3. Responsibilities of the Investigator

Responsibilities of the Investigator

The principal investigator’s primary responsibility in human subjects’ research is to ensure that the rights and welfare of the participants are protected.  Safeguarding the participants from undue risk is the ethical responsibility of each person who is involved, either directly or indirectly, in conducting research at Northeastern University.

Investigators must assure that each member of the research team carries out all research procedures in accordance with ethical principles of research.  These principles of Justice, Autonomy and Beneficence are set forth in the Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research and are codified as regulations in Title 45 Code of Federal Regulations Part 46.  Investigators are strongly encouraged to read these and other relevant documents available at the U.S. Department of Health and Human Services Office for Human Research Protections (OHRP) web site.

As an integral part of ethical conduct of research, federal guidelines require an independent review of protocols involving human subjects before an investigator can begin the study.  This is true at all research institutions, such as Northeastern, that receive federal funding for such research. This independent review process provides an unbiased evaluation of the risks, promotes the safety of research participants and documents that the research, when conducted as approved, will be in accordance with federal regulations.

At Northeastern, the Office of Human Subject Research Protection (HSRP) and the Institutional Review Board (IRB) serve this independent review function. It is the policy of Northeastern University that no activity involving human subjects be undertaken until those activities have been reviewed and approved by the University’s Institutional Review Board (IRB).

Information regarding approval procedures and other necessary guidelines for human research at the University are found in this document, Policies and Procedures for Human Research Protections.  Investigators are responsible for adhering to the guidelines provided here, and should read it prior to submitting an application for review.

Protocol reviews are prospective.  No retrospective approvals can be granted. Performing research with human subjects without prior IRB approval is unethical, illegal, and may jeopardize the rights and welfare of participants in research.  A project that is conducted without IRB approval is subject to termination or other action by the University.

In order to receive federal funding for research with human participants, Northeastern University must have a Federal Wide Assurance (FWA) approved by the United States Department of Health and Human Services.  In this signed agreement, Northeastern University assures the federal government that all university research will be conducted in accordance with federal regulations for research.  Any violation of research guidelines by the university or an investigator jeopardizes this agreement and threatens the University’s federal funding.

These federal regulations are the minimal standards for research.  State laws or University policies may impose additional requirements as deemed appropriate, but may not decrease requirements. Northeastern University’s FWA number is 4630.