If the research project requires access to Confidential Health Information for which Queensland Health is the data custodian, a Public Health Act application may be required. In the first instance, you should contact the Data Custodian from the site at which you wish to obtain the research data. The Mackay Hospital and Health Service Data Custodian expects to receive your entire project including Ethics, in conjunction with the Research Governance Officer the Data Custodian will review your entire project and provide feedback/approval.
The Public Health Act 2005 (PHA) establishes the process for assessing health information held by Queensland Health for approved research projects.
The PHA applies to all researchers (internal and external to Queensland Health) who are undertaking research using identifiable or potentially re-identifiable health information for which the researchers are unable to obtain participant consent to use their personal or identifying information for a research purposes.
Details on obtaining approval to access to confidential health information under the PHA are available at the Queensland Health website.
Data custodians within Queensland Health
Signatures are required from the relevant data custodians to complete PHA applications prior to submission.
Requesting an exemption from HREC review for a Quality Assurance / Quality Audit Activity
The requirements for submitting an exemption/endorsement request to the HREC with the intent to publish the results of the Quality Assurance / Audit activity are provided in this guideline.
Queensland Civil and Administrative Tribunal
For patients who cannot consent for themselves, but are eligible to participate in clinical trials, it is a requirement to seek QCAT approval for the study before it commences.
As a general rule, the and the prohibit the disclosure of personal information such as medical records without a lawful reason to do so. As a general rule, consent of the patient will be sufficient to overcome that prohibition. Where consent of a patient has not been obtained, there remain several grounds for retrospective data collection. Retrospective data collection from health service records for the purposes of research requires consent to access patient information, unless a waiver of consent has been granted by a HREC and approval has been obtained as per Chapter 6, Part 4 of the Public Health Act 2005 (QLD) (PHA information & application form).
Health service employees may also access patient records for quality assurance purposes (i.e. “evaluating, managing, monitoring or planning health services”) without consent under section 150 of . It is best to consult with your relevant Research Governance Officer in relation to any proposed use of existing medical records.
Section 144 of the provides that a child’s parent or guardian may only provide consent to disclosure of a child’s medical records where “the disclosure of the confidential information is by a health professional who reasonably believes the child is of insufficient age or mental or emotional maturity to understand the nature of consenting to the disclosure”.
Accordingly, where the disclosure is not being performed by a health professional or where competence is established, then the provision of a parent or guardian’s consent will not overcome the default prohibition against disclosure. If there is no other lawful reason under the to disclose the confidential information (e.g. “the child consents to the disclosure” and “the disclosure of the confidential information is by a health professional who reasonably believes the child is of insufficient age or mental or emotional maturity to understand the nature of consenting to the disclosure”), generally, an application under Chapter 6, Part 4 of the Public Health Act 2005 would have to be sought (PHA information & application form).
Participating in Research must be voluntary and based on sufficient information and adequate understanding of both the proposed research and the implications of participation in the research. The National Health and Medical Research Council have a number of templates that can be used, some relating more to your project than others but providing a good outline for inclusions and language. When completing your Participant Information and Consent Form the NHMRC National Statement Chapter 2.2 General Requirements for Consent should be reviewed and considered as this is the guide used by the HREC reviewing your project for ethical approval/ endorsement.