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125 Insights from a Process Improvement Co-op in the Development of an Informed Consent Professional Certificate (ICPC) Course

Published online by Cambridge University Press:  03 April 2024

Marisabel Davalos
Affiliation:
University of Miami
Kenia F. Viamonte
Affiliation:
University of Miami
Cynthia Gates
Affiliation:
Human Subjects Protection Consultant
Olveen Carrasquillo
Affiliation:
University of Miami
Erin N. Kobetz
Affiliation:
University of Miami
Carl I Schulman
Affiliation:
University of Miami
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Abstract

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OBJECTIVES/GOALS: The objectives of the ICPC Course were 1) to define elements needed to 'build' a solid framework for the creation of an effective informed consent document; 2) to examine various regulatory references and their importance in the context of the informed consent process; and 3) to review helpful tips and best practices of the informed consent process. METHODS/STUDY POPULATION: This 7-week course was a multi-disciplinary effort by the Miami CTSI, the Regulatory and Monitoring Support Office and the Human Subjects Research Office (HSRO), as part of their co-op partnership. The CTSI’s Network of Clinical Research Professionals (NCRP) (over 1995 members and established to offer and enhance education, training, and overall career development and networking for the U’s diverse research workforce) served as the target audience. The lead HSRO official was the course content developer and served as instructor. The Director of the HSRO served as the certificate & program coordinator. Additionally, this course indirectly fulfilled part of the requirements of the Institution’s AAHRPP re-accreditation. RESULTS/ANTICIPATED RESULTS: 70 persons attended all sessions and received their certificate. A post-course survey was deployed (n=70). 69 respondents were extremely satisfied with course content; 67 were likely to recommend the course to a colleague. Feedback highlights include: appreciation for time taken to organize/offer the course; presenter knowledge and preparation; and that case studies/examples were up-to-date and applicable. As an added incentive to participate in the course, both the School of Nursing and the Medical School provided CEU credits and the Society of Clinical Research Associates (SOCRA) accepted documentation of candidate participation in continuing education programs for recertification. DISCUSSION/SIGNIFICANCE: Based on a need identified through a multi-disciplinary process, a successful Informed Consent Professional Certificate Course was created and implemented. Respondents indicate extremely high satisfaction with the course and felt it was very relevant and applicable to their practice.

Type
Education, Career Development and Workforce Development
Creative Commons
Creative Common License - CCCreative Common License - BYCreative Common License - NCCreative Common License - ND
This is an Open Access article, distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives licence (https://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is unaltered and is properly cited. The written permission of Cambridge University Press must be obtained for commercial re-use or in order to create a derivative work.
Copyright
© The Author(s), 2024. The Association for Clinical and Translational Science