The following review levels and definitions are defined by the Code of Federal Regulations, Title 45, Part 46, published by the Office for Human Research Protection.
Actions of the Institutional Review Board
Once successfully submitted, the AU IRB Chair and the Institutional Research Data & Research Specialist are automatically notified via IRBNet. The Specialist will review the application within five business days to ensure it is complete. The Application will be labeled Acknowledged if all required documents are included or Information Required if documents are missing and/or incomplete. Details will be communicated with the Primary Investigator about what specific documents are missing. Once the Application is complete, it will move forward for review. The AU IRB Chair will then determine the Type of Review required and assign reviewers accordingly. Applications requiring full convening of the IRB are held pending the next scheduled IRB meeting.
Types of Review
Exclusions are studies that do not require the Primary Researcher to submit an IRB Application for reasons which center on whether the proposed activity meets the definition of research, is inherently low risk, or for which protections are mandated elsewhere (i.e., research that is FDA-regulated). Those specific categories to qualify as Excluded research are listed in Appendix A.
The Research Determination Tool guides the Primary Investigator through the decision process for Exempted research. If a research proposal meets the criteria for Exemption (specific categories for this determination can be found on the U.S. Department of Health and Human Services website), an IRB Application does not need to be submitted. In general, research proposals meet the criteria for Exempted Review if there is no more than minimal risk, participant selection does not involve vulnerable populations (i.e., children, prisoners, cognitively impaired individuals, fetuses, etc.), and if secondary or de-identified, aggregate data from a group is used.
When a research proposal involves minimal risk and meets other requirements for human participant protections (see Appendix B for the conditions that must be met to qualify for Expedited Review), the IRB Application qualifies for Expedited Review. These reviews are conducted by the AU IRB Chair and at least one other member chosen by the Chair based on a rotating review schedule or by expertise required by the proposal. Reviews are to be completed with 1 week of the Acknowledgement notification from AU IRB. Applicants may be requested to provide additional information, clarify information, or submit additional documents. The PI is notified vias IRBNet when an Approved decision is reached and will be provided with an official letter of Approval by the AU IRB Chair.
Research previously approved by the convened IRB undergoes Continuing Review until its expiration date, which is 1 year after initial approval unless a Study Continuation form has been approved. Continuing Review is an administrative process completed by the AU IRB Chair. Further information about the criteria for Continuing Review can be found in Appendix C.
Full Review by the Convened IRB
Review Outcomes
- Approved - As IRB Approval is only granted for one year, the Primary Investigator must apply for Study Continuation if the research extends beyond that year. Applicants must also contact the IRB with any changes to the research protocol (using the Study Modification form) and upon completion of the research (using the Study Completion form).
- Approved with Conditions - If any of the required information is not included in the Application or if additional details are necessary, researchers may receive this decision. They will receive a letter that specifies what information is needed. These documents should be added to the Application in IRB Net using the Instructions for Submitting a Subsequent Package in a Project.
- Not Approved – This decision is made for Applications which do not meet the requirement to minimize risk or have not provided adequate protections for vulnerable participants or have an incomplete or inadequate Informed Consent process. The researchers will be notified of this decision and can resubmit an Application up to a limit of three times to gain Approval, after which a new Project must be started for consideration.
Operations of the Institutional Review Board
- Organizational Authority
- Communication
- IRBNet generated
This procedure establishes the process to prepare for a convened AU IRB Meeting. The IRB Chair sends an agenda at least seven calendar days prior to the scheduled full IRB meeting and provides access via IRBNet for Review of Applications. Overall scientific and scholarly validity is reviewed with specific attention to the provision of clear details regarding the objectives, background, setting, procedures, data and safety monitoring plan, risks, potential benefits, and alternatives to participation.
Attendance is recorded in the meeting minutes, with notation of whether that is in-person or via teleconference. Members will be asked to acknowledge any Conflicting Interests for individual applications during the review of the agenda. A quorum (defined as greater than one half of all IRB members being present) must be maintained for all IRB activity and applications may be deferred if quorum is in jeopardy.
Consultants are asked to present their review but are not included in the vote on the proposal. When research involves vulnerable populations, at least one individual who is knowledgeable about or experienced in working with such participants will be present at the meeting. Once discussion has ensued on the IRB application under consideration, a motion is made to approve, approve with conditions, defer, disapprove, or suspend/terminate the application and a vote is taken. A record of the additional information, any substantive changes, and/ or required modifications, is made and shared with the investigator as per the communication plan noted above. Minor or prescriptive changes or requirements may be reviewed for approval by the IRB Chair; otherwise, the full IRB will meet to review the materials and vote on its approval.
