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