Research Guidelines

Please find a selection of relevant research policies and guidelines for SESLHD. 

If you are looking for specific forms and templates, please click here. 
 

International

• International Conference on Harmonisation (ICH) - Good Clinical Practice Guidelines (E6)
• The Declaration of Helsinki (2008).

National

• NHMRC National Statement on Ethical Conduct in Research Involving Humans 
• Access to Unapproved Therapeutic Goods - Authorised Prescribers
• Import and/or supply of an unapproved therapeutic good – Special Access Scheme 
• Australian Code for the Responsible Conduct of Research
• ICH/GCP Annotated with TGA comments
• Therapeutic Goods Administration (TGA)
• Medicines Australia
• https://www.nhmrc.gov.au/sites/default/files/documents/attachments/ethical-considerations-in-quality-assurance-and-evaluation-activites.pdf

NSW Health Policies

Ethics

• Ethical Review for External Entities
• Operations Manual: Human Research Ethics Committee Executive Officers
• Operations Manual: Human Research Ethics Committees
• Quality Improvement & Ethical Review: A Practice Guide for NSW
• OHMR LNR Guidelines 
• National Mutual Acceptance scheme 
• Requirements of the Human Tissue Act 1983 in relation to research and use of tissue
• Research - Ethical & Scientific Review of Human Research in NSW Public Health Organisations
• Research - Human and Animal Research and the National Health & Medical Research Council Act 1992
• Standardised Patient Information Sheets (PIS) 
• Fee Policy for Review of Commercially Sponsored Research 
• Data Safety Monitoring Boards (DSMBs).

Governance

• Research - Ethical & Scientific Review of Human Research in NSW Public Health Organisations
• Research - Human and Animal Research and the National Health & Medical Research Council Act 1992
• Research - Authorisation to Commence Human Research in NSW Public Health Organisations
• Clinical Trial Research Agreements for Use in NSW Public Health Organisations
• NSW Health Research Ethics and Governance
• Operations Manual: Research Governance Officers
• Research Governance in NSW Public Health Organisations
• Fee Policy for Review of Commercially Sponsored Research 

Clinical Trials

• Australian Clinical Trial Handbook
• Standards of Scientific Review of Clinical trials 
• CTN and CTX schemes for clinical trials
• Clinical Trial Research Agreements for Use in NSW Public Health Organisations
• Clinical Trials - Insurance and Indemnity
• Safety Monitoring and Reporting for Clinical Trials Conducted in NSW Public Health Organisations
• Guidance: Safety monitoring and reporting for clinical trials
• Risk-based Management and Monitoring of Clinical Trials Involving Therapeutic Goods
• Reporting of Serious Breaches of Good Clinical Practice (GCP) or the Protocol for Trials Involving Therapeutic Goods

Specialised HRECs

• NSW Civil and Administrative Tribunal (NCAT) - Guardianship division - Clinical trials
• Aboriginal Health and Medical Research Council (AH&MRC)
• NSW Population and Health Services Research Ethics Committee
• Justice Health & Forensic Mental Health HREC 

Local

All Research related SESLHD policies and guidelines can be located here.

The inclusion of links to external websites does not imply any endorsement or support by South Eastern Sydney Local Health District or Ministry of Health or the State of New South Wales. See our Disclaimer for more information.