Forschung, Karl Landsteiner Privatuniversität
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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

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
 

Other

  • US Department for Human Research Protections - Institutional Review Board Registry
    ohrp.cit.nih.gov
Commission on Ethics and Scientific Integrity