• 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 the second Tuesday of every month during the academic year, from 11:30-12:30. Between meetings, 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. 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 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 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.

    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 to irb@hamline.edu for answers.