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Human studies

Reforms overdue for ethical reviewing

The US government is seeking to exempt low-risk research involving human participants from ethical review. We consider this reform to be long overdue, and not just in the United States.

In our view, the lengthy and costly process of ethical review is overprotective in low-risk studies such as surveys, aptitude testing and ordinary psychology experiments, and could undermine scientific progress. The cost of ethical clearance for an Australian study of a low-risk public-health intervention, for example, was estimated at Aus$25,000 (US$19,000) (A. G. Barnett et al. Res. Integr. Peer Rev. 1, 16; 2016).

This overprotection stems partly from the skewed incentives for reviewing committees, hired by institutions to design and implement protection policies. These custodians are held accountable for failure but not rewarded for success, which encourages overly conservative and lengthy ethics-clearance procedures.

Changes to protective rules are unlikely when the possible risks loom larger than the cost savings. This is because of the disproportionate weighting of rare extreme events — for instance, a risk increase of 0% to 1% may be seen as more alarming than one from 40% to 41%. Institutions may therefore opt to play safe, despite the low probability of such events.

These factors cause the costs of protective regulations to outweigh the benefits in low-risk studies. We should accept that zero-risk research is an impossible goal that cannot justify the diversion of scarce public resources from improving collective knowledge and benefiting society. As such, the costs of overprotection raise ethical concerns of their own.

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Correspondence to Lionel Page.

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Page, L., Page, K. Reforms overdue for ethical reviewing. Nature 544, 161 (2017). https://doi.org/10.1038/544161d

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