Human Research Protections and Integrity

UMBC IRB Protocol Creation and Submission Process

Kuali is a cloud-based electronic research administration tool. Use Kuali for IRB protocol submissions.
Link to Kuali Protocols – umbc.kuali.co/protocols/
Link to Kuali Information – Kuali At UMBC
Link to Kuali Protocol Training Guides

Exempt Review 

The IRB Chair screens studies for exemption determination. Such research must fall within one of the federally designated exempt review categories and be no more than “minimal risk” If the study is not found exempt, it will need to go through expedited or full-committee review. This link describes the exempt application and review process. Exempt determinations take approximately two weeks. 

Expedited Review 

Members of the IRB review expedited review protocols to determine “minimal risk” to participants and fit into an expedited review category of research. This link describes the expedited application and review process. Expedited reviews take approximately four weeks. 

Full-Committee Review 

Protocols greater than “minimal risk” must be reviewed and discussed at a formally convened meeting of the IRB. Full-committee review protocols must be submitted no later than thirty (30) days before the scheduled meeting. This link describes the full board application and review process.  The current committee meeting schedule is found here.  

Classroom Projects 

The IRB has developed guidelines to advise faculty instructors on what are acceptable topics, the use of the consent process, and faculty responsibilities for  human subjects research class projects. 

Student Research Using Data from a Faculty Advisor’s Protocol 

Student researchers may wish to carry out research projects or studies that involve using data collected on a faculty advisor’s IRB approved protocol.  Please follow this  process to obtain either exempt or expedited IRB approval. 

Secondary Data Use Research  

Investigators who plan to use, study, or analyze restricted or identifiable private information for data for secondary research purposes will follow these steps for data use agreement procedures and to obtain IRB approval. On the other hand, research with publicly available, de-identified sources of data or if information can no longer be connected to the identity of the subjects, follow these steps.

Planning Phase Administrative Request 

When an investigator has plans to perform human subjects research in the future that lead to the submission of grant applications, submit this planning phase administrative request 

IRB Reliance Agreements (formerly called IAAs) 

Involving external research collaborators on an IRB activity? Consider the potential of a reliance agreement 

Not Human Subjects Research 

Human subjects review depends on how regulatory requirements and IRB processes apply.  Review the IRB’s guidance here. 

• Planning Phase Administrative Requests

• Add study team members from external institutions or sites
• The Office of Sponsored Programs (OSP) and Data Use Agreements

A major investigator responsibility is to be compliant all IRB policies, decisions, conditions, and requirements. This means ensuring that the research is implemented as specified in the approved IRB protocol. Click on the below topics to review what is required after the IRB provides approval.

• Maintaining Protocol Files
• Amendments to Research Protocols
• Renewal/Continuation of Research Protocol
• Reporting of Deviations and Non-Compliance
• Reporting of Adverse Incidents or Events
• Protocol Violations
• Protocol Closures
• Post Approval Monitoring (PAM)

• IRB Reliance Agreements
• Recruitment of Participants

The goal of the consent process is to facilitate a prospective participant’s or legally authorized representative’s understanding of the reasons why an individual might or might not want to participate in a research study. The responsibility for the investigator in the consent process is to: 

• Provide more information when requested by subjects 
• Make sufficient time and opportunity to discuss the research 
• Answer questions to improve a subject’s understanding 

Click Here for Additional Consent Information and Template Documents

• PAM PI Self-Assessment Form

IMPORTANT NOTE: ALL HUMAN SUBJECTS USE TRAINING MUST BE REPEATED EVERY 5 YEARS.

 First step:

• Using your UMBC login credentials, click on the University of Maryland, Baltimore County Single Sign On (SSO) login link on the CITI Program’s website.  
• Persons with a current CITI login will be directed to their current CITI course list.
• If you do not have a current CITI login, you will see this screen. Click on the appropriate link and follow the below instructions
• Click on Register link in top right.
• Set up an account for yourself – in “Select Your Organization Affiliation” section, make sure to select “University of Maryland, Baltimore County” by typing it in box. Then follow the rest of the instructions to create your account.
• When asked “Which courses do you plan to take”…
• Scroll to “Question #1” and under “Human Subjects Courses” choose one of the following:

Students conducting less than minimal risk research – Appropriate for Undergraduate Students working on classroom research. All Undergraduate students working on independent research should take the Social/Behavioral course.

Social/Behavioral Research Course – Appropriate for All Students, Faculty and Staff

Research with pre-existing data, records data or laboratory specimens – Appropriate for researchers with no direct contact with Human subjects and/or Secondary Data Use

GCP – Social and Behavioral Research Best Practices for Clinical Research – Appropriate for researchers conducting research in a clinical setting

GCP for Biomedical Research – Appropriate for researchers working with FDA regulated drug, device or biologic studies.

• Scroll to “Question #7” and under “Information Privacy and Security” choose one of the following:

Health Information Privacy – Required for those working with HIPAA protected Data

Information Security Course – Suggested for all UMBC Researchers

Family Educational Rights and Privacy Act (FERPA) – Suggested for those working with data that is protected under FERPA

• Once courses selected, click “Submit”
• Then complete the courses

Your CITI training record is automatically fed into the Kuali IRB protocol record.

Once the initial training period has ended, CITI will provide instruction to renew training modules with a refresher course.

Key research team members (e.g., co-principal investigators) from other institutions who are “engaged” in a UMBC IRB approved protocols must have a record of current human subjects protection training and recorded in the Kuali IRB protocol record. The IRB prefers members of the research team complete appropriate CITI training modules. Persons who have completed CITI training at another institution should affiliate their CITI account with UMBC. After affiliating with UMBC, CITI will ask you to complete any modules required by UMBC that may not have been required by the current research team member’s institution.  Review CITI’s guidance on how to add/change your affiliated institution or transfer completions for more information.

The IRB will also accept completion of the Office for Human Research Protections Human Research Protection Training module for non-UMBC affiliated investigators who participate in UMBC IRB approved protocols. UMBC PIs are required to upload evidence of training completion in the protocol.

UMBC’s Office of Research Protections and Compliance provides a wide variety of training.  ORPC has presented to departments, labs and administrative groups on campus.  We would be more than happy to meet with you or your unit.  Please feel free to contact us at IRB@umbc.edu.