IRB Review Categories
There are three categories of research for which interaction with the IRB is necessary. Note that certain kinds of research do not require interaction with the IRB; these kinds of research are discussed on the relevant IRB subpage.
1. Exempt research requires relatively minimal interaction with the IRB in order to determine whether the research meets the criteria for exemption. There are four types of exemption relevant to research at Colorado College, all of which have exemption determination forms on the CC IRB homepage: the educational exemption, the interaction exemption, the benign behavioral intervention exemption, and the secondary research exemption.
Note that the first three of these requests require consent forms to be sent along with the request, while the interaction exemption determination form also requires a copy of any educational tests, surveys, or interview schedules (or a description of the research taking place in a public setting.
2. Expedited research requires a regular review but this review can be carried out by a single member of the IRB. The IRB Chair carries out all expedited reviews at present on a rolling basis. There are a number of categories of expedited research, all of which can only be reviewed on an expedited basis if the research is minimal risk or involves no risk of harm. (See the subpage on harm for more discussion of minimal risk research.) Several of these categories involve biomedical research; please contact the IRB Chair, Amanda Udis-Kessler, directly (email@example.com) to discuss any of these types of expedited research. Other relevant types of expedited research are:
- Collection of data from voice, video, digital, or image recordings made for research purposes
- Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies
Note that some of these kinds of research may either be exempt or no longer count as research; the federal government's expedited categories predate its current regulations on exempt research and research that the government itself no longer counts as research. Contact Amanda with questions.
Expedited research requires that the regular IRB application be filled out and sent to Amanda with all relevant attachments, including a consent process.
Two expedited research-related regulations have changed recently. The first change is that research continuing after a year that does not involve changes in the research process and in which no adverse (harmful) events have occurred no longer needs a request or review for continuation. The second change is that there is a new subcategory of expedited research involving limited IRB reviews for several exemptions in which there is potential concern about the confidentiality or privacy of participants; see exemptions 2 and 3 on the homepage for more information.
3. Full-Board research consists of research that is not exempt and cannot be reviewed on an expedited basis, most often because of the likelihood that it will cause more than minimal harm. Full-Board research requires all members of the IRB to meet and determine whether the research can be approved, needs to be modified first, or must be rejected on legal and/or ethical grounds.
The application process is the same for expedited and Full-Board research, and all researchers doing non-exempt research are encouraged to send the application and attachments to the IRB chair with the expectation that their research is likely to be reviewable on an expedited basis. If this turns out not to be the case, the IRB chair will inform the researcher.