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. 2016 Oct 18;20(2):219–227. doi: 10.1007/s11019-016-9741-2

Table 1.

Recommendations for ethical P4 trials

1. Crowdfunding should generally be explored before a P4 trial is considered, and it may be necessary to combine crowdfunding with P4
2. If the worst-off in society tend to benefit in the long run, a temporary inequality to those who cannot afford to participate in a P4 trial may be justified
3. Research ethics committees must ensure that the design of trials is not compromised because of their P4 nature; specifically, all current trial standards regarding blinding, randomization, sample size and dose escalation must be met
4. Extra safeguards against the therapeutic misconception must be put in place: those who “pay to play” are paying for participation in a trial that aims to provide social value through generalisable knowledge. They are paying for involvement in research, and any potential benefit to the patient/participant is merely an unlikely side effect