The Informed Consent Process at the Investigator Site- Who decides if it is adequate and GCP compliant, Ethics Committee, Sponsor, or Investigator?

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.
• The communication interactions between these entities that enables/disables the protection of the study subjects.
• The practical limitations of each entity in the system to achieve regulatory expectations of compliance.
• The divergent perspectives of each entity in the system that compromise the regulatory expectations of performance.
• How to anticipate these risk factors.
• How to conduct clinical trials that proactively address these risk factors.
• The inspectional documentation objectives.
• How current inspectional requirements exceed the regulations or guidance on this topic.
• Required documentation at the investigator site, ethics committee, and sponsor.
• The value of SOP as “due diligence”.
• The value of the protocol “due diligence”.
• Definition of first study related procedure.
• Implementation of IC prior to the first study related procedure.
• The role of the 1572, delegation of authority form, associated staff training and documentation thereof.
• Who is qualified to implement the IC process at the investigator site.
• What is an adequate IC process- who, what, where, when.
• How, when, and where to report GCP deviations in the IC process.
• Actions that the regulatory agency expect as a result of these reports of deviations.
• The regulatory enforcement risk, liability, and exposure of the ethics committee, the investigator, and the sponsor for GCP noncompliance in implementing voluntary informed consent.

Who Will Benefit:

• Ethics Committee members
• Regulatory Affairs
• Clinical Research Associates
• Clinical research project managers
• Clinical quality assurance
• Clinical Investigators and staff

Instructor Profile:

Steve Schwartz, is the founder of Solaris Research Corporation. He has a background in basic virology research, progressing into 10 years clinical research program administration in the pharmaceutical industry. Entering the CRO industry, he performed clinical monitoring and clinical quality assurance field service using that expertise to achieve a management position at the director level. 10 years of CRO experience culminated in the formation of his full service CRO in 1989, under the initial name of Commonwealth Clinical Research Corporation- now Solaris Research Corp. Steve has also served as the investigator for several phase four clinical trials. He has served on an academic IRB. After a brief retirement he worked as Senior Manager, Global Clinical Operations/ GCP for Reckitt Benckiser Pharmaceuticals from March 2008 until July 2012. The objectives of successfully completing two clinical programs, building a global clinical research function, and developing a novel therapeutic biologic agent were completed in July 2012. Escaping from the corporate environment he is again in retirement he continues to speak and consult internationally to enable the sharing of his experience and expertise in CQA, regulatory affairs, and clinical operations including SOP, TMF, clinical monitoring, best practices.

Relevant to Clinical Quality Assurance, Steve and his associates have designed basic and advanced CQA courses for delivery to Health Canada and US Government agencies, to the pharmaceutical industry, and to academic institutions. Solaris Research provided clinical program management, clinical monitoring, CQA auditing and regulatory consulting. Solaris Research published an electronic clinical trial conduct newsletter from 2000 to 2008.

Steve has a BS degree in microbiology/infectious disease with graduate courses in immunology/virology and pharmacology, and business management. Steve has made many presentations on clinical operations, clinical monitoring, study program management, and CQA.

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