Ethical Review of Research
In Australia, all research studies involving human participants, human tissues and clinical data must adhere to the NHMRC National Statement on Ethical Conduct in Research Involving Humans (2007, updated May 2015) (the National Statement). Projects for every such research study must be approved by an accredited Human Research Ethics Committee (HREC).This is known as Ethical Approval.
NSW Health Policy Directive PD2010_056 Research - Authorisation to Commence Human Research in NSW Public Health Organisations sets out the mechanism to be used by Public Health Organisations (PHO) to authorise the commencement of human research projects at sites under their control. LHD compliance with this policy is mandatory. All research projects involving humans must be authorised by the Chief Executive (or Designee) before research may commence at any PHO. This is known as Research Governance Site Authorisation.
Within WSLHD, human research proposals are first submitted to the Research Office for managing and administering the ethical and governance review processes. If you are new to making ethics and governance submissions, or would like to refresh your knowledge, information documents provided to you below.
Human Research Ethics
Ethics examines the proposed study for scientific, clinical and ethical validity, ensuring as far as reasonably practicable, that the benefits of the study outweigh any risks to participants. Ethical approval can be sought for studies at single or multiple PHO sites and facilities, and some external organisations affiliated with WSLHD.
Human Research Governance
Research governance examines the proposed quality, safety, privacy, risk management and financial management of the study. Research governance approval is required after ethical approval for each PHO site/facility within WSLHD where the study will be undertaken.
Research Ethics & Governance Information System (REGIS)
NSW Ministry of Health Office for Health and Medical Research (OHMR)
National Health & Medical Research Council (NHMRC)
Therapeutic Goods Administration
WSLHD Research Office
Phone: (02) 8890 9007
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