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.

Biobanks are collections of samples of human body substances (e.g. tissue, cells, DNA, proteins, blood or other body fluids) that are usually linked or can be linked to data and information from the donors.

The samples for the biobank can be obtained in different ways:

  1. residual material from a routine procedure (blood collected for diagnostic purposes, surgically removed tissue...),
  2. additional samples collected during a routine procedure without a separate intervention (e.g. without an additional puncture for blood collection),
  3. samples collected exclusively for research purposes (either samples collected directly for the biobank, additional samples collected in the course of another clinical study or residual samples from clinical studies).

A vote by the ethics committee is required in advance for each biobank installation. Specific research projects planned on the samples and data must be submitted separately to the ethics committee before implementation (with reference to the vote on the biobank in question).


Information for participants

An initial written information and declaration of consent must be obtained from the donors regarding the storage of their samples in the biobank. For concrete research projects within the planned framework of the biobank, a separate consent of the patients is subsequently no longer required.

This information/consent form must contain the following essential points (in addition to the usual information, see sample information for clinical studies):

  • A rough description of the research area (a blanket consent to "use the samples for future research purposes" is not legally possible),
  • the storage location and the person responsible for storage and destruction,
  • information on whether genetic studies are also planned,
  • information that participants can withdraw their consent at any time and that the samples will be destroyed in this case,
  • information that all research projects on the samples will be submitted to the ethics committee before they are carried out,
  • information regarding the communication of individual study results: Individual results should only be shared in exceptional cases if they are of immediate clinical relevance to the individual and scientifically validated. Donors must be explicitly informed that they have the choice to refuse to share results. In the case of communication of individual results obtained by means of genetic analyses in accordance with the Genetic Engineering Act (GTG), the provisions of the GTG must also be complied with.

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