Step 3 - General Research Compliance Submission Guidance

KCU Student Research Activity Application

Students receive approval to perform any research activity prior to starting the project with a faculty mentor (either at KCU or an external institution). Once the student and faculty mentor have selected a project and it is approved by KCU or an external Institutional Review Board (IRB), Institutional Biosafety Committee (IBC) or Institutional Animal Care and Use Committee  (IACUC), then the student should complete the KCU Student Research Activity Application and send it directly to the Research Compliance Office for review, guidance on research compliance requirements and approval.

If the student and faculty mentor have selected a project and the project has not been submitted or received any internal or external approval by the appropriate research compliance oversight committee, the student should contact the Research Compliance Office for direction on next steps prior to completing the research activity application.  

• Student research-related rules and approval criteria

CITI Training

Through the Office of Research Compliance and Dalal Canyon, a decision will be made to determine if your activity fits the federal definition of research. If your project aligns with the federal definition of research, you must maintain compliance with the federal regulations regarding the act of researching.

Complying with the federal research rules begins with obtaining the required research education and certification through the Collaborative Institutional Training Initiative (CITI), depending upon what type of research will be conducted. Additional information can be found here. 

The University has developed policies regarding which CITI training courses are required. The following links provide basic information about registering for the training and some information about which courses are likely required based on University policies. However, you should confirm the required courses with Research Compliance Administrator Dalal Canyon. 

• KCU IRB policy on required CITI training for human specimens or data or human subjects’ research (IRB).
• KCU IBC policy on required CITI training for cadavers, human specimens, biohazardous or toxic materials or rDNA research (IBC).
• KCU IACUC policy on required CITI training for animal research (IACUC).
• General FAQs regarding IRB, IBC and IACUC and CITI training.

A copy of every investigator, co-investigator or any additional research personnel’s CITI training completion certificates must be submitted with the IRB, IBC or IACUC application. 

IRB, IACUC or IBC Approval

The next step in research compliance is demonstrating that the research is being conducted in a safe manner according to the KCU standard operating procedures and policies and any applicable federal regulations or guidelines. Additionally, humans, human specimens or data, or animals being studied must be protected to the extent that the benefits of research outweigh the possible harms, and that proper steps are taken to minimize those risks.

This involves submitting descriptions of your research protocol and data management to the IRB for work with humans or human data or specimens, the IACUC if it involves animals, and the IBC for work with cadavers, laboratory or human specimens, and any biohazardous or toxic materials. All submissions to these committees are placed through the Research Compliance System portal.

• IRBNet System FAQs 
• The Institutional Review Board Committee (IRB) Information
• The Institutional Animal Care and Use Committee (IACUC) Information
• The Institutional Biosafety Committee (IBC) Information
• Frequently Asked Questions for IRB, IBC or IACUC research applications

Approval of KCU’s research compliance will vary based upon the complexity and type of research. The application and all submitted forms will be reviewed by the respective committee at their monthly meetings, as applicable. Delays in the process usually stem from incomplete section responses or vague details within the applications. This results in committee requests for clarifications and modifications, followed by application revisions and subsequent re-submission to the respective committees.

The strongest applications follow these recommendations:

• Complete the IRB, IBC or IACUC application, including the provision of CITI training certificates for all research personnel.
• Ensure there are no discrepancies between sections.
• Answer all of the questions completely.
• Ask your principal investigator mentor to view all documents before submission or re-submission.

Along with the IRB, IBC or IACUC research application, submit all research-associated forms for the committees’ review. Confirm your list of needed forms with the research compliance administrator. 

• IRBNet submission process FAQs

Expected research compliance forms include, but are not limited to:

• Active CITI training completion certificates (not expired).
• Conflicts of interest disclosure forms.
• Copies of any element of the study as applicable, including:
  • Study advertisement/recruitment emails
  • Study consent forms that would be provided to participants
  • Study documents (e.g., surveys)
• Any forms that are not in English should have both originals and English-translated copies.
• All details and specifics should be confirmed with the Office of Research Compliance.

Standard Operating Procedures for Research Compliance

• IRB
• IBC
• IACUC
• Research