What's New? HIPAA for Research Training The "For Whose Eyes Only?" HIPAA for Research online training and quiz IS NOW OPTIONAL and may be accessed through Blackboard.

Third EVMS IRB EVMS has contracted with Chesapeake Research Review, Inc. (CRRI), a specialized professional services firm, to serve as a third EVMS IRB. To learn more about the protocol submission process, CRRI contact information and questions, please contact the EVMS Research Subjects Protections Office at 446-8423.

IRB Audit Checklist An audit checklist created for investigative staff may help ensure compliance with federal regulations and EVMS IRB policies, ensure self-monitoring and may also prepare for routine site audits conducted by Research Compliance Coordinators in the Office of Research.

IRB Training Requirements for All Investigators and Researchers

Regulatory Compliance

The role of Regulatory Compliance in the Office of Research is to increase the knowledge of, and sensitivity to, issues surrounding the responsible conduct of research at EVMS.

• EVMS Federal-wide Assurance
• EVMS HIPAA Research Policies
• Conflict of Interest Policy

Standard Operating Procedures

• Standard Operating Procedures for Good Clinical Practice! EVMS researchers may use these SOPs purchased from Thomson Publishing or similar SOPs for study management of clinical research.
• EVMS IRB Standard Operating Procedures (SOPs)

Reporting of Unanticipated Problems/Adverse Events

The EVMS IRB requires the prompt reporting of all unanticipated problems and all adverse events involving risks to subjects or others, regardless of severity. Report local adverse events to the IRB within five business days. Promptly report events at other sites. Use the same reporting mechanisms as outlined in the SOPs for both adverse events and unanticipated problems, local and non-local.

Definitions

• Research - a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
• Human Subject - Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains:
  (1) data through intervention or interaction with the individual, or
  (2) identifiable private information.

Human Subject Research

Federal Regulations:

• 45 CFR Part 46 - Protection of Human Subjects
• 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

Virginia State Laws for Human Subjects Research:

• § 32.1-162.16. Definitions: Human Subjects
• § 32.1-162.17. Exemptions
• § 32.1-162.18. Informed Consent
• § 32.1-162.19. Human Research Review Committees
• § 32.1-162.20. Applicability of Federal Policies  
• § 32.1-162.21. Definitions: Cloning
• § 32.1-162.22. Human Cloning Prohibited; Civil Penalty

Reference Materials:

• EVMS IRB Home Page
• EVMS IRB Training Requirements
• Research and Training Requirements for Faculty, Staff, Students and Volunteers
• Human Subject Regulations Decision Charts (9/98)
• NCI Human Participant Protections Education for Research Teams
• The Belmont Report
• The Nuremberg Code
• The NIH IRB Guidebook, 1993
• Frequently Asked Questions for the Requirement for Education on the Protection of Human Subjects
• Institutions Engaged in Research - Federal interpretation of "engagement in research" for institutions.
• OHRP Compliance Activities: Common Findings and Guidance - 9/1/2000
• Research on Human Specimens - Are You Conducting Research Using Human Subjects?
• OHRP Tips on Informed Consent

Research Integrity Policies at EVMS

• Scientific Misconduct Policy
• Conflict of Interest Policy

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