Institutional Review Board at Tufts Medical Center and Tufts University

Tufts Health Sciences Tip of the Month

1. Changing the Principal Investigator (PI) of a research study is considered an amendment.
In order to change the PI on a research study, please submit the following to the IRB:

• A cover letter with signatures from the both the current PI and new PI
• A financial conflict of interest (COI) form for the new PI
• Confirmation that the new PI has completed the CITI education requirements
• Revised documents replacing the former PI with the new PI’s name, such as the informed consent form, subject materials, protocol, etc.

An Institutional Review Board (IRB) is a federally mandated organization of scientific and non-scientific persons, whose charge is to review research studies involving human subjects to ensure subject safety and welfare. While responsibility for the conduct of a research study ultimately lies with the Principal Investigator, an IRB is to ensure that any research study under its jurisdiction is in compliance with federal, state, and institutional regulations. By special arrangement, the Tufts Medical Center and Tufts University Health Sciences Campus IRB may also review protocols from Tufts Medford Campus.

The Tufts Medical Center and Tufts University Health Sciences (TUHS) IRB has jurisdiction over and services Tufts Medical Center, the Floating Hospital for Children, New England Eye Center, Tufts University School of Medicine, Tufts University School of Dental Medicine, Cummings School of Veterinary Medicine, the Jean Mayer U.S. Department of Agriculture Human Nutrition Research Center on Aging at Tufts University, and the Friedman School of Nutrition.

The Tufts Medical Center and TUHS IRB is divided into two IRBs, IRB-Red and IRB-Blue. Each IRB meets once a month. The IRBs do not specialize; each is constituted and equipped to review any type of research study involving human subjects.

The IRB office is another resource available to faculty, staff, and students conducting human subjects research at Tufts Medical Center and Tufts University. The IRB office staff is available to provide guidance and assistance with protocol and informed consent form (ICF) development, research education and training, and information and direction on federal research-related regulations and guidances, state laws, and institutional policies.

The IRB office is also available to assist investigators with monitoring of research, preparation for a site visit (e.g. sponsor, FDA), and orientation of new researchers to human subject protection matters. The office staff is also available to help provide orientation to new study coordinators.

In addition, the IRB office provides administrative support for the institutional Scientific Review Committee (SRC).