As these samples would be subsequently used in UK10K,the EAG were interested in recommendations concerning consent and REC approvals that needed to be included in the EGF.
Under the recommendations, patients' consent figures at two crucial points: they have a choice of whether to undergo clinical sequencing at all, and they have a choice of whether to follow up on any incidental findings by undergoing medical treatment.
Community Consultation The University of Washington and Group Health have also implemented a consensus process with key stakeholders to develop recommendations concerning consent, data sharing, and return of research results to subjects.
Completeness was evaluated according to a definition that conformed with government recommendations: "Informed consent is a procedure to ensure that a patient, client, and research participants are aware of all the potential risks and costs involved in a treatment or procedure.
In general, informed consent recommendations were most positively rated.
The prominence of informed consent recommendations is not surprising.
Clearly, for specific health care settings or patient populations, it is reasonable to interpret the evidence and to consent recommendations on a local level.
The physician-patient relationship (physicians' misguided and/or enthusiastic recommendations), patients' informed consent on the basis of manipulated data, and the resulting patient harm are of concern.
One of their recommendations addressed patient consent: "When there is high-quality evidence supporting off-label use of a medicine, the usual process of obtaining consent for treatment should be followed.
High level of agreement with these two informed consent recommendations is consistent with the wide recognition and popular acceptance of the principle of respect for autonomy [ 54- 56] and suggests that these stakeholders agree that participants should be aware of the package on offer as part of their overall participation [ 39, 57].
