Participant inclusion & informed consent - checklist Sample Clauses

Participant inclusion & informed consent - checklist. This checklist serves as a quality guidance for local BeyondSilos Pathway Teams (second wave pilots) who have not already prepared the form. Next paragraph will report an example. Please fill in: ID-number Participant: Date: Name BeyondSilos staff member: Y/N - Participant received correct information and accurate explanations about the study design, the criteria of assignment to the control group (usual care) or the intervention group (new integrated care ICT supported). Y/N - It was discussed with participant that selection and enrolment / inclusion in the Project is voluntary, consistent with the preferences, freedom, dignity and expectations of the subjects. Information and explanation provided/received on [Date] Provided by [Name] Remarks: Y/N - Needs and safety of participant relevant to her/his eligibility to participate in the Project have been discussed and evaluated with full, but confidential, transparency within the multidisciplinary pathway teams that are responsible for the participant throughout the Projects life cycle. By [names of professionals] Date [date of pathway team participant evaluation] The following topics were actively discussed by the pathway team and were concluded as follows [tick box: Y/N]:  Participant was found eligible by the pathway team.  No extra/additional physical and / or other health risks were identified for the participant when enrolling in the Project.  No extra/additional risks in electronic data sharing were identified for the participant when enrolling in the Project.  Participant is not / does not feel in a dependent position or suffers from cognitive impairments, that could influence Informed Consent process and (if needed) additional measures (e.g. Involving a relative) are organised.  Continuity of service and technology after the end of the project will not jeopardize the participant unacceptably.  Participant does not reveal extra 'dropout risks'. Conflict of interest  Y/N - Participant and/or relatives have declared no conflict of interest with enrolling in the Project. Informed Consent  Y/N - Participant has given consent after being thoroughly informed by the Project dedicated person.  Y/N – Informed consent has been provided in writing and is stored sufficiently safe.  Y/N – Participant has been informed that she/he is free to withdraw consent to participation at any time.  Y/N – Participant has been informed about and has access to processes for making complaints.  Y/N - Participants is...
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