Research, according to federal regulations, is a systematic investigation (an organized, scientific way of collecting information, using a series of questions or observations) designed to develop or contribute to generalizable knowledge. Data is collected from a “human subject”, who is a living individual about whom an investigator (a faculty member or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.
This definition is important to remember when students (undergraduate and/or graduate) are contemplating to conduct independent class projects, senior theses, master’s projects and doctoral dissertations. Faculty advisors play an important role is in the student’s design and development of human participant research project and are ultimately responsible for the protection of the subjects, even if the student is the primary researcher and actually directs the project. Advisers shoulder the responsibility for students engaged in independent research, and instructors are responsible for research that is conducted as part of a course.
Student researchers may wish to conduct their own lines of inquiry as part of an independent study, a senior thesis, master’s project or doctoral dissertation. using data collected on a faculty advisor’s IRB approved protocol. The IRB does allow for this type of research provided the level of risk does not change, no additional benefits are realized by participants, and the scope of the student’s research project does not significantly differ from the parent protocol.
Rather than burden the student researcher with completing a full application for review and approval, the IRB requests the student and his/her advisor submit a protocol amendment. Kuali IRB uses the term “amendment”, rather than “modification”. Faculty advisors should access the Kuali Protocols Portal to create a protocol application. These changes must be submitted at least two (2) weeks beforehand. The Kuali Protocol User Guide has a searchable table of contents to the specific sections of Guide to assist you in creating a protocol.
Have a Kuali technical issue or problems with access? Contact the ORPC on this online form and we’ll send your issue to VPR Research Administrative Systems
IRB Application and Pre-review Consultation
The ORPC staff is available to answer any questions regarding the 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 submission to completion of the study. The ORPC will send comments to investigators within one week if there are revisions required. Final versions are then forwarded to the IRB for review. If you have any questions, please contact us at compliance@umbc.edu.