What documents must be submitted?
The documents must be submitted online within the submission deadline of the respective ethics committee meeting.
The Ethics Committee would like to point out that a formally complete application must be available on the last day of the submission deadline. Should additions be necessary at this point for formal reasons, these are possible at any time, but the application can only be dealt with at a later meeting. It is therefore recommended that the initial submission be made a few days before the submission deadline.
After formally complete and confirmed submission (confirmation of receipt by the Ethics Committee), the application form completed online must be downloaded in PDF format and, provided with all necessary signatures, handed in to the office of the Ethics Committee (P.O. Box KL Ethics Committee on the ground floor of Building X) no later than before the respective meeting day. All other required documents are uploaded online as PDF files (Attention: only PDF files may be uploaded).
Application forms that have not been created online in the ECS cannot be accepted.
The template informed consent, including the current version on data protection, must be used for patient information.
Online submission
- The application must be marked as "BA/MA thesis, diploma thesis, etc. ".
- The KL Private University (or the commercial sponsor, if applicable) must be stated as the "Sponsor"; the supervisor must be named as the contact person of the sponsor. This person also bears full responsibility for the implementation of the project (see below).
- The scope of the student's activity must be described in detail.
- According to the Medical Act, the following activities may be carried out by students in each case under the guidance and supervision of the training doctors:
- Taking the medical history
- Simple physical examination of the patient including
- Blood pressure measurement
- blood sampling from the vein
- administering intramuscular and subcutaneous injections
- Assistance with other medical activities
- Informing a study participant about participation in the clinical study is only possible in the presence of a responsible physician.
- In any case, the name of the supervisor, including a telephone number that can be reached at the clinic, must be stated in the patient/proband information.
- The protocol and, if applicable, the patient information must be labelled with the date and version.
- If the work does not represent an independent study, but is carried out as part of a larger study, the project plan and the student's declaration of commitment must be submitted.
The Ethics Committee recommends following the structure and outline of the model protocol.
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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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.
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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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