• Institutional Review Board (IRB)

    PROTOCOL REVIEW AND APPROVALS DURING THE COVID-19 PANDEMIC

    The IRB is continuing its work exclusively online until further notice, including review and approval of research proposals and amendments and, where needed, virtual review meetings with the board.  Please direct questions or concerns to IRB@hamline.edu 

    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 is continuing its work exclusively online until further notice, including review and approval of research proposals and amendments. Virtual IRB meetings take place monthly September, 2020-May, 2021. See Review Timelines section for meeting dates and submission deadlines.  

    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 2020-21
    Chair: Gina Erickson, Criminal Justice & Forensic Science (term ends June 2022)
    Social Science: Erik Asp (term ends June 2021); Endalkachew Chala (term ends June 2023); David Davies (term ends June 2023); Jennifer Will (term ends Aug 2023)
    Business: Austin Miller (term ends June 2023)
    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: Rebecca Neal (term ends June 2022); Betsy Parrish (term ends June 2021)
    Support staff: 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 Protocol applications are reviewed by IRB on a rolling basis.  The IRB requires 2-3 weeks from the date of submission of all materials for review and notification of its 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 Wednesday 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, 2020-21: 
    Submission deadlines in 2020: September 1, October 1, November 2, and December 1
    (Virtual) Meeting dates in 2020: September 16, October 14, November 11, and December 9
    Submission deadlines in 2021: February 1, March 1, April 1, May 3
    (Virtual) Meeting dates in 2021: February 10, March 10, April 14, May 12
    NOTES: No meeting in January 2021



    Required Training and Application Forms and Process

    1. COMPLETE THE REQUIRED TRAINING
    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 THE REQUIRED PROTOCOL APPLICATION FORM 
    To complete one of the required application forms linked below: download it as a Microsoft Word* document to your computer, rename it, and save using the following naming rubric: researcher last name_faculty PI/advisor last name_Application_date form will be submitted  

    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. COMPLETE THE REQUIRED CONSENT FORM
    To complete a Consent Form use one of the templates linked below: download it as a Microsoft Word* document to your computer, rename it, and save using the following naming rubric: researcher last name_faculty PI/advisor last name_Consent_date form will be submitted   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. SUBMIT YOUR APPLICATION USING THE REQUIRED SUBMISSION FORM
    Complete the IRB Submission Form and upload all the required documents outlined in the training module. All required attached documents must be submitted using Microsoft Word format.* 

     5. EMAIL IRB WITH ANY QUESTIONS
    Email any questions to IRB@hamline.edu. You will also receive your approval and/or requested revisions from this email account. Failure to address all requested modifications will result in a request for re-submission.

    *Note: Microsoft Office 365 is available to all Hamline community  members when logged into VDI.  When not in VDI, go to Office 365 and sign in using your Hamline credentials.

    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.

    Q: The application form asks me about any conflicts of interest.  What does this mean?
    A: A conflict of interest occurs when you or a member of your family or anyone else working on a research project has a financial or equity stake in the sponsor of a project or in the results of the research. Being paid to conduct research is NOT a conflict of interest if the compensation received is not dependent on the results of the research.

    Q: What is a Reliance Agreement?
    A: A Reliance Agreement is an agreement between two or more institutions that allows an institution's IRB to rely on another, unrelated institution's IRB for review of human subjects' research.

    Q: What is a continuation or closure form and when is it required?
    A: Protocols that are approved as Expedited or Full expire after 365 days from the date of protocol submission. The form you will receive allows for both closure  and continuation. If all data collection is concluded after 365 days researchers must complete and submit the closure section of the form; if data collection is ongoing, researchers must complete and submit the continuation section of the form.  Exempt protocols expire five years after the date of protocol submission and do not require  closure or continuation documentation.

    Q. My protocol doesn't expire until the Fall; why am I receiving a closure request form in the middle of May?
    A.
    If your project involves student researchers you will receive a closure request form in the middle of May.  This allows the IRB to connect with students who plan to graduate in that same year. If the research is finished, you are asked to complete and submit the form.  If the research is ongoing and you will be a Hamline student beyond the middle of May, email the IRB to provide them with this information.  Under these circumstances, you are expected to complete the closure materials after the aforementioned 365 day period.

    Q. I am a professor teaching a research seminar and some of the projects will involve students interviewing subjects.  Do these projects require an IRB review?
    A.
    No IRB review is needed for required student projects that are only for a class, i.e. not for presentation or publication.

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

     

    Resources for Researchers

    Comparison: Characteristics of Human Subjects Research vs. Other Project Types

    Certain activities may have the characteristics of research and involve some level of interaction with people. However, IRB review is only required for projects that meet the federal definition of research involving human subjects. Please use the information in the table below to determine whether your project meets this federal definition. If the project has one or more of the characteristics in the first column, the project may require IRB review.