Table 1.

Scenario Outlines.

Scenario	Description
1	A hospital doctor also has a research position at the local university. Patients seeing this doctor have agreed to allow different researchers (including those in other countries) to use their information and tissue samples for a variety of future studies. Patients will not know which researchers will use their information, or how their information will be used. Personal identifiers like name, date of birth and address have been removed from all information files and tissue containers. The doctor has been using the information and samples for a research project, which includes obtaining genetic information from the samples through a technique called genotyping. To save money, the doctor engages an overseas laboratory to conduct this test. The doctor wants to share some of their genotyping and medical information with a group of international researchers for a collaborative project. The information will be shared with other researchers through a cloud-based platform. Researchers will only be able to view and analyse the data within this system, they cannot copy the data to their own computers and use their own software to analyse it. Although information has been stripped of personal identifiers, there is a very slight chance it could be re-identified. The doctor has approval from their Human Research Ethics Committee (HREC) to share the patients’ information with international researchers for the collaborative project.
2	A cancer researcher has a tissue bank of pancreatic cancer tumours, and surrounding normal tissue, which were collected from Aboriginal and Torres Strait Islander participants. Whole genome sequencing was performed on both the tumour and normal tissue in 2013. The researcher now wants to publish the results of the research, but the journal requires the whole genome sequence data to be deposited in a public repository. The repository allows only approved researchers to access and analyse the information. The information will be shared to approved researchers through a cloud-based platform. Although information has been stripped of personal identifiers, there is a very slight chance it could be re-identified. The original participants agreed to allow the original researcher to keep their tissue for use in further research on pancreatic cancer. The consent did not say anything about sharing their data for other purposes, or whether individual results of any future research would be returned to participants. The researcher has decided that it will be difficult and impractical to recontact the participants to obtain their consent to share their information, especially since the researcher estimates that half of the participants are likely to have already passed away. The researcher therefore gets approval from their HREC to waive the requirement for consent to share the anonymous genomic data. This means the HREC makes the decision as to whether the researcher can share the genomic data without the approval of the original research participants.
3	After obtaining approval from their HREC, a researcher recruits participants with a particular disease for a clinical trial of a new and original treatment/medication. The trial is funded by a private for-profit company. As a part of the trial, participants will need to provide blood samples for genotyping. The blood samples are stored in a centralised biobank operated by the same company funding the clinical trial. The biobank maintains a database of genomic information that is linked to the individual donors’ medical information. Personal identifiers like name, date of birth and address have been removed from all of the information files and blood sample containers. Although information has been stripped of personal identifiers, there is a very slight chance it could be re-identified. The biobank will be maintained by the company with unclear future storage and sharing practices. Participants may withdraw from the clinical trial at any time but the company states that this does not include the ability to withdraw from the future use of their samples since they will already have been added to the biobank in a de-identified form. Any future use or sharing of participants’ samples will require HREC approval.