Table 1 Four forms of justification for use of personal data/tissue

Subject authorisation

Data subjects may consent to the use of data or tissue for a specified purpose (specific consent), or else agree to a wider range of uses, subject to a trustworthy system of oversight (broad consent) [10, 11]. Either way, ethical justification for the use comes in part from subjects being given the opportunity to exercise their autonomy in deciding whether the stated use is permissible [12, 13].

Anonymisation

Regulatory regimes typically exclude anonymised tissue and data from consent requirements, in part on the grounds that if it is sufficiently impracticable for someone to be able to re-identify someone in a dataset, the individual risk profile of using the data will be exceedingly low [7, 14]. Interestingly, Singapore’s Human Biomedical Research Act is the first in the world to require consent even for anonymised secondary tissue research, so this justification would not be available there.

Subject benefit

In some cases it may not be possible to obtain consent, but the research would directly benefit the subject. In this case, the benefit to the subject would have to be deemed as weightier than any privacy/autonomy interest the subject would have in limiting the use of their data or tissue. Some forms of emergency research could fall in this category, though it is unlikely to be applicable to secondary data/tissue studies under consideration here.

Public interest

In other cases, data cannot be anonymised,^a it would not be practicable to obtain consent, and the relevant use is not of direct benefit to the individual. Still, a waiver could be justified on the grounds it contributes to the public interest. Here, that contribution to the public interest would similarly have to be sufficient to override any privacy/autonomy interest individuals may have in limiting the use of their data or tissue.