IRB procedures for classroom research
This information is intended to clarify the requirements and procedures of the IRB with respect to student research projects involving human subjects. The IRB hopes to provide some consistency, eliminate confusion and misunderstandings, and to make the process as streamlined as possible while still adhering to federal regulations.
All faculty members who plan to assign their students research projects involving collection of data from human subjects are required to consult the IRB compliance coordinator prior to assigning the project. This requirement includes interviews, surveys, and observational studies, as well as more active interventions. The coordinator will make one of three determinations: 1) no further action or involvement by the IRB is required; 2) an application for “blanket exemption” is appropriate; or 3) each individual student needs to submit his or her own application.
The IRB has had, and will continue to have, a procedure for granting “blanket exemptions” to faculty supervising class research whenever possible. Blanket exemptions are granted for: 1) research projects assigned as part of coursework activity that have the sole intent of teaching students how to conduct research and which have no intent of gathering data for later use in publication; and for 2) research projects that might lead to publication but can be categorized as exempt (for example, anonymous surveys on non-sensitive topics or certain evaluations of programs in an educational settings).
When a blanket exemption is not deemed appropriate, the coordinator can often be helpful in thinking about how to alter the research plan to meet the criteria for blanket exemption. If a blanket exemption is not attainable, the coordinator can provide consultation on the preparation of submissions by individual students.
These procedures are consistent with past practice. However, some faculty have not been thoroughly informed about the requirement of contacting the IRB about all intended student research activities involving human subjects. It is a requirement that the IRB, not the researcher, make the determination about whether or not a research activity can be considered to be exempt and regulations demand that the necessary paperwork be on file with the IRB.
Faculty members are required to obtain explicit permission from the IRB compliance coordinator before filing for a blanket exemption. This prior approval process should help eliminate unnecessary paperwork for both faculty members and IRB staff.
Please note that all faculty members supervising student research involving collection of data from human subjects, even exempt research, must complete the online CITI training program. Students conducting research under the auspices of a blanket exemption will be covered by the faculty member’s CITI certification. All students conducting research involving human subjects that is not covered by a blanket exemption and who are applying individually for IRB approval must also complete the online training. Information about this training can be found on the IRB website at http://www.umb.edu/orsp/irb.
For additional information regarding this procedure, please contact IRB Administrator Kristen Kenny at 617-287-5374 or human.subjects@umb.edu.