Northern Kentucky Health Department
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.
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 Departmentís
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
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:
not be engaged with another IRB
clients or employees of the NKHD as subjects
records of clients or employees of the NKHD
staff or facilities provided by the NKHD
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 participantsí 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.
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.
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
If approved for internal review, research requests will then be reviewed by
the Health Departmentís 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.
An in-person meeting to discuss details of the research study will
be scheduled with members of the Research Review Team and the research
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
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.
Every attempt will be made to provide a final decision no later than 30 days
after receiving the completed NKPHI Research Proposal.
Once the Research Review Team gives approval for a research project, the
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.
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
An appropriate member of the Health Departmentís staff, as per the
requirements of the academic institution or research organization, will
serve as preceptor or liaison to each respective research study.
The Health Departmentís preceptor/liaison and research investigator, working
will ensure that all research materials are provided to the
NKPHI at the completion of the research project.
The research investigator
must submit all findings
to the District Director of Health and collaborating NKHD staff at the
completion of the research project.
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.
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.
download the Research Partnership Agreement form,
download the Research Proposal form,
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.