Research Policies and Procedures

Below are the policies and procedures related to research opportunities with the Northern Kentucky Health Department. A copy of the Research Proposal form can be found at the bottom of the page.

A. POLICY

Supported by the Northern Kentucky District Board of Health, one of the 10 Essential Public Health Services is to contribute to and apply the evidence base of public health. Due to the Northern Kentucky Health Department’s proximity to major universities and the reputation of the quality services provided by the Northern Kentucky Health Department (NKHD), the Health Department is often asked to make its patient population and staff available for research studies. In addition, NKHD staff often initiate and participate in research, in an effort to improve services and programs.

While the Health Department has a commitment to participating in research, research undertaken should not compromise the quality provision of Health Department services or programs, nor adversely affect the physical, social and/or psychological well being of participants. It should also be understood that participation in any research project is voluntary.

Research should be utilized to advance the health and safety of people residing, working and/or visiting within the jurisdiction of the Northern Kentucky Health Department, and possibly have beneficial impact that could be applied throughout the region, Commonwealth of Kentucky or the nation. At no time should participation in research financially benefit an individual member of the Health Department.

The Northern Kentucky Health Department will adhere to industry standards in research, and to all applicable Kentucky laws and administrative codes set forth in 45 CFR Part 46, 45 CFR Part 164 and 920 KAR 1:060.

The NKHD will rely upon the Cabinet for Health and Family Services Institutional Review Board (CHFS IRB) for review of research projects involving human subjects or their records (as defined by 45 CFR 46.102(f)), unless the research investigator has access to another registered IRB. Research involving human subjects must be sent to the CHFS IRB for review and approval if the study:

• Is not/will not be engaged with another IRB

• Involves clients or employees of the NKHD as subjects

• Involves records of clients or employees of the NKHD

• Uses NKHD staff or facilities provided by the NKHD

• Is conducted, supported financially, endorsed or approved by the NKHD or Cabinet for Health and Family Services

The declining of participation of any party at any time will in no way affect the eligibility of any subject to participate in other programs or to receive services provided by the Northern Kentucky Health Department.

B. PURPOSE OF POLICY

To provide guidelines to conduct and participate in research and to protect the health, integrity (including participants’ rights, privacy, anonymity and confidentiality), and informed consent of any participant in a research project involving staff and/or clients of the Northern Kentucky Health Department.

C. PROCEDURES

1. All inquiries for permission to conduct research with or within the Northern Kentucky Health Department shall first be made via an application with the Northern Kentucky Public Health Institute (NKPHI). Each application must include a completed NKPHI Research Proposal. 

2. The Director of the NKPHI will forward a copy of the completed NKPHI Research Proposal to the District Director of Health for first right of refusal or to allow it to proceed for internal review. When needed, the District Director of Health will make the final decision on approval of research projects dealing with either sensitive topics or vulnerable populations. 

3. If approved for internal review, research requests will then be reviewed by the Health Department’s Research Review Team within 10 working days of receiving the application. This team will consist of the District Director of Health, the Director of the NKPHI, the Director of Clinical Services, the Director of Population Health, the Director of Environmental Health and Safety, and management representatives from other divisions or programs that might be involved in the research project. A Research Review Team member may select a designee to represent them in their absence. 

4. An in-person meeting to discuss details of the research study will be scheduled with members of the Research Review Team and the research investigator. The Director of the NKPHI will provide copies of the NKPHI Research Proposal to each member of the Research Review Team prior to the meeting, and will be responsible for ensuring team members review all items on the NKPHI Research Review Checklist so critical elements of the research project are considered. 

5. If the Research Review Team deems that a research project requires or may require a review from an IRB, the research investigator must obtain either approval or exemption from an IRB prior to performing an activity at or for the Health Department, and provide a copy of official IRB approval/exemption documentation. In the absence of a requirement by the Health Department for the use of the CHFS IRB process, the IRB from the respective academic institution or research organization shall be used. Questions or inquiries regarding proposed research projects should be directed to the CHFS IRB Administrator. 

6. Every attempt will be made to provide a final decision no later than 30 days after receiving the completed NKPHI Research Proposal. 

7. Once the Research Review Team gives approval for a research project, the research investigator will sign and date the NKPHI Research Partnership Agreement, which will then be signed and dated by the faculty advisor (if student involved), NKHD Division Director(s) involved with the research project, and District Director of Health. 

8. The signed/dated NKPHI Research Proposal, IRB documentation (if needed), and signed/dated NKPHI Research Partnership Agreement will be placed on file with the Northern Kentucky Public Health Institute prior to initiation of the research. 

9. An appropriate member of the Health Department’s staff, as per the requirements of the academic institution or research organization, will serve as preceptor or liaison to each respective research study. 

10. The Health Department’s preceptor/liaison and research investigator, working collaboratively, will ensure that all research materials are provided to the NKPHI at the completion of the research project. 

11. The research investigator must submit all findings to the District Director of Health and collaborating NKHD staff at the completion of the research project. 

12. The research investigator must acknowledge the contributions of the Northern Kentucky Health Department, as well as the District Director of Health and NKHD staff who collaborated on the research project (by name), in all final research products, presentations and publications. 

13. Prior to submission, the research investigator must submit for review and approval all proposed publications to the District Director of Health and NKHD staff who collaborated on the research project, and provide a deadline for review. 

To download the Research Partnership Agreement form, click here.

To download the Research Proposal form, click here.

Please email completed forms, in original .doc file format, to Louise.Kent@nkyhealth.org. Rename the Research Parternship Agreement and Research Proposal file to include your initials and the date before submitting.