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A single IRB for all research involving human participants - the Ngee Ann Polytechnic (NP) experience
HEDY GOH, CHUA KUANG CHUA & LAU QUEK CHOON
Singapore Research Ethics Conference 2018
Overview
Operations of the IRB
Project review process
HBRA compliance
IRB - Function
Ngee Ann Polytechnic IRB was established in 2013
Board – Chairperson (medical doctor), Co-chair, Secretariat (2), Members (8 Acad faculty), external lay member (1) and external scientific member (1) and admin staff (2); IT support (2)
Review, approve and monitor the ethical aspects of research projects that involve human participants, tissues, body fluids or personal data for adherence to established ethical practices in research
IRB - Function
Oversight on all the different research fields in the Polytechnic E.g. social, education, engineering and human biomedical research projects.
Many of our projects do not fall within the scope of the HBRA, but require IRB review as the funding agencies need IRB approval and also PIs intend to publish their research
IRB’s role is to guide PIs in the ethical and safe conduct of their research
IRB - Operations
Approach Complete online system from application to review, approval, monitoring and
archiving
Support & guide PIs
In-house platform – Sharepoint Secure login through VPN
System upgrades & maintenance
IT support from Computer Centre; NP-IRB Secretariat & admin team
Insurance – IRB members and Clinical Trials insurance for PIs
NP-IRB One-stop Portal
User experience - completely paperless process
Project application, review, clarifications and approval
Project Progress ◦ Progress and Final Reports
Email triggers to alert and remind PIs for submission of reports
◦ Protocol Amendment
◦ Project Extension
NP-IRB One-stop Portal
Adverse Event Reporting
Streamlined reporting of Adverse Event staff report any incident via NP-WSH Incident Reporting portal
NP-IRB Secretariat will be notified if the adverse event involved participants in IRB approved projects
Online Archive of completed projects Storage of project records with retrieval, security, access rights and backup
functions
NP-IRB One-stop Portal
Downloadable templates ◦ Participant Information and Consent Form
◦ Risk Assessment form
NP-IRB One-stop Portal
Internal Audit – projects and system
Security - backup & access rights
Briefings for staff & Directors
Staff training & resources
Training Programs & Resources ◦ Online CITI Program
◦ HBRA, PDPA, Conferences, Seminars & Workshops
FAQs
NP-IRB Homepage
Application Process
Online Project Application
Submission for Endorsement by Director
NP-IRB Project Review
Project review after submission
Exempted Approval
Expedited Approval
Full Board Approval
Resubmission Rejected
NP-IRB Project Review
Monitoring of project
Half-yearly progress
report
Random audit checks
Final report Project
extension Protocol
amendment Adverse
event
NP-IRB – Challenges Common mistakes / errors Insufficient information in protocol
what is required of research participants; experimental design
Role of collaborators - not clear
Informed consent form - not clearly written; insufficient information
Risk assessment / safety PIs may not have sufficient technical knowledge of the research done by
collaborators
Challenges All PIs to understand the importance of research ethics
All PIs to comply with PDPA
NP-IRB – Best Practices
Best practices Encourage PIs to attend seminars and training on research ethics
All PIs attend CITI program
Research Code of Conduct & Research Data Management Policy
Share & learn from other IHLs and RIs
Nature of projects to be reviewed social, education, engineering and human biomedical research projects
(funded and non-funded)
HBRA Compliance
TIARAS registration & notification of IRB
Research Code of Conduct commitment to highest standards of ethics and integrity in research
ostates staff members’ responsibility to adhere to research integrity
o defines types of research activities and research misconduct
As part of Code of Conduct for NP staff; annual declaration exercise
HBRA2015 Part 5, section 23(2)
HBRA Compliance
Research Data Management Policy and System NP has both rights and responsibilities towards data generated from research
◦ Research data should be
◦ stored in durable form & immune to subsequent alteration
◦ permits a complete retrospective audit
◦ for a minimum period of 10 years, unless ethical, professional or funding body guidance requires otherwise
◦ Online research data management system
HBRA2015 Part 5, section 23(2)
Thank You