10 Tips for Submitting to the IRB and Starting your Study

Event Information
Product Format
Prerecorded Event
Presenter(s)
Length
90 Minutes
Product Description

10 Tips for Submitting to the IRB and Starting your Study

In performing human subjects’ research, an investigator has to send his/her protocol to the Institutional Review Boards, IRB, for approval. Often seen as "black holes"  that one submits to and waits for a determination, submitting a study to Institutional Review Boards can seem like a daunting and intimidating task. Thus, investigators are always looking for tips and strategies that will make this submission process less puzzling and faster.

Our expert speaker Sarah Fowler-Dixon, in this power packed session, helps you demystify the intricacies of IRB submission. You get tips on simple steps that may be taken by the investigator/research team in making his/her submission more IRB ready and thus receiving fewer contingencies which in turn accelerates the IRB review and approval process.

You get training on IRB requirements with relevant definitions, US Federal Regulations, ethical Codes, relevant guidance from NIH, OHRP, and ICH and information for international research.

Here are few additional topics covered in the session: 

  • What holds up your study in review?
  • When to submit to an IRB?
  • When is an individual or institution engaged?
  • Regulatory requirements essential for engagement.
  • What is considered human subjects?
  • When is your activity research?
  • How to approach human subject’s research study that needs an IRB review?
  • What do you mean by “not human subjects”?
  • Decision Tree for human subject requirements
  • Learn from the examples of Not Human
  • Which categories do HHS exempts?
  • What does exempt really mean?
  • Find out the use of OHRP guidance
  • Know what US regulation governs and apply to your study
  • What types of statues should you look for?
  • What are the criteria for research approval?
  • The risk classifications for the minors
  • How to identify the vulnerable population?

Who should attend?

  • Human Subjects Research
  • Healthcare interested in exploring the field of Clinical Research
  • New Clinical Research Coordinator positions (1-2 years)
  • New Principal Investigator positions
  • Administration in charge of Clinical Research
  • Regulatory Compliance

 

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About Our Speaker

Sarah Fowler Dixon

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...   More Info
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