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BioBanking Congress - Day 3

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Wednesday, October 3


Informed Consent Content & Process Requirements for Biobanking Studies*

Course Description

This course presents the elements of the informed consent document and the components of the process, specifically as they relate to biobanking studies. Industry specific scenarios are presented to reinforce important concepts, for example: Wording considerations given FDA’s recent feedback, execution timing, evaluating and documenting capacity to consent, voluntariness, when a HIPAA authorization is required, withdrawal of consent, and more. Discussions also include reported poor regulatory performance regarding informed consent, and successful solutions for practices that increase the protection of human subjects in clinical research.

Participants will receive 7 hours (0.7 CEUs) from Accreditation Council for Pharmacy Education for full participation. 

Learning Objectives

  • Examine required content of the Informed Consent Form (ICF) particularly as they relate to biobanking studies: Are all stakeholders checking?
  • Define the informed consent process per regulations and best practices
  • Clearly define who and what determines if consent has been adequately executed
  • Evaluate exceptions for obtaining consent, and the role of the research site, Institutional Review Board (IRB), and sponsor in the process
  • Apply clear documentation of the informed consent process, including withdrawal of consent
  • Review elements that must be included in an authorization for use and disclosure of protected health information
  • Compare and contrast HIPAA authorization and the informed consent process

Who Should Attend

This course is designed for anyone involved in the informed consent process, particularly for bio banking studies.


Elizabeth NelsonElizabeth Ronk Nelson, M.P.H.

Elizabeth has over 20 years of experience in medical and clinical research. During her career, she has managed clinical trial site operations as a clinical research program coordinator and researcher and has served as an IRB Quality Assurance Specialist and a Senior (GCP) Auditor, Trainer, and Compliance Director. Her professional areas of specialization include fraud detection and prevention; mock FDA audits; customized, audit finding-specific, risk-based training; independent GCP quality systems and compliance audits; SOP and training program development and gap analysis; corrective and preventative action (CAPA) and quality systems improvement plans for GCP; customized skill-based training for clinical research professionals; clinical investigator site and IRB development and quality improvement (QI) plans; vendor audits/assessments; and site selection/qualification assessments. Ms. Nelson has extensive experience in investigating and pursuing suspect clinical data cases and has worked professionally with industry and government representatives to pursue legal actions for severe noncompliance cases.

*Separate Registration Required

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