At the end of this training program, participants will be able to differentiate between consent and assent, identify when to use the long form and when to use the short form, describe the consent process using best practices.
This webinar will provide a review of regulatory requirements and a comprehensive discussion of the “how-to” to develop best practices and sharpen your skills when engaging with potential study participants and their significant others. Determining when assent is needed, understanding how it differs from consent. Planning your approach, who should be involved in the discussion and when you should involve them? Documentation of consent, what is required and where should it be recorded.
The instructor’s extensive knowledge and experience in clinical research conduct, including special populations that require competency evaluations makes her well suited to answer your questions and offer guidance in the practice of recruitment and consent.
Why Should You Attend:
Whether you are a new clinician, or have years of experience, operationalizing best practices for recruitment and informed consent in research is a core skill that differs in many ways from clinical consent. You may know the regulations, but developing the mastery of effective evaluations of competency and understanding of study subjects and management of involvement of trusted others in a HIPAA compliant fashion are operational skills that improve your practice and your outcomes.This webinar will provide a review of regulatory requirements and a comprehensive discussion of the “how-to” to develop best practices and sharpen your skills when engaging with potential study participants and their significant others. Determining when assent is needed, understanding how it differs from consent. Planning your approach, who should be involved in the discussion and when you should involve them? Documentation of consent, what is required and where should it be recorded.
The instructor’s extensive knowledge and experience in clinical research conduct, including special populations that require competency evaluations makes her well suited to answer your questions and offer guidance in the practice of recruitment and consent.
Areas Covered in the Webinar:
- Elements of Informed Consent
- HIPAA and Recruitment - Who Can You Approach and When
- Consent Process and Key Milestones
- Evaluation of Competence
- Documentation of Consent- Long Form and Short Form
- When Assent is Needed
Who Will Benefit:
- Investigators
- Coordinators
- Health System Administrators
- Clinical Research Compliance Staff/Officers
- Industry Managers and Monitors
Course Provider
Jennifer Holcomb,