Part II - Summary Guide for Investigators | KCTCS

Part II

Summary Guide for Investigators

Who must follow the KCTCS policy and procedures for the protection of human subjects?

Any administrator, faculty or staff of the Kentucky Community and Technical College System who is responsible for research activity involving human subjects must follow the KCTCS policy and procedures for any research activity that involves human subjects.

To what activities do the KCTCS policy and procedures apply?

To any research activity that involves human subjects, whether such research is undertaken on a large or small scale, whether it is preliminary or fully designed, whether it is student or faculty research, whether it is externally funded or not, and whether it involves minimal risk or more than minimal risk. [See Part III, B]

Who reviews human subjects research?

All research involving human subjects must be submitted for review to the KCTCS Human Subjects Review Board, unless the research complies fully with the criteria for one or more specific exemption categories. Determination of whether a research project is exempt from formal review must be made in consultation with the KCTCS Human Subjects Review Board (859-256-3187). 

When must a research activity involving human subjects be reviewed?

Prior to the initiation of activity, prior to the implementation of changes in previously approved procedure involving human subjects, and at least annually during the lifetime of the project. If the project is being proposed for external funding, review should take place prior to or shortly after submission of a proposal to the sponsor. [See Part I, Part III, Part III, C, 5]

What is the process?

Here is the simple Seven Step process:

  1. Employee/researcher selects and completes either the Exempt or Non-Exempt form.
  2. District CEO signs (and, therefore, approves) the form.
  3. The appropriate form is submitted to the System Vice President
  4. If exempt – approval/non-approval is made at the Vice President level.
  5. If non-exempt – the Human Subjects Review Board (HSRB) is convened for approval/non-approval.
  6. Employee/researcher will be notified of approval/non-approval in writing.
  7. Appropriate documentation will be maintained by the employee/researcher and by the System Vice President.

How can an investigator obtain further information or advice regarding the use of human subjects?

An investigator can contact the Human Subject Review Board throuogh Anthony Pinson at anthony.pinson@kctcs.edu or 859-256-3389.