125 Insights from a Process Improvement Co-op in the Development of an Informed Consent Professional Certificate (ICPC) Course
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; an...
| Main Authors: | , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Cambridge University Press
2024-04-01
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| Series: | Journal of Clinical and Translational Science |
| Online Access: | https://www.cambridge.org/core/product/identifier/S2059866124001225/type/journal_article |
| _version_ | 1797226905300107264 |
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| author | Marisabel Davalos Kenia F. Viamonte Cynthia Gates Olveen Carrasquillo Erin N. Kobetz Carl I Schulman |
| author_facet | Marisabel Davalos Kenia F. Viamonte Cynthia Gates Olveen Carrasquillo Erin N. Kobetz Carl I Schulman |
| author_sort | Marisabel Davalos |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-24T14:32:20Z |
| format | Article |
| id | doaj.art-b60aa100c9734136b398e1b9628011fd |
| institution | Directory Open Access Journal |
| issn | 2059-8661 |
| language | English |
| last_indexed | 2024-04-24T14:32:20Z |
| publishDate | 2024-04-01 |
| publisher | Cambridge University Press |
| record_format | Article |
| series | Journal of Clinical and Translational Science |
| spelling | doaj.art-b60aa100c9734136b398e1b9628011fd2024-04-03T02:00:21ZengCambridge University PressJournal of Clinical and Translational Science2059-86612024-04-018363710.1017/cts.2024.122125 Insights from a Process Improvement Co-op in the Development of an Informed Consent Professional Certificate (ICPC) CourseMarisabel Davalos0Kenia F. Viamonte1Cynthia Gates2Olveen Carrasquillo3Erin N. Kobetz4Carl I Schulman5University of MiamiUniversity of MiamiHuman Subjects Protection ConsultantUniversity of MiamiUniversity of MiamiUniversity of MiamiOBJECTIVES/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.https://www.cambridge.org/core/product/identifier/S2059866124001225/type/journal_article |
| spellingShingle | Marisabel Davalos Kenia F. Viamonte Cynthia Gates Olveen Carrasquillo Erin N. Kobetz Carl I Schulman 125 Insights from a Process Improvement Co-op in the Development of an Informed Consent Professional Certificate (ICPC) Course Journal of Clinical and Translational Science |
| title | 125 Insights from a Process Improvement Co-op in the Development of an Informed Consent Professional Certificate (ICPC) Course |
| title_full | 125 Insights from a Process Improvement Co-op in the Development of an Informed Consent Professional Certificate (ICPC) Course |
| title_fullStr | 125 Insights from a Process Improvement Co-op in the Development of an Informed Consent Professional Certificate (ICPC) Course |
| title_full_unstemmed | 125 Insights from a Process Improvement Co-op in the Development of an Informed Consent Professional Certificate (ICPC) Course |
| title_short | 125 Insights from a Process Improvement Co-op in the Development of an Informed Consent Professional Certificate (ICPC) Course |
| title_sort | 125 insights from a process improvement co op in the development of an informed consent professional certificate icpc course |
| url | https://www.cambridge.org/core/product/identifier/S2059866124001225/type/journal_article |
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