Types of Study Review by the IRB
Within myIRB, the researcher indicates the Type of Review they feel is appropriate for the study. The IRB often proceeds on that basis, but may determine that a different type is appropriate.
Is the proposed activity research?
The Code of Federal Regulations (CFR) defines research as a “systematic investigation … designed to develop or contribute to generalized knowledge.” Many activities that involve collection of data from or about people are excluded from this definition, for example evaluation of a social program under contract with the sponsor, for purposes of assessing and improving the program; psychological studies created by students in a research methods class; or surveys of patient satisfaction with healthcare providers to improve the quality of services.
Whether or not the findings of the work will be published or otherwise disseminated is thus not critical in making an activity “research.” Many undergraduate and graduate theses are never published, but are still “research” as the intent is to contribute to generalized knowledge. Conversely, a methods-class project or program evaluation may have the potential to put their participants at risk, but this does not make it research that needs review by the IRB. Similarly, the CFR now specifically excludes “scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected”.
It is common for an activity to have both evaluation and research purposes. Investigators may be under contract to evaluate a program, but also have scientific interests in the project which will be communicated to peers. Similarly, an instructor may supervise a student project with the hopes that it may generate “publishable results.” As a consequence, IRB02 looks closely at the stated purpose of the proposed activity. If there is any chance that the results of the activity will be reported as a scientific contribution, it will be considered as research, and subject to review prior to implementation.
Many IRB02 studies involve evaluation of social or educational programs and interventions. These may be ongoing programs, or programs designed or developed by the researchers. In either case, we need to distinguish between participation in the program, and in the assessment of the program. If a person may take part in the program, but decline to be part of the assessment, we may determine that the program itself is not research, which is limited to the assessment activities. Another common situation is where students in classes are given a novel instructional approach, and/or asked about their perceptions of the class or method. Here again, if all students take part in the activities as part of the regular course requirements, the ”research component” may be limited to student ratings and other comments, or obtaining of class artifacts and performance on exams or final grades.
Studies that do not have any research purpose do not need to be submitted to the IRB. If it is clear that a submitted study is in fact not research, we will advise that the study be withdrawn from myIRB. If you are uncertain about whether your study qualifies as research, you should contact the IRB02 office or submit it to myIRB for further assessment.
Exempt Human Subjects Research
45 CFR 46.104(d) describes several categories of human subjects research activities that may be “exempt from the requirements” of the CFR. This does not mean they are exempt from IRB review or oversight. The majority of studies submitted to IRB02 qualify for one of the exemptions below, and are ultimately reviewed and approved “as exempt:”
Research conducted in established educational settings, and involving instructional techniques or classroom management methods [46.104(d)(1)]. In many cases, IRB02 has exempted such educational research. “Established educational settings” of course includes, but may not be limited to, formal educational institutions. On the other hand, the mere use of schools as a setting for the research – for example, implementation and assessment of anti-bullying programs – would not qualify a study for this exemption.
Educational tests, surveys, interviews or observations of public behavior [46.104(d)(2)], unless (a) the information recorded is identifiable, and (b) could reasonably place subjects at risk if disclosed, and (c) provisions to protect privacy and confidentiality are deemed by the IRB to be inadequate. The last condition was added in the 2019 revisions to the CFR. As a consequence, most studies involving surveys, interviews or focus groups, even on sensitive topics with identifiable information or participants, now qualify for this exemption.
Benign behavioral interventions [46.104(d)(3)]. A new category of exemption introduced in 2019 that allows exemption of studies that involve experimental manipulation of conditions to test causal hypotheses about behavior, with the same provisos as with surveys and interviews. The exemption will not apply to studies that pose a risk of “serious adverse lasting impact” on any subject, those that subjects may find “offensive or embarrassing,” or those that involve active deception (e.g., providing false feedback about performance).
Importantly, the above exemptions for surveys, etc. (d2), and for benign behavioral interventions (d3), cannot apply to research involving children.
Secondary Research involving the access of identifiable data, if these sources are (i) publicly available or (ii) the information is “recorded by the researcher in such a manner that participants cannot be readily identified” [46.104(d)(4)]. Typically, a researcher obtains a data set generated by other projects (whether for a research purpose or not), and agrees not to make any effort to identify or contact participants. Less commonly, the exemption may apply to cases where the researcher themselves had previously generated the information as part of a non-research project or class activity, but retrospectively decides that it would be valuable to communicate findings more generally. In such cases, the IRB will closely look at circumstances of the original data collection, and may recommend either informing participants of the emerging research interest in their data, obtaining consent from participants for that use, or doing a new study in that context as a research project.
Studies that may receive expedited review:
Most non-exempt human research studies submitted to IRB02 will receive “expedited review,” because they present no more than minimal risk, and fall into one of several specified categories of research that qualify for expedited review by an individual IRB member (typically the Chair or Vice Chair). The expedited reviewer will on occasion seek a second review from another Board member or an outside expert or consultant, or refer the study to the Full Board for review. A study can be approved by this expedited process, but cannot be disapproved. In such cases, the study will be referred to the Full Board.
The most common basis for expedited review by IRB02 involves “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) [Category 7]. (With the new exemption for “benign behavioral interventions,” many studies that previously received expedited review will now be exempt).
The expedited list includes collection of data by certain noninvasive procedures “routinely employed in clinical practice,” including passive recording of muscular, brain, or circulatory activity, moderate physical exercise or dietary interventions, and certain kinds of biomechanical and kinesiological studies. [Category 4]. Note that brain imaging methods such as fMRI, and interventions such as tCMS, must be reviewed by IRB01, whether or not they qualify for expedited review.
Studies requiring the review of the full IRB02 at a convened meeting:
Studies that may involve more than minimal risk to research participants are reviewed by the IRB02 at a convened meeting. IRB02 meetings are held monthly at a time and place that is subject to change from semester to semester. Information regarding the time and place of meetings may be obtained by contacting the IRB02 office. Studies that necessitate review at a convened meeting must be received in the IRB02 office prior to the first work day of the month.
In practice, the large majority of studies received by IRB02 qualify for exempt or expedited review, as they involve no more than minimal risk to participants. Similarly, studies involving potentially vulnerable populations, such as students, children or prisoners, may concern benign aspects of behavior (e.g., measurement of attitudes toward recreational activities), or provide adequate protection of participant’s rights and well-being that make it a minimal-risk study, and as such may qualify for expedited review.
Principal Investigators and Co-Principal Investigators may attend the IRB02 meeting to provide information to the members, but they may not be present during the final discussions and vote. IRB02 members may not participate in the review and approval process of their own studies.
Studies where procedure plans or research instruments are not yet complete
Various funding agencies may require documentation of IRB review and approval before awarding funds to support the research. However, the specific plans for any human subjects research may not be in place at that point. In such cases, the IRB may recommend limiting the submission to describe preparatory activities and goals of the research, and a broad description of what future human subjects research will be added to the study in later revisions. The IRB can approve such a submission as exempt, “not human subjects” research.