Investigator Manual

Northeastern University (NU) fosters a research environment that promotes and respects the rights and welfare of individuals recruited for and/or participating in research conducted by or under the auspices of the University.

There are a number of resources available to the research community conducting human subject research. The Investigator Manual is designed to guide researchers through policies, procedures and best practices related to the conduct of human research that are specific to Northeastern University.  The manual is comprehensive and covers everything from who can serve as PI, the IRB review process, and post approval activities.

In addition to this manual, the HSRP’s Office website has also drafted multiple documents pertaining to human subject research:

• Guidance Library
• Templates
• Reviewer Guides
• Checklists
• Operating Procedures & Best Practices

1 INTRODUCTION

2 DEFINING HUMAN SUBJECT RESEARCH

3 RESEARCHER ROLES AND RESPONSIBILITIES

4 IRB REVIEW PROCESSES

5 CONDUCTING HUMAN SUBJECT RESEARCH

6 POST APPROVAL RESPONSIBILITIES