• Institutional Review Board (IRB)

     
    IMPORTANT NOTICE: Final Revisions to the Common Rule went into effect January 21, 2019. The Revised Common Rule is now in effect; Hamline’s IRB submission and review process has been updated.  More details and a summary of major changes.

    WHAT IS THE INSTITUTIONAL REVIEW BOARD?
    The purpose of the Hamline University Institutional Review Board is to protect the rights and safety of research participants and to facilitate research activities. All research projects involving human subjects must be submitted to the IRB prior to recruiting participants or beginning any data collection. Only Hamline faculty members can serve as principal investigators on a research protocol.  Use the link for more on Faculty Advisor ResponsibilitiesNoncompliance with the policies and requirements of the IRB and its associated federal regulations may lead to disciplinary action. 

    WHAT ARE THE TYPES OF IRB REVIEW?
    There are three types of IRB review: Exempt, Expedited, and Full Board. The review type under which an application falls is based on specific criteria outlined in federal guidelines.  While the researcher should indicate the type of review they believe best fits their application, the final determination of review type will be made by the IRB chair or designated IRB member. To determine if you need to submit an application for IRB review, use these decision trees.
    Exempt Review determination is defined by federal regulation 45CFR46.104. It does not mean investigators are "exempt" from having to submit an application or protocol details to the IRB.  More details...
    Expedited Review is defined by 45CFR 46.110.  It does not mean a quick or light review and includes seven specific expedited review categories.  More details... 
    To determine if your protocol is likely to be exempt or expedited, refer to these checklists:
        Checklist for exempt protocols 
        Checklist for expedited protocols
    Full Board Review is reserved for research that involves more than minimal risk to the subject and is determined following a review by the entire IRB committee.  More details...

    REVIEW TIMELINES 
    Exempt and Expedited Review applications require 2-3 weeks from the date of initial submission for review and notification of the IRB's decision.
    Full Board Review applications are reviewed monthly (the second Tuesday of each month) during the academic year.  Applications for full board review must be received one week prior to the monthly meeting date; late submissions will be considered at the following month's meeting.

    HOW TO SUBMIT AN APPLICATION
    1. All researchers must complete the Hamline IRB training before submitting an IRB protocol application. Please note that the training is in two sections: 1) the training presentation and 2) an addendum that covers the new 2019 Revised Common Rule changes, as well as the Hamline IRB submission process and requirements.  You must view the training presentation up to the 45 minute point, and then finish the training by reading the addendum slides.
    2. Complete an IRB Submission Form and upload required documents (outlined in the training module). All documents must be submitted as Word documents (to preserve formatting). Google Docs and PDFs will be rejected.
    Exempt Review Protocol Application
    Expedited Review Protocol Application
    Full Board Review Protocol Application
    Approved Protocol Amendment form (for changes to an already-approved protocol)
    Protocol Continuation or Closure form (for use with an already-approved protocol)
    3. Use one of the Consent Form Templates linked below.  The IRB will only approve use of a consent document that uses one of the templates below. Do not delete section headings or alter the order of the sections. If your protocol is approved, the IRB will insert the approval number and expiration date on your consent document for use in your study. Please note that for each template, instructions for completing the forms, as well as areas where specific information is needed, are highlighted in yellow.
    General Requirements for Informed Consent (45CFR46.116 and 117)
    Template: Informed Consent for research that involves physiological or biological testing 
    Template: Informed Consent for social science and related research  
    Template: Informed Consent for education research
    4. Email any requested revisions to IRB@hamline.edu. Failure to address all requested modifications will result in reject and a request for re-submission. 

    IRB MEMBERS
    The following individuals comprise the current Hamline University IRB: 
    IRB Chair: Lisa Stegall (term ends August 2019); Kathy Thomsen (term ends June 2020)
    Social Science: Erik Asp (term ends June 2021); Gina Erickson (sabbatical for 2019-20; term ends June 2023)
    Business: Jae Lee (term ends June 2020)
    External member: Anthony Clapp (term ends June 2021)
    Natural ScienceJen Robb (sabbatical for Spring 2020; term ends June 2021)
    Education: LeeAnn Godfrey (term ends June 2020); Betsy Parrish (term end June 2021)