NIH Investigator Manual for Human Subjects Research

Introduction

This investigator manual is intended to provide information regarding the conduct of human subjects research on NIH protocols and will describe the federal regulations as well as NIH Human Research Protection (HRPP) policies that address this research. It will also explain what types of human subjects research are exempt from IRB review as well as those that need to be submitted to the IRB for review. Additionally, this investigator manual will describe investigator responsibilities within the context of human subjects research as well as the process for submitting new protocols, amendments, continuing review applications, and new information related to events that occur during the course of human subjects research that require reporting to the Institutional Review Board (IRB). Important points related to the conduct of such protocols will also be covered. Topics to be addressed also include research with special populations, research subject to the Food and Drug Administration (FDA) regulations and international research. When relevant, key points, flow diagrams, charts, checklists, and other items that the investigator may find helpful are included.

Each chapter of this Investigator Manual has an overview followed by subsections that begin with key points targeted to the specific topics being addressed.   Information is arranged in a question and answer format that follows the key points in each chapter subsection.  The Table of Contents is arranged so the reader can navigate to specific chapters by clicking on the title chapter.  The reader can also click on specific key points or questions for each chapter that are all listed in the Table of Contents.

For additional information on policies referenced and terms used in this investigator manual, please see the NIH HRPP polices and the glossary of terms used in the HRPP policies. References in this manual to the HHS regulations for the Protection of Human Subjects are based on the 45 CFR 46 revised Common Rule (the 2018 Common Rule) unless otherwise noted. For additional definitions (e.g. from the pre-2018 Requirements or the FDA regulations at 21 CFR), please see the glossary and specific NIH HRPP policies.