Appendices E – Genetics
Appendices B – Drugs
Signature Authority
Some processes require institutional signature. Certain people at the University have been delegated signature authority from the Board of Trustees through the President and senior University officers for certain efforts. This page provides an overview of the signature authority responsibilities and delegates for research-related areas.. Sponsored Programs Sponsored Programs is responsible for providing the appropriate […]
Human Subjects Training
The Charles River Campus (CRC) IRB requires all individuals involved in human subjects research to complete training in human subjects protection via the Collaborative Institutional Training Initiative (CITI) Program which must be completed by both the Principal Investigator and all study staff listed on the protocol before the protocol can be approved. This training includes […]
Clinical Trial Billing Notification
Appendix H: Prion Research/Creutzfeldt-Jacob Disease (CJD) Guidelines
Creutzfeldt-Jacob Disease (CJD) is one of a group of neurodegenerative diseases called transmissible spongiform encephalopathies (TSE) (or prion diseases) which affect humans (e.g., Kuru, Fatal Familial Insomnia and Gerstmann-Sträussler-Scheinker syndrome of humans) and a variety of domestic and wild animal species (e.g., Scrapie of sheep, “Bovine Spongiform Encephalopathy [BSE] or Mad Cow Disease” of cattle […]
LaNeia Thomas
Responsibilities, Ethics, and Regulations for Human Subjects Research
Principal Investigator Responsibilities Reducing Risk in Qualitative Research Reportable Events Confidentiality Consent Documents HIPAA Privacy Rule & Protection of Protected Health Information (PHI) Research Ethics
Initial Submissions
A step-by-step guide for submitting an IRB protocol for human subjects research on BU’s Charles River Campus. Step 1: Determine if IRB Approval is Required Not all projects require IRB review and approval. Before getting started, determine if IRB approval is required. Step 2: Complete the Required Human Subject Protection Training The Charles River Campus […]
Responding to the IRB
If the CRC IRB requires further changes or information about your submission, you will receive either an email or a letter with the requested modifications. Before preparing and submitting a response to an IRB review, be sure to touch base with an IRB Analyst if you have any questions. Please note, investigators have 60 days […]