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

Why Should You Attend:

The number of clinical trials continues to increase. Clinical trials are no longer solely conducted at academic research centers or hospitals. Stand-alone facilities set up to conduct research are being established. Partnerships are being formed between traditional centers and the community. Multi-site studies are becoming the standard. Yet the regulations have not changed and IRBs must interpret what is currently available to them in order to review and approve clinical trials. Included in the mix is pressure for IRBs to move faster and to consolidate their reviews. This has prompted a variety of new IRB review models.

This webinar will explain IRB models, including IRB as the HIPAA Privacy Board. It will discuss the current issues surrounding IRB review and potential use of IRB consortiums.

Areas Covered in the Webinar:

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

Who Will Benefit:

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

Instructor Profile:

Dr. Sarah Fowler-Dixon, PhD, CIP is Education Specialist and instructor with Washington University School of Medicine. She has developed a comprehensive education program for human subject research which has served as a model for other institutions. She crafted budgets, policies, procedures, reporting, and training for the new program. She has initiated the planning, development, authorship and implementation of many human subjects’ research policies, practices, guidelines, submission and reviewer forms often working with state and federal authorities. She has provided consultation regarding ethical, federal, state, and institutional requirements for faculty and staff both in the design and execution of their projects and teaches research ethics and regulatory affairs and the fundamentals of research management to graduate and undergraduate students. More recently, she led a task force in the development of the Community Engaged Research Program at Washington University.

Dr. Fowler-Dixon has simultaneously served as an Independent Consultant, providing expertise and creating supplemental educational materials, including a copyrighted workbook. Prior to joining Washington University, she was the Educational Development and Learning Specialist for Saint Louis University serving on various committees to improve research, procedures, community outreach, and retention.

Topic Background:

When IRBs were first mandated in 1974 research was much different. Most research was conducted in a laboratory and funded by NIH. In the last decade, clinical research has taken off bringing with it new challenges and novel research. In order to keep up with the changing demands, IRBs have to work faster and smarter often faced with complex decisions for which there may be no precedent.

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