Patients' involvement in ethics committees. A view from Austria.
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Transcript of Patients' involvement in ethics committees. A view from Austria.
A view from Austria
Andrea HeckenbergEthics Committee of Vienna Medical University
Patients’ involvement in ethics committees
Composition of the EC in Austria
Medical experts of all disciplines
A member of the nursing staffA member of the pharmacyA member with ethical expertise A lawyerA statisticianA member of an organisation representing patients (patient advocacy)A representative of an organisation of people with disabilitiesA senior citizen representative
Regulated in the Hospital Act, the Medicines Act, the Medical Devices Act and the University Act
Potential role of the patient in the EC
study specific
• evaluation of the ICF• assessment of risk and burden
general
• giving additional impact to the opinion of the EC, thereby strengthening its position, in addressing recurring issues, e.g.– poor quality of ICFs– legal restrictions that „over-protect“ participants and prevent
valuable research
Possible ways of collaboration
External review
Participation in EC meeting
– Patient with the specific disease• for each study the presence of a different patient is
required
– „Generic“ patient• a person representing „the patient‘s view“ is present
throughout the meeting
For choosing appropriate patient participants the EC will have to be able to rely on a well organised patient organisation network