Human Research Ethics and Governance

What is Human Research?

Human Research is conducted with or about people, or their data or tissue.

Human participation in research is therefore to be understood broadly, to include the involvement of human beings through:

  • taking part in surveys, interview of focus groups
  • undergoing psychological, physiological or medical testing or treatment
  • being observed by researchers
  • researchers having access to their personal documents or other materials
  • the collection and use of their body organs, tissues or fluids eg: skin, blood, urine, saliva, hair, bones, tumor and other biopsy specimens or their exhaled breath
  • access to their information (in individually identifiable, re-identifiable or non-identifiable form) as part of an existing published or unpublished source or database
In addition, the conduct of human research often has impact on the lives of others who are not participants. When this impact is reasonably foreseeable, it may raise ethical questions for researchers and for those ethically reviewing research.

All research involving humans conducted, within the NSW public health system, must be ethically and scientifically reviewed and approved by a Health Human Research Ethics Committee (HREC) - in accordance with the National Statement on Ethical Conduct in Human Research (National Statement – 2007).

Quality Assurance/Improvement Projects

Quality assurance / improvement activities may raise ethical issues requiring review. Individuals engaged in these activities in the NSW public health system should refer to the NSW Health Guideline Human Research Ethics Committees – Quality Improvement & Ethical Review: A Practice Guide for NSW (GL2007_020). Consultation should also occur with the Public Health Organisation involved in order to determine the process adopted by the Public Health Organisation for the ethical review of quality improvement / assurance activities.

If you are still unsure which level of risk is relevant to your research project – please refer to the National Statement on Ethical Conduct in Human Research (2007) to determine the level of risk for the proposed study.

Within NNSW and MNC LHDs – Quality Assurance applications may be reviewed for approval by the Chair/s of the HREC. Quality Assurance applications are not required to be submitted to a full HREC Meeting and do not receive Ethics approval.

NCNSW and MNC LHD staff may click here - to access further information regarding quality assurance/improvement projects

What is Research Governance?

Research Governance is a framework through which institutions are accountable for the scientific quality, ethical acceptability and safety of the research they sponsor or permit.

The Governance process ensures compliance with a broad range of regulations, legislation and codes of good practice to achieve and continuously improve research quality across all aspects of healthcare by:

  • Safeguarding the dignity, rights, safety and well-being of participants
  • Protecting and promoting the integrity of research and investigators
  • Enhancing ethical and scientific quality
  • Minimising risk
  • Monitoring practice and performance and
  • Promoting good practice
  • The Research approval and authorisation process

 

Approval and authorisation of all Research Proposals (both Full NEAF and Low Negligible Risk (LNR) within any NSW Health Public Health Organisation is a two-stepped process as follows:

Step 1: Ethical Approval

Applications for research to be conducted in either the Northern NSW Local Health District (NNSW LHD) and/or the Mid North Coast Local Health District (MNC LHD) only - must be submitted to an approved Health Human Research Ethics Committee.

Information and contact details of NSW Health Human Research Ethics Committees is available from:
http://www.health.nsw.gov.au/ethics/Pages/contacts-hrecs.aspx

Information regarding the National Mutual Acceptance of Single Ethical Review of Multi-centre Clinical Trial Research is available from: http://www.health.nsw.gov.au/ethics/Pages/nma.aspx

North Coast NSW (NCNSW) Human Research Ethics Committee (HREC).

The NCNSW HREC is responsible for:

  • Granting or withholding ethical approval of proposed research; and
  • Monitoring approved research.

Where the Committee is satisfied that research is not being or cannot be conducted in accordance with the approved protocol and that, as a result, the welfare and rights of participants are not or will not be protected, the Committee may withdraw approval.

The NCNSW HREC is constituted and operates in accordance with the National Health and Medical Research Council’s National Statement:

The National ethics Application Form (NEAF) is to be completed for all ethics applications and is available on line at:

 

Step 2. Governance authorisation

In addition to ethical approval site authorisation is required via the Site Specific Assessment (SSA) process.

No research is to be undertaken until both ethics approval and governance (SSA) authorisation is granted. The SSA application form must be submitted with all supporting documentation, as listed in the HREC approval letter/s, for review to the appropriate Research Governance Officer/s within the NNSW &/or MNC LHD’S. The SSA and application to HREC may be submitted concurrently however, site (Research Governance) authorisation cannot be granted until final Ethics approval has been obtained.

The SSA form is available at:

Further information is available from:

Research Ethics

Northern NSW and Mid North Coast Local Health Districts

Rebecca Lavery

A/Research Ethics Officer
NCNSW Human Research Ethics Committee

C/- Murwillumbah District Hospital
8-10 Ewing Street
Murwillumbah NSW 2484
(02) 6672 0269 0421 028 924

Research Governance

Northern NSW Local Health District:

Rebecca Lavery

A/Research Governance Officer
C/- Murwillumbah District Hospital
PO Box 821
Murwillumbah NSW 2484
(02) 6672 0269 0421 028 924

Mid North Coast Local Health District:

Ms Maureen Lawrence

Research Governance Officer

C/- Administration
Kempsey District Hospital
River Street
Kempsey NSW 2440
04 2888 2170 (Mondays and Tuesdays)

 

Click here – for information about preparing an application to the NCNSW HREC

Click here – for information about submitting an application to the NCNSW HREC

Click here – for information about preparing and submitting a Research Governance application to the NNSW or MNC Local Health Districts