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Patients signed informed consent when participating in SICCA but did not sign a specific informed consent for these studies.
Like, if she asked, "How did I play tonight?," would I have to have a specific, informed answer?
A specific informed consent was not required according to Local Ethics Committee rules for retrospective and observational study design (the patient management was not influenced or changed).
This rationale may shed light on the special importance of informed consent to research participation, where the knowledge gap is greater, and where there is a specific informed consent right to withdraw from research at any point.
A specific informed consent was obtained from the patients included in the study.
A specific informed consent was obtained from each participant before study entry.
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A distinction can be made between general versus specific informed consent.
Specific informed consent for the QL sub-study was obtained.
Specific informed consent had not been sought for this study.
Specific informed consent for participation in the research was obtained from all patients.
Specific informed consent was obtained from all participants before specimens were collected.
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