If your research involves human subjects or is regulated by the Food and Drug Administration (FDA), it requires review and approval from an institutional review board (IRB). Start by answering these questions:

1. Is it human subjects research?
   • Is your project a systematic investigation designed to produce generalizable knowledge?
   • Will your research collect information or specimens from living individuals through interaction or interventions?
   • Will you collect, use, analyze, or create identifiable information or biospecimens about living individuals?
2. Is it research involving the FDA?
   • Does the research involve the study of a drug, biologic, or device regulated by the FDA?
   • Will research data be reported to the FDA?
3. Our Decision Tree guides you through a determination of whether IRB review is required and, if so, which type of application form most likely fits your project. This Decision Tree video will walk you through completing the Decision Tree.

If you answered yes to 1 or 2 above, then your study requires IRB review and approval.

If neither 1 or 2 apply to your project, please consider whether your project might qualify as Not Human Subjects Research or Quality Improvement. You may contact the IRB office for additional guidance.

At KU Medical Center there are five IRB review and application types:

• Review Type Tutorial

• Flexible IRB Review

  Projects that are minimal risk and are not associated with federal funding or support may qualify for Flexible IRB Review. Examples include behavioral interventions or minimal-risk biomedical procedures. Flexible IRB review allows abbreviated IRB applications and consent forms, streamlined review by IRB Chair or staff members and elimination of the continuing review requirement. Visit Flexible IRB Review for more detailed information.

• Secondary Research

  Secondary research involves the analysis of data or specimens that have been or will be collected for non-research purposes. Secondary research may also include analysis of data or specimens that were collected under other research protocols. Examples include chart reviews, use of existing specimen repositories, and big data research.

• Exempt Research

  Exempt research involves low-risk studies, federally funded or supported, that meet criteria specified by federal regulations. Examples include online surveys, interviews and focus groups, and research on education or curricula.

• Expedited Research

  Expedited research includes studies, federally funded or supported, that meet specific categories in the federal regulations and involve no greater than minimal risk. Expedited review procedures allow the IRB to review without convening a full IRB meeting. Examples include analysis of non-invasive collection of biospecimens, MRI studies, creating a data registry or repository for future studies, or minimal risk behavioral interventions.

• Full-Board Review

  Full-board studies are those that do not qualify for any of four categories above. These studies are reviewed at convened board meetings. KU Medical Center IRB meetings occur six times monthly.

Two charts provide additional help to select the appropriate application form:

• IRB application type for projects under federal regulation (PDF)
• IRB application type for projects when federal regulations do not apply (PDF)

• Submission requirements are tailored to the type of IRB submission. Users will answer basic questions on the 'Smart Tabs' of the electronic application and upload key documents into the relevant tabs. The list of Documents to Prepare (PDF) guides the study team about which items should be uploaded into eCompliance.
• Please find more information on the how to submit a new study page.

All KU Medical Center and KULC faculty may exercise the privilege of being named as principal investigator (PI) or project director on proposals. University or hospital staff may qualify to serve as PI when approved by the appropriate chair, dean, center director or hospital administrator. Qualifications for PIs are determined by the HRPP in consultation with institutional leaders.

Faculty members from affiliated institutions may be approved to serve as PI for a KU Medical Center project on a case-by-case basis.

For more detailed information about PI responsibilities visit IRB SOP 18.0.

All KU Medical Center research personnel, KU Medical Center staff, affiliated staff and collaborators from other institutions who participate in human subjects research at KU Medical Center must pass and maintain current Human Research Protection training. KU Medical Center partners with CITI (Collaborative Institutional Training Initiative) to provide Human Research Protection training. Training must be renewed every three years.

Research personnel should complete either the Biomedical Basic Course or the Social-Behavioral Basic Course, depending on the type of research activity planned. Advanced courses may be required if research involves vulnerable populations. For research personnel who previously completed Social-Behavioral training and are now involved in biomedical research, an additional course "FDA Research for Social-Behavioral Investigators" will satisfy this requirement.

The CITI system also is used for training in Good Clinical Practice (GCP) and Responsible Conduct of Research (RCR), if applicable. However, GCP and RCR training are separate requirements and can NOT be substituted for the Human Subjects Protections requirement.

Detailed information on how to access, complete and verify training can be found in the CITI Guide to Getting Started (PDF). While it is important to complete your CITI training for Human Research Protection and Conflict of Interest in a timely manner, we ask that you wait until you have access to eCompliance before you log into CITI. Once you are able to log into eCompliance, you can log into CITI and click on the LOG IN THROUGH MY INSTITUTION link.

The Research Institute provides additional training information and guidance on RCR and GCP training.

Research proposals are submitted through our electronic IRB system called eCompliance. eCompliance houses all IRB review activities and serves as the official source for all IRB-approved documentation.

Accessing eCompliance

• KU Medical Center faculty or staff members can access the system using their KU Medical Center username and password.
• For dually-appointed personnel, please choose the campus with which a specific project is associated and then login with those credentials
• KU Medical Center students may need accounts enabled by the system administrator if they have not served on previous studies. Please contact the Office of Integrity & Compliance for assistance.
• For individuals affiliated with KU Medical Center research, but not an employee or student at the University, please contact your principal investigator (PI). The Account Requestor list by KU Medical Center Department will help the PI identify your contact to request an account.

eCompliance Guidance

Detailed instructions for how to prepare documents, access, navigate and submit within the eCompliance system are provided in the eCompliance Guidance document (PDF). Departmental training and eCompliance assistance can be arranged by contacting the IRB Office.

The Health Insurance Portability and Accountability Act of 1996 (HIPAA) is a federal law that provides safeguards that protect patient privacy. HIPAA requirements are tailored to the type of research and may affect data collection, data sharing, recruitment, informed consent, and collaborations with external entities.

• PHI Checklist (PDF)
• Common Rule SOP HIPAA: Confidentiality, Privacy, and Security of Data (login required)
• Application for Waiver of HIPAA Privacy Authorization for Studies using PHI
• Application for Partial Waiver of HIPAA Privacy Authorization for Recruitment Purposes

Visit the KU Medical Center Privacy Program for more detailed instructions.

• Additional information about recruiting can be found on the IRB recruiting guidance page.

• The PI must submit the initial submission and all major updates and modifications. PI Proxy can submit minor updates such as study team updates and responses to minor provisos. Full details are in the PI Proxy section of the eCompliance Guidance pdf. Send Proxy change requests to IRBHelp@kumc.edu.
• Requirement for PI to request proxy change in

• Guidance and forms are available on the KUMC Emergency Use

• Ensure the team member list is up-to-date and all have current COI disclosures.
• Only study team modifications can be attached to CRs; all other types of modifications to the study must be submitted separately.
• Use the most recent CR Supplement Form from the IRB Forms list.
• PI must submit the CR. Proxy can submit subsequent responses to clarifications.

• IRB Guidance has more information on specific types of research and review.
• Please see our Tutorials and Resources page for more assistance.
• For specific questions related to your submission, please e-mail the IRB Coordinator listed in eCompliance. Please note that comments left in eCompliance may not be seen by IRB staff due to system notification protocols unless “Notify IRB Staff” is selected in the comment form.
• Requests to change PI Proxy, add funding sources, or other general questions can be sent to IRBHelp@kumc.edu.