Dr. Günter Siwetz
Dr. Andrea Kainz, LL.M
Ethikkommission des Landes Steiermark
Amt der Steiermärkischen Landesregierung
Fachabteilung Gesundheit und Pflegemanagement - Sanitätsdirektion
Tel.: +43 (316) 877-4341
Assessment of clinical studies
- The Ethics Committee of the State of Styria evaluates planned clinical studies to be performed by registered physicians. The assessment is to be performed before the start of the study to determine whether the project is safe. Finally, the Committee issues a vote or a reasoned opinion in favour of or against the project.
- Its primary focus is on the protection of the study participants, their informed consent and the quality of the expected study results.
- The legal basis for the activities of this committee are the applicable provisions of the Medicinal Products Act (APG) and Medical Devices Act (MPG); in addition, the assessment is carried out in compliance with the principles of the Declaration of Helsinki and also the EC-GCP and the ICH-GCP (Good Clinical Practice).
- Within the scope of the assessment, the Ethics Committee pays particular attention to, amongst others, the relevance and scientific nature of the planning and conduct of the study, patient information, the conditions of consent for participation in the study, the risk-benefit ratio for the trial subjects, medical ethical justifiability, discontinuation criteria, the suitability of the physicians and staff involved in the study, the appropriateness of the trial centres and insurance coverage.
- The Ethics Committee is therefore required to consider medical, ethical, legal and scientific aspects for its decisions.
- In accordance with the legal provisions stipulated in the AMG and MPG, the multidisciplinary committee is composed of individuals who are working both in the healthcare sector and also in non-medical professions.
- The committee is independent with respect to the fulfilment of its tasks, and the members may not be subject to any directives within the scope of this activity.
- The meetings of the Ethics Committee are not open to the public and are chaired by the chairperson or his or her deputy.