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.