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If patient incapacity or time urgency prevents informed consent, governance authorities and patients' relatives or advocates may need to reach an agreement by discussion, even for retrospective cases.
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Suggestions are to supplement informed consent with governance structures, often with participant representation; and to enable individuals to have greater say about the use of their information through information technology.
We discuss certain limitations of the conventional concept of informed consent and its governance system and suggest the potential of an alternative process using information technology.
The most important finding for us regarding the practical use of the ICF template was the necessity to review the concept of conventional informed consent and the ethical governance system.
If that is so, how can citizens, through voting, manage to give free and informed consent to their manner of governance, which is normally thought to be the source of the legitimacy of a democracy?
Clinical governance requires informed consent, appropriate patient counselling and follow-up.
Recommendations from the deliberative forum include issues of informed consent, privacy protections, collection of biospecimens, governance of biobanks, and how to manage the process of introduction between biobanks and potential donors.
Research governance requires patients give informed consent to participate in clinical trials.
One of the proposed solutions to these challenges involves trading off a reduction in the specificity of informed consent protocols with an increased emphasis on governance.
Yet, there is little consensus regarding the effective governance of secondary research uses, beyond adherence to the terms of informed consent.
In particular, ethical questions about the governance of such collections and the compatibility of secondary use with informed consent have been identified and discussed [ 3, 4].
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CEO of Professional Science Editing for Scientists @ prosciediting.com