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Section 3 (Chapters 3.1 & 3.5), Glossary and Revisions to Section 5 National Statement on Ethical Conduct in Human Research, 2007 submission

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Specific Comments
2. Chapter 3.1

Element 3: Consent

Recent years have involved a move away from giving people the option to consent to research, particularly as it pertains to data linkage. The recent Australian Census is an example of data linkage being carried out without either opt-in or opt-out consent of those whose data is being used. It is my view that this is unacceptable. I appreciate that individual consent may not have been practical in the past because it was not an issue that most data custodians would have considered, but data linkage is now an established research technique. Researchers working on data linkage studies should be required to obtain consent and to work with data custodians to implement procedures to obtain opt-in or opt-out consent. For example, new patients at a hospital could be offered a choice when they join the clinic to opt in or out of having their health records used for research purposes or in epidemiological data linkage studies, census forms could also include a consent option. The continuing failure of data linkage researchers to obtain consent for their studies violates the dignity and autonomy of individuals.

I therefore urge the review to add a section to Element 3 encouraging researchers who use data linkage techniques to work with custodians to obtain consent from people when they provide data to a custodian (e.g. hospital or government agency). Additionally, researchers should be required to ensure that wherever possible the right of an individual to consent or not consent to participation in research takes precedence over the quality of the data obtained.

2. Chapter 3.1

Element 4: Data Collection and Management

Recent work has emphasised that data that is sufficiently rich can be reidentifiable. Just as genomic data and biobank data is, in-principle, re-identifiable, sufficiently rich datasets are also re-identifiable. The Guidelines should refer researchers to OAIC guidelines on de-identifying data and research participants should be informed of how their data will be anonymised if applicable. Researchers and ethics committees should take into account the type of data that is being collected and what kinds of techniques are proposed to prevent re-identifiability. A study measuring reaction times following an experimental manipulation may only require personal information to be stripped from response sets, while a study that involves tracking location via a mobile phone may require more sophisticated de-identification methods such as data perturbation.

I recommend that 3.1.44 should be broadened to take into account the re-identifiability of non-biological data. An additional clause should also be added to require consideration of OAIC or other relevant guidelines on data de-identification processes which may be applicable.

2. Chapter 3.1

Element 5: Communication of Research Findings

3.1.70: What legal protections exist for the confidentiality of research participants?

I recommend that the wording of this section be made more specific such that when participants are informed of potential court ordered/law enforcement related disclosures that they are informed of the specific legal protections or lack thereof that exist.

5. Glossary

I suggest adding 'data linkage' and 're-identifiable data' to the glossary.

Page reviewed: 10 July, 2018