science

Expedited and Full Committee Review

Minimal risk studies that fall under the categories of research eligible for Expedited Review do not need to go to a convened IRB meeting and are received on a rolling basis.

If you are submitting a new study (either expedited or full committee/convened meeting), refer to the following instructions:

Attach the following documents to the eIRB Smart Form (also available in the eIRB Library and our Forms and Templates pages):

  • Protocol: Submit the protocol provided by the study Sponsor or, if there is no Sponsor created protocol, submit a protocol developed by the PI for investigator-initiated research. You can utilize either the form or the MS Word document for your study

  • Form 4 (Radiation): Submit when the research includes research-related radiation.

  • Form 10A – Request to Assume Oversight: Submit to request Tufts IRB serve as the IRB of record for non-Tufts sites – see instructions for Single-IRB Review.

  • Form 10C – Request for Independent/Institutional Agreement: Submit to request Tufts IRB oversee collaborators who are not at a research institution – see instructions for Single-IRB Review.

  • 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).

  • Site-Specific Appendix: Submit if the protocol does not already contain site-specific details such as recruitment and consent (typically multi-center protocols are not tailored to this site). You can utilize either the form or the MS Word document for your study.

  • Informed Consent Forms: Please use the applicable template and modify to suit the needs of your study, including assent forms for enrolling minors ages 7-17.

  • Grant: If the study is grant funded, and Tufts is the grant recipient, submit a copy of the grant documentation that concerns this study (i.e. the research methods and procedures of this study as described in the grant).

  • International Checklist:  Submit for studies that will include an international site where Tufts MC/Tufts University is the primary overseeing site, grant recipient, or data coordinating center.

  • Data safety monitoring board (DSMB)*charter: If a DSMB exists for the study, submit the DSMB charter. *A “DSMB” could also be called a Data Monitoring Committee (DMC), Independent Data Monitoring Committee (IDMC), Safety Advisory Committee (SAC), Data Review Board (DRB) or any group or committee that exists to protect the safety of study subjects, the credibility of the study, or the validity of the results.

  • Subject Materials: Submit any materials that will be provided to, seen, or heard by subjects (e.g. questionnaires, scripts (telephone and voicemail), instruction sheets, etc.).

  • Recruitment Materials: Submit all advertisements and recruitment material, such as flyers, recruitment e-mails or letters, newspaper advertisements, radio advertisements, social media postings, etc.

  • Tufts MC Clinical Research Recruitment Website form: Submit for all new Tufts Medical Center studies that utilize an Informed Consent Form. This is a Tufts Medical Center institutional requirement. This form for posting studies on the recruitment website is optional for Tufts University, MelroseWakefield, and Lowell General studies.

  • 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.

  • Clinicaltrials.gov Form: Submit for all new studies that utilize an Informed Consent Form. This is an institutional requirement and must be submitted in order to receive IRB approval.

  • 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