The Informed Consent Process at the Investigator Site

Why Should You Attend:

The purpose of this course is to explore the divergent perspectives and practical limitations of the ethics committee, sponsor, and investigator as the basis for this continuing and troubling GCP non compliance observation. No one in the clinical research field intends to provide inadequate Informed Consent. We will discuss a case study that includes findings/observations. The GCP non-compliance challenges in this system of shared responsibility will be presented.

This course is not a regulatory review of the regulations or guidance on informed Consent. This course will ask questions about the roles of the clinical research entities who share the responsibility to implement adequate voluntary informed consent- the process. The divergent perspectives of the sponsor, investigator, and ethics committee lead each to sometimes very different determinations of compliance. There are, for many of these questions, not any obvious correct answers. Your comments and questions will hopefully enable each course participant to reach their own conclusions.

At the closure of this course- We will discuss, time permitting, a case where the sponsor and ethics committee did not want to know about investigator failure to provide adequate informed consent- what happened and the surprising outcome will be presented.

Areas Covered in this Webinar:

• The inspectional focus on adequate informed consent, the document and the process.
• What GCP is and is not.
• The regulatory/ethical priority of clinical research.
  • FDA, ICH
  • Declaration Of Helsinki
  • Belmont Report
• The role of the sponsor, investigator, and ethics committee in this process of implementing voluntary informed consent.