UMBC IRB administrative staff are updating IRB protocol forms in Kuali to align with institutional policy taking effect October 3, 2024 in regard to employees interacting with minors on campus. The updated IRB forms will guide PIs and their research personnel in completing the required fingerprinting and background check through Talent Acquisition, before approving research activities involving minors. For existing IRB protocols, PIs will be prompted to answer these updated form fields when initiating amendments. Additionally, IRB administrative staff will contact PIs of active IRB protocols for research involving minor human subjects, and require these research teams to complete the fingerprinting and background check processes before interacting with any additional minors on campus. UMBC faculty and staff who need to have background checks and fingerprinting completed can coordinate with HR/Talent Acquisition directly by contacting hrbackground@umbc.edu
UMBC has an Institutional Review Board (IRB) whose responsibility is to protect the rights and ensuring the safety of human subjects participating in research. The IRB requires that all investigators who are affiliated with UMBC and who are engaged in research, regardless of funding, comply with both UMBC procedures and federal regulations regarding the protection of human subjects in protocol activities.
The UMBC Institutional Review Board (IRB) has responsibility of providing oversights of research activities involving human subjects and ensuring that ethical standards for safeguards and protection of participants.
Research with human subjects, regardless of funding, conducted under the auspices of UMBC, is reviewed approved by the IRB in compliance with federal regulations, its Federalwide Assurance and institutional policies and procedures. The University of Maryland, Baltimore County has a Federalwide Assurance (IRB registration number: IORG0000202 / FWA number: 00000069 approved through 06/16/2026) from the Office for Human Research Protections. Protocols describing research with human subjects must be submitted to and approved by the IRB before research use can begin.
Additionally, all personnel involved in protocol involving humans must complete required training prior to conducting the research.
Briefly, the protocol review process entails:
UMBC IRB Protocol Creation and Submission Process
This information will assist investigators in the planning, development and submission of human participant use protocols for review and approval by the IRB. Review types are described below. The below submission type provides a link to the Kuali Protocols Portal as well as the IRB Protocol User Guide. The Guide has a searchable table of contents to the specific sections to assist in creating a protocol.
Kuali is a cloud-based electronic research administration tool. Use Kuali for IRB protocol submissions.
Link to Kuali Production – umbc.kuali.co
Link to Kuali Information – Kuali At UMBC
Link to Kuali Protocol Training Guides
Who Can Be an IRB Principal Investigator and Who Are Study Personnel?
Principal Investigator
A Principal Investigator (PI) is someone who is involved in conducting human subjects research studies and has the primary responsibility for the design and implementation of research involving human subjects. The IRB considers persons eligible as a PI who has a faculty appointment (full/part time) the department where human subjects research activities are conducted. This allows persons to create, submit and manage protocols in the Kuali Protocols system. The PI must attest in an IRB application that they, as well as all research staff involved in the study, are aware of and understand their individual and collective responsibilities for human subjects research related tasks including obtaining informed consent, creating and following procedures for safeguards and protections of human research participant well-being, personnel training, etc.
Undergraduate students and Masters or Doctoral Candidates may serve as a PI, but a faculty member must co-sign an application and serve as a “research advisor” for the protocol. The student’s as well as the research advisor’s human subjects research expertise and training is evaluated by the IRB. Student investigators do have the ability to create a Kuali IRB protocol and submit to the IRB for review and approval. Faculty advisors must review and “sign off” the protocol before the IRB performs its review. The process to follow is explained in the IRB Protocol User Guide.
The IRB expects the students and faculty advisors to be knowledgeable about human research regulations , IRB procedures as well as complete required CITI human subjects training courses. It is expected by the IRB that research advisors devote time and effort in evaluating a student’s proposed project, supervise the student in the conduct of the research, assist the student in solving issues and be the resource to the student in promptly reporting incidents to the IRB.
Study Personnel
Kuali pull personnel data from HR; this allows for ease of adding current personnel to a protocol. Anyone listed on the study can prepare changes to the study; however, only the PI or can submit the change.
