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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. The U.S. Department of Health and Human Services (HHS) created a comprehensive list of scenarios in which institutions would be considered to be engaged or not engaged in human subject research. Please review these scenarios and other resources  here:

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 submit the following in hard copy to the IRB Office for review:

Research conducted at in the US:

1. Cover letter that includes:

  • Project title
  • The funding source for the project, if any
  • The purpose of this research
  • The study activities that will take place at Tufts University Health Sciences and/or Tufts Medical Center
  • State whether Tufts researchers will have interaction/intervention with study subjects
  • Whether the project or any component of the project has oversight from another IRB
  • Any other information you would like to convey about the project

2. Letter of support from institution conducting research confirming the involvement of the Tufts investigator or amendment approval letter confirming addition of Tufts researcher to the existing protocol.

3. Any additional supporting documents (for example, IRB approval letter, letters from another institution about the study, recruitment materials etc.)

Research Conducted at an International Site:

1. Cover letter that includes:

  • Project title
  • The funding source for the project, if any
  • The purpose of this research
  • Geographical location of the research
  • Research activities that will take place at an international site and description of Tufts researcher’s involvement in these activities
  • Whether the project or any component of the project has oversight from local ethics committee, or government entity in the host country:

I. If there is an oversight, submit their approval letter
II. If there is no oversight, submit a letter of support from a local expert authority confirming that the local research regulations do not require review.

  • Any other information you would like to convey about the project

2.Letter of support from institution conducting research confirming the involvement of the Tufts investigator.

3.Any additional supporting documents (for example, approval letter, letters from another institution about the study, etc.)

The IRB will review the submission and might contact you for additional information and/or request additional documentation once the level of required review for the project is determined.

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 or intervention with study subjects
  • Whether the project or any part of it has oversight from another IRB
  • Whether another IRB is aware that Tufts researcher will be engaged in their study
  • Which study activities will take place at Tufts and whether any of Tufts resources will be used

If you have questions about what documents and information should be included, please do not hesitate to call the IRB Office at 617-636-7512.