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Exemption Submission Requirements

Exempt research is research that meets the criteria set forth in 45 C.F.R. §46.101(b). If you are submitting an exempt research proposal, submit the following documents to the IRB office (Box 817; Tupper Floor 1), in hard copy (paper copy), with original signatures:

  1. Cover letter: A letter stating this is a new study, providing the IRB with additional information you would like to convey about this research, including information about any collaboration with other institutions/organizations. The cover letter must be signed by an eligible PI per Tufts PI Eligibility Policy.

Forms

  1. Request for Exemption Form: A new study form (signed by the PI). This form serves as the Protocol and should contain all required information. A separate Protocol should not be submitted.
  1. Form 7: If the research solely consists of retrospective (existing) review of existing records and/or specimens and identifiers will not be recorded by the investigator. (For studies that require a Form 7, do not submit a separate protocol or Request for Exemption Form.)

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 as 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
    • Contact information for the study team
  1. Recruitment and participant materials (e-mails, advertisements, surveys, etc.)
  1. letter of support from the appropriate person at the institution/organization who has authority to provide access for the following:
    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
  1. Grant: If the study is funded by a grant.
  1. 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.
  1. Any other supplemental document for review of the study.

To be completed by all research team members

  1. Conflict of Interest (COI) Form:
    • Please have every research team member (including the PI) complete a financial COI form and keep these in your study records.
    • A copy of the PI COI form needs to be submitted to the IRB.
    • Copies of any research team members’ COI forms are to be submitted only if a conflict (“yes” response to one or more of the questions) is noted.
  1. Human Subjects Research Education Requirements: Mandatory education must be completed by all research team members before you can receive IRB approval.