Institutional Review Boards (IRBs): The Changing Landscape and the Effect on the Conduct of Clinical Research 2015

Topics

• Current issues surrounding IRB review
• IRB models, including IRB as the HIPAA Privacy Board
• Assurances and agreements to facilitate IRB review
• Regulatory framework for IRB review: 21 CFR 50, 56 and 45 CFR 46
• Accreditation and how this has changed IRBs
• Potential use of IRB Consortiums

Who should Attend

• Clinical Research Associates
• Clinical Quality Assurance Professionals
• Study Coordinators
• Project Managers, or others involved in site and IRB assessment Clinical Investigators
• Clinical Research Coordinator
• IRB Members IRB Professionals
• Administration in charge of Clinical Research
• Investigator positions
• Those involved in health plans and health care clearinghouses
• Regulatory Compliance