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The recently announced settlement between Arizona State University and the Havasupai Indians, however, brings the difficulties of informed consent documents into sharp focus.
There is no obvious solution to the particular difficulties of informed consent in this situation, and so previously patients have been enrolled in AMI trials on the basis of more or less comprehensive consent procedures.
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The shift to outsourcing raises issues about data integrity, regulatory oversight, language difficulties, the meaning of informed consent among a much poorer population, the standards of clinical care, the extent to which corruption may be regarded as routine in certain countries, and the ethical problem of raising a population's expectations for drugs that most of that population cannot afford.
The practical difficulties associated with the implementation of informed consent clearly hinges on the specific model of informed consent.
Patients or consumers are likely to experience difficulties not only during the process of informed consent, but also afterwards, when they receive and interpret their test outcomes.
Significant, but surmountable practical difficulties cannot as such rule out any implementation of informed consent, although they may be relevant to further ethical considerations of whether or not to prioritise the implementation of a given model of informed consent.
Whichever way the requirement of informed consent is implemented it seems unreasonable to characterise the practical difficulties as insurmountable.
Formulating the ICF template taught us the difficulty in setting a specific policy regarding data sharing and returning results, and we noted the specific ethical characteristics of informed consent in Japan.
Which raises the question of informed consent.
"It goes to the whole issue of informed consent.
And can it be assessed in the temporal realm of informed consent?
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com