IRB Advisor (Vol. 14, No. 6) - June 1, 2013

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 Listing:

Editor
Melinda Young

Associate Managing Editor
Jill Drachenberg
AHC Media

Executive Editor
Russ Underwood
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:

  • Consent form specialists assist investigators and board members
  • OHRP letters focus on informed consent issues
  • Community research requires compromise
  • Michigan BioTrust consent options
  • FDA's draft guidance clarifies IRB roles
  • University creates new model for shared review
  • Central vs. local IRB for multisite research
  • FDA: Obtain IND for C. diff treatment

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 Melinda Young, Associate Managing Editor Jill Drachenberg, Executive Editor Russ Underwood, 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.

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