KDHE Institutional Review Board (IRB)
What is the KDHE IRB?
The KDHE Institutional Review Board (IRB), sometimes called the Human Subjects Review Board, includes members with diverse backgrounds and is designed to implement basic ethical principles for people during KDHE public health research activities. The KDHE IRB is committed to protecting people’s health, emotional well being, or social well being during public health research.
What does the IRB do?
The IRB protects volunteers for public health research by requiring investigators to assure that volunteers:
- understand and consent to the research they are volunteering for,
- understand the potential risks to the research,
- are willing to take those risks,
- and that the volunteer may withdraw from the research at any time without penalty or retribution.
How often does the KDHE IRB meet?
The KHDE IRB will meet every quarter from 1 to 3 p.m. on the following dates:
February 28, 2014
May 30, 2014
August 29, 2014
November 21, 2014
Who needs to get approval of the KDHE IRB?
IRB approval is needed for any research that involves data obtained through intervention or interaction with the individual, or from identifiable private information. Approval must be granted BEFORE the research begins.
Once approved, the IRB reviews the status of the research at least annually until the research is finished, to ensure the welfare of the volunteers is being maintained. The IRB has the authority to suspend or terminate approved research that is not being conducted in accordance with the IRB's requirements, or that has been associated with unexpected serious harm to subjects.
How do I know if IRB approval is needed?
The IRB distinguishes research from the routine activities of public health. A determination that an activity is exempt from the IRB approval process does not imply that investigators have no ethical responsibilities to subjects in such research; it means only that the regulatory requirements related to IRB review do not apply to the activity. If there is a question about whether a planned or existing activity is routine public health service, exempt from IRB review, or whether it is research that needs IRB review and approval, please contact the KDHE IRB Chair (Nathan Bainbridge, NBainbridge@kdheks.gov).
Is it public health practice or research?
This is one of the most important questions in public health practice.
For a few activities in pubic health. distinguishing public health practice and research is easy. Practice is about protecting the public’s health. It includes epidemiological investigations, surveillance, programmatic evaluations, and clinical care for the population. It is the collection and analysis of identifiable health data by a public health authority for the purpose of protecting the health of a community.
Research involves human subjects for the purpose of generating knowledge that benefits those beyond the participating community who bear the risks of participation. Public health practitioners engage in research activities for reasons similar to any researcher’s interests: they seek to explore hypotheses, advance current knowledge, and contribute to the welfare of persons beyond the study itself.
It can be difficult to distinguish between practice and research beyond the easiest of cases. Differentiation is needed to help dispel unnecessary IRB review delays and obstacles for public health practice, avoid mistreatment of human subjects or privacy infringements, and eliminate burdens on IRBs and public health practitioners. Approaches to distinguish public health practice from research have been developed in governmental, private sector, and scholarly settings. KDHE follow the guidelines in the report on public health practice vs. research by the Council of State and Territorial Epidemiologists (CSTE).
More on Public Health Practice vs. Research
More information on Human Subjects Research and IRB
Office of Human Subjects Research Protection http://www.hhs.gov/ohrp/education/training/introduction.html
IRB Procedures, Submission Forms and Projects
- IRB Request Form (.doc)
- IRB Exemption Request Form (.doc)
- IRB Procedures for Researcher (.pdf)
- IRB Submission (.pdf)
IRB Committee Members