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 email@example.com or call (410)837-4057.
UB IRB Kuali General Campus Guide Instructions (PDF)
Learn more about research at UBalt.
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 firstname.lastname@example.org.
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 email@example.com 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 2021-22)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 2021 Semester IRB meeting dates:
- Wednesday, August 25, 2021
- Wednesday, September 15, 2021
- Wednesday, October 20, 2021
- Wednesday, November 17, 2021
- Wednesday, December 15, 2021
- Gabriela Wasileski, PhD, Associate Professor, School of Criminal Justice (Chair)
- Kathryn Summers, PhD, Associate Professor, Division of Science, Information Arts and Technologies (Vice Chair)
- Hugh McClean, LLM, JD, Assistant Professor of Law and Director of The Bob Parsons Veterans Advocacy Clinic
- John J. Donahue, PsyD, Associate Professor, Division of Applied Behavioral Sciences
- Kevin Wynne, PhD, Assistant Professor, Department of Management and International Business
- Nima Zahadat, Assistant Professor, School Criminal Justice
- Aiden Faust, MLS, MA, Head of Special Collections, Robert L. Bogomolny Library
- Stefanie Hamberger, IRB Coordinator, Office of Sponsored Research (Non-voting - Coordinator & Secretary)