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.
Who Can Be an IRB Principal Investigator and Who Are Study Personnel
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.
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.
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 firstname.lastname@example.org.
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.
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.
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.
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.
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.