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.
- 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
This course is designed for anyone involved in the informed consent process, particularly for bio banking studies.
The course will be led by one of the following instructors:
Elizabeth Ronk Nelson, M.P.H.
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There will be a 15 minute morning break, 1 hour lunch break, and 15 minute afternoon break on each training day.
- Interactive discussion
- Sample document review
Registration fees include assorted breakfast items that will be available each day ½ hour prior to the start of the seminar. Also included is a Networking Lunch that will be served each training day.
Special rates are available for multiple attendees from the same organization. Contact Elizabeth Andrews at 781-972-5418 to discuss your options and take advantage of the savings.
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Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 7 hours (0.7 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# 0778-0000-12-054-L01-P. Released 10/12.
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471.
This seminar will be co-located with: