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 Institutional Review Board
Additional EVMS Resources
- 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.
- REDCap Link - EVMS requires the use of REDCap for any EVMS study involving data collection (surveys, record reviews, electronic data transfers, etc.). The IRB office recommends the use of REDCap for all other sites submitting studies involving data collection. REDCap already addresses many of the data protetion concerns when working with human subjects.
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