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