Ethics Advisory Board and the Ethics Commission for Security-Relevant Research

The Ethics Commission for Security-Relevant Research are specifically dedicated to the challenges of security-relevant research, especially in connection with so-called dual-use problems - i.e. research projects whose results could be used for both civilian and improper purposes, for example for military or harmful purposes. 

It supports researchers at Leipzig University in the ethical and security-related assessment of their projects, for example in the context of information security, biological research, artificial intelligence or social risks from technical applications. The following principles apply:

• The Ethics Commission for Security-Relevant Research is a subcommittee of the Ethics Advisory Board.
• The consultations and procedures are free of charge, confidential and generally voluntary, but may be mandatory by order of the Ethics Advisory Board.
  Members, experts and supporters are obliged to maintain confidentiality.
• The Ethics Commission for Security-Relevant Research meets as often as the business situation requires, but at least once a year.
• The Ethics Commission for Security-Relevant Research reports on its activities once a year in anonymized form to the Senate and the “Joint Committee on the Handling of Security-Relevant Research” of the German Research Foundation and the German National Academy of Sciences Leopoldina.

Who can contact the Ethics Commission for Security-Relevant Research?

• All members and affiliates of Leipzig University can (and should, if necessary) contact the Ethics Commission for Security-Relevant Research —especially if they are planning or conducting research projects with potential security risks.

When should the Ethics Commission for Security-Relevant Research be involved?

• Before the start of a research project, if:
  • there could be significant risks to human dignity, life, health, freedom, property, the environment, information security, or peaceful coexistence.
  • the research project could produce knowledge, technologies, or products that could be misused by third parties (dual use).
• During an ongoing project, as soon as new security-related risks become apparent.
• If the Ethics Advisory Board bindingly orders consultation with the Ethics Commission for Security-Relevant Research.

How does the procedure work?

• The (process) consultation is provided upon written request to the Ethics Commission for Security-Relevant Research office. The request should include a project description that is understandable to laypersons and a presentation of the security-relevant aspects. Previous or parallel applications must be disclosed.
• If necessary, the Ethics Commission for Security-Relevant Research may consult experts and request additional documentation or explanations. The person seeking advice has the right to be heard, may submit a statement, and may inspect expert opinions.
• The Ethics Commission for Security-Relevant Research assesses whether and how the project is legally and ethically justifiable from a safety perspective, issuing recommendations or conditions for risk minimization where necessary.
• The assessment is communicated in writing and, if changes are required, justified.
• The Ethics Commission for Security-Relevant Research must be informed immediately of any new or unexpected risks that arise during the project. It may then adapt or revoke its opinion and request changes.
• In fundamental cases, additional advice may be sought from the Joint Committee of the DFG and the Leopoldina. den Gemeinsamen Ausschuss von DFG und Leopoldina eingeholt werden.

The Ethics Commission for Security-Relevant Research is currently being set up - the composition of the commission is currently being prepared. At the same time, a dedicated website is being created to provide comprehensive information on the procedure, contact persons and advisory services. It will also provide further recommendations and materials.

The German Research Foundation (DFG) and the Leopoldina have jointly addressed the tension between academic freedom and scientific responsibility. On the subject of the possible misuse of research results, they have formulated recommendations for dealing with security-related research and established a “Joint Committee” as an advisory body. 

Information Broschure: “The Handling of Security-Relevant Research in Germany - An Overview”

The Federal Office for Economic Affairs and Export Control (BAFA) provides information to raise awareness of export control objectives among universities and research institutions and to support them in applying foreign trade law. The BAFA website also contains two publications, “Export Control in Research and Science” and the “Handbook on Export Control and Academia.”

Leipzig University faces up to challenges in academia and society and its responsibility for the consequences of research findings, especially for humankind and the natural world. In order to meet this responsibility, Leipzig University has set up an Ethics Advisory Board, which reports to the Rectorate and is part of the Research Commission. The statutes of the Ethics Advisory Board at Leipzig University define the Ethics Advisory Board and regulate its tasks and procedures. The following principles apply:

