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.
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).
For studies that include tissue banking, refer to the tissue banking worksheet when developing the tissue banking consent.
This includes requests for an Individual Investigator Agreement (IIA), where Tufts IRB would assume IRB oversight for an individual not otherwise an employee or agent of Tufts or an IRB Authorization Agreement (IAA), where Tufts IRB would assume IRB oversight for or cede IRB oversight to a collaborating institution.
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.