Investigator Manual: 1. Introduction

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

In the review and conduct of research, actions by NU will be guided by the principles (i.e., respect for persons, beneficence, and justice) outlined in the Ethical Principles and Guidelines for the Protection of Human Subjects of Research (often referred to as the  Belmont Report) Human research will be performed in accordance with the Department of Health and Human Services (DHHS) policy, and regulations at 45 CFR 46 (also known as the “Common Rule”), and the Food and Drug Administration regulations at 21 CFR 50 and 21 CFR 56. Furthermore, the actions of NU will conform to all other applicable federal, state, and local laws and regulations as well as policies of NU’s network of domestic campuses.

Northeastern University’s Department of Human Research (DHR) holds a Federalwide Assurance (FWA), approved by the U.S. Department of Health & Human Services. This is an assurance of compliance with the federal regulations for the protection of human subjects in federally funded research. The FWA is also approved by the Office for Human Research Protection (OHRP) for federal-wide use, which means  other departments and agencies that have adopted the Common Rule may rely upon the FWA for the research that they conduct or support.

There are several 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.

The DHR’s website has also drafted multiple documents about human subject research:

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