There is a pressing need for well thought-out models for valid informed consent and information provision in the context of a lot of complex and fluid information in non-targeted personal genome testing.
Competence is task- and context specific [ 3], and a competent decision is required for a valid informed consent next to voluntariness and being well informed.
Thus there is a longstanding discussion of the exact informational requirements for valid informed consent [ 21- 26].
In the following we will assume that to be valid informed consent requires that the person providing consent is adequately informed about his options and their consequences, and that consent is provided without undue influence.
Hence, informing children and adolescents is even more challenging than informing adults eligible for bariatric treatments in order to obtain valid informed consent [ 27, 76].
It is difficult to inform eligible persons in a way that ensures valid informed consent [ 68, 69] or assent as the evidence of long-term effectiveness and safety of bariatric procedures is not clear.
When doctors were asked whether they thought the amount of information provided to patients was sufficient for valid informed consent, 72.5% answered 'yes', 16.1% answered 'no'; while 11.4% answered 'don't know'.
Provision of comprehensible information is vital if patients are to provide valid informed consent.
In order that a valid informed consent is given, U.S. federal regulations specify eight pieces of information that must be disclosed to research participants, ethically valid informed consent demands more than just disclosure [ 54].
Valid informed consent consists of three major elements: 1) adequate disclosure of information, which requires sufficient time; 2) adequate participant or proxy understanding of information received; and 3) voluntariness of the decision; without real or perceived threat or coercion, either explicit or implicit [ 44– 44].
Further discussion and research are needed to determine exactly what (selection of) information (and to what level of detail) is most crucial for valid informed consent.
