Research Education

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Human Research Series

Modules A, B and C

The human research series, intended for MCW employees whose job responsibilities include any aspect of human research, are optional modules that can be taken in any order.  Individuals are welcome to choose which modules to attend, according to their job needs.

There are currently three modules (modules A, B, C) held quarterly on a rotating monthly basis, lasting 1.5 hours each.  Topics are "IRB Processes", "IRB News Hour" (changing topics), and "Conducting Human Research at Froedtert Hospital:  What You Need to Know". Sessions are typically small in size, allowing time for questions, interaction, and networking.   (Scroll down for program purpose and agenda).

Walk ins are welcome, however, please check this web page for cancellations. An RSVP ensures enough handout copies are available.

Dessert is provided. Feel free to bring a lunch.

 

Module A:  IRB Processes

Presented by Faye Overly, MCW IRB Office

Wednesday, December 16

Noon - 1:30 p.m. 

 MFRC 3095

Module B:  IRB News - Research Banks at MCW and Froedtert Hospital: IRB Training for Bank Personnel

David C. Clark, PhD, Assistant Dean for Clinical Research

January 2010
TBA

Noon - 1:30 p.m.

TBA

Module C:  Conducting Human Research at FH:  What You Need to Know

Presented by Nancy Schallert and Roberta Navarro, OCRICC, FH

February 2010
TBA

Noon - 1:30 p.m

TBA

The MCW Human Research Packet provides information about administrative aspects of conducting human research at MCW. Contact information, web links, educational requirements and optional educational opportunities are listed.

Audience - Human Research Team Members

Contact - Nancy Larrick, nlarrick@mcw.edu, 456-7365

 

Module A - IRB Processes 

Instructor:  Faye Overly, IRB Coordinator II

Purpose:  This interactive session focuses on the MCW IRB submission process and the use of eBridge for human study submissions.

Agenda: Discuss the MCW IRB submission process, common misconceptions, content of forms for submission, reportable events, and insight into the protocol review process by the committee.  It focuses on eBridge- electronic human studies submission process to the MCW/FH Institutional Review Boards (IRBs).  eBridge - Human Research Training is a suggested pre-requisite.

Module B - IRB News (rotating topics)

Instructor:  David Clark, PhD, Assistant Dean for Clinical Research

Purpose:  This interactive session focuses on elements of banking for human research purposes. Individual questions are welcome in this small group session.

Objectives:   Review MCW IRB policy on banking data and bio-specimens; Discuss definition of "data"; Differentiate among identified, coded, de-identified and anonymous (anything) and its relationship to banks; Compare banking consent documents and study consent documents; Define role and responsibilities of the bank custodian; Review IRB requirements for conducting research with banked data or specimens

Module C - Conducting Human Research at Froedtert Hospital:  

                                      What you need to know

By: Office of Clinical Research and Innovative Care Compliance (OCRICC)

Instructors: Nancy Schallert, Director, Corporate Compliance, Internal Audit, & OCRICC, FH and Roberta Navarro, Manager, OCRICC

Purpose:  This session provides an opportunity to learn directly from the source about the services that provided and required by OCRICC.

Agenda:  Overview of OCRICC, identify which human research conducted at FH requires OCRICC approval, identify timeline for approval, and where to find tools and resources.

 

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