• Institutional Review Board (IRB)

    MISSION STATEMENT

    The mission of the Institutional Review Board (IRB) at Hamline University is to promote ethical and responsible research involving human participants by safeguarding the participants’ rights, welfare and privacy in accordance with federal regulations and guidelines.

    WHAT IS THE IRB?

    Faculty from across the university agree to serve on the IRB and represent the natural sciences, social sciences, arts and humanities, and business disciplines such as marketing and management. In keeping with federal guidelines, Hamline’s IRB has at least five members of varying backgrounds in order to provide complete and thorough review of human participant research and its institutional, legal, scientific, and social implications. The IRB also includes at least one external member not affiliated with Hamline, and at least one member outside of the natural sciences. The IRB is assisted administratively by two staff members, and is overseen by the Provost.

    Hamline’s IRB is registered with the U.S. Department of Health and Human Services (HHS), and approved by the Office of Human Research Protections of HHS. Hamline assures these federal agencies that all activities related to human participant research undertaken by Hamline researchers, regardless of source of support, will be reviewed and accorded the appropriate approval by the IRB in compliance with federal regulations and the ethical principles as outlined in the Belmont Report. The Belmont Report’s primary purpose is to protect participants in research studies and consists of three principles: beneficence, justice, and respect for persons.

  • Institutional Review Board (IRB)

    IRB Meetings and Membership

    The IRB meets for full board reviews on the second Tuesday of every month during the academic year, from 11:30-12:30. For 2019-20, the 2019 meetings are scheduled for September 10, October 8, November 12, and December 10; the 2020 meetings are scheduled for February 11, March 10, April 14, and May 12. There is not a meeting scheduled for January 2020 and meetings for June, July, and August 2020 are currently TBA. Between each meeting, the chair and IRB members review applications that do not require full board review.

    Membership on the Hamline IRB is in accordance with federal guidelines that requires “at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution.” (See e-CFR §46.107). Membership can change periodically; faculty who are interested in ensuring that Hamline can continue its robust research activities are encouraged to serve on IRB when an opening becomes available.

    IRB MEMBERS 2019-20
    Chair: Kathy Thomsen, Fine Arts (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, Augsburg University (term ends June 2021)
    Natural Science: Jen Robb (sabbatical for Spring 2020; term ends June 2021)
    School of Education: LeeAnne Godfrey (term ends June 2020); Betsy Parrish (term end June 2021)
    Support staff: Yvonne Wells-Ellis, Amanda Roll-Kuhne

    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. Use this survey to determine if your research requires you to submit an application for IRB review.
    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 participants 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 submission of all materials for review and notification of the IRB's decision. A missing training quiz score or required documents may significantly delay the the turnaround time for review. 
    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. A missing training quiz score or required documents may significantly delay the the turnaround time for review. 
    Meeting and Submission Dates for Full Board Review Applications:
    Submission dates in 2019: September 3, October 1, November 5, and December 3
    Meeting dates in 2019: September 10, October 8, November 12, and December 10
    Submission dates in 2020: February 4, March 3, April 7, May 5
    Meeting dates in 2020: February 11, March 10, April 14, May 12
    NOTE: No meeting in January 2020; meeting and submission dates for June, July, and August 2020 are TBA.



    Required Training and Application Forms

    REQUIRED TRAINING
    1. Before submitting an IRB Protocol Application, all researchers must complete the Hamline IRB Training. Begin your training by downloading and reviewing the video or the slide presentation.  To complete the training take the quiz; a quiz score is required before your application is considered complete. 

    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.

    Suspension or Termination of IRB Approval of Research

    The IRB has the authority to suspend or terminate approval of research that is not being conducted in accordance with the pre-approved requirements or that has been associated with unexpected serious harm to subjects. (e-CFR §46.113)

    Links to Forms and Templates

    Frequently Asked Questions

    Frequently Asked Questions

    Q: Can a person be exempted from completing the IRB training?
    A: Everyone who is part of the IRB proposal must go through the IRB training; this is a federally mandated requirement. Even if you have gone through IRB training at another school or have been on an IRB at some time, you must still complete the training.

    Q: If I took the training quiz at a date that is earlier than that of my current submission is it necessary to redo the training?
    A: If you completed the training quiz any time after late January 2019, there is no need to repeat it for later or additional submissions.

    Q:I can't access the documents on the website and/or the training module.
    A: You must be signed into your Hamline Google account to access these files.  If you have multiple Google accounts open on your mobile device, you may have to sign out of all except the Hamline account.

    More questions?  Please send an email toirb@hamline.edu for answers.