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All submissions must include a cover letter with the signature of an eligible Principal Investigator (PI) per Tufts PI Eligibility Policy. If you have questions about the documents and information that need to be submitted, do not hesitate to call the IRB Office at (617) 636-7512.

For Deidentified Data/Specimens:

If the data/specimens have already been collected and are completely deidentified (with no access to the code) then the project could be eligible for Non-Human Subjects research. Submit in hard copy (paper copy) with original PI signature:

  1. Cover letter that includes:
    • The activities and intended purpose of the project
    • Any other information you would like to convey about the study
    • Information about any collaboration with other institutions
    • Information about the funding source, if any
  1. A letter from the source of the data/specimens confirming the following:
    • Specimens will be deidentified
    • The study team will have no access to the key code (the list that matches the code to the subject identifiers, if one exists), and that the
    • Data/specimens being used in this study were previously collected with Informed Consent (if applicable) and the use is within the scope of the original ICF. A copy of the original ICF may be requested for confirmation.

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

For QA/QI (Quality Assurance/Quality Improvement) Projects:

If you think that the project you are planning to conduct might be considered a quality assurance/quality improvement initiative, submit the following in hard copy with original PI signature:

  1. Cover letter that includes:
    • The activities and intended purpose of the project
    • State whether there is intent/likelihood to produce generalizable knowledge from this project
    • What products (reports, presentations, etc.) will result from it, if any, and who is the intended audience
    • Where any and all research activities will take place and on what institutions’ behalf
    • Whether data will be sent/shared outside of Tufts
    • Information about the funding source, if any
  1. If this project is being performed on behalf of another institution/organization, include a letter of support attesting that the project activities are being performed for QA/QI purposes.
    • Please note: this letter must be from the appropriate person at the organization who has the authority to make this determination.
  1. Any additional supporting documents (for example, IRB approval letters, letters from another institution/organization about the study)

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

For Engagement Determinations:

If you believe the project you are proposing does not engage Tufts Medical Center or Tufts University in human subject research, submit the following in hard copy with original PI signature:

  1. Cover letter that includes:
    • The funding source for the project, if any
    • The purpose of this research
    • The study activities that will take place at Tufts University and/or Tufts Medical Center
    • State whether Tufts researchers will have interaction with study subjects
    • Whether activities will be conducted as fee-for-service
    • Whether the project or any component of the project has oversight from another IRB
  1. If this project is being performed on behalf of another organization, include a letter of support from the PI at the other institution confirming the involvement of the Tufts investigator.
  1. Any additional supporting documents (for example, IRB approval letters, letters from another institution about the study)

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