IRB Advisor (Vol. 15, No. 3) - March 1, 2015

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Release date: March 2015

Valid through: March 2018

Target Audience

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

Subjects

  • NIH guidance on single IRBs may leave more questions than answers
  • More success, less stress with multi-institutional CIP study group
  • Session outline for a CIP study group
  • Study: FDA clinical trial site violations not being reported in peer-reviewed literature
  • New scale can provide answers to levels of risk in socio-behavioral studies
  • Comic assent and informed consent for biobanking provides new way to learn about study participation

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

Credit Available

Physicians

  • Maximum of 1.5 AMA PRA Category 1 Credit(s)

Nurses

  • 1.25 ANCC Contact Hours

Sponsor

This activity is sponsored by AHC Media.

Accreditation Statement

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

Physicians

AHC Media designates this enduring material for a maximum of 1.5 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Nurses

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 Listing

Authors

Melinda Young, Jill Drachenberg

Editors

Physician Editor: Mark Schreiner, MD

Nurse Planner: Kay Ball, RN, PhD

AHC Media executive editor: Russ Underwood

Associate Managing editor: Jill Drachenberg

Financial Disclosure

Editor Melinda Young, Executive Editor Russ Underwood, Associate Managing Editor Jill Drachenberg, Physician Reviewer Mark Schreiner, MD, and Nurse Planner Kay Ball, RN, PhD, report no consultant, stockholder, speaker’s bureau, research, or other financial relationships with companies having ties to this field of study. 

Copyright 2015, AHC Media. All rights reserved.