Institutional Review Board (IRB)


COVID-19 Update in Regard to Human Subjects Research:

**Please understand that this statement is in the process of still being developed, and is subject to change as on campus/state guidelines change.

The BU Institutional Review Board (IRB) will continue to meet (remotely) on a monthly basis.

Given that minimizing risk to subjects is at the core of research ethics, we must minimize potential exposure to COVID-19 when engaging in research.

Faculty and staff may continue to conduct remote/online/secondary research.

All face to face human subjects research is suspended until further notice, unless IRB and Provost approval are received.  Review the options below on how to proceed with changes to currently approved studies that involve face to face interactions.  We are strongly encouraging everyone to consider ways in which human subjects research can be conducted remotely.

1. Faculty/staff who need to revise their research protocols to include remote interactions with human subjects or new methods of data storage should submit those revisions to the IRB for review and authorization.  This can be done by going to your study in IRB Manager, and starting an x-form to “Request for Modification in Protocol”

2. For research involving human subjects that cannot be done remotely, the PI must submit a plan for how to conduct the research while following the guidelines of the PA Department of Health, as well as complying with BU campus rules and/or the rules of the location for the work.  In this scenario, the PI must submit a detailed plan as to how they will minimize risk of the face to face interactions in the green phase, but also how they will stop/suspend research if the research location were to transition to a yellow/red phase.  The detailed plan should include references to any guidelines/best practices shared from their respective National organizations/governing bodies. If taking place at an off-campus location, an approval letter is needed from the organization (i.e. school/hospital).  The BU
IRB will review the modified protocol at a full board meeting to ensure appropriate precautions are taken to minimize exposure to risk, and weigh the benefits, relative to the risks.
The IRB/research office will also work with the Provost and others administrative officials for additional approvals.

      This plan can be submitted by going to your study in IRB Manager, and starting an x-form to “Request for Modification in Protocol”.

3. If you choose to delay or suspend  a face to face study until a later time, please send an email to BU-IRB@bloomu.edu with the following information:  Study #, and a note that you plan to suspend the research until a later date due to COVID-19 face to face limitations.  Then make note of this when it’s time to submit the annual check-in or continuing review in IRB Manager. 

New Applications:

If you are planning to submit a New Application for the upcoming academic year that cannot be done remotely (i.e. involves face to face interaction), the process in #2 above will be followed.  However, it is strongly encouraged that you consider how to conduct human subject research remotely. 

Contact:  Any question on the above processes, may be submitted to the bu-irb@bloomu.edu.


The Bloomsburg University Institutional Review Board for the Protection of Human Subjects mission is to assure that, in research involving human subjects, the rights and welfare of the subjects are adequately protected. The IRB reviews research involving human subjects to ensure that subjects are not placed at undue risk and that they give uncoerced, informed consent to participate in the research.

Overview of Process

All projects that meet the definition of research with human subjects must be reviewed and approved. The IRB staff initially screens submissions to determine the completeness. Submissions may be returned to the PI for changes before the review type is assigned. The review type may be reassessed at any time during the review process. If you have a question on whether or not your project requires IRB approval please review:

Does my project require IRB review and approval?
Does my project require IRB review and approval? Flow Chart

IRB Contact Information
Office of Research and Sponsored Programs
213 Centennial Hall
570-389-4322

BU-IRB@bloomu.edu

Director - Sadie Hauck
IRB Chair - Jeffrey Leitzel
Administrative Assistant - Christine Orlando

Complete a study application

You will need to use IRBManager. Please make sure to have completed CITI Training requirements before completing an application as this will be an automatic return to you and your study staff. Please see our guide for assistance on obtaining a certificate. For additional questions, contact the IRB by email at BU-IRB@bloomu.edu.

IRB Consent Form Template

The BU IRB has provided a sample consent template for your study.

Delete all instructions in red before submitting to the IRB. Customize the language in black as needed to fit your study.

Other Resources

IRB Policy – PRP 3990
How to create an IRBManager application
Investigator Responsibility
IRB FAQ's
 

IRB Members

Jeffrey Leitzel, BU-IRB Chair
BU-IRB-Chair@bloomu.edu
570-389-4232

Kyle Beyer
Roger Benefiel
Father John Szada – Non-BU affiliated member
Doreen Jowi
Christina Force
Carroll Walter – Non-BU affiliated member
Deborah Stryker
Cheryl Jackson

Alternate IRB Members

Kate Beishline
Skye Chernichky-Karcher
Wendy Lee
Erin Brummett
Scott Mehall
Denise Davidson
Susan Dauria
Shelley Scarpino

IRB Meetings and Deadlines

Committee meetings are held monthly. When needed, one summer meeting may be scheduled. Protocols must be submitted two weeks prior to a meeting date to be considered for review.

Fall 2020
September 11, 11am
October 16, 3pm
November 11, 11am
December 4, 3pm

*These will be held thru Zoom. Please contact IRB for more meeting information*