Target audience: 

Institutional Review Board members

Institutional Review Board chairs

Learning objectives: 
  1. Regulatory and ethical responsibilities for conducting and reviewing human subject research will be presented to learners, and learners are expected to turn this information into applicable knowledge to be used when reviewing human subject research projects. Through the quality of reviews and the number of questions received by the HRPP from reviewers, it will be assessed whether or not learners turned the information into knowledge. Also, audits by MCW’s Corporate Compliance, audits by the FDA, and audits by AAHRPP will help determine how well learners grasped the concepts.
  2. Learners will be instructed of the differences between clinical and research activities as well as the regulatory and institutional oversight requirements for type of each activity. With this information, learners should be able to properly distinguish between clinical activities and research activities, which will aid them in understanding and carrying out their responsibilities for oversight of each activity. The comprehension of this objective will be assessed through review of the documentation provided by learners for each activity and the discussions that arise throughout the activity.

  3. Learners will be provided with various resources that aid in the interpretation of policies and regulations and the application of ethical principles to human research subject protections. It is hoped that learners will use these resources to assist them in review of human subject research projects. Through discussions and feedback in surveys for this activity, the degree to which learners utilize these resources to carry out their responsibilities will be assessed.

Faculty & credentials: 


Kristin Busse, PharmD

Activity Director: David Clark, PhD

Planning Committee:
Kathryn Gaudreau
Sara Griffin
Faye Overly
Roxanne Pritchard

All persons in control of content have NO relevant financial relationships to disclose.


IRB Coordinator
Phone number: 
+1 (414) 955-8422

ACCME Accreditation Statement:
The Medical College of Wisconsin is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

AMA Credit Designation Statement:
The Medical College of Wisconsin designates this live activity for a maximum of 1.0 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Hours of Participation for Allied Health Care Professionals:
The Medical College of Wisconsin designates this activity for up to 1.0 hours of participation for continuing education for allied health professionals.

Session date: 
04/02/2019 - 2:00pm to 3:00pm CDT
The Medical College of Wisconsin
8701 Watertown Plank Road
MFRC 3075
WI 53226
United States
  • 1.00 AMA PRA Category 1 Credit(s)™
    AMA PRA Category 1 Credit(s)™
  • 1.00 Hours of Participation
    Hours of Participation credit.

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