Expedited and Full Committee

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

If you are submitting a new study (either expedited or full committee/convened meeting), submit the following documents to the IRB office. All documents must be submitted in electronic form (via flash drive) as well as a signed paper original to the IRB Office (15 Kneeland Street, Tupper 1) or by interoffice mail to Box #817.

1. Cover letter: A brief cover letter stating this is a new study and providing the IRB with any additional information you would like to convey about the study, including information about any collaboration with other institutions.

2. Form 1: Submit for all new study submissions, except for studies that are retrospective medical record/chart/computer database/specimen review and databases created for research purposes, which require a Form 7.

3. Form 2 (Drug): Submit when the research includes testing the safety and/or efficacy of a drug. Submit a copy of the Investigator’s Brochure and/or study drug information.
   

   Drug is defined as articles intended for the use in the diagnosis, cure, mitigation, treatment, or prevention of disease or other condition and articles (other than food) intended to affect the structure or any function of the body (this includes dietary supplements).

4. Form 3 (Device): Submit when the research includes testing the safety and/or efficacy of a medical device. Submit a copy of the Operator’s Manual and/or Device Manual.

5.  Form 4 (Radiation):  Submit when the research includes research-related radiation. Submit the version signed by the Radiation Safety Officer.

6.  Form 6 (Tissue Banking): Submit when the research includes tissue banking, which is defined as storage of any specimens for unspecified future use. Submit a copy of the tissue bank’s policies or answer questions 14a –14d.
   

   For studies that include tissue banking, refer to the tissue banking worksheet when developing the tissue banking consent.

7. Form 10
   • Form 10A – Request to Assume Oversight Version Date:01/15/2019
   • Form 10B – Request to Cede Review Version Date:01/15/2019
   • Form 10C – Request for Independent/Institutional Agreement Version Date:01/15/2019

7. 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.
8. 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).
9. 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.
10. 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).
11. 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.
12. 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 and Safety Monitoring Committee (DSMC), 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.

13. Subject Materials: Submit any materials that will be provided to, seen, or heard by subjects (e.g. questionnaires, scripts, instruction sheets, etc.).
14. Recruitment Materials: Submit all advertisements and recruitment material, such as flyers, recruitment e-mails or letters, newspaper advertisements, radio advertisements, social media postings, etc.
15. 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 studies.
16. 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.
17. 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.