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Opting in for opt-out consent

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A place for opt-out consent in the National statement on ethical conduct in human research

In most human research, potential participants are provided with detailed information so that they can make a fully informed choice about whether to participate in the project. The requirement for explicit consent reflects the value that our society places on individual autonomy.

The National statement on ethical conduct in human research 2007 (updated December 2013) (National Statement; http://www.nhmrc.gov.au/_files_nhmrc/publications/attachments/e72_national_statement_131211.pdf) currently qualifies the need for explicit consent by allowing human research ethics committees (HRECs) to approve limited disclosure for low-risk research where no practical alternative exists and the potential benefits of the research justify it. An example is research that involves observing people’s behaviour, where disclosing the nature of the research may change the behaviour being studied.

The other option offered to HRECs is to allow the requirement for obtaining explicit consent to be waived. A common example is analysis…

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