Which projects must be submitted?
The Ethics Committee must be notified of any study involving patients or subjects in which any form of intervention is used, or in which identifiable patient material or data is used. This statement is derived from Article 1 of the Declaration of Helsinki.
Furthermore, animal experiments must be reviewed by the Ethics Committee before submission to the Federal Ministry of Science, Research and Economy (BMWFW).
The Animal Experiments Act 2012 (TVG 2012) defines an animal experiment as "any use of animals for experimental, educational or other scientific purposes [...] which may cause pain, suffering, distress or lasting harm [...] to the animals". An animal experiment already exists if the adverse effects likely to be inflicted on the animals correspond at least to the stress caused by a needle puncture.
Furthermore, the provisions of the KL Good Scientific Practice apply:
"According to the current Austrian legal situation and international guidelines, all research projects involving human subjects must be submitted to an ethics committee for review. This includes all measures involving patients and/or test persons, identifiable human material (e.g. blood, serum, tissue samples, DNA) or data (e.g. medical records), which are carried out for the purpose of gaining knowledge and/or which do not exclusively serve the health benefit of the patients and/or test persons on whom the measures are carried out. In this context, it is irrelevant whether it concerns the testing of a medicinal product, a medical device, a new method or another research project.
"No submission to the Ethics Committee is required for medical acts that are solely for the health benefit of an individual patient:in."
Contact: Prof. Franz Trautinger, Chairman of the Ethics Committee
The following questions serve as a basis for self-assessment as to whether a planned research project that uses empirical data collection methods (e.g. a questionnaire study) must be reviewed by the KL Ethics Committee:
- Does the research project involve the collection of identifiable personal data?
- Does the research project involve the collection of health-related data?
- Should patients (i.e. subjects who are selected as study participants due to certain diseases or certain symptoms) be included?
- Should subjects from vulnerable groups within the meaning of the Helsinki Declaration (e.g. children/minors, institutionalized persons (prisoners), persons unable to give consent, dependent persons, refugees, .... see below) be included?
If, according to self-assessment, all of the above questions can be clearly answered in the negative, approval of the research project by the KL Ethics Committee is not necessary. In case of doubt, the ethics committee must be contacted before the start of the research project.
If a statement from the ethics committee is desired for studies not subject to ethics committee approval ("waiver"), the complete project must be submitted to the committee before the start of the project (submission via ECS). The applicant must confirm fulfillment of the above criteria (1 - 4) in detail in a cover letter. After formal verification of the correctness of the information, the Committee will issue a confirmation that the project does not require an assessment and that the procedure complies with national and institutional rules.
Use of "residual material" (patient:internal material that would otherwise be discarded) e.g.: Urine, blood and blood components, secretions and other body fluids, tissue, etc.
Contact: Prof. Franz Trautinger, Chairman of the Ethics Committee ethikkommission@kl.ac.at
"Residual material" may be used for research projects without obtaining patient consent under the following conditions:
a) The samples are anonymous, i.e. no identifying characteristics such as date of birth, name, address, possibly also the time of collection are associated with the samples. No disease-related data that would allow identification may be collected.
b) Tracing back to the patient is not possible and
c) The samples are obtained from routine medical practice and were not collected prospectively for a specific research purpose or a tissue bank.
Projects using "residual material" must always be submitted to the EC before the project begins. If the above points are fulfilled, the EC may waive the need for an assessment and issue an informal confirmation that there is no need for an assessment and that the project complies with national and institutional rules and recommendations.
Some groups and individuals are particularly vulnerable and may have an increased likelihood of being wronged or incurring additional harm.
ICH-GCP (1996)
Definition: “Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate.”
Identified Vulnerable Groups: Members of a group with a hierarchical structure, such as medical, pharmacy, dental, and nursing students; subordinate hospital and laboratory personnel; employees of the pharmaceutical industry; members of the armed forces; persons kept in detention; patients with incurable diseases; persons in nursing homes; unemployed or impoverished persons; patients in emergency situations; ethnic minority groups; homeless persons; nomads; refugees; minors; and those incapable of giving consent.
Repeal of the Ordinance on the Reporting Requirement for Non-interventional Studies
The Ordinance on the Reporting Requirement for Non-interventional Studies was repealed on 07.10.2022 by Federal Law Gazette II No. 374/2022 (RIS - BGBLA_2022_II_374 - Bundesgesetzblatt authentisch ab 2004 (bka.gv.at)).
A reporting obligation for non-interventional studies within the meaning of Section 2a (3) of the Medicinal Products Act, Federal Law Gazette I No. 23/2020, or Article 2, paragraph 2 Z4 of Regulation (EU) 536/2014 thus no longer exists.
Non-interventional studies (NIS) - BASG
Other questions and interventions
- Blood samples
- gene tests.pdf (92.34 KB, PDF)
- Collection of body fluids
- Establishment of biobanks
- Creation of registers
- Questionnaire surveys
- Retrospective data collection ("chart review")
- Post-mortem examinations
- BA and MA theses, diploma theses, dissertations if they examine patients or subjects or data from them
- Projects involving the use of animals
Submission to the Ethics Committee
Filing procedure
The Ethics Committee reviews research projects conducted at the University Hospitals of Karl Landsteiner Private University. If you are in doubt as to which ethics committee you should submit your project to, please send an enquiry to ethikkommission@kl.ac.at. In general, the competence depends on the origin of the patients, patient data and samples.
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What documents must be submitted?
The documents must be submitted online within the submission deadline of the respective ethics committee meeting.
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Online submission
The documents must be submitted online in the ECS, the submission and administration system of the Ethics Committee, within the submission deadline of the respective Ethics Committee meeting.
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