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UID:2140535:Event:76429
DTSTAMP:20260413T081234Z
SUMMARY:Webinar on Assessing Risk in Human Research Protocols By Mento
 rHealth
DESCRIPTION:Training Options  Duration: 90 Minutes  Friday, November
  3, 2017   |   10:00 AM PDT | 01:00 PM EDTOverview:    All rese
 archers want their studies to be reviewed and approved quickly. The le
 vel of risk assigned a research protocol affects: mode of review, whet
 her or not additional approvals outside of the IRB are needed, need fo
 r additional protections, frequency of review, consent requirements, n
 egotiation of indemnification language and several other factors.Why s
 hould you Attend: Understanding how risk levels are assigned and makin
 g preliminary determinations when a study is proposed can help complia
 nce officers, study coordinators, researchers and research administrat
 ors 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 a
 nd what they can affect will assist those who attend in conducting ris
 k assessments of their own. Areas Covered in the Session:The importanc
 e of research risks defined in 21 CFR 50 and 45 CFR 46Delve into how r
 esearch risks affect IRB approval and review based on allowable action
 s in 21 CFR 50Review consent possibilities as allowed by the regulatio
 nsDiscuss need for indemnification language in consent forms based on 
 risk levelsConsider how risks can be minimized by using preliminary ri
 sk assessmentsWho Will Benefit:Human Subjects ResearchClinical Researc
 h Coordinator PositionsInvestigator PositionsAdministration in Charge 
 of Clinical ResearchRegulatory ComplianceThose Involved in Health Plan
 s and Health Care ClearinghousesSpeaker Profile Sarah Fowler-Dixon, Ph
 D, CIP is Education Specialist and instructor with Washington Universi
 ty School of Medicine. She has developed a comprehensive education pro
 gram for human subject research which has served as a model for other 
 institutions. She crafted budgets, policies, procedures, reporting, an
 d training for the new program. She has initiated the planning, develo
 pment, authorship and implementation of many human subjects research p
 olicies, practices, guidelines, submission and reviewer forms often wo
 rking with state and federal authorities. She has provided consultatio
 n regarding ethical, federal, state, and institutional requirements fo
 r faculty and staff both in the design and execution of their projects
  and teaches research ethics and regulatory affairs and the fundamenta
 ls of research management to graduate and undergraduate students. More
  recently, she lead a task force in the development of the Community E
 ngaged Research Program at Washington University. Dr. Fowler-Dixon has
  simultaneously served as an Independent Consultant, providing experti
 se and creating supplemental educational materials, including a copyri
 ghted workbook. Prior to joining Washington University, Dr. Fowler-Dix
 on was the Educational Development and Learning Specialist for Saint L
 ouis University serving on various committees to improve research, pro
 cedures, community outreach, and retention.Price - $139Contact Info:Ne
 tzealous LLC -MentorHealthPhone No: 1-800-385-1607Fax: 302-288-6884 Em
 ail: support@mentorhealth.comWebsite: http://www.mentorhealth.com/Webi
 nar Sponsorship: https://www.mentorhealth.com/control/webinar-sponsors
 hip/\n\nFor more information visit https://medtechiq.ning.com/events/w
 ebinar-on-assessing-risk-in-human-research-protocols-by
DTSTART;TZID=America/New_York:20171103T100000
DTEND;TZID=America/New_York:20171103T113000
CATEGORIES:webinar
LOCATION:Online
WEBSITE:http://www.mentorhealth.com/control/w_product/~product_id=8011
 13LIVE?medtechiq_nov_2017_SEO
URL:http://www.mentorhealth.com/control/w_product/~product_id=801113LI
 VE?medtechiq_nov_2017_SEO
CONTACT:8003851607
ORGANIZER:Netzealous LLC -MentorHealth
ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/
 file/get/2562015769?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="Roger St
 even":https://medtechiq.ning.com/profile/RogerSteven
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