Webinar on Assessing Risk in Human Research Protocols By MentorHealth

Training Options  Duration: 90 Minutes 
Friday, November 3, 2017   |   10:00 AM PDT | 01:00 PM EDT

Overview:    All researchers want their studies to be reviewed and approved quickly. The level of risk assigned a research protocol affects: mode of review, whether or not additional approvals outside of the IRB are needed, need for additional protections, frequency of review, consent requirements, negotiation of indemnification language and several other factors.

Why should you Attend: Understanding how risk levels are assigned and making preliminary determinations when a study is proposed can help compliance officers, study coordinators, researchers and research administrators understand where the potential risk lies and how that will affect conduct of the study. Understanding the risk determinations will also provide explanations as to why there may or may not be flexibility in review and approval of studies. Knowing how these decisions are made and what they can affect will assist those who attend in conducting risk assessments of their own.

Areas Covered in the Session:

The importance of research risks defined in 21 CFR 50 and 45 CFR 46
Delve into how research risks affect IRB approval and review based on allowable actions in 21 CFR 50
Review consent possibilities as allowed by the regulations
Discuss need for indemnification language in consent forms based on risk levels
Consider how risks can be minimized by using preliminary risk assessments

Who Will Benefit:
Human Subjects Research
Clinical Research Coordinator Positions
Investigator Positions
Administration in Charge of Clinical Research
Regulatory Compliance
Those Involved in Health Plans and Health Care Clearinghouses

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 lead 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.