HHS Announces Proposal to Improve Rules Protecting Human Research Subjects
For More information and instructions on how to submit comments on the NPRM, click here
Institutional Review Board: The University of Baltimore has established the Institutional Review Board (IRB) in compliance with federal regulations governing research involving human subjects funded by the US government. All research involving human subjects conducted by faculty, staff or students at the University must comply with the federal regulations set forth in 45 CFR 46. Please also see the USM policy here.
The primary purpose of the IRB is to assure the protection of the rights and welfare of human subjects, that is, those who volunteer to participate in any kind of research study or survey conducted by UBalt investigators. This includes the protection of private and/or confidential information, which the individual can reasonably expect will not be made public without their consent. Special considerations and additional protections are considered when the research involves vulnerable populations, such as prisoners, children, pregnant women, human fetuses and the cognitively impaired.
All UBalt faculty, staff, and students, who anticipate using human subjects in a research project should complete an online Kuali Protocols IRB application available at https://ubalt.kuali.co/protocols/portal/protocols or in the tools section of MyUB. You must attach sample study instruments (surveys, interview questions, etc), and applicable consent documents in your Kuali application. Please submit any questions regarding your IRB application to the IRB coordinator at firstname.lastname@example.org or call (410)837-4057.
UB IRB Kuali General Campus Guide Instructions (PDF)
Learn more about research at UBalt.
Please see the following link for UBALT IRB submission requirements, procedures and FAQ's: The UBALT IRB (procedures and FAQS)
External reliance is the process of using a single IRB for review of multiple sites or investigators at multiple institutions for non exempt human subjects research. You may request that UBalt IRB rely on an external IRB for review and approval of your research or for us to provide approval for non-affiliated investigators or sites conducting collaborative research. Such collaborative research requires a reliance agreement, a formal, written document that provides a mechanism for an institution engaged in research to delegate institutional review board (IRB) review to an independent IRB or an IRB of another institution.
If you are thinking of pursuing an external reliance agreement, please contact the IRB to have an informal discussion prior to submitting your protocol to the IRB for review. Please note that if the majority or all study participants are UBalt students, if the recruitment is occurring at UBalt, or if the primary testing site is at UBalt, the investigator is required to submit a full IRB protocol for review at UBalt and external reliance will not be considered. In all situations, external reliance will be considered for approval, but the UBalt IRB reserves the right to request a full protocol for approval before IRB approval is granted.
Documents and Forms
UB staff, faculty and students can now access on-line training for human subjects research in social science and responsible conduct of research (RCR), among others at no cost to you. Training modules can be accessed through the nationally recognized CITI Program. Please follow the instructions here to obtain a login for the CITI training. For questions about on-line research training, please contact the IRB coordinator at (410) 837-4057 or email@example.com.
All UBalt faculty, staff, and students, who anticipate using human subjects in a research project should complete an online Kuali Protocols IRB application available at https://ubalt.kuali.co/protocols/portal/protocols or in the tools section of MyUB. You must attache sample study instruments (surveys, interview questions, etc), and applicable consent documents in your Kuali application. Please submit any questions regarding your IRB application to the IRB coordinator at firstname.lastname@example.org or call (410)37-4057.
Before a protocol can be submitted in Kuali, researchers must complete the following CITI training modules:
Student researchers – Group 1 Student Researchers and Group 4 Revised Common Rule.
Faculty and Staff researchers- Group 2 Faculty/ Staff Researchers and Group 4 Revised Common Rule.
**Researchers must upload their completion certificates into the attachment section of their protocol in Kuali before it will be reviewed. Any protocol that is submitted without these attachments will be sent back without review. **
Please see training link above for instructions on how to create and log in to your CITI account.
IRB Review Timelines
Investigators (faculty, staff, librarians and students) should allow ample time for review of their IRB applications before commencing work on a research project. The timelines below are provided as an estimate only. The Board meets as frequently as necessary to allow for thorough and timely review of protocols and research projects.
- Exempt Review – 2 weeks
Approved Exempt protocols do not expire or need to be renewed, but an amendment must be submitted via Kuali protocols if you modify your study.
- Expedited Review – 3 weeks
Approved Expedited protocols do not expire or need to be renewed (unless specified in your approval letter), but an amendment must be submitted via Kuali protocols if you modify your study.
- Full IRB Review – 5 weeks
IRB protocols that require Full Board review must be submitted in Kuali no later than 10 days before the monthly meeting to be added to the agenda for review for that month. Meeting dates are posted in the Current members and IRB Meeting Dates tab.
**Approved Full Board protocols expire one year from approval date and must be renewed to continue your research. You must submit your renewal application in Kuali 6-8 weeks before your protocol expires. This gives the Board time to review at a monthly meeting before the protocol expires. **
- Amendment/Modification Review - 2 weeks
Current Members and IRB Meeting Dates (Academic Year 2023-24)Meeting dates
IRB Full Board meetings are held once a month, throughout the semester. Protocols requiring Full Board review must be submitted in Kuali at least 10 business days before the current month’s meeting to be reviewed at that month’s meeting.
Spring 2024 Semester IRB meeting dates:
- Wednesday, January 31, 2024
- Wednesday, February 21, 2024
- Wednesday, March 27, 2024
- Wednesday, April 17, 2024
- Wednesday, May 15, 2024
- John J. Donahue, PsyD, Associate Professor, Division of Applied Behavioral Sciences (Chair)
- Gabriela Wasileski, PhD, Associate Professor, School of Criminal Justice (Vice Chair)
- Kathryn Summers, PhD, Associate Professor, Division of Science, Information Arts and Technologies
- Gregory Dolin, Assistant Professor of Law
- Nusta Carranza Ko, Assistant Professor, School of Public and International Affairs
- Jerry Yu, Associate Professor, Department of Finance and Economics
- Fatemeh Rezaei, University Archivist, Robert L. Bogomolny Library
- Jared Dmello,Ph.D Criminal Justice & Criminology, External member
- Stefanie Hamberger, IRB Coordinator, Office of Sponsored Research (Non-voting - Coordinator & Secretary)
USM System Reliance Agreement for SoTL
In Fall 2021, the Kirwan Center for Academic Innovation partnered with the Human Research Protection Program in the UMCP Division of Research to develop a Systemwide IRB protocol for USM faculty engaging in Scholarship of Teaching and Learning (SoTL) research projects that pose minimal risk to participants. The Kirwan Center oversees the standing SoTL IRB protocol that has been approved by UMCP’s Institutional Review Board. The University of Baltimore has entered into this reliance agreement. With this agreement, faculty can propose specific SoTL projects that pose minimal risk to participants using a streamlined amendment form that will go to the UMCP IRB for expedited review.
All SoTL research that presents minimal risk can use this new process, though, it is important to mention that you do not have to use this process if you would prefer to send it to UBalt IRB.
For more information please visit the SoTL page: https://blogs.ubalt.edu/celtt/category/excellence-of-teaching-and-learning/scholarship-of-teaching-and-learning/ or contact:
Dr. Jessica Stansbury
Director of Teaching and Learning Excellence
University of Baltimore