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Women’s and Children’s Health Network
Ngangkitya ngartu itya kangkawardli
Acknowledgement
The Women’s and Children’s Health Network acknowledges Aboriginal people as the First Peoples and Traditional Custodians of Country throughout South Australia. We acknowledge and respect their ongoing and deep spiritual connection and relationship to land, air, sea, waters, community and country. We pay our respect to their Elders past, present and emerging.

Aboriginal and Torres Strait Islander people should be aware that this website may contain images, voices and names of people who have passed away.

Human Research

The Human Research Ethics Committee (HREC) is responsible for the review, and where appropriate, approval of research or research audit projects involving patients, patients’ families, patient tissue, patient information, and/or WCHN staff.

On this page:

Further information Contact HREC

The WCHN Human Research Ethics Committee's (HREC)

The WCHN Human Research Ethics Committee's (HREC) has responsibility to review, and where appropriate, approve research or research audit projects involving patients, patients’ families, patient tissue, patient information, and/or WCHN staff.

The HREC's responsibilities are outlined in its Terms of Reference:

Protocols involving a drug or therapeutic substance are also reviewed by the Drug and Therapeutics Clinical Trials Group (DTCCTG). The DTCCTG is an advisory and recommending body to the WCHN HREC. Its responsibilities are outlined in its Terms of Reference:

Before commencing a research project or research audit, approval must be obtained from the WCHN HREC. In addition, research governance approval is required for all research projects before they may commence.

It is highly recommended that the Site Specific Assessment (SSA) application for research governance is submitted concurrently with the HREC application to avoid any delays in project commencement.

The WCHN Human Research Ethics and Research Governance Standard Operating Procedures (SOPs) have been developed for research ethics and research governance matters. They apply to WCHN researchers, external researchers (including students) who are undertaking research at a WCHN site, WCHN research ethics committee members and other staff involved in the conduct and oversight of health and medical research at WCHN. The SOPS take into account the regulations, legislation, ethical and governance principles and guidelines for the responsible conduct of research.


Good Clinical Practice (GCP) training

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Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting clinical research that involves the participation of human participants. Compliance with GCP provides public assurance that the rights, safety, and well-being of clinical research participants are protected, consistent with the principles of the Declaration of Helsinki, and that the research data is credible.

As part of the implementation of the National Clinical Trials Governance Framework and the Therapeutic Goods Administration (TGA) GCP Inspection Audits, investigators will be required to undertake GCP training and subsequent refresher training to meet compliance as mandated by SA Health.

The various Health Networks are working with SA Health towards ensuring that all staff involved in any clinical research (not only those involved in the design and conduct of clinical trials) undertake GCP training and hold a current certificate in GCP. This includes principal investigators, associate investigators, trial managers/coordinators and research nurses etc.

To ensure WCHN is compliant with the minimum training requirements, all staff (WCHN, SAHMRI, University etc) involved with undertaking any clinical research at WCHN must undertake GCP training. Evidence of GCP training will be part of the research ethics and research governance approval processes.

Initial certification is usually undertaken face-to-face with an accredited provider. However, due to COVID-19, SA Health is yet to advise if face-to-face training will be required for those undertaking GCP training for the first time, so on-line GCP training is deemed appropriate.

There are various free and user-pay GCP training courses available that meet the TransCelerate GCP training minimum criteria and provide evidence of compliance by staff when completed. WCHN will accept any course that meets the TransCelerate GCP training minimum criteria. These courses can be found via the following link:

As an example, the following two links are for free on-line GCP training courses:

Each requires the user to register for a login before commencing the training.

Researchers are encouraged to undertake such GCP training as a priority.

Please note: This is interim advice and further information will be provided when available from SA Health.

Further information


The WCHN HREC is a NHMRC-certified Committee that operates in accordance with the principles set out in the National Statement on Ethical Conduct in Human Research. The National Statement is produced by the National Health and Medical Research Council (NHMRC). For more information on the NHMRC, visit:

Waivers of Consent

Following careful consideration and full committee review, the WCHN HREC grants waivers of consent under strict circumstances based on the following criteria outlined in paragraph 2.3.10 of the National Statement on Ethical Conduct in Human Research.

  1. Involvement in the research carries no more than low risk.
  2. The benefits from the research justify any risks of harm associated with not seeking consent.
  3. It is impracticable to obtain consent.
  4. There is no known or likely reason for thinking that participants would not have consented had they been asked.
  5. There is sufficient protection of participants’ privacy.
  6. There is an adequate plan to protect the confidentiality of data.
  7. In case the results have significance for the participants’ welfare there is, where practicable, a plan for making information arising from the research available to them.
  8. The possibility of commercial exploitation of derivatives of the data or tissue will not deprive the participants of any financial benefits to which they would be entitled.
  9. The waiver is not prohibited by state, federal, or international law.

The Research Office can be contacted for more information on waivers granted by the WCHN HREC: HealthWCHNResearch@sa.gov.au


For more information regarding submissions to the WCHN HREC, see the relevant links below.

Contact HREC

Queries about HREC can be discussed with the Executive Officer and/or Chair of the WCHN HREC:

Phone

(08) 8161 6521

Email

HealthWCHNResearch@sa.gov.au