Research

All terms and definitions used in this policy follow those adopted by 45 CFR Part 46.102 and 920 KAR 1:060.

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 Northern Kentucky Health Department.

People who are subjects of research studies have certain protections under federal law 45 CFR Part 46 (the Code of Federal Regulations, Title 45, Public Welfare: Part 46, Protection of Human Subjects). Federal law requires that all agencies who receive funds from any federal agency must have an Institutional Review Board (IRB) review, approve, and provide assurance regarding non-exempt research in regard to protecting the confidentiality and safety of research subjects.

One of the 10 Essential Public Health Services, as supported by the Northern Kentucky District Board of Health, is to "improve and innovate public health functions through ongoing evaluation, research, and continuous quality improvement."  Due to our proximity to major universities and our various program areas, NKY Health is often asked to make its patient population and staff available for research studies. In addition, NKY Health staff often initiate and participate in research in an effort to improve services and programs. 

While NKY Health has a commitment to participating in research, the study should not compromise the quality or provision of services or programs, nor adversely affect the physical, social and/or psychological well-being of participants. All participants must have any understanding 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 NKY Health and possibly have beneficial impact throughout the region, Commonwealth of Kentucky, and/or the nation. At no time should participation in research financially benefit an individual member of NKY Health. 

All research utilizing NKY Health staff and/or clients will adhere to federal law and to all applicable Kentucky laws and administrative codes set forth in 45 CFR Part 46 and 920 KAR 1:060 to protect the rights and welfare of human subjects. Additionally, all existing policies and procedures relating to client confidentiality and Health Insurance Portability and Accountability Act (HIPAA) laws must be adhered to regardless of whether the research is exempt or non-exempt from IRB involvement. 

NKY Health will rely upon the Kentucky Cabinet for Health and Family Services Institutional Review Board (CHFS IRB) for review of non-exempt research projects involving human subjects or their records (as defined by 45 CFR 46.102(l)), unless the principal investigator has access to another registered IRB.  For more information on exempt research, visit CFR Part 46.104.

Research involving human subjects that is not/will not be engaged with another IRB must be sent to the CHFS IRB for review and approval if any of the following apply to the study:   

• Involves present or former clients or staff of NKY Health as subjects. 

• Involves records of present or former clients or staff of NKY Health. 

• Uses NKY Health staff or facilities provided by NKY Health.

• Is conducted, supported financially, endorsed or approved by NKY Health or the Kentucky 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 NKY Health.  

1. All inquiries for permission to conduct research with or within NKY Health shall first be made via the completion of NKY Health's Research Proposal Form.

2. Planning staff will forward a copy of the completed Research Proposal Form to the District Director of Health for refusal or permission to proceed for internal review. (The District Director of Health will make the final decision on approval of research projects dealing with either sensitive topics or vulnerable populations.) 

3. When approved for internal review, research requests will be reviewed by NKY Health's Research Review Team within 10 working days of receiving the application.

4. Planning staff will schedule a meeting with members of the Research Review Team and the principal investigator(s) to discuss details of the research study. Planning staff will provide copies of the Research Proposal Form to each member of the Research Review Team prior to the meeting. The form will be used to review the study.

5. When the Research Review Team deems that a research project requires or may require a review from an IRB, the principal investigator(s) must obtain and submit either approval or exemption from an IRB prior to performing any activity at or on behalf of NKY Health. If no IRB is obtained from another academic institution or research organization, the CHFS IRB process shall be utilized. The principal investigator(s) shall direct all questions or inquiries regarding proposed research projects 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 Research Proposal Form. 

7. The signed/dated Research Proposal Form and IRB documentation (if needed) will be placed on file with planning staff prior to initiation of the research. 

8. An appropriate member of NKY Health’s staff, as per the requirements of the academic institution or research organization, will be designated to serve as the primary contact person for each respective research study. 

9. NKY Health’s primary contact for the study and the principal investigator(s), working collaboratively, will ensure that all research materials and all findings are provided to the planning staff upon completion of the research project. 

10. The principal investigator(s) will follow all guidelines pertaining to the Research Findings section outlined below.

This team will consist of:

• The District Director of Health

• The Planning Staff

• The Director of Clinical Services

• The Director of Population Health

• The Director of Environmental Health and Safety

• Management representatives from work units or programs that might be involved in the research project.  

A Research Review Team member may select a designee to represent her/him in her/his absence. 

1. Prior to submission, the principal investigator(s) must submit for review and approval all proposed publications to the District Director of Health and NKY Health staff who collaborated on the research project and determine a reasonable deadline for review. 

2. The principal investigator(s) must acknowledge (by name) the contributions of NKY Health, as well as the District Director of Health and NKY Health staff who collaborated on the research project, in all final research project documentation including but not limited to presentations, news articles, journal articles, and other publications.  

3. NKY Health may elect to be a co-author in articles submitted for publication.

4. The principal investigator(s) and/or research associates may be asked to present related research findings to NKY Health staff in a presentation format.

3/24/2023:

• Updated Purpose, Policy, and Procedures sections

  • Added confidentiality/HIPAA requirements

  • Reviewed administrative code links

• Added Definitions and Research Findings  sections

• Updated and revised Research Proposal Form into electronic version

• Archived former Research Proposal and Research Partnership Agreement forms

10/4/2022: 

• Updated Policy Header

• Reviewed and updated administrative code links