More Information on Protocol Review Categories

Certain types of low-risk research submissions may be determined by us to be “Exempt” from IRB oversight. A determination of "Exempt" is not an Approval, but instead an official determination that a PI can proceed with a project without further IRB involvement.

Questions we consider while making this determination:

(1) Are vulnerable populations (e.g., prisoners, minors, pregnant women) involved?

(2) Will the PI collect direct identifiers and if so, which ones and for what purpose?

(3) Will the PI collect indirect identifiers and if so, which ones and for what purpose?

(4) Will the PI collect sensitive information?

(5) Could collecting and/or retaining this data pose any risk to participants?

(6) Are participants able to make a fully informed decision about whether to participate or not?

We recommend CITI training for all researchers conducting research involving human subjects; however, at this time, it is not required for applications judged to be Exempt.

Here are some examples of projects often proposed by SU faculty, staff, and students that are typically considered to be Exempt:

(1) Educational research. Using student-related data to evaluate curricula or other pedagogical practices, provided that students cannot be identified, the students are not minors, and participation remains voluntary.

(2) Interview/survey research on benign (non-sensitive) topics. Investigating topics about which disclosing any data would not embarrass or harm (socially, economically, etc.) a participant.

(3) Public officials or professional/program evaluation. Asking professionals about techniques, outcomes, or best practices regarding program effectiveness.

(4) Existing (extant) data.  Analyzing existing data (collected by someone else or some other organization), either de-identified or to be used in such a manner that no individual could be identified in the analysis, which would be anonymous and/or aggregated.

(5) Taste testing, food quality, and marketing research. Collecting data on public opinion regarding taste or perception of benign issues (e.g., clothing or music preferences).

All PIs who wish to submit an Exempt-level proposal to the IRB should do so through our OneAegis portal. Sign into OneAegis using your SU credentials, choose the option to begin a new submission (Xform), and then choose the "Exempt" option if you think that is appropriate for your project.

The initial determination of Exempt will be made by the Director or Committee Chair. This determination will typically take less than a week after submission by a PI. However, if the submission is missing documentation and/or is not clear methodologically, the Director or Chair will first ask for feedback. Occasionally, the Director or Chair may disagree with a PI's self-designation of "Exempt" and escalate the project to Expedited -- this necessarily lengthens the review timeline.

Please keep in mind that if you receive a determination of Exempt, you do not need to do any Continuing Review Reports, Close-Out Reports, etc.  Your project will not be assigned a tracking number by the IRB and we will not follow up with you unless we receive complaints from participants and/or you report a problem to us. 

If you do decide at a future date to change your protocol, you will have to submit a new application to us within OneAegis, precisely because we don't track Exempt protocols.

Projects reviewed at the Expedited level involve some privacy or psychological and/or physical risk to human subjects participants, but to a minimal degree. You must complete CITI human subjects training for Expedited submissions.

Expedited projects typically share some common characteristics.  These include:

(1) The research collects direct identifiers linked to responses of a more personal or sensitive nature.

(2) The research focuses on potentially vulnerable populations (e.g., children, adults with decisional impairments, prisoners, homeless persons, elderly individuals, undocumented citizens).

(3) The research activity may cause distress for participants beyond what would be normal in everyday life.

(4) There is a possibility of undue influence by the researchers or the research program (e.g., research activities in the workplace in which a supervisor may have recruitment responsibilities).

All PIs who wish to submit an Expedited-level proposal to the IRB should do so through our OneAegis portal. Sign into OneAegis using your SU credentials, choose the option to begin a new submission (Xform), and then choose the "Expedited" option if you think that is appropriate for your project.

Expedited submissions will be assigned to individual Board members by the Director and the subsequent peer review typically takes two weeks. However, if the submission is missing documentation and/or is not clear methodologically, the peer reviewers will almost certainly ask for revisions and re-review. For re-review, our reviewers are again given two weeks. Thus, an Expedited submission can take about a month to process, starting from submission all the way to Approval.

Please keep in mind that if you receive a determination of Expedited, you will need to do Continuing Review Reports annually until your project is concluded, at which point you will need to submit a Close-Out Report to the IRB.  All of these processes can be done in OneAegis.

If you do decide at a future date to change your protocol, you will need to submit a Modification Request to us within OneAegis, linked to your Expedited submission (which will have a tracking/ID number).

When research activities pose risks to participants significantly higher than those encountered in daily life, the study will need review by the full IRB. You must complete CITI human subjects training before you submit a project for review at the Full-Board level.

Full-Board studies must be submitted at least three weeks before the scheduled monthly meeting of the IRB, so that everyone on the IRB has time to review the study. Meetings typically, but not always, occur on the second Friday of every month.  Decisions will be communicated to the Project PI the following week.

Full-Board projects often involve:

(1) Minors (individuals under the age of 18), when the study involves sensitive information.

(2) Pregnant women, fetuses, or neonates. (If a subject becomes pregnant during the course of the study, you must submit a protocol modification form to be reviewed by the Full Board.)

(3) Incarcerated subjects or persons under a correctional sentence (parolees).

(4) Individuals with decisional impairments.

(5) Research involving abuse, drug use, STIs, and sexuality in discriminatory contexts.

(6) Research involving deception (withholding information so that participants cannot adequately give informed consent) if the study involves sensitive information.

(7) Certain biomedical procedures.

(8) Experimental procedures that may place subjects at higher risk.

(9) Research involving heightened physical discomfort, risk of injury, invasive procedures, vulnerability to harassment, invasion of privacy, or information creating legal vulnerability.

(10) Research involving the use of drugs, dietary assessment/manipulation, or any medical/clinical assessment of non-anonymous patients or volunteers.