It is college policy to ensure that the rights and welfare of human subjects are adequately protected in research conducted under its auspices. In addition, federal and state laws and regulations require these protections. In order for the college to fulfill its responsibility and to comply with the law and regulations, all human subjects research conducted under college auspices must receive appropriate review and approval.
Does my project need to be reviewed?
Before the review process, researchers must be sure that their project is, in fact, human subjects research as defined by the federal government. In order to qualify as human subjects research, the following must be true:
LEVEL 1: Department Level Review (Department Level Checklist)
Certain student research projects do not have to be submitted for Institutional Review Board approval but should be reviewed at the department level. Projects that may be reviewed at the department level include laboratory projects, educational exercises and class projects, and action research within a classroom with performance or grades as the sole outcome measure. Each department is to designate one representative to the IRB to serve as the reviewer for department level protocols. In order to qualify for department level review, the research must be disseminated only within the BSC campus. For example, research presented at the Student Research and Creativity Celebration or theses bound and filed in the library may be reviewed departmentally, but any research that will be presented at regional or national conferences or published in journals should be reviewed at Levels 2, 3, or 4. All faculty research, all research that may be risky or on a sensitive topic, or that includes children, except as noted for action research, must be reviewed at Levels 2, 3, or 4.
If your protocol falls under this level of review, contact your department's IRB representative.
LEVEL 2: Exempt or Limited Review (Certificate of Exemption form)
The federal government uses the term "Exempt" to indicate that a protocol is exempt from the higher levels of review because of its low risk for harm. This does not mean that the project is exempt from oversight. Exempt projects simply require less paperwork. Projects that qualify for Exempt or Limited Review include, but are not limited to:
LEVEL 3: Expedited (Expedited or Full Board Review form)
Projects that are more intrusive than exempt projects or that require the participation of children (aside from action research as noted in Levels 1 and 2), may qualify for Expedited Review. In this case, the protocol is similar to that of the Full-Board Review, but the project is reviewed by one designated member of the IRB. The designee may approve the project, request additional information, or submit the proposal to the IRB for Full-Board Review and approval. Some examples of Expedited Review projects include, but are not limited to:
LEVEL 4: Full-Board Review (Expedited or Full Board Review form)
Full-Board Review is the highest level of review for human subjects protocols and is designed for projects that are sensitive in nature. The review is conducted at the next scheduled meeting of the IRB. Some examples of Full-Board Review projects include, but are not limited to:
Do I need ethics training?
All faculty members conducting human subjects research or supervising student research need to complete ethics training, as specified by the federal regulations. All students conducting human subjects research at Levels 2, 3, or 4 also need to complete this training. We encourage students conducting Level 1 research to complete the training as well, but this is not mandatory. Although researchers may complete other federally-approved training programs to satisfy this requirement, we encourage researchers to complete the CITI program, for which the college has a site license. To access this training, visit the CITI website https://www.citiprogram.org/.
◊ An Investigator's Guide to Research with Human Participants (.pdf)
|Last Updated on Wednesday, 22 July 2015 15:44|