IRB FAQ Levels of Review

What is full board review?

Review as a fully convened meeting is required for all applications that are determined to be Level III protocols. This means that an application cannot be approved without first being reviewed at a fully-convened IRB meeting. When an application is reviewed at a convened IRB meeting the research protocol is listed on the meeting agenda for discussion and subsequent voting by the board for approval, tabling, approve contingent, or disapproval. PIs must attend the meeting to address questions or comments from the board. If a graduate student is the PI, then their faculty adviser for the project must also be in attendance at the IRB meeting. You will receive an email from the KSU Compliance office if your application is being reviewed as a Level III protocol.

My protocol is being reviewed as a level III application but I cannot attend the meeting. What should I do?

Notify the IRB office that you cannot attend the meeting. Your protocol will be added to the next agenda or we can organize a conference call.

What does exempt review mean?

exempt means that your project is exempt from having an annual review. It does not mean that your project is exempt from IRB review. For a project to be exempt from annual review it must fit into one of three categories.

research conducted in established or commonly accepted education settings, involving normal educational practices.

Research involving the use of education tests (cognitive, diagnostic, aptitude, achievement) survey procedures interview procedures, or observation of public behavior, unless (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects, and (ii) disclosure of the human subjects' response outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.

Research involving the collection or study of existing data documents, record, pathologic specimens or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.

ONLY the IRB can determine if a project is exempt and does not need further review.

What are some examples of research that may be exempt?

biographies
analyzing de-identified data that is available publicly
service or course evaluations
oral histories that are designed solely to create a record of specific historical events

I am just adminstering a survey or questionnaire, do I need IRB approval? What if I am only interviewing a few people or having a small focus group?

Yes. All proposals that will involve research with human subjects that will be conducted under the auspices of KSU must be prospectively reviewed by the IRB, including those studies involving only a few subjects. Depending upon the types of data collected, the project may be eligible for exempt from annual review or expedited review. In addition, the IRB may require additional safeguards for vulnerable populations involved in this type of research.

If I am teaching at a Pre-K or K-12 school, can I conduct research there?

Probably. You will need to provide the IRB with written documents from the designated authority at your school district that is able to officially approve research to be conducted in the class room.

I am a teacher, can I do research in my own classroom with my own students?

Probably. If you teach at a Pre-K or K-12 school, you will need written documents from the designated authority at your school district that is able to officially approve research to be conducted in a classroom.

Also, you will need to include information in the consent form's risks section that students may feel pressure to participate since you are their teacher. Please note that participation or non-participation will have no affect on their grade or standing in your class.

I've already started a research project and didn't realize that I needed to receive IRB approval first. What should I do?

The research activities must be reported to the IRB as soon as possible. The IRB may not grant retroactive approval. If approval was not obtained prospectively, a researcher should immediately cease study procedures and contact the IRB. The researcher will be asked to submit an application to the IRB for review and included an explanation for why s/he thought that IRB approval was not required. Based on the information provided, the IRB will conduct an inquiry.

Do I need IRB approval if my data collection will be conducted off campus?

All proposals that will involve research with human subjects and that will be conducted under the auspices of KSU must be submitted to the KSU IRB for review and approval or exemption. This requirement applies regardless of the physical site of research activity - this includes online activity as well.

What is an FWA?

Under the Department of Health and Human Services (DHHS) human subject protection regulations, 45CFR46.103, requires that every institution engaged in human subjects research supported or conducted by DHHS must obtain an assurance of compliance approved by the Office of Human Research Protections (OHRP). Most academic research institutions have a Federal Wide Assurance (FWA), which allows them to conduct many different types of research projects. The assurance formalizes the institution's commitment to protect human subjects. KSU, like many universities, extends protections of the federal regulations to all research conducted under the auspices of the institution, regardless of source of funding or lack thereof.

What is KSU's FWA?

00001853

What are the researcher's responsibilities if a serious or unexpected adverse event occurs?

All adverse events that occur during the conduct of a research protocol involving human subjects must be addressed in accordance with sound professional judgement, and requirements of the sponsor, federal regulations, and institutional policy. The adverse event must be reported to the IRB as soon as possible via the Annual Review - Periodic Review - Adverse Event form.