Barnett International's Core Curriculum courses are comprehensive role-based clinical research training programs designed to provide industry professionals with hands-on training in a dynamic virtual setting. Held four times a year during our “Clinical Research Training Weeks,” courses offer clinical research-focused, performance-based training and core competency development.

Informed Consent Content & Process Requirements for Biobanking Studies

Upcoming Courses

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 con-sent, and successful solutions for practices that increase the protection of human subjects in clinical research.

Learning Objectives

Examine required content of the Informed Consent Form (ICF) particularly as they relate to biobank-ing 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.

Instructor

The course will be led by one of the following instructors:

Elizabeth Ronk Nelson, M.PH.

Click here for complete trainer biographies

Course Outline

Day One: 8:30 a.m. – 5:00 p.m.

Introduction to Ethics in Informed Consent: Roles and Responsibilities: Sponsor/Monitor; Institutional Review Board; Clinical Investigator
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: OHRP; OCR; FDA; NIH

Interactive Activities

Interactive discussion
Sample document review

Registration Fees

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 Melissa Dolen at 781-972-5418 to discuss your options and take advantage of the savings.

Click here for our seminar cancellation policy

Accreditation Information

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. Released: 10/18.

Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.

This seminar will be co-located with: