Types of Study Review by the IRB
Studies are initially reviewed by the IRB02 Chair or Vice-chair to determine:
- If the proposed activity is research, as defined by the Code of Federal Regulations (as opposed to program evaluation or quality assurance, for example)
- If it is research, if it is exempt from IRB review
- If it is not exempt, whether it qualifies for expedited review
- Whether it needs to be reviewed by the convened Board
Is the proposed activity research?
The Code of Federal Regulations 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, including 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. Whether or not 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 to be reviewed by the IRB process.
It’s not uncommon for such activities to have both service 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 very 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.
Studies that may be exempt from review by the IRB
45 CFR 46.101(b) describes several categories of research activities that may be exempt from IRB review.
One broad category concerns evaluation of “normal educational practices,” instructional techniques or classroom management methods [46.101(b)(1)]. In some cases, IRB02 has exempted such educational research from review; more commonly, there are other components to the research (for example, examination of student personality characteristics and how this influences their response to lessons, teacher profiles, etc.) that need review, so the IRB tends to be fairly conservative in granting this exemption.
Similarly, 46.101(b)(2), which allows exemption for “educational tests, surveys, interviews or observations of public behavior,” as long as no identifiable data are collected the disclosure of which could put the participant at risk for various harms. We also interpret this exemption narrowly, and rarely exempt studies from review merely because they involve benign tests or questionnaires.
Research involving the “collection or study of existing data, documents, records, pathological or diagnostic specimens, if these sources are publicly available or if the information is recorded by the researcher in such a manner that participants cannot be identified” [46.101(b)4)], may also be exempt from review. This is the most common grounds for exemption from IRB02 review. Several considerations are particularly important in making this judgment:
- Even if the data provided to the investigator include identifiers, they may still be “recorded” for the investigator’s research stripped of those identifiers. In such cases, the work may still be exempt from review.
- The data must already exist at the time the study is submitted. The IRB cannot exempt from review data that will be collected at some point in the future.
There are a few challenging areas with this exemption. For example, if an instructor decides after a term has ended that data from student projects or assignments are worthy of scientific study and publication, and argues that the data is (a) already existing and (b) will be de-identified, we are likely to suggest that they submit a study for collection of a new data set from an upcoming class, as we cannot provide retrospective approval of a research project. Under some circumstances, for example if the conditions of collection were a unique opportunity, we may suggest that the instructor seek approval from the students for use of their data for research purposes.
Another challenging circumstance is when the investigator is a director of a sevice program, and the data are initially generated as part of a program evaluation or clinical treatment, but the investigator intends from the outset to also use the data for scientific purposes. In such cases, we strongly recommend that approval for use of the data for such purposes be sought from the program participants up front, and IRB approval for the effort obtained, rather than treat the data at some later point as “exising and de-identified.”
Investigators are cautioned that the decision as to whether a study meets the criteria for exemption rests with the IRB02. Under normal circumstances, the Chair is able to review studies in this category within five business days after receipt of a substantively complete submission.
Studies that may receive expedited review:
A list of specific research categories that, while not exempt, may receive “expedited review,” is provided by the regulations.
Research that involves no more than minimal risk and falls within one or more of these following categories (as outlined in and listed below) can receive expedited review under most circumstances.
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) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.” that is otherwise not exempt from review [category #7].
The list includes certain procdures that might be considered clinical or biomedical in nature, but do not involve invasive methods. These include collection of excreta, sweat, or uncannulated saliva; non-invasive procedures routinely employed in clinical practice (i,e., weighing, testing of sensory acuity, thermography, electrocardiography, electroencephalography, or MRI); moderate physical exercise or dietary interventions, and certain kinds of biomechanical and kinesiological studies.
Collection and recording of data from participants 18 years or older using
This means that most studies that involve no more than minimal risk and do not involve vulnerable populations of research participants (other than minors) and are not otherwise exempt from full IRB02 review (see above), may receive expedited review. In that case, the person doing the preliminary determination of a protocol’s status (as described above, the Chair or Vice-chair) will proceed with the expedited review. They will on occasion seek a second review from another Board member or an outside expert or consultant.
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 (see below).
Studies requiring the review of the full IRB02 at a convened meeting:
Studies require review by the full IRB02 at a convened meeting unless they meet the criteria for expedited review or exemption. This means studies that may involve more than minimal risk to research participants, or involve vulnerable populations of 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 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
Other studies where there is no immediate involvement of human participants, such as training grants or where the research protocol is not complete or the research instruments are yet to be developed, generally fall into a special category (“Indefinite Plans”) that are reviewed solely by the UFIRB Chair in the same manner as exempt studies. Upon completion of review a letter advising to proceed with the funding request will be sent to the Principal Investigator. A copy of this letter is sent to the Office of Research, Technology and Graduate Education. When funded a detailed protocol describing the research (including the informed consent process and research instruments) must be reviewed and approved by the IRB02. Allow up to four weeks for this process.
For all studies the IRB02 assessment of risks and anticipated benefits involves:
- Identifying the risks associated with the research, as distinguished from the risks the participants would encounter even if not participating in research;
- Determining that the risks will be minimized to the extent possible;
- Identifying the probable benefits to be derived from the research;
- Determining that the risks are reasonable in relation to the benefits to research participants, if any, and the importance of the knowledge to be gained;
- Assuring that potential participants will be provided with an accurate and fair description of the risks or discomforts and the anticipated benefits; and
- Determining intervals of periodic review, and, where appropriate, determining that adequate provisions are in place for monitoring the data collected.
In addition, the IRB02 will determine the adequacy of the provisions to protect the privacy of research participants and to maintain the confidentiality of the data, and where the participants are likely to be members of a vulnerable population, determine that appropriate additional safeguards are in place to protect the rights and welfare of these research participants.