In some specific circumstances, Tufts researchers may be engaged in activities that would be considered human subject research but do not engage Tufts in human subject research. HHS has created a comprehensive list of scenarios in which institutions would be considered to be engaged or not engaged in human subject research. Please review the following links for guidance:
Note: The Principal Investigator should not make the final determination as to whether a project constitutes human subject research or not; that determination may only be made by the IRB.
What do I need to submit to the IRB?
If you think that the project you are planning to conduct does not engage Tufts Medical Center/Tufts University in human subject research, please review the information below. The IRB considers these points in making its determination, so please ensure that the information covered below is addressed in your submission:
Whether Tufts researchers will have interaction with study subjects.
Whether the project or any part of it has oversight from another IRB.
Which study activities will take place at Tufts.
What the purpose of this research is.
Please provide the information requested above in a cover letter addressed to the IRB. Please ensure that any applicable supporting documents (e.g., IRB approval letters, letters from another institution regarding the study) are included in the submission. If you have questions about what documents and information should be included, please do not hesitate to call the IRB Office.
Please call the IRB office if you are planning to conduct international research and someone will help guide you, as the requirements for this type of research differ. Please also refer to the information on our website regarding international research.