submission Guide - New Exempt Study.

When do I need to obtain IRB approval?

IRB approval is required BEFORE starting any data collection. This is very important. If you begin your research and start collecting data without prior IRB approval you risk not being able to use the data and would need to begin the collection process again.

When may I begin data collection for my study?

You must receive written approval from the IRB before beginning participant recruitment, data collection or data analysis. A notice will be sent to you via e-mail when your project has IRB approval.