IRB Guidance

reddot.gif (813 bytes) PI Responsibilities

reddot.gif (813 bytes) Preparing an IRB Application – Where Do I Begin?

reddot.gif (813 bytes) Template for preparing a detailed protocol – to be used when no sponsor’s protocol is available – REQUIRED for submissions on or after November 1, 2016 for initial review of clinical trials involving a medical (drug or device) or surgical intervention [Word]

reddot.gif (813 bytes) Local Context Review of International Research [Word]

reddot.gif (813 bytes)  Short Consent Form Process For Non-English Speaking Subjects

reddot.gif (813 bytes)  Guidance for Abbreviated IDE Requirements [PDF]

reddot.gif (813 bytes)  Students in Research [PDF]

reddot.gif (813 bytes)  Repositories

  • Repository Investigator’s Responsibilities [PDF] 
  • Recipient Investigator’s Responsibilities [PDF]
  • INSPIR Instructions for Repositories [Word Doc]

reddot.gif (813 bytes)  Decision Tree for Determining Engagement in Research [PDF]

reddot.gif (813 bytes)  Consenting Decisionally Impaired Subjects

reddot.gif (813 bytes)  Non-English Speaking Subjects

reddot.gif (813 bytes)  BMC’s New Clinical Research Billing Process – [Word Doc]

reddot.gif (813 bytes)  CRRO Seminar Series Presentation

Primary teaching affiliate
of BU School of Medicine