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Department IRB policy

The University’s Institutional Review Board (IRB) provides one of the most important core functions of the Office of Research. The IRB oversees humans subjects research, both funded and unfunded, and whether minimal or significant risks are involved. Protecting the safety of human subjects is paramount. Protection of investigators and the university, should adverse events occur in the course of a research project, is also the responsibility of the IRB. Non-compliance issues are reportable offenses, often requiring federal notification. All forms can be found on the IRB website: www.umassmed.edu/CCTS/irb.

 The department encourages and supports faculty in developing clinical and education research.  Please find out more  about available resources and collaboration on Ambulatory Research Consortium (ARC) website.

 This policy below  pertains to IRB applications submitted by department faculty and those in which faculty are co-investigato, mentees or students:

Steps for IRB submission from FMCH department:

  1. Internal department review is required prior to formal IRB submission.  Please contact Philip G Day (Philip.Day@umassmed.edu) with your IRB application draft for review and colusiltation.
    • Please expect a 14 days turnaround time to review your draft. 
    • Urgent requests will be reviewed on a case-by-case basis. 
  2. Formal IRB submission (online: www.umassmed.edu/CCTS/irb).
  3. Upon formal IRB submission,  Department Chair and their designees are notified.

Additional resources:

IRB Application Submission Flowchart

FMCH Research Forum IRB Presentation

Does evaluation require IRB review?

Quality Improvement Activities

Program Evaluation:  When is it Research?

How to Distinguish Research From Quality Improvement