When a research protocol reaches ORSP, the IRB chair assigns each human subjects research protocol to a specific category of review, depending on the purpose, methods, and risk-to-benefit ratio of that study.
The federal regulations detail the three categories of research review: full committee review, exempt review, and expedited review of non-exempt research. This section will describe each category, followed by examples of projects that would be assigned to that category.
Projects that meet the definition of human subjects research as defined by the federal regulations will undergo full or expedited committee review. The revision cycle includes an administrative screening, pre-review, return of necessary revisions, then assignment to part or all of the board for review. Full board review requires addition to the agenda of the next board meeting. The committee generally requires further revisions before granting full approval in a letter to the investigator. Training in human subjects research via the CITI course is required fo research in this category.
“Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.” 45 CFR part 46.102(d)
“Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains
(1) Data through intervention or interaction with the individual, or
(2) Identifiable private information.”
Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject.
Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.” 45 CFR part 46.102 (f)
Research protocols in categories defined by the federal regulations (46.101 (b), which exhibit no or very low risks, are assigned to the Exempt research category by the IRB chair. This category of research does not undergo full committee review, but is reviewed administratively by the chair. The chair conducts the final review and signs off.
To determine the research review status, the IRB office requires a full protocol submission including all related documents such as recruiting script, final survey or interview instruments, and an informed consent process and documents. Training in human subjects research via the CITI course is strongly encouraged but not required.
Review of Exempt Research protocols addresses the same elements as review of Non-Exempt Research protocols. However, Exempt review is typically faster than non-exempt review, because protocols do not need to be assigned to a committee meeting agenda. The IRB recommends that students conduct exempt research if possible to avoid delay in receiving approval.
Secondary analysis of existing data is exempt research, if the data sources are publicly available, or if data is reported in the aggregate. If not either of these, then the investigator must record the information so that subjects cannot be identified, either directly (by name, address, etc) or indirectly through identifiers (school, grade taught, ethnicity).
Existing data usage requires a brief protocol telling us what the researcher intends to do with the data, and a letter of permission from the owner of the data saying the current investigator may use the data, and what identifiers the data will come with, if any. Please be aware that in smaller samples, indirect identifiers may actually identify a subject.
If the information is coded anyway, the owner of the data must state in the permission letter that the code key will never be revealed to the current investigator, or that the key has been destroyed and it will not be possible to identify the subjects.
Expedited review is carried out on protocols that fit very specific descriptions in the regulations. Please be aware that this type of review typically takes longer, despite its name, than exempt review.
This category is assigned to research that is not exempt for some reason, according to the regulations, but is lower risk than research requiring full committee review, usually because the methods are non-invasive and the research is social/behavioral/educational.
Research with materials (data, documents, records or specimens) that have been collected, or will be collected for non-research purposes (such as medical treatment or diagnosis).
Research with voice, video, digital or image recordings in research that would otherwise be exempt. Risks need to be adequately described in the protocol and consent; the uses to be made of the recordings and their fate need to be stated explicitly; and recordings may only be of activities of a non-sensitive nature.
Research employing focus groups in studies that would otherwise be exempt. The subjects must be adults, the content of a non-sensitive nature, and the consent form must adequately present the risks associated with a focus group. (Each protocol must contain the paragraph addressing extra protections for focus groups found under “informed consent” in Forms and Templates.)
Focus groups not eligible for expedited review include those where disclosure of the participant’s responses outside the research could reasonably place the participants at risk of criminal or civil liability or be damaging to the participants’ financial standing, employability or reputation; where sensitive issues are discussed; where the research includes a manipulation; or where a vulnerable population is involved.
Continuing review of greater-than-minimal-risk research previously approved by the IRB where: (a) the research is permanently closed to enrollment of new subjects; all subjects have completed research-related activities; and the research remains active only for long-term follow-up of subjects or (b) no subjects have been enrolled and no additional risks identified or (c) remaining research activities are limited to data analysis.
Continuing review of research previously approved and determined, at a convened IRB meeting, to be research involving no greater than minimal risk, where no additional risks have been identified.
Utilization of the following category more fully for review of some low-risk protocols: Research on individual or group characteristics or behavior or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation or quality assurance methodologies. (this refers only to research that is not Exempt.)
Expedited review status will be determined, reviewed and approved by the IRB Chair and reviewed by other IRB members as needed.