IRB Advisor 1005 - IRB Advisor - May 01, 2006

Target Audience:

This activity is intended for physicians who organize, lead, or participate in clinical trial research.

Accreditation:

AHC Media is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

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

Credit Designation:

AHC Media designates this enduring material for a maximum of 1.5 AMA PRA Category 1 CreditsTM. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
 
This activity has been approved for 1.5 nursing contact hours using a 50-minute contact hour.

Provider approved by the California Board of Registered Nursing, Provider # 14749, for 1.5 Contact Hours.

Faculty

Editors
Suzanne Koziatek

Melinda Young

Editorial Group Head
Lee Landenberger
AHC Media, formerly Thomson American Health Consultants

Managing Editor
Alison Allen
AHC Media, formerly Thomson American Health Consultants

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

Physician Reviewer
Alan Sugar, MD
Chairman
New England Institutional Review Board Professor of Medicine
Boston University School of Medicine

Editorial Advisory Board Member
J. Mark Waxman, JD
Partner Foley & Lardner
Boston

Author
Marjorie Speers, PhD
Executive Director
Association for the Accreditation of Human Research Protection Programs

Subjects:

  • Clinical trial problems in England raise ethical questions in US
  • Research is changing IRB views about PTSD studies
  • Consent, confidentiality key in PTSD research
  • The FDA launches guidance initiative
  • Liaison efforts can improve compliance
  • Different disciplines, similar challenges

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, Editorial Group Head Lee Landenberger, Managing Editor Alison Allen, Nurse Planner Kay Ball, RN, MSA, CNOR, FAAN, Physician Reviewer Alan Sugar, MD, Editorial Advisory Board Member J. Mark Waxman, JD, and Author Marjorie Speers, PhD report no consultant, stockholder, speaker’s bureau, research, or other financial relationships with companies related to the content in this CE/CME activity.

Copyright 2006 AHC Media. All rights reserved.