Privacy vs. progress: Government’s move in medical research consent

Health Industry Hub | November 3, 2023 |

In a delicate balancing act, the Australian government has addressed the growing tension between the public’s demand for medical advancements and the necessity of adhering to the Australian Privacy Principles. Amid ongoing consultations for the Privacy Act Review, concerns have surfaced regarding the requirement for consent to be both ‘current’ and ‘specific,’ potentially constraining medical research in evolving fields.

The Privacy Act 1988 (Cth) and the Australian Privacy Principles (APPs) are designed to safeguard individuals’ control over their personal information by mandating transparency in information handling by agencies and organizations. In most cases, this necessitates obtaining valid consent from individuals for the collection, use, and disclosure of their personal information. However, exceptions to this rule exist to accommodate legitimate public interests.

Researchers working with health information for research purposes or utilising previously collected health data for secondary research must either employ de-identified information, seek consent from research participants, follow the Privacy Act’s section 95 guidelines (for Commonwealth agencies), or adhere to the “permitted health situation” rules outlined in section 95A (for private organisations).

The Privacy Act Review garnered a multitude of proposals for reform, with specific attention in research. The government has now officially accepted the following key proposals.

Broad Consent for Research

Under this proposal, a legislative provision is set to permit broad consent for research. This form of consent is designed to accommodate scenarios where it is impractical to fully identify the purposes of collecting, using, or disclosing personal or sensitive information at the point of consent. This broader approach is expected to foster flexibility, especially in rapidly evolving areas of research.

Broadening Scope of Research Permitted Without Consent

This proposal calls for further consultation to expand the scope of research that can be conducted without consent under the Privacy Act. Currently, exemptions for private organizations pertain to research relevant to “public health or public safety,” a term broadly defined to encompass various activities. Stakeholders have expressed the need to extend these exemptions beyond “human research” to include endeavors like environmental and climate change research.

Developing a Single Exception for Research Without Consent

In a bid to reduce complexity and streamline the regulatory framework, the government has agreed to consider the creation of a single exception for research without consent. This would involve consolidating the various guidelines into one comprehensive set, offering clarity to researchers and alleviating administrative burdens.

In 2008, the Australian Law Reform Commission (ALRC) recommended the extension of research exemptions beyond health and medical research to cover all forms of human research, citing international examples from the UK, Canada, and New Zealand. The Privacy Act Review echoed these sentiments, emphasizing the public interest in the controlled further use of personal and sensitive information in diverse areas of research, including environmental and climate change studies.

The next steps involve government consultations to address these proposals, providing a clear path forward for the intersection of medical research and privacy principles. As we anticipate the drafting of amendments to the Privacy Act, it remains to be seen how consent for future research endeavours will be shaped, and how the guidelines for research conducted without consent will evolve to strike a delicate balance between medical progress and privacy protection.

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