Statistical Concepts for Non-Statisticians
April 13-14, 2015
Philadelphia, PA
Comprehensive Monitoring for Medical Devices
April 8-10, 2015
San Francisco, CA
Monitoring Clinical Drug Studies: Beginner
April 14-16, 2015
San Diego, CA

Navigating the Unusual Consent Process

Upcoming Courses
Course #: BI12065
July 29, 2015
1:00 PM - 2:30 PM Eastern

Course Description

Informed consent is a challenging process with any clinical trial subject; ensuring understanding and agreement with a form detailing a medical study and filled with legal jargon can be time consuming and stressful. In addition, when we are faced with unusual consent situations, and the rules are not readily available, we run into questions regarding ethics and regulatory ramifications. This web seminar is designed to address some of the more unusual consent situations and address the regulations, guidances, and input from ethics committees on developing the consent document and managing the informed consent process. Considerations for use of the short form, legally authorized representatives, exceptions to the standard consent process, pediatric assent, and challenges with impaired subjects will be discussed.

Learning Objectives

  • Review the informed consent process and key element requirements
  • Apply informed consent principles and standards to case studies representing “unusual” circumstances 
  • Address processes for developing informed consent templates that meet the needs of unique study populations

Who Should Attend

  • Principal Investigators
  • Study Coordinators
  • Clinical Research Associates
  • Study Managers
  • Regulatory Affairs Professionals
  • Medical Writers


Nikki Christison, B.S.

Click here for complete trainer biographies 

Registration Fees


Includes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, please call 1-800-856-2556 for pricing.

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 1.5 hours (0.15 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation.  Barnett International will mail ACPE statements within three weeks of program completion.  ACPE#: 0778-0000-14-045-L01-P.  Released: 3/14.

Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471.