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Who should attend 10 Tips for Submitting Human Subjects Protocols - By Compliance Global Inc.
Human Subjects Research Personnel, Healthcare Agencies interested in exploring the field of Clinical Research, New Clinical Research Coordinators, New Principal Investigators, Administration in charge of Clinical Research, Regulatory Compliance Personnel
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Seminar Summary:

Simple Federal regulation tips to speed up IRB approval for human subjects’ submission. (see full course description)

 
 
 

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Training Course Syllabus:


Overview

Institutional Review Boards (IRB) also known as ethics committees or ethical review boards were established by federal regulation in 1974. IRBs are independent committees designated to approve, monitor and review biomedical and behavioral research involving human subjects.

The Institutional Review Board’s training mission is to protect the rights and welfare of human subjects’ training participants and therefore must review any proposed study that wishes to interact or intervene with human subjects or their private, identifiable information. Reviews take place, at a minimum, before a research study begins, any time there is a modification or reportable event that must be submitted, and at the time of continuing review.

Why Should You Attend

In conducting human subjects’ research, an investigator must send his/her protocol to the Institutional Review Board (IRB) for approval. Often seen as “black holes” that one submits to and awaits a determination, submitting a study to an IRB can seem like an arduous, daunting task. Because of this, investigators are always looking for tips that will make this process less mysterious and faster.

Areas Covered in this Webinar

This webinar is designed to remove some of the mystery of an IRB human subject submission by providing tips on simple steps that may be taken by the investigator/research team in preparing his/her submission, making it more IRB ready and therefore receiving less contingencies which in turn speed up the IRB review and approval process.

Learning Objectives

What holds up your study in review?
When to submit to an IRB training
When is an individual or institution engaged?
Federal regulation requirements for engagement
What is considered human subjects?
When is your activity research?

Who Will Benefit

Human Subjects Research Personnel
Healthcare Agencies interested in exploring the field of Clinical Research
New Clinical Research Coordinators
New Principal Investigators
Administration in charge of Clinical Research
Regulatory Compliance Personnel

Speaker Profile

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, 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.

Seminar Summary:

Simple Federal regulation tips to speed up IRB approval for human subjects’ submission. (see full course description)

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