Human Research Protection Program

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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 made available.

Feel free to bring a lunch. Complete 2014 schedule.

Questions: Contact Roxanne Pritchard.

 

Module A - IRB Processes

Instructor:  Faye Overly, QA/QI Specialist

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 IRB committee.  It focuses on eBridge; the electronic human studies submission process for the MCW/FH Institutional Review Boards (IRBs).  eBridge Human Research Training is a suggested pre-requisite.

Module B - IRB News (Topics rotate between Banking and other IRB news topics)

1. Banking Session

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

2. IRB News - Topic Varies

Instructors: Panel Varies

Module C - Conducting Human Research at a Froedtert Entity:
  What you need to know

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

Instructor: Presented by Nancy Schallert, Director, Corporate Compliance & Internal Audit

Purpose:  This session provides an opportunity to learn directly from the source about the services that are 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 & resources.

 

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