Take advantage of our $850.00 price by registering early!
* After Friday, September 14, 2018, costs are $1050.00.
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 con-sent, 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 biobank-ing studies: Are all
- 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
- 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
Ronk Nelson, M.PH.
Click here for complete trainer
Day One: 8:30 a.m. – 5:00 p.m.
- Introduction to Ethics in Informed Consent:
Roles and Responsibilities: Sponsor/Monitor; Institutional Review Board;
- Consent Requirements: Research and Identifiable Information:
- Informed Consent: Document Elements: Regulations and Guidance; OHRP; FDA; ICH; NCI
- Confidentiality: HIPPA; HITECH; GINA
- Informed Consent: Process:
- Regulatory Findings:
- Interactive discussion
- Sample document review
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 Melissa Dolen at 781-972-5418 to discuss your options and take
advantage of the savings.
Click here for our seminar
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
issue a receipt of completion for earned CEUs within three weeks of program
completion. ACPE#: 0778-0000-18-067-L01-P.
this course at your company! For more information, contact Naila Ganatra at +1
This seminar will be co-located with:
CHI's 9th International
Leaders in Biobanking Congress 2017
October 25-27, 2017