Faculty of Engineering & Natural Sciences:

• Main member: Univ. Prof. DI Dr. Rene MAYRHOFER (Chair)
• Substitute member: Univ. Prof. Dr. Christina OLAVERRI-MONREAL

Faculty of Social Sciences, Economics & Business:

• Main member: Univ. Prof. Dr. Claudio BISCARO
• Substitute member: Univ. Prof. Dr. Bernad BATINIC

Faculty of Law:

• Main member: Univ. Prof. Dr. Elisabeth GREIF (deputy chair)
• Substitute member: Dr. Karin NEUWIRTH

Faculty of Medicine:

• Main member: Univ. Prof. Dr. Soyoung LEE
• Substitute member: Univ. Prof. Dr. Erika ZELKO

Interdisciplinary:

• a.Univ. Prof. Dr. Klaus MIESENBERGER

The Ethics Advisory Board prepares reports in its area of ​​responsibility regarding the ethical safety of planned research and publication activities and can submit recommendations on how to handle any ethical issues that may arise.

The Ethics Committee oversees research and publication projects conducted by scholars and researchers at the JKU and for which funding bodies or journals may request clearance certificates on the grounds that the research or publication project touches on ethical issues.

In accordance with Section 30 of the 2002 Universities Act, Section 8c of the Federal Hospitals and Sanatoria Act, the Ethics Committee has no authority in matters falling within the responsibility of the Ethics Committee and other corresponding federal and state regulations, or in the area of responsibility held by the Animal Ethics Council.

In accordance with § 30 of the 2002 Universities Act, the JKU Ethics Commission for evaluating clinical trials involving drugs and medical devices, as well as new medical methods and applied medical research involving humans, conducted at the JKU's Faculty of Medicine, the Kepler University Hospital, other hospitals and facilities, and physicians in private practice located in Upper Austria. As a certified ethics committee, the JKU-EK is responsible for evaluating applications submitted for multicenter clinical trials in accordance with § 41b para. 1 of the Austrian Medicines Act (AMG as amended by Federal Law BulletinI No. 23/2020) and § 17 of the Medical Devices Act 2021.

In addition, the Ethics Committee is responsible for evaluating nursing research projects, the use of new nursing and treatment approaches, and new methods of nursing and treatment.

Please see: https://www.jku.at/medizinische-fakultaet/organisation/jku-ethikkommission/ to learn more.

First, contact the Office of the Ethics Advisory Board by e-mail and request an application form. Return the completed form (Including all of the required attachments) by e-mail. We will then initiate the next steps. See the Pt. "Procedure" as well.

The Ethics Advisory Board convenes its meetings as required. Applications for an expert opinion regarding a clearance certificate are decided by the Ethics Committee no later than eight weeks after receiving the application documents.

Clearance certificates may be requested by funding agencies or journals when ethical issues are involved in the research or as part of the proposed publication.

No, clearance certificates are free of charge.

No. The JKU is not required to submit research projects to the Ethics Advisory Board for comment. Submissions to the Ethics Committee are always on a voluntary basis.

As a rule, clearance certificates are issued for research projects in which the funding agency requests an opinion by the Ethics Advisory Board, or for the findings from a publication that is to be published in a scientific journal and requires an ethics statement.

Generally, it is possible.

No. The research application submitted to the funding agency does not have to be submitted to the Ethics Committee. This contains information considered irrelevant to the Ethics Advisory Board.

You can submit the application to the Ethics Advisory Board independently from the research application (which is still often being worked on).

The project information required for the Ethics Committee's evaluation (along with all of the other required documents) are listed in the application form. The application to the Ethics Committee should briefly describe the overall project and address the ethical aspects in greater detail. In addition, the application requires CVs from those responsible for the project, information about the test subjects, participants' consent forms, documentation sheets and data management plans, as well as any other documents.

Yes. As long as the experimental design details have not yet been determined, or documents (such as questionnaires, consent forms, etc.) are not yet available, you do not have to submit them. However, the research project, and in particular the intended data collection, has to be adequately described in order to be evaluated. In addition, the ethically sensitive aspects must be clearly identified and a detailed description of how they will be taken into account must be provided.

No. Each research proposal will be considered on an individual basis. The ethical questions are different in each case, and each ethically significant situation can be addressed differently.  It is essential to be aware of ethical aspects and to adopt an ethically sensitive approach tailored to the project in question.

No. Ethics Committee members will only address submitted applications. The Office of the Ethics Advisory Board will be happy to answer any questions regarding the formalities and procedures.

Checklist for the Applicant

This checklist is designed to help the applicant consider aspects that the JKU’s Ethics Committee will consider in an application. However, remember that this list is not exhaustive, and each application will raise its questions.

1) Summary of the Research

• Is there likely to be a worthwhile outcome? (The purpose is not to conduct a methodological review, but research should be of sufficient merit to justify the time and effort contributed by participants).

• Do the potential benefits of the research balance against the potential risks to participants?

2) About the Participants

• How will permission or access to participants be obtained? Are the gatekeepers involved identified/on board with evidence provided?

• What are the inclusion/exclusion criteria for participants? Are these appropriate?

• How will consent be obtained? Is this method appropriate? Can the researcher be sure that participants can give their informed consent that is free from coercion? (Informed consent is not necessarily required in all cases, but if it is not to be gained there must be a good reason).

• What is the potential for harm to participants – pain, discomfort, stress? (almost all research involving participants will have some potential for physical or psychological harm and the risk should be acknowledged). How will this be minimized/addressed/managed?

• Is the researcher likely to uncover any issues unrelated to the research? (e.g. illegal activity, illness or disease etc). How will the researcher handle such an eventuality?

• Are participants able to withdraw from the research and how will this be done?

• Are participants potentially vulnerable (i.e. because of the situation they find themselves in e.g. asylum seekers, refugees) or vulnerable? Are the implications of this addressed?

3) About the Data

• What measures have been taken to ensure anonymity, confidentiality, and security of personal information concerning research participants? Are these appropriate to the research? Are these realistic?

• Who will have access to the data?

• How long will data/recordings/samples be held? Does this take into account any intended future use?

• How will they be stored?

4) Supporting Documentation

• Are relevant supporting documents included? (e.g. information sheets, consent forms, interview schedules or interview topic guides, non-standardised questionnaires etc.)

• Are materials for participants clear and free from technical terms, jargon and abbreviations as far as possible to enable participants to give their ‘fully’ informed consent to take part in the research?

• Are the materials appropriate for the intended audience (e.g. children and young people)?

• Is it clear to participants in the information sheet:

- whether their data will be anonymous/confidential/aggregated?

- how to withdraw?

- what is being asked of them and what they are contributing to?

- what their data will be used for and any potential future use?

- how the data will be managed?

- how to complain if they wish to do so?

- who is leading the research and how to get in contact with them?

5) General Considerations

• Is there enough detail in the application?

• Are the dignity, rights, safety, and well-being of participants considered?

• Will the researcher be safe? Is there a procedure in place for risks to the researcher?

• Does the research have any implications for the reputation of the University?

• Are there any obvious gaps, ambiguities, or uncertainties in how the research will be carried out?