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 and our Forms and Templates pages):

Forms

• 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 not be submitted.

• Research COI form: Submit the completed PI’s research COI form as well as COI forms from research team members who have indicated a “YES” response in any field on the form.

• Form 12 (MelroseWakefield and Lowell General): Submit if you will conduct some or all research activities at MelroseWakefield Healthcare and/or Lowell General Hospital (including remote activities involving MelroseWakefield/Lowell General personnel or patients).

• Letter of Support Form – Permission to Conduct Research at Another Institution – Required if Tufts personnel will conduct research at another institution.

• 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

• Letter of Support Form – Providing De-identified Specimens or Data  – Required if you will receive coded or de-identified data and/or biospecimens from another researcher or institution

Other Documents

• Consent Information Sheet: If you plan to recruit study participants, they should be provided with an information sheet that they can retain (e.g. attached to a recruitment email or distributed in hard copy) that includes the basic elements of consent listed on Form 7. Use of our Consent Information Sheet Template is recommended.

• Recruitment and participant materials (e-mails, phone and voicemail scripts, advertisements, surveys, etc.)

• Grant: If the study is funded by a grant.

• 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.

• Any other supplemental documents for review of the study. 

To be completed by all research team members

• Research Financial Interest Disclosure / Conflict of Interest (COI) Form: The PI and each research team member* are to complete this form. The PI’s completed COI form must be submitted 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 their 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. *For a definition of “research team member,” see the Investigator Manual.​​​​​​​

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