Frequently Asked Questions - IRB

• I’ve received IRB approval. Can I request any student data or any FERPA-protected student data from Institutional Research?

  IRB approval is separate from the approval of data requests. Institutional Research (IR) will make the decision on whether to grant your data request access. Please see the following guidance on this:

  • https://research.kennesaw.edu/compliance/docs/Guiding-Principles-Access-to-PII.pdf
  • https://ferpa.kennesaw.edu/

  The University does not release FERPA-protected data without consent unless it is for institutional purposes (see above links for reference). We suggest obtaining consent from relevant students for the pieces of data you need for your project and then present this to IR.

  Please also consult our student data information page for more details and a link to the FERPA consent form.

• Do I need to get IRB approval before I request data, or should I secure the approval to receive the data before submitting an IRB form?

  Yes, you need to secure IRB approval for your project before requesting data. Data requests go through IR and they will need to see an IRB approval letter to fulfill any requests for sensitive information for a research project.

  Please also consult our student data information page for more details and a link to the FERPA consent form.

• Can I get access to email addresses from IR and send mass emails for recruitment to my project?

  No. This is prohibited. We recommend recruitment through flyers, social media, & KSU Today. Mass emailing students and/or faculty is not allowed at KSU

  Please also consult our student data information page for more details and a link to the FERPA consent form.

• Do I have to submit my research proposal to the Institutional Review Board (IRB)?

  IRB review and approval is required for projects that:

  1. Meet the federal definition of research

  Federal regulations define research as "a systematic investigation, including development, testing, and evaluation, designed to develop or contribute to generalizable knowledge."

  and

  2. Involve human subjects

  Federal regulations define a human subjects as "a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual or (2) identifiable private information."

• How do I submit an application to the IRB?

  Instructions for IRB application submission can be found here:

  https://research.kennesaw.edu/irb/cayuse-human-subjects.php. 

• What are the types of IRB review?

  There are three types of IRB review: Full board, Expedited, & Exempt. Please visit IRB Review Classifications for detailed information. 

• If my research qualifies as exempt, does this mean that I don't have to submit an application to the IRB?

  The IRB must decide whether a study can be classified as exempt. Even though an investigator may be certain that a research project classifies as exempt, it still must be submitted to the IRB for review.

• I’m a student and I’m doing a class project. Does that mean I need to complete an IRB application?

  Class projects or assignments involving human subjects are generally conducted for educational purposes or training solely to fulfill a course requirement leads to the fact that there is no intent to develop or contribute to general knowledge. This would not meet the regulatory definition of research & therefore would not need to be submitted to the IRB. However, if there is need for clarification, we are happy to answer any questions. Please note that it is expected that KSU students, faculty, & staff will uphold the same ethical treatment of those participants even if there is no need for IRB review.

• What is the faculty advisor's role in a student's project? 

  The faculty advisor is an active mentor to the student researcher and shares the responsibility for the ethical conduct of the research with the student. The advisor must support the student in the conduct of the research project after IRB approval is attained. This includes maintaining participant protections, minimizing risk, & overseeing withdrawal procedures. It is also the faculty advisor’s responsibility to ensure that ongoing IRB reporting requirements (e.g., unanticipated problems, continuing reviews, study closure, etc.) are met in a timely manner, even after the student graduates. The faculty advisor must certify the IRB application via Cayuse on the student's behalf.

• How long does it take for my project to be reviewed by the IRB?

  This depends on the type of review your study falls under. If your study is categorized as exempt, expedited, or a limited IRB Review, then please allow 14 business days for a complete review. Full-board reviews happen based on our meeting schedule and submissions must be received at least 1 month before the next meeting.

• Can the IRB approve a project retroactively? 

  No. There is no provision in the federal regulations that allow for IRB approval of research that has already been conducted. If data was collected for purposes that the IRB determines to be non-research (e.g., program evaluations for library or educational programs not initially intended to be used for research), IRB approval can be sought for the data analysis going forward.

• How long must I retain IRB records? 

  Federal regulations require research records to be retained for at least three years after the completion of the research (45 CFR 46). However, research involving identifiable health information is subject to HIPAA regulations, which states records must be kept for six years. Research sponsors may require records to be kept for a longer amount of time than federal regulations require. In sum, you must keep your records for a minimum of 3 years or longer, depending on the longest applicable standard.

• What CITI Training do I need to take? If I'm partnering with another member from an outside institution, do they need to take the training too? 

  CITI Training information can be found on the CITI Online Training page of our website. Depending on the nature of the research study, it is recommended either, “Social, Behavioral, & Educational Research with Human Subjects” or “Biomedical Research with Human Subjects” is taken. 

  If your collaborator has documentation of their institution’s required human ethics training, then you can email that to us. However, if they do not have specific human ethics training, then they will need to complete the KSU required CITI training. They can do this by signing up through CITI and affiliating with KSU. A KSU email is not required to do this.

• I just received a notice from the IRB that my study is not human subjects research. What does that mean? 

  This typically happens with student projects. We find that the results of the study are not meant to generalize to a greater population. For a study to meet the HHS definition of research, the study must be intended to contribute to a generalizable knowledge. If you are unsure if your study meets the definition of human subject’s research, please see these policies. If you are still unsure after reading these definitions, you may email us to clarify and ask questions. This determination simply means we (IRB) do not have the purview over your study as it was submitted in your application. You may continue your study without IRB purview.

• I'm a staff member or student and I keep getting an error message when I try to log into Cayuse. Why is this happening? 

  Students & staff members do not have automatic access to Cayuse and must request one through our website. Please look at the Cayuse Page on our site for more information on how a student or staff member can request access. 

• I can't figure out how to attach a document to my protocol. What do I do?

  If no attachment features are functioning on Cayuse, please email all the study attachments with the study number to: irb@kennesaw.edu.

• I have a study that I received IRB approval for years ago. Why can't I find it in Cayuse? 

  The only reason we would recommend having an older study uploaded into Cayuse is for a renewal or modification. If you have a study that is not yet uploaded into Cayuse, then please email us with the study information for us to upload as a LEGACY study. 

• I'd like to make a change to my protocol. How do I do that? 

  Under the study details page (NOTE: not this is not the same as submission details page), you will click the upper left blue + button to add a modification submission. Any changes in protocol should be reflected throughout the entire application and not just on the modification page. If the changes to your study change the purpose, participation population, or procedures, then you may have to submit a new initial application instead of a modification to the original study. Always be sure to reach out to our office for clarification on this, if needed.

• How do I use Cayuse?

  UITS has done a walk-through guide on how to create an initial submission in Cayuse. While the submission form has been updated since this guide was created, the guide does cover all the basic information you need to know. This form can be found on the Cayuse section of our website.

• I can't find my GRA in Cayuse to add them to my study. What do I do?

  If you are looking for any additional research team members and cannot find them on Cayuse, then that means they do not have a profile created yet. Please visit the Cayuse section on our website to find out how your GRA can request access to Cayuse. Once they have a profile created, you will be able to add them to the study.