The Institutional Review Board for the Protection of Human Subjects (IRB) ensures clients or employees of the Cabinet involved in research as subjects are adequately protected. The IRB also protects subjects of research conducted, supported, endorsed, approved or sponsored by the Cabinet, including research conducted by individuals, students, employees, professors, universities, for-profit institutions, non-profit institutions, government agencies or other entities.
Protecting the safety and welfare of research subjects involves prevention of physical, emotional and psychological harm that might result from the research activity, as well as any harm due to breach of confidentiality, including unauthorized disclosure of health information protected under the Health Insurance Portability and Accountability Act.
Institutional Review Board Administration (CHFS IRB): The Cabinet for Health and Family Services Institutional Review Board (CHFS IRB) was established pursuant to Kentucky Administrative Regulation 920 KAR 1:060 to protect the rights and welfare of human subjects involved in research.
The Cabinet for Health and Family Services IRB, which was established and operates pursuant to 45 CFR Part 46, 45 CFR Part 164, and 920 KAR 1:060, ensures that any research involving human subjects or their records is conducted safely and protects their safety, welfare and privacy.
The Review Process:
All submissions are pre-reviewed by an IRB staff member who may provide feedback. The intent is to prepare the protocol for an expedited or full committee review.
Screenings for exemption are pre-reviewed and feedback may be provided, but they are approved by the CHFS IRB Administrator and the CHFS Board members are informed of the determination.
Submissions may be sent to CHFS ODA IRB CHFS.IRB@ky.gov or directly to Imelda.pastrano@ky.gov .
The review process, from pre-review to approval, generally takes about 4-6 weeks.
FORMS
Continuation Review Form
IRB Guidelines
HIPAA Guidelines
HIPAA Waiver App
Research Proposal Outline
Research Request Form