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Table 2 Candidate criteria for assessing the public interest in allowing consent waiver

From: Clarifying how to deploy the public interest criterion in consent waivers for health data and tissue research

Addressing a health priority

Many countries and institutions have identified top priorities in health or other areas. There are also the Sustainable Development Goals that have been set by the UN as key priorities for good health and well-being [23]. IRBs could rely on such a list, using it as a proxy for the areas of greatest public concern and favour waiver applications that address such areas – though being on this list would not be decisive in being granted a waiver. Rather, it would provide a good ethical reason in favour of waiver, setting the balance more towards that option.

Scientific robustness

All research should be scientifically valid in order to be approved, but studies may vary in terms of their robustness – that is, the extent to which the study as designed will be able to answer its research question(s) with a high degree of confidence. More robust studies will be more likely to contribute to generalisable knowledge, and thereby the public interest. Examples of factors contributing to robustness would be sample size, appropriateness of statistical methodology, and quality of the data. This would require independently verifiable evidence of such robustness to be submitted to any ethics decision-making body.

Open access of publications and datasets

As the primary output of biomedical research is knowledge that is meant to benefit future practice, allowing open access can help ensure such findings are indeed disseminated widely and have as much impact as possible [24]. This will require some extra expense on the part of research budgets, but should have the general social benefit of contributing to knowledge sharing. The recent move by several European funders to require publication of articles in open access journals that do not charge subscriptions might go some way towards ameliorating this difficulty, by putting pressure on an outdated model of high-cost academic publishing [25]. Such policies might also extend to deposits of raw data, after sufficient embargo periods to allow the primary researchers to publish from their own results.

Non-patentability/copyright of findings

While patents and copyright may serve the public interest by incentivising valuable research, they can also inhibit it by raising the cost of interventions and keeping those valuable insights out of the public domain. A research project committed to ensuring findings are kept on a creative commons or similar license would have a stronger case for contribution to the public interest than one that does not. Due to funding restrictions, not all valuable research may be able to meet this criterion, but the increased use of this criterion by ethics bodies might have the effect of putting pressure on funders to at least loosen or liberalise such license.

Translatability

Research whose results have direct, measurable relevance to practice or policy would in virtue of this have a greater claim to contribution to the public interest. For research that is more preliminary or concerned with proof of principle, evidence may instead be put forward of ‘clinical promise’: an explanation of how the research, in combination with other studies and evidence bases, could eventually lead to translational impact. This draws on the concept ‘clinical promise’ that has recently been urged by Kimmelman and Federico as a criterion for approval of first-in-human clinical trials [26].