IRB Advisor 902 - IRB Advisor - Feb 01, 2005

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.

Subjects:

  • Vioxx, NIH crises lead to questions about drug safety and IRBs’ role
  • 2005 issues: Stem cell research, noncompliance
  • IRB application helps educate researchers
  • New web site centralizes multicenter submissions
  • Newborn subjects, vulnerable families

Objectives:

  • establish clinical trial programs using accepted ethical principles for human subject protection
  • describe the regulatory qualifications regarding human subject research
  • comply with the necessary educational requirements regarding informed consent and human subject research
  • apply the necessary safeguards for patient recruitment, follow-up, and reporting of findings for human subject research
  • explain the potential for conflict of financial interests involving human subject research
  • discuss reporting adverse events during research.

Financial Disclosure:

Editor Suzanne Koziatek, Editorial Group Head Lee Landenberger, Managing Editor Alison Allen, Nurse Planner Kay Ball, and Physician Reviewer Alan Sugar, MD, report no consultant, stockholder, speaker’s bureau, research, or other financial relationships with companies related to the content in this CE/CME activity.