Improved Regulatory Compliance in Research Informed Consent and Assent Taking for Minors in KKH
Care Process & Redesign
Training ＆ Education
Singapore Healthcare Management Congress
SingHealth
31 December 2021
Improve regulatory compliance in informed consent and assent taking for minors. Significant increase in compliance and reduction in NCs achieved by targeted training and process redesign.
Year Submitted: 2021
Published Date: 31 December 2021
Tags: Care Process ＆ Redesign, Training ＆ Education, Quality Improvement, Workflow Redesign, Risk Management, Virtual Learning Platform, Education Platform
About this Content
Aims
Improve regulatory compliance in informed consent and assent taking for minors.
Background
Numerous non-compliances (NCs) observed during audits, potentially risking minors’ rights and causing legal implications.
Methods
Root Cause Analysis identified lack of training materials and complex guidelines. Developed and shared training slides and posters.
Results
80% reduction in average non-compliance per consent post-intervention. P-value < 0.001 indicates significant improvement.
Conclusion
Significant increase in compliance and reduction in NCs achieved by targeted training and process redesign.
Lessons Learnt
Sustainability ensured through continued sharing of resources and awareness initiatives within the research community.
Additional Information
Shortlisted for SHM 2021 in Risk Management Category.
Keywords
Non-Compliances, Research Ethics, Regulatory Compliance
Innovators' Details
Innovators' Details
Healthcare Cluster(s) | SingHealth |
Organization(s) Involved | KK Women and Children Hospital |
Platform(s) | Singapore Healthcare Management Congress |
Healthcare Professional Group(s) | Healthcare Administration |
Applicable Specialty or Discipline | Healthcare Administrators, Clinical Research |
Project Lead(s) | Kathy Liaw |
Project Member(s) | Vivien Fu |
Connect with this contributor!
Kathy Liaw - singaporehealthcaremanagement@singhealth.com.sg
Project Attachment
C622_KKH_SHM2021_Improving_Regulatory_Compliance_Informed_Consent_Assent_Taking_for_Minors.pdf