Recruitment and Informed Consent: The Cornerstone of Ethical Clinical Research

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

Instructor Profile:

Jennifer Holcomb, MA, CCRC, is a clinical research professional with over 20 years of experience in the field. She is currently consulting privately. Ms. Holcomb has worked in nationally accrediting Institutions with AAHRPP. Her experience also includes serving in executive leadership roles at research institutions including Duke University, UCHealth System and University of Louisville. She provides guidance and leadership in the establishment and development of policies in the conduct and management of clinical research. Her key areas of expertise include clinical trial budgeting and contract negotiations as well as regulatory knowledge including international ICH GCP standards. Ms. Holcomb has extensive experience in training and education and served as Vice Chair of the ACRP Professional Development Committee for 4 years.

Topic Background:

Informed and involved study participants are empowered medical decision makers. They ensure the highest quality of data collected and successful study completion. To improve clinical research participation, participant retention and accuracy of data collected- we must begin with an investment in the recruitment and informed consent of our most valuable partners in clinical research, study subjects. Understanding the regulatory requirements is essential; operationalizing them is a skill.

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