The following links will lead to important information, such as:
- EVMS FederalWide Assurance with Health and Human Services which outlines our promise to conduct human subject research within the confines of the regulations;
- Link to CITI training (required human subjects training)
- EVMS-Sentara Healthcare Analytics and Delivery Science Institute (HADSI) – provides assistance with statistical planning and analysis
- Main regulatory bodies for human subject research (OHRP and FDA) and HIPPA regulations.
- Note the OHRP and FDA have guidance documents to assist in interpretation of the regulations, as well as long-standing ethical policies and acts.
- EVMS-Sentara Healthcare Analytics and Delivery Science Institute
- CITI Program (Training) Please email the IRB office (IRBfirstname.lastname@example.org) for instructions on how to create your CITI account.
EVMS Institutional Review Board
- Please email the IRB office (IRB-INFO@EVMS.EDU) for a copy of EVMS Standard Operating Procedures.
- IRB Manager Webpage
Office of Human Research Protections (OHRP)
- 45 CFR Part 46 - Protection of Human Subjects
- The Belmont Report
- The Nuremberg Code
- The World Medical Association Declaration of Helsinki
- Research on Human Specimens
- OHRP Decision Trees
Food and Drug Administration (FDA)
- 21 CFR Part 50 - Protection of Human Subjects
- 21 CFR Part 56 - Institutional Review Boards
- 21 CFR Part 312 - Investigational New Drug Application
- 21 CFR Part 600 - Biological Products
- 21 CFR Part 812 - Investigational Device Exemptions
- Good Clinical Practice in FDA-Regulated Clinical Trials
Office of Civil Rights (OCR) - HIPAA regulations