Research Governance and Ethics Resources

Research in Justice Health and Forensic Mental Health Network (the Network) is reviewed, approved and conducted in accordance with relevant policies, guidelines and legislation.

This includes, but is not limited to:

 

Justice Health and Forensic Mental Health Network

Guidelines on the Publication of Journal Articles and Conference Presentations

 

NSW Ministry of Health

PD2007_035

Human Research Ethics Committees: Standards for Scientific Review of Clinical Trials

PD2008_030

Fee Policy for Review of Commercially Sponsored Research

PD2008_046

Ethical Review for External Entities

PD2010_055

Ethical and scientific review of human research in NSW Public Health Organisations

PD2010_056

Authorisation to commence human research in NSW Public Health Organisations

PD2011_006

Clinical Trials – Insurance and Indemnity

PD2011_028

Clinical Trial Research Agreements for Use in NSW Public Health Organisations

GL2006_021

Human Tissue – Requirements of the Human Tissue Act 1983 in relation to research & use of tissue

GL2007_016

Standardised Patient Information Sheets (PIS)

GL2007_020

Quality Improvement & Ethical Review: A Practice Guide for NSW

GL2010_014

Operations Manual: Human Research Ethics Committee Executive Officers

GL2010_015

Operations Manual: Research Governance Officers

GL2011_001

Research Governance in NSW Public Health Organisations

GL2013_009

Human Research Ethics Committees: Standard Operating Procedures for NSW Public Health Organisations

PD2017_039

Safety Monitoring and Reporting for Clinical Trials Conducted in NSW Public Health Organisations

 

National Health & Medical Research Council (NHMRC)

Australian Code for the Responsible Conduct of Research (2018)

Ethical Considerations in Quality Assurance and Evaluation Activities (2014)

Guidelines approved under Section 95A of the Privacy Act 1988 (2014)

Guidelines approved under Section 95AA of the Privacy Act 1988 (2014)

National Statement on Ethical Conduct in Human Research (2007) and all updates

NHMRC Position Statement: Monitoring and Reporting of Safety for Clinical Trials (2009)

Ethical conduct in research with Aboriginal and Torres Strait Islander Peoples and communities: Guidelines for researchers and stakeholders (2018)

Keeping research on track II (2018)

 

Privacy legislation

Health Records and Information Privacy Act 2002 (NSW)

Information and Privacy Commission NSW – Statutory Guidelines on Research (2004)

Privacy and Personal Information Protection Act 1988 (NSW)

 

Therapeutic Goods Administration (TGA)

Note for guidance on good clinical practice (CPMP/ICH/135/95 – Annotated with TGA comments)

Note for guidance on clinical safety data management: definitions and standards for expedited reporting (CPMP/ICH/377/95 – Annotated with TGA comments) (July 2000)