Research at TUSDM

TUSDM students, residents, staff, and faculty

Research at TUSDM

Submitting Your Research Study to the IRB

Research on human subjects is any research in which the investigator obtains information about a living individual through intervention or interaction with the individual (such as administering medication or having the person fill out a survey), or from identifiable private information that should be protected (including observation of behavior in a nonpublic setting).  It also includes any research that used personal information such as identified/identifiable secondary data or blood/tissue samples. 

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’s goal is to ensure that any research study under its jurisdiction is in compliance with federal, state, and institutional regulations.

Here at Tufts, we have two IRB offices.

Tufts Health Sciences IRB

  • Reviews clinical studies and any research involving protected health information under HIPAA regulations

Social, Behavioral and Educational Research IRB

  • Reviews social, behavioral and educational research not involving HIPAA information (e.g., survey about student opinions)

Before submitting ANYTHING to the IRB, you must send it through Dental Research Administration (DRA) first. 

For general questions about IRB issues, please contact:

Ann-Marie Billig
Senior Research Affairs Specialist
617-636-3715
Ann-Marie.Billig@tufts.edu

or

Natalie Sadek
Senior Research Coordinator
Natalie.Sadek@tufts.edu

Your Principal Investigator/ Professor should be your primary source of information about how to develop a realistic protocol and how to go about getting the protocol approved by the IRB.  A student may not be listed as the principal investigator (PI).  The PI must be a Tufts faculty member. The student may be listed as a co-investigator, but your PI has primary responsibility regarding IRB issues.

There are IRB educational requirements that need to be completed by all students engaged in human subject research and should be completed prior to submitting a protocol to the IRB, including Collaborative Institutional Training Initiative (CITI Program) and Good Clinical Practices (GCP).  These are reading modules that can be viewed on your time, with follow-up exams. Please email Ann-Marie for instructions on how to access these trainings within the Tufts Learning Management System.

To get started, please view the annotated IRB protocol templates  and study design checklists, and select the one that best fits your proposed study activities.

Once you have completed the protocol template to the best of your abilities, please email it to Ann-Marie Billig/Natalie Sadek, who will assist you with the IRB submission process, including the preparation of any needed supplementary documents, collection of conflict of interest forms, and uploading all documents to eIRB.

After your study has been submitted, the IRB will review the study package. After reviewing the required documents, the IRB office will decide whether your protocol requires full IRB review or not. Full IRB review normally takes six to eight weeks, while a determination of exemption can often be done in about two-four weeks. The timeliness of approval of your study to begin research activities will greatly depend on the study team’s responsiveness to DRA’s emails regarding IRB queries!

Upon IRB approval, DRA will schedule a study initiation visit with your team to review the IRB-approved protocol and study documents and discuss study logistics.