science

Tufts Not Engaged in Research

In some specific circumstances, Tufts researchers may be involved in activities that would be considered human subjects research but in a way that does not engage Tufts in said human subjects 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. In addition, many journals and/or national organizations require a formal determination from the IRB in order to submit a manuscript or abstract.

What do I need to submit to the IRB?

If you think that the project you are planning to conduct does not engage Tufts Medicine / Tufts University in human subject research, submit the study in eIRB. Include the items listed below and follow  the Step-by-Step Guide to Submitting a New Study.

Note: Question #5 in the eIRB smart form is: “Will an external IRB act as the IRB of record for this study?” Choose No, even if another IRB has reviewed and approved the research. This question is asking whether Tufts will need to formally cede review to another IRB with a reliance agreement. If Tufts is not engaged in the research, a reliance agreement will not be necessary.

  1. In place of a Protocol, complete Form 15: Engagement to describe your project.
     
  2. Letter of Support Form – Permission to Conduct Research at Another Institution or Letter of Support Form – Providing De-identified Specimens or Data completed by the institution conducting research, OR IRB approved protocol letter confirming the involvement of Tufts investigators.
     
  3. Letter of Support Form – Permission to Recruit Employees or Students – Required if you will directly target employees, residents, students, interns and/or fellows for recruitment.
     
  4. If Tufts patients are directly targeted for recruitment, documentation of permission from the head of the appropriate department/division.
     
  5. Any additional supporting documents (recruitment materials, etc.).
  1. In place of a Protocol, complete Form 15: Engagement to describe your project.
     
  2. Letter of Support Form – Permission to Conduct Research at Another Institution or Letter of Support Form – Providing De-identified Specimens or Data completed by the institution conducting research.
     
  3. IRB approval letter and IRB approved protocol from the institution conducting the research.
     
  4. Any additional supporting documents (recruitment materials, 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.

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.

Additional Responsibilities of the Investigator

  • If Tufts is acting as a sub-site or subcontractor on a larger grant, please ensure that you have contacted the Tufts Grants and Contracts office (TuftsMCGrantsContracts@tuftsmedicine.org) or Tufts University Research Administration. 
  • The principal investigator should have on file a copy of the IRB approval letter from collaborating sites.