IRBs and the changing landscape

Duration: 60 Minutes
This clinical research training will explain the Institutional Review Board (IRB) models. It will discuss the regulatory framework for IRB review including 21 CFR 50, 56 and 45 CFR 46.
IRB Review
Instructor: Sarah Fowler Dixon
Product ID: 500940

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.

Areas Covered
  • 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
Why Should you Attend
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.

Objectives of the Presentation
  • Learn about various IRB models
  • Understand when various models are used
  • Become familiar with assurances and their uses
  • Delve into what the future may hold
Who can Benefit
  • Study Coordinators
  • IRB Administrators
  • Research Administrators
  • Researchers and Investigators
  • Compliance Personnel
$300
Recorded Session for one participant
Get life time access with download option!
Book this course
Pay Now
  $450.00 Training CD
Free shipment within 4 Working Days of placing the order. Get life time access for unlimited participants.
  $550.00 Training USB Flash Drive
Free shipment within 4 Working Days of placing the order. Get life time access for unlimited participants.
For multiple location please contact our customer care team +1-510-857-5896.
How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Sarah Fowler-Dixon, PhD, CIP is an 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, Dr. Fowler-Dixon was the Educational Development and Learning Specialist for Saint Louis University serving on various committees to improve research, procedures, community outreach, and retention.
View More