IRB Advisor 1608 - IRB Advisor - Aug 01, 2012

Target Audience:

This activity is intended for clinical trial research physicians and nurses.

Accreditation:

AHC Media is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center's Commission on Accreditation.

Credit Designation:

This activity has been approved for 1.25 nursing contact hours using a 60-minute contact hour.

Provider approved by the California Board of Registered Nursing, Provider # 14749, for 1.25 Contact Hours.

Nurses licensed in California should retain this credit letter for four years.

Faculty

Editors
Suzanne Koziatek
Melinda Young

Associate Managing Editor
Jill Drachenberg
AHC Media

Nurse Planner
Kay Ball, RN, PhD, CNOR, FAAN
Perioperative Consultant/Educator
K & D Medical
Lewis Center, OH

Physician Reviewer
Mark S. Schreiner, MD
Associate Professor of Anesthesia in Pediatrics
University of Pennsylvania Chair
Committee for the Protection of Human Subjects
The Children's Hospital of Philadelphia

Subjects:

  • OHRP & FDA issue new guidance on transferring approved projects
  • Cultural issues should be addressed in IC process
  • Pre-review process results in faster IRB review process
  • National Children's Study tests shared IRB model
  • Quality improvement study hampered by IRB concerns
  • Recordings of IRB meetings show gaps in discussions
  • Lower-income patients less likely to be in cancer trials

Objectives:

  • establish clinical trial programs using accepted ethical principles for human subject protection
  • apply the mandated regulatory safeguards for patient recruitment, follow-up and reporting of findings for human subject research
  • comply with the necessary educational requirements regarding informed consent and human subject research

Financial Disclosure:

Editor Suzanne Koziatek, Editor Melinda Young, Associate Managing Editor Jill Drachenberg, Nurse Planner Kay Ball, RN, PhD, CNOR, FAAN, and Physician Reviewer Mark S. Schreiner, MD, report no consultant, stockholder, speaker's bureau, research, or other financial relationships with companies related to the content in this CNE/CME activity.

Copyright 2012 AHC Media. All rights reserved.