Investigators Guide

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Introduction

The University of Louisville (UofL) Human Subjects Protection Program (HSPP) Investigator’s Guide (IG) is a researcher reference guide detailing the policies, procedures and regulations governing human subjects  research.  The IG also describes the requirements for submitting research proposals for review by one of the UofL’s Institutional Review Boards (IRBs).

This guide describes and explains the various aspects of the review process and regulatory requirements. Principal Investigators and their key personnel should familiarize themselves with the contents of the guide. In addition, they should carefully review the sections of the guide that address their specific research activities before submitting proposals to the IRB.

As of the date of publication or revision, the guide presents the most current human subjects research information available.  Since the field of human subject protection is constantly evolving, sections of the guide may be subject to change. The Human Subjects Protection Program (HSPP), an office in the Office of the Executive Vice President for Research and Innovation (EVPRI), will keep the University of Louisville community apprised of changes as they occur.

The Institutional Review Boards (IRBs) at the University of Louisville  review all University affiliated human subjects research, regardless of funding, to ensure the rights, welfare, and protection of all subjects.

The UofL IRB or designee of the IRB is, by University policy, the entity or person authorized to determine whether research involving coded private information or specimens constitutes human subjects research. The person(s) authorized to make the determination will be knowledgeable about the human subject protection regulations. Investigators do not have the authority to make an independent determination that research involving coded private information or specimens does not involve human subjects.  For additional information on this subject consult the OHRP document “Guidance on Research Involving Coded Private Information or Biological Specimens.”

When activities whose status relative to the regulatory definition of research, the involvement of human subjects, or eligibility for exemption may be in doubt, the chair of the appropriate University of Louisville IRB will make the final determination.  To assist the chair in making these decisions, the chair may utilize documents and guidance provided by organizations like the CDC, the Oral History Association, etc., that may conduct research in these grey areas such as public health inquiries or oral history projects.