IRB submissions

All submissions to the IRB are completed and managed online through the IRB system called Mentor. 


Review the information and instructions for submitting projects by selecting topics to the right.


Contact IRB staff for assistance
IRB@ascension.org
414-465-3059 



IRB Office Hours
IRB staff have dedicated time where they are available:

Wed: 9-11am 
Jackie Kirchen; 414-465-3134

Thur: 12-2pm
Dee Burns; 414-465-3059




Before you Begin

  •   Is your project Human Subject Research?

    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

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

  •   Get a Mentor Account

    Mentor is IRB's electronic 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 Mentor.

    Emergency Use requests do not need to be submitted through Mentor.

    Request a Mentor Account
    If you don't already have an account in Mentor, you must request a user account before you can begin your submission. Before staff can be added to a study in Mentor, they must have an account. 

    Click here to request an account and complete your Mentor user profile.
    You can only use this online request if you have an email address from Ascension Wisconsin or common research affiliates (i.e. affiliated physician group, local academic institution). If you have a non-affiliated email address (or and email like like Gmail), complete this form instead.

    Information and Resources

IRB Submissions

  •   New Study Submission
    Information and Resources


    IRB Forms & Templates

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

    • Protocol Template
    • IRB application and submission forms
    • Consent form templates 
  •   Continuing Review and Study Closure
    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

     

  •   Changes to Research/ Amendments
    Any proposed changes to existing protocols must be reviewed by the IRB before they are implemented. The only exception to this requirement is a protocol deviation that may be necessary to eliminate an apparent immediate hazard to a given research subject, which must be reported to the IRB within 48 hours.

    Information and Resources

  •   New Information/ Reportable Events

    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

  •   IRB Reliance/ Single IRB Review
    For research projects that are being conducted at multiple sites, Investigators may request for a single IRB to conduct the IRB review for both institutions. For a single IRB review to occur, the IRBs must establish an IRB Reliance Agreement (IRA) so that one IRB can defer oversight to the other IRB. Requests for the AW IRB to rely on the review of another IRB are evaluated on a case-by-case basis. This evaluation focuses on all aspects of a study including, but not limited to: study procedures, level of risk, researcher history and experience, conflicts of interest not otherwise precluding ceding and funding.

    See the IRB Reliance page for details on IRB reliance and single IRB review.

FAQs 

  •   IRB Review Requirements

    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.

     

  •   Mentor Online Submission System

    What is Mentor?

    Mentor eIRB is the online submission and document management system used by the Ascension Wisconsin IRB. All research submissions must be completed online using the electronic IRB submission system Mentor.  Mentor can be accessed online from any device. 

    See the Mentor page for more information about getting access to and using Mentor.
  •   IRB Submission Process

    How do I submit a protocol to the IRB for review?

    All research submissions must be completed online using the electronic IRB submission system Mentor. Information and instructions are located on the Submission Process Web page.

    To access Mentor, you will need to request an account; review the “Get a Mentor Account” section above.

     

    What do I need to submit?

    The IRB needs to have enough information to make the determination that the research meets the regulatory criteria for approval, including minimizing risks to subjects and informed consent.

    What documents you submit varies slightly by study but will generally include a protocol, and IRB application form outlining how the study will be conducted locally, a consent form and HIPAA authorization (if not requesting ta waiver), data collection tools, recruitment advertisements or flyers, and questionnaires or surveys.

    If the study includes an investigational drug, device or biologic, you should also include the product information, like the Investigator’s Brochure, and supporting documentation form the FDA, including the IND/IDE/510(k) approval notice and form 1572.

    For studies that received a federal grant, the section of the grant application related to human subject research must also be submitted.

    You can view submission guides for new studies in Mentor.

     

    Can I get help with my submission?

    Yes. The IRB office staff strives to provide information and assistance to investigators and research staff throughout the submission process. We can answer any questions that you have about the IRB submission process, Mentor system or human subject research requirements.

    The IRB Chairs and research mentors are available on a limited basis to help with protocol development and statistical analysis on Investigator Initiated research projects. You can contact the IRB staff for more information.

    Our Research Education and Quality Management (REQM) specialists also provides services for researchers like study start up consultations to set up your research regulatory files or Investigator self-assessment reviews. (REQM) operates independently from the IRB and you can review the REQM tools and services here.

     

    Where can I get help with Mentor eIRB?

    Mentor eIRB training and assistance is offered to individuals on an ongoing basis. Contact the IRB staff with any questions or to schedule a training time.

    You can also refer to the Mentor User Guide and instructions on the submission forms.


    How long will it take for me to obtain approval to do my study?

    That depends on the type of study and the completeness of your submission. 

    Research projects that involve only minimal risks are eligible for expedited review and you should allow at least 2 weeks for IRB review from the time that the submission is complete. Research projects that involve greater than minimal risk to participants will need to go to the full board for review. The Wheaton IRB meets on the fourth Wednesday of every month. For applications requiring full board review, you should allow at least 4-6 weeks for review and approval of your study.