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1. Does my project need Kansas Department of Health Environment (KDHE) Institutional Review Board (IRB) approval?

If your project is considered research and it uses information from human subjects, it should be reviewed by an IRB. If your research uses data from KDHE collected on human subjects or is funded in any part by KDHE and involves human subjects, then it should be reviewed by the KDHE IRB.

2. What types of activities do not need IRB approval?

• Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.
• Public health surveillance activities, including the collection and testing of information or biospecimens, are conducted, supported, requested, ordered, required, or authorized by a public health authority. The activity needs to be conducted by a public health authority to meet this criterion. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).
  • It should be noted that the Fetal Infant Mortality Review (FIMR) projects, while considered public health surveillance, do require KDHE IRB approval. Per K.S.A 65-2422d(d) KDHE shall permit the use of data contained in vital statistical records for research purposes only, but no identifying use of them shall be made. KDHE shall permit the use of birth, death, and stillbirth certificates as identifiable data for purposes of maternal and child health surveillance and monitoring only with approval from the KDHE IRB.
• Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.
• Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.

3. What paperwork do I need to submit for IRB review?

• New Project Request Form (PDF)
• Copy of a previous IRB approval letter for the same project, if applicable
• A copy of the consent form. If the consent form has changed from a previous study administration, please track changes so that the committee can easily see any updates.
  • Please note that under the revised 2018 Common Rule, part of 45 CFR 46, the requirements for informed consent have changed. The intent of these changes is to facilitate the subjects' understanding of the proposed research and ensure that they understand how their data and biospecimens may be used.
• A copy of the protocol. If the protocol has changed from a previous study administration, please track changes so the committee can easily see any updates. The protocol should outline how the survey will be administered (paper, online, etc), who will be taking the survey, data security procedures including where the completed surveys will be kept until data entry is completed and how long all surveys will be kept before they are destroyed.
• A copy of the survey questions. If the survey instrument has changed from a previous administration, please track changes so the committee can easily see updates.
• Human subjects research certification for the principal investigator and any co-principal investigators.
• Resume or CV for the principal investigator and any co-principal investigators. Resumes should contain sufficient detail so that the committee is assured that researchers are qualified to conduct the requested research.

4. When and where are KDHE IRB meetings held?

The KDHE IRB meets quarterly in Topeka, Kansas. Please email the IRB Chairperson for the date and time of the next meeting. Each project that needs full review by the KDHE IRB must submit required paperwork no less than two weeks before a scheduled IRB meeting. A representative from the project should also plan to attend the quarterly meeting to give a brief overview of the project and answer any questions. If travel to Topeka presents an undue burden, please contact the IRB Chairperson.

5. Who participates in the Kansas Department of Health Environment (KDHE) Institutional Review Board (IRB)?

The KDHE IRB has at least five members of varying backgrounds in order to provide a complete and adequate review of human research and its institutional, legal, scientific, and social implications. The Board also includes at least one member who is not affiliated with KDHE and one member who is not a scientist.