Review of initial applications for non-research projects, non-human subjects research projects, and exempt research
Projects that do not meet the definitions of research or a clinical investigation by the Department of Health and Human Services’ Office for Human Research Protections (OHRP) or the Food and Drug Administration (FDA), or that do meet these definitions but is considered by OHRP to be exempt should be finalized by the IRB Administration within 4-6 weeks of submission. In most cases, the IRB Administration will take one or more of the following actions regarding these projects within 4-6 weeks of submission:
1. Determine the study is not research, not human subjects research, or is exempt from IRB review according to OHRP or FDA regulations.
2. Request more information from the PI regarding their project through the Human Ethics (IRB) submission system.
3. Determine that the study is non-exempt research requires IRB review as described below.
If you are unsure if your project is research, human subjects research, or exempt human subjects research, you may contact the IRB Administration at irb@appstate.edu or 828-262-4060.
IRB review of Human Subjects Research
Researchers are encouraged to submit initial applications for non-exempt research in the Human Ethics (IRB) submission system at least 10-12 weeks prior to when they plan to begin recruitment of human subjects for research.
Technical Review.
All initial applications will receive a regulatory and administrative review by the IRB Administration (which we call a “technical review”) to ensure that the submission is complete, internally consistent, and clearly describes the aspects of the research related to the criteria for IRB approval as outlined in OHRP regulations:
- Minimization of risks: risks to subjects should be minimized by using the least risky procedures possible to attain the necessary data, and through sound study design.
- Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result: in order to determine if the risks are reasonable it relation to the benefits, we require clear descriptions of the study questions, the rationale for conducting the research, the study procedures, the risks, how the risks will be mitigated, and documentation of the expertise of study personnel to conduct the research.
- Equitable selection of subjects: who will be recruited and how they will be recruited should be clearly described in your application, as should any relationship you have with the subjects population (i.e. ASU students).
- The informed consent process and materials: Thno e materials should be consistent with the procedures and risks described in your application and must contain all of the required elements of consent described by OHRP and contained in our informed consent template.
- Data and Safety Monitoring: In clinical trials, studies involving an intervention, or studies that are more than minimal risk, the plan for monitoring the data collected to ensure the safety of subjects should be included with your application.
- Confidentiality protections: Adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data should be clearly described.
- Vulnerable populations: When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons, additional safeguards must be clearly described in the application to protect the rights and welfare of these subjects.
The technical review will involve requests for further information regarding the points above and will continue until all sections of the application are complete, clear, and consistent with one another. Submitting incomplete, inconsistent, poorly designed, or unclear applications will result in significant delays in the IRB review and approval of your application to conduct human subject research.
Determination of the necessary level of review.
Once the technical review is complete, your study will be reviewed by the IRB Chair with consultation from the Administrator and other IRB members with expertise in the particular area of research. They will make a preliminary determination of risk and determine if the study procedures meet one of the categories of research determined by OHRP to be eligible for expedited review by a sub-committee by the IRB. There can be three outcomes from this review:
1. Further requests for information and clarification of your application in Human Ethics (RIB).
2. A determination that the study is eligible for review by a sub-committee of the IRB.
3. A determination that the study is not eligible for expedited review, and will be added to the agenda for the next monthly full IRB meeting based on the availability of IRB members with sufficient experience in the area of the proposed research, and on the overall application load of the meeting.
Expedited IRB Review.
Applications eligible for expedited review will be reviewed by a sub-committee consisting of the IRB chair and any other IRB members, consultants, and IRB administration staff they deem necessary for conducting a thorough review. Initial applications reviewed by expedited process can have three possible outcomes:
1. Your study will be approved as is.
2. The sub-committee may request further information regarding the criteria for approval, application completeness, and application clarity, or for specific changes to study materials. In this case, once the PI responds to the sub-committee, the IRB Chair, or an IRB member appointed by the Chair will review the new information and determine if the study can be approved or if more changes are necessary.
3. A determination that the application needs to be reviewed by the full IRB. In this case, your application will be added to the agenda for the next monthly full IRB meeting based on the availability of IRB members with sufficient experience in the area of research, and on the overall application load of the meeting.
You will receive written notification of the outcome of expedited review within one week of the review.
Full IRB Review of Research.
Initial applications that require full IRB review will be reviewed at the next available monthly meeting, based on the ability of the IRB to have quorum, the presence of IRB members with experience with the research procedures and population described in the application, and space on the meeting agenda. The IRB meets as needed to review human subjects research applications every third Tuesday each month. You can find the schedule for upcoming meetings here.
You will be notified regarding when the IRB will review your application, and invited to attend the meeting to answer any questions the IRB might have regarding your research.
There are three possible outcomes for a study reviewed by the full IRB:
1. Approval. In this case, the IRB decides that the study meets the criteria for approval without requiring any additional changes.
2. Approval with stipulations. The IRB decides the study will meet the criteria for approval if specific changes are made to the application. Once you have made the stipulated changes, they will be verified by the IRB Administration, the IRB chair, or the primary IRB reviewer (as decided by the convened IRB) and you will receive full approval.
3. Deferral. The IRB defers action on the application until you provide further, substantive information regarding the criteria for approval of research. Any change you make to the application will be subject to additional technical review, and once the application contains the new information and is clear and complete, it will be re-reviewed by the full IRB at the next available meeting.
4. Disapproval. The IRB decides criteria for IRB approval cannot be met even with substantive changes to the application.