The Royal Children's Hospital Melbourne

Research Governance and Ethics

Useful links

Internal Guidelines
Databank and Biobank Guideline
Case Report Guideline
Case Report RCH Consent Template for publications
Social Media Guideline
C ell lines in Research Guideline
Conducting research in Overseas Guideline
Electronic submission (document naming) Guideline
RCH Research Policies and Procedures
Research Governance Framework
CRDO Standard Operating Procedures

Using EMR for Research

RCH Privacy Brochure
Parkville EMR - Appropriate use for Research
Process for Parkville EMR Access for External Monitor, Inspectors & Auditors
Managing Access for a Research Study Monitor
ERM User Guide

Legislation and External Guidelines
Australian Code for the Responsible Conduct of Research
Declaration of Helsinki
Good Clinical Practice (GCP), with TGA annotations
Human Tissue Act (Vic) (1982)
NHMRC Guidelines Approved under Section 95A of the Privacy Act 1988
NHMRC National Statement for Ethical Conduct in Human Research
The Australian Clinical Trial Handbook
Victorian Health Privacy Principles, extracted from Health Records Act 2001
National Mutual Acceptance (NMA) Process

Campus links
Drug Trial Subcommittee (DTS) Terms of Reference
RCH Research Policies & Procedures
RCH HREC Submission Fees
Clinical Epidemiology & Biostatistics Unit (CEBU)
Clinical Research Development Office (CRDO)
Other links
Department of Education - Victorian Government
Health Complaints Commissioner
Medicines Australia
National Health & Medical Research Council (NHMRC)
Therapeutic Goods Administration website
Victorian Managed Insurance Authority(VMIA)
National Mutual Acceptance (NMA) Process

RCH Human Research Ethics Committee
RCH HREC Membership
RCH HREC Review Process Summary (flow diagram)
RCH HREC Standard Operating Procedure
RCH HREC Terms of Reference