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Exemption Submission Requirements

Minimal risk studies do not need to go to a meeting and are received on a rolling basis.

Exempt research is research that meets the criteria set forth in 45 C.F.R. §46.104. If you are submitting an exempt research proposal, attach the following documents to the eIRB Smart Form (also available in the eIRB Library):

Forms

  1. Form 7 (Request for Exemption Protocol): This form serves as the Protocol for the study and should contain all required information that would be included in a full protocol submission. A separate Protocol should notbe submitted.
  2. Research Financial Interest Disclosure Form: The PI and each research team member are to complete this form. The PI is to submit his/her completed COI form to the IRB office. Any form(s) from research team members with “YES” responses are also to be submitted to the IRB office by the PI. The PI is to retain in his/her study files the completed form(s) for research team members who answer “no” to all. Please refer to the Tufts University Conflict of Interest Policy or the Tufts Medical Center Policy on Industry Conflicts of Interest.

Other Documents

  1. Consent Documentation: If you plan to recruit study participants, they should be provided with an information sheet that they can retain (can be in the body of an  email or as a separate sheet if survey conducted in hard copy) that includes the basic elements of consent listed below:
    • A statement that they are being asked to participate in a research study and study summary
    • A statement that their participation is voluntary
    • A statement about any potential risks, i.e. risks to their academic standing/employment/receipt of benefits or care
    • A statement about any potential benefits
    • A statement about how their confidentiality will be maintained
    • A statement about compensation
    • A statement about alternatives to study participation
    • Contact information for the study team
  2. Recruitment and participant materials(e-mails, phone and voicemail scripts, advertisements, surveys, etc.)
  3. Letter of support from the appropriate person at the institution/organization who has authority to provide access for the following (if applicable):
    1. Recruitment of students/employees/patients or other participants outside the department or institution of the PI
    2. Hosting your study in a department or institution outside that of the PI
    3. Release of data/specimens to be used in the study
  4. Grant: If the study is funded by a grant.
  5. International Checklist: For studies that propose to include an international site where Tufts MC or Tufts University is the primary overseeing site, grant recipient, or data coordinating center.
  6. Any other supplemental documents for review of the study.

To be completed by all research team members

  1. Human Subjects Research Education Requirements: Mandatory education must be completed by all research team members before you can receive IRB approval.