
Forms, guidelines
Patient information - clinical studies, genetic examinations
Applicants are requested to use templates for patient information and the linguistic_design_of_patient_information_en.pdf (91.77 KB, PDF) (german only) as a guideline for the patient information.
Templates for patient information can be found
- on the website of the Forum of Austrian Ethics Committees
-
and on the website of the Medical University of Vienna
The sample information for clinical studies is a simplified version and is intended for studies that are not subject to the AMG or the MPG, nor do they represent a new medical method in the sense of the KAKuG. On the one hand, it is intended to support the applicants in the drafting of the document and, on the other hand, to facilitate the assessment by the ethics committee due to the given structure.
A separate patient information sheet must be provided for patients who are temporarily incapable of giving consent.
Draft patient information for temporarily incapacitated patients
If minors aged eight years or older are included, a separate, age-appropriate patient information sheet for the children/adolescents must be provided in addition to the information sheet for the parents (if necessary, separate information sheets for different age groups).
recommendations_for_information_and_consent_for_children_and_adolescents.pdf (59.35 KB, PDF)
If an additional optional part with gene analyses is foreseen, a separate patient:inside information must be provided for this.
gene tests.pdf (92.34 KB, PDF)
Recommendations of the Ethics Commitee on obtaining informed consent for telephone interviews
Written informed consent may be waived for questionnaire studies conducted at the KL that meet the following criteria:
Telephone interview/ online surveys that
- are pseudonymised (i.e. in which no identifying characteristics such as date of birth, name, address are collected), in which
- the research project involves only a minimal risk for the study participants, for which
obtaining consent by telephone does not adversely affect the rights and welfare of the study participants, and - the scientific value of the project would be impaired by the requirement of written informed consent (e.g. through selection bias and other restrictions on recruitment).
- the project would be impaired in its scientific value by requiring written consent (e.g. through selection bias and other restriction of recruitment).
If, according to the self-assessment of the project leaders, all of the above points are fulfilled, the following procedure (which must be specified in the study protocol) is recommended:
- Transmission of a cover letter / information letter to patients / subjects;
- Defined time interval until telephone call;
- Keeping a predefined telephone protocol including documentation of consent;
In addition to the information in the protocol, the fulfilment of the above criteria must be described in detail and confirmed by the applicants in an accompanying letter.
In all other cases, handwritten consent must be obtained.
For clinical trials according to the AMG and some MPG studies, no-fault subject insurance is required. The Lower Austrian Ethics Commission is responsible for this.
For clinical trials that are not subject to the AMG or MPG, the Ethics Committee may require the conclusion of an insurance policy.
The Ethics Committee draws attention to the fact that a low-cost framework insurance is available for academic studies conducted in the area of the Regional Health Agency.
The required confirmation of insurance can be applied for by the investigator/physician in accordance with the guideline on the organisational and financial handling of the implementation of clinical research projects in the Lower Austrian provincial and university hospitals.
Download: Guideline for pilot studies (German only)
Coordination Centre for Clinical Trials
Assistance with authorities and EC submissions; information as well as forms for the registration of clinical trials
https://www.meduniwien.ac.at/hp/kks/
Ethics Committees in Austria
- Ethics Committee of the Medical University of Vienna
https://www.meduniwien.ac.at/web/ueber-uns/ethikkommission/ - Forum of Austrian Ethics Committees
www.ethikkommissionen.at/ - Lead Ethics Committee of the Medical University of Graz
https://www.medunigraz.at/ethikkommission - Ethics Committee of the Medical University of Innsbruck
www.i-med.ac.at/ethikkommission - Guiding Ethics Committee of the City of Vienna according to KAG, AMG and MPG
http://www.wien.gv.at/gesundheit/strukturen/ethikkommission/index.html - Guiding Ethics Committee of the Province of Lower Austria
www.noe.gv.at/Gesundheit/Gesundheitsvorsorge-Forschung/NOe-Ethikkommission.html - Guiding Ethics Committee of the Province of Upper Austria
http://www.kepleruniklinikum.at/lehre-forschung/ethikkommission-des-landes-ooe/ - Ethics Committee of the Province of Salzburg
salzburg.gv.at/ethics-commission - Bioethics Committee at the Federal Chancellery
https://www.bka.gv.at/bioethikkommission
Other
- US Department for Human Research Protections - Institutional Review Board Registry
ohrp.cit.nih.gov