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Patients' involvement in ethics committees. A view from Austria.
- 1. A view from Austria Andrea Heckenberg Ethics Committee of Vienna Medical University Patients’ involvement in ethics committees
- 2. Composition of the EC in Austria Medical experts of all disciplines A member of the nursing staff A member of the pharmacy A member with ethical expertise A lawyer A statistician A member of an organisation representing patients (patient advocacy) A representative of an organisation of people with disabilities A senior citizen representative Regulated in the Hospital Act, the Medicines Act, the Medical Devices Act and the University Act
- 3. 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
- 4. 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