Criterion C3.6 – Research

        1. Criterion C3.6 – Research

Indicator


C3.6 A Our practice has all research approved by an ethics committee.

C3.6 B Our practice confirms that the appropriate indemnity is in place for research, based on the level of risk.

C3.6 C Our practice only transfers identified patient health information to a third party for quality improvement or professional development activities after we have obtained the patient’s consent.

If your practice has not conducted any research, this Criterion is not applicable.

Why this is important

The National Health and Medical Research Council (NHMRC) has developed the Australian code for the responsible conduct of research (the Code), which promotes integrity of research and provides guidance about responsible research practices.

The Australian Institute of Aboriginal and Torres Strait Islander Studies has produced Guidelines for ethical research in Australian Indigenous studies. You could refer to these guidelines if your patient sample includes Aboriginal and Torres Strait Islander peoples. 

When conducting research, you must ensure that the collection, use and disclosure of data comply with privacy laws. Even if your practice is using de-identified patient health information, there are still some situations where you must obtain informed patient consent.

Human research ethics committees (HRECs) review research proposals to ensure that they are ethically acceptable and in accordance with relevant standards and guidelines. Your HREC will decide on the necessary patient consent requirements for your research project.

There are many HRECs operating in institutions and organisations across Australia. A list of HRECs registered with the NHMRC is available at on their website.

You can find details about the RACGP’s National research and evaluation ethics committee on the website.

The Code and consent requirements apply to all research situations. For example, they apply even if a member of the practice team is not conducting research themselves, but is contributing to someone else’s research.

Meeting this Criterion

The NHMRC’s Australian code for responsible conduct of research defines ‘research’ as follows:

... includes work of direct relevance to the needs of commerce, industry, and to the public and voluntary sectors; scholarship; the invention and generation of ideas, images, performances, artefacts including design, where these lead to new or substantially improved insights; and the use of existing knowledge in experimental development to produce new or substantially improved materials, devices, products and processes, including design and construction.
It excludes routine testing and routine analysis of materials, components and processes such as for the maintenance of national standards, as distinct from the development of new analytical techniques.
It also excludes the development of teaching materials that do not embody original research.

The practice team must be familiar with the NHMRC’s Code when participating in research.

In addition, you may wish to develop a policy that includes information about:

  • selecting a specific group of patients (eg patients with depression, Aboriginal and Torres Strait Islander patients) on whom the research is to be conducted
  • the process and documentation of ethics approval
  • the use of a specific room in which to conduct the research
  • data storage, record keeping and compliance with privacy laws
  • relevant training for the practice team
  • information provided to patients.

Research indemnity and risk

It is important to understand the potential risks that individual research activities may have on your practice and patients. You must confirm that the appropriate indemnity is in place for research, based on the research project’s level of risk.

The NHMRC National statement on ethical conduct in human research 2007 (updated 2018) (National Statement) gauges research by the amount of risk it may pose to people involved in the research. The NHMRC describes low risk and negligible risk as follows.

The expression ‘low risk research’ describes research where the only foreseeable risk is one of discomfort. Research in which the risk for participants is more serious than discomfort is not low risk.
The expression ‘negligible risk research’ describes research in which there is no foreseeable risk of harm or discomfort; and any foreseeable risk is no more than inconvenience.21

Individual medical practitioners must ensure that they are insured or indemnified for every context in which they practise, including involvement in any medical research, it is recommended that practices obtain their own advice about whether they require indemnity insurance for any research.

An example of high-risk research is a clinical trial. If your practice is involved in a clinical trial, your practice will usually be indemnified by the sponsor (eg a university or a drug company), but you need to make sure that the indemnity covers your liabilities. If it does not, you will need to get a separate insurance policy or indemnity.

If the research is not a clinical trial, it is recommended that you discuss all potential risks with your practice team and the lead external researcher as well as your insurance broker or indemnity insurer to determine whether you require extra insurance to indemnify your practice for research.

To assist with these discussions, external researchers may be able to provide a written document outlining the level of risk their research will pose to your practice and/or patients.

In all cases, the practice’s GPs each need to ensure that their individual medical indemnity insurance covers their research activities, or purchase top-up or separate insurance cover that provides the appropriate level of indemnity required to participate in research. Failing to hold sufficient insurance cover may leave the practice’s GPs with an uninsured personal liability in the event of an adverse event for which a claim is made. The costs of defending such a claim, even where the practice GPs are not liable, may still be significant.

Quality improvement activities, ethics and consent

In general, the purpose of a practice’s quality improvement or clinical audit activities is to improve the delivery of a particular treatment or service. Before transferring health information to a third party you need to seek specific consent from patients. The RACGP has developed Guiding principles for managing requests for the secondary use of de-identified general practice data to support practices to make informed decisions about releasing practice data. The use of de-identified data does not require specific or express consent. The RACGP recommends that patients be made aware of the practice’s approach to the collection and security of healthcare information for primary and secondary purposes, and whether it provides de-identified data to third parties. The RACGP encourages you to include information about quality improvement activities and clinical audits in the practice’s policy that addresses the management of health information. You could seek patient consent by including this information in new patient registration forms and asking patients to indicate if they consent to this use of their health information and to its transfer. You must make patients aware that declining to participate in research will not affect the care they receive at the practice.

Ethics approval is not required for quality improvement activities where the primary purpose is to monitor, evaluate or improve the quality of healthcare delivered by the practice.

Meeting each Indicator

C3.6 A Our practice has all research approved by an ethics committee.

You must:

  • keep evidence of ethics approval for research activities
  • maintain records of any research activity that has gone through the ethics approval process
  • retain documentation of patients’ consent for the required period.

You could:

C3.6 B Our practice confirms that the appropriate indemnity is in place for research, based on the level of risk.

You must:

  • maintain records of appropriate indemnity for your practice and GPs based on research activity level of risk.

You could:

  • have a process addressing practice communication with external researchers and their risk requirements
  • contact your indemnity insurer to confirm you have the appropriate level of cover for the research being undertaken where it is not explicit in your policy.

C3.6 C Our practice only transfers identified patient health information to a third party for quality improvement or professional development activities after we have obtained the patient’s consent.

You must:

  • document in the patient’s health record the patient’s consent for you to transfer their health information to a third party to conduct quality improvement activities
  • inform patients that declining to participate in research will not affect the care they receive at the practice
  • maintain a privacy policy.

You could:

  • maintain a policy addressing the management of patients’ health information
  • seek patient consent for the use and transfer of health information on new patient registration forms.