Adding Study Team Members
- All study team members must have completed the required IRB training in CITI before creating a role in Kuali. The IRB will verify this training during review
- Select which Researcher Role personnel will follow.
- Describe, where applicable, in the data access and consent document/processes sections how personnel are involved
Changing Study Team Members
- Changes to study team members must have completed the required IRB training in CITI before creating a role in Kuali. The IRB will verify this training during review Select which Researcher Role personnel will follow.
- Update, where applicable, in the data access and consent document/processes sections how personnel are involved
Add study team members from external institutions or sites
When a PI is collaborating with research personnel from external (outside) organizations and institutions, those personnel cannot be added directly into Kuali. One option to do so is to request a Sponsored Account that provides temporary UMBC identities to access to Kuali Protocols. Faculty or staff member from the department performing research may request access from DoIT. This person will act as the affiliation sponsor for a period up to one year, with the option of extending the affiliate access.
Include in the protocol description the purpose for requesting access to Protocols and describe what roles and responsibilities they will have for the term of the affiliation with the human subjects research. Choose in the data access and consent document/processes sections how personnel are involved. Include evidence of human subjects research training in the protocol.
If an affiliation is not required, only provide a description in the protocol narrative on what responsibilities this person will perform in the research and if data access and consent document/processes are required.
Training
The IRB requires that all identified research personnel, including faculty, graduate students and undergraduate students complete the on-line education module. Training must be completed before submitting an application. Please review the requirements for human subjects use training.
Humans Subjects Research Protocol Submission Types
Principal investigators may make the initial determination about the type of review appropriate to the project for submission via Kuali IRB. However, final review determination rests with the IRB. If another type of review is more appropriate, the ORPC notifies the investigator to re-submit via Kuali IRB.
IRB Application and Pre-Review Consultation
The ORPC staff is available to answer any questions regarding the Kuali IRB submission process and IRB review of research studies. We also provide pre-review consultation to discuss all aspects of IRB review, from preparing the Kuali IRB submission to completion of the study. Questions or comments? Send them to IRB@umbc.edu.
When will a Principal Investigator hear from the IRB about study approval?
The length of time a study will take from submission to receiving an approval notification received depends on the type or level of review stated below. The ORPC staff, working in concert with the IRB, will make every effort to work with investigators to process protocol submissions promptly. If additional changes are needed, it can take longer depending on reviewer questions or protocol load.
Would my proposed project require IRB review?
That depends. There are examples of what “could” be considered Not Human Subjects Research. Contact the ORPC with information and your questions before starting the project.
Kuali IRB for Protocols must be used for all applications submitted for review. Please select the applicable review type and follow the instructions for submission procedures.
All investigators, advisors and research team personnel (staff, students, and volunteers) who participate in the design and/or the conduct of human subjects research (including exempt research) must be appropriately trained in the protection of human subjects. Note that external evaluators, consultants or transcriptionist who are involved research, but will not have any contact with human participants or identifiable data, are not required to take this training.
Research personnel must complete the below required modules before the IRB provides approval. Personnel may also choose to supplemental coursework in each module specific to research project needs. Training module descriptions are available here. Follow instructions below. UMBC may accept evidence of training (e.g. certificate of completion) from another institution (see below). Upload Please forward these documents to compliance@umbc.edu for review.
CITI also offers Responsible Conduct of Research (RCR) Courses. While useful to inform on the aspects of RCR, these courses do not provide the content the IRB requires to fully inform investigators of the ethics and procedures of conducting human subjects research. These RCR modules cannot be substituted for the below training courses but are required for NSF, NIH, USDA funded research and some UMBC graduate Programs. Please be sure IRB training modules are only listed in the protocol application.
Questions or issues regarding training? Click this link: Research compliance feedback and reporting research concerns.
Kuali is a cloud-based electronic research administration tool. Use Kuali for IRB protocol submissions.
Link to Kuali Production – umbc.kuali.co
Link to Kuali Information – Kuali At UMBC
Link to Kuali Protocol Training Guides
Have a research compliance concern? See Research compliance feedback and reporting research concerns