University of Vienna Ethics Committee
University of Vienna Ethics Committee
Establishment and composition
§ 1. (1) An Ethics Committee is established at the University of Vienna.
(2) The Ethics Committee consists of eleven members. Their term of office is four years in each case.
(3) One member having an authorisation to teach is appointed from each of the following subject areas:
life sciences,
natural sciences,
social and economic sciences,
psychology,
law,
theology,
philosophy and education, as well as
sport and nursing science.
(4) The respective heads of the academic organisational units may propose suitable persons to the Rectorate for the appointment of these members. The appointment is made by agreement between the Rectorate and the Senate.
(5) The Rectorate, the Senate and the University Board each delegate one additional member. These members do not have to be members of the University of Vienna.
(6) A substitute member is appointed or delegated in the same manner for each member. It is also possible to appoint or delegate two substitute members for members, with the order of representation being determined on the occasion of the appointment or delegation.
(7) The appointment is valid for the respective term of office of the Ethics Committee. If a member resigns prematurely, a new member is appointed or delegated for the remainder of the term of office. Members of the Ethics Committee may be reappointed.
(8) In this capacity, the members of the Ethics Committee are free from instructions and have to maintain secrecy.
(9) The rules of procedure for collegial bodies of the University of Vienna (University Gazette of 13 November 2003, 2nd edition, no. 6 as amended) apply mutatis mutandis, unless stated otherwise in this part of the Statutes. The Ethics Committee may lay down rules concerning the procedure to be followed by it. These rules may also stipulate the requirement to call on external experts. These rules require approval from the Rectorate and the Senate and are published in an appropriate form at the University.
(10) Each and every member of the Ethics Committee abstains from performing his/her duties if he/she is biased, in particular if he/she is involved in a project to be reviewed. He/she is represented by his/her substitute member.
Tasks of the Ethics Committee
§ 2. (1) The Ethics Committee prepares expert reports on the following research projects:
1. Research projects on or with people: These are studies which may threaten the physical or mental integrity, the right to privacy, other subjective rights or prevailing interests of subjects.
2. Research projects on animals: These are studies in which animals are used in a way that goes beyond mere observation or medical care. This is particularly the case where research involves the manipulation of animals or the killing of an animal for the purpose of organ or tissue removal, or the creation and use of transgenic animals.
(2) In its expert report, the Ethics Committee assesses whether the protection of the rights, safety and welfare of the subjects (para. 1, sub-para. 1) or compliance with animal protection and welfare law (para. 1, sub-para. 2) are adequately ensured when implementing the research project.
Initiation of the review process
§ 3. (1) The Ethics Committee may only act upon a written application stating reasons which is submitted by university members who are responsible within the framework of their official duties for carrying out a research project within the meaning of section 2, para. 1. The statement of reasons for the application includes the specific need for an assessment by the Ethics Committee (e.g. a request of a funding body or a publication medium).
(2) In the case of research projects that are to be financed by university funds, the Rectorate or the heads of the respective academic organisational units may request an expert report from the Ethics Committee. This justifies a need according to para. 1.
(3) In the case of research projects which are to be carried out as part of diploma or master theses, the respective supervisors or the competent body responsible for study matters may apply for an expert report from the Ethics Committee. The application may only be submitted immediately before the topic is approved (section 15, para. 3 of the section of the University’s Statutes governing university studies) and has to be justified.
(4) In the case of research projects within the framework of doctoral theses, the respective supervisors or the competent body responsible for study matters as well as the researcher himself/herself may apply for an expert report from the Ethics Committee. The application may be submitted in the course of the preparation of the doctoral thesis agreement at the earliest and has to be justified.
Required documents
§ 4. The application must be enclosed with a research plan and documentation of the research project. This documentation contains statements on the professional qualifications of the academics involved in the research project, the objective of the study, the methods applied and the funding of the project. Special reference has to be made to all circumstances relevant to ethical justifiability within the meaning of section 2, para. 2. In the case of experiments on or with humans, the possible risks for the subjects are described. Any possible conflicts of interest of the involved academics have to be disclosed. In addition, the application includes, in any case, rules on the suspension or premature termination of the research project, on the possible reimbursement of expenses incurred by subjects and on the protection of personal data. The Ethics Committee may request additional information to define the research project in detail.
Expert reports
§ 5. (1) The Ethics Committee draws up an expert report in which it assesses the research project on the basis of section 2, para. 2. The decision requires the approval from at least six members of the Ethics Committee. Any objections to the research project are defined in detail and justified.
(2) If, during deliberations of the Ethics Committee, any concerns should arise which could lead to a negative assessment of the research project within the meaning of section 2, para. 2, the applicant is informed, stating the relevant reasons, and given the opportunity to submit written and oral statements. If the doubts cannot be dispelled, the Ethics Committee enables him/her to amend the research project accordingly or withdraw the application.
(3) The expert report from the Ethics Committee is forwarded to the applicants.
(4) An expert report from the Ethics Committee pursuant to section 3, para. 3 is brought to the attention of the examiners and the competent body responsible for study matters in the course of the submission of the academic thesis.
Resubmission
§ 6. (1) An already positively evaluated research project is referred back to the Ethics Committee if
1. the implementation will deviate from the research plan or from the other submitted documents in such a way that it has an impact on the assessment within the meaning of section 2, para. 2 or
2. unexpected adverse consequences occur for test subjects or animals within the meaning of section 2, para. 2.
(2) In such cases, the Ethics Committee may request the submission of the documents necessary for drawing up its expert report. Any resubmission still requires the compliance with legal obligations.
Reporting requirements of the Ethics Committee
§ 7. The Ethics Committee submits an annual written report on the requests received, the expert reports prepared and any other activities to the Rectorate, the Senate and the University Board.
Entry into force and transitional provisions
§ 8. (1) These provisions enter into force on 1 May 2011. The term of office of the first Ethics Committee ends upon expiry of the third academic year following entry into force.
(2) Any republication enters into force on the day following its announcement in the University Gazette.
As of: 29 March 2017
The only legally binding version is the German version published in the University Gazette.