Review Categories & Timeline

If your study involves human subjects, the IRB must assess whether risks exist in the data collection process, regardless of your intent to present or publish. We recommend CITI training for all researchers conducting research involving human subjects; however, it is not required for applications judged to be Exempt. 

Examples of Exempt projects:

• Educational research. Using student-related data to evaluate curricula or other pedagogical practices, provided that students cannot be identified, and participation remains voluntary if activities are additional to required course activities.

• Research that is already protected adequately by existing policies. Some types of research do not need the protective measures required by human subjects regulations because the research provides adequate protections to subjects through other regulations. This does not mean that because you are doing research in a clinic that must adhere to HIPAA regulations, you qualify for Exempt status with the IRB -- but it does mean that you can present that argument to us in your application and we will evaluate it.

• 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.

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

• 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.

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

If your project falls within one of the preceding, potentially Exempt categories, the IRB will then consider:

• Are vulnerable subjects involved (for example: children or prisoners)?

• Will you collect or keep direct (name, address, phone number) or indirect (demographics, etc.) identifiers?

• Will you collect private or sensitive information/data?

• Could collecting or retaining this data any risk to participants?

If the answer is YES to any of these four questions and/or your project does not appear to fit the preceding Exempt categories, the IRB will likely request an Expedited/Full-Board submission. 

Before completing an Exempt application, we recommend that you consult with the IRB regarding the level of review that your project will require.

Unlike Exempt research, 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 before you submit a project for review at the Expedited level.

Here is a Complete list of biomedical categories permitted under expedited review, according to Federal regulations 45 CFR 46.110. 

Common characteristics of Expedited projects:

• The research collects direct identifiers (including voice, video, digital, or image recordings) linked to responses of a more personal or sensitive nature.
• The research focuses on potentially vulnerable populations (e.g., children, adults with decisional impairments, prisoners, homeless persons, elderly individuals, undocumented citizens).
• The research activity may cause distress for participants beyond what would be normal in everyday life.
• 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).
• Methodologies may include (in person, or via phone/Skype, etc.) interviews, surveys, and focus groups.

When research activities pose risks to participants significantly higher than those encountered in daily life, the study will need review by the full IRB Committee. You must complete CITI human subjects training before you submit a project for review at the Full-Board level. Full-Board reviews require more time for both you and for the Committee, so be sure to read the timeline information below.  

Full-Board reviews typically involve:

• Minors (under the age of 18), when the study involves sensitive information.
• 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.)
• Incarcerated subjects or persons under a correctional sentence (parolees).
• Individuals with decisional impairment (depending on the nature of the study, this population may meet expedited criteria).
• Research involving abuse, drug use, sexuality, AIDS.
• Research involving deception (withholding information so that participants cannot adequately give informed consent) if the study involves sensitive information.
• Certain biomedical procedures.
• Experimental procedures that may place subjects at higher risk.
• Research involving heightened physical discomfort, risk of injury, invasive procedures, vulnerability to harassment, invasion of privacy, or information creating legal vulnerability.
• Research involving the use of drugs, dietary assessment/manipulation, or any medical/clinical assessment of non-anonymous patients or volunteers.

The SU IRB Office is currently experiencing personnel changes. In particular, we are in the process of onboarding a replacement for the role of IRB Director. We ask for your patience as ALL research applications, regardless of status, are taking longer to process during this period.  

Exempt studies: reviewed on a rolling basis.

Expedited studies: reviewed on a rolling basis). Once you have resubmitted clarifications or revisions to meet conditions for approval, the IRB will issue a formal approval letter. 

Full-board studies: You must submit full-board studies 2-3 weeks before the monthly meeting (see IRB Full Board schedule for meetings and deadlines). Please plan to attend a short segment of the meeting to provide any clarifications. The IRB will provide feedback after the meeting. Once you have attended to further revisions, the primary reviewers will determine whether the protocol meets conditions for approval. If so, the IRB will issue a formal approval letter. Rarely, a protocol may require a second full-board review and revision process. 

NOTE: The IRB does not assign protocols for review to our faculty reviewers during formal University breaks and holidays. Additionally, the SU IRB conducts no full-board reviews over summer.