• The Ethics Advisory Board advises members of the Leipzig University community.
• Applications are voluntary. Applications are often prompted by the requirements of external funding bodies, which make an opinion by the Ethics Advisory Board a prerequisite for financial support. In such cases, but also in others, the Ethics Advisory Board at Leipzig University provides assistance to the responsible academics by offering advice and assessing ethical aspects of their research. This does not affect the academics’ own responsibility for their actions.
• The Ethics Advisory Board works on the basis of applicable laws and academic standards. Accordingly, national and international recommendations, and declarations of professional societies in the relevant fields and the German Research Foundation (DFG) are taken into account on the basis of the current state of science and technology.
• The Ethics Advisory Board can only issue an opinion if the research project has not yet begun.
• If you will be working with personal data in your research project, please contact the Data Protection Officer before submitting your application. This is essential in order to evaluate a research project and for the Ethics Advisory Board to issue an opinion. All documents of relevance for data protection matters – revised after consultation, if necessary – must be complete when the application is submitted. Multiple consultations are also possible. Applicants should contact the Data Protection Officer three to four weeks prior to the Ethics Advisory Board submission deadline.
• The Ethics Advisory Board does not conduct a legal review of the project.
• Applications for review for projects within the scope of theses (up to Master's degree) must always be submitted together with the supervisor (or Pl of the project).

The Ethics Advisory Board assesses ethical aspects of research projects involving human subjects that do not fall within the remit of the Ethics Committee at Leipzig University’s Faculty of Medicine. The research projects are usually externally funded research projects, commissioned research and development, and theses.

1. In what form can applications be submitted?

The application can be submitted in paper form or by email. If you are submitting the application electronically, please combine all the necessary as an attachment in a PDF document with a maximum size of 30 MB. If you are submitting documents that you cannot send as a PDF, please attach them separately in electronic form or send them to our office marked with the applicant’s name. Application documents will not be returned. A copy will remain on file for ten years. Copies made for the purpose of the assessment will be destroyed once the assessment is complete.

Application documents may be submitted in English. However, all documents relating to data protection should be presented in German.

2. What should the application contain?

An application for evaluation of a project by the Ethics Advisory Board at Leipzig University should contain

• The completed application form
• A short project summary (no more than two to three pages) and
• A detailed description of the ethically relevant aspects of the project.

An application for evaluation of a project by the Ethics Advisory Board at Leipzig University can contain

• A records of processing activities pursuant to Article 30 of the General Data Protection Regulation, if the project will involve the processing of personal data.

The Leipzig University Data Protection Officer is responsible for assessing applications received by the Ethics Advisory Board from a data protection perspective. This is essential in order to evaluate a research project and for the Ethics Advisory Board to issue an opinion. Whether the completion of the register of processing activities is necessary should be coordinated with the data protection officer. The directory of processing activities (if necessary) must first be created digitally in the data protection management system (DPM). Contact the data protection officer in this regard. You can then generate a PDF and attach it to the application. All documents of relevance for data protection matters – revised after consultation, if necessary – must be complete when the application is submitted. Multiple consultations are also possible.

Please contact the Data Protection Officer three to four weeks prior to the Ethics Advisory Board submission deadline.

The guide contains a detailed catalogue of questions that provides orientation as to which ethical implications of the research project need to be addressed. The nature of the application must be oriented towards the research project in question. Name the strategy to address ethical implications, from participant preparation and recruitment to data analysis, storage, and presentation.

3. What other application documents are required?

The Ethics Advisory Board reserves the right to ask specific questions of the applicant during the consultation and decision-making process. Upon request, further documents may need to be submitted (e.g. written statements by third parties on the project, or questionnaires). In particular, all declarations of consent and information texts for the research subjects and, if applicable, their legal representatives must be submitted to the Ethics Advisory Board. In addition, a statement must be enclosed explaining whether applications with the same or similar content have already been submitted previously or simultaneously – and, if so, where and with what result.

4. In what form will the opinion be issued and how long will it take?

After carefully reviewing the documents submitted, the Ethics Advisory Board will examine in particular whether

• all precautions have been taken to minimise the risk to subjects,
• there is an appropriate balance between the benefits and risks of the project,
• the consent of the subjects or their legal representatives has been obtained,
• there are any data protection aspects to consider when conducting the project and the Data Protection Officer needs to be involved

and, if necessary, issue an opinion on ethical aspects of planned research projects.

The Ethics Advisory Board normally issues an opinion eight weeks after receiving the complete application. If the Ethics Advisory Board receives an exceptionally high number of applications or there are other special circumstances, please note that it may take longer to process individual applications. If appropriate, it may recommend processing by another ethics committee. We recommend applying sooner rather than later.

5. What if there are any changes?

The Ethics Advisory Board must be informed without undue delay of any changes or events that may directly or indirectly have a significant influence on the research project, its outcome or consequences. In this case, please outline and briefly explain these necessary changes in writing. It will not be necessary to submit a new application.

The Ethics Advisory Board may change its earlier assessment or subsequently add further requirements if

• significant changes occur or
• anything comes to light that may compromise the safety and well-being of the subjects.

 Approval of the research project by the Ethics Advisory Board will lose its validity if

• changes are subsequently made to the research project that have not been approved by the Ethics Advisory Board,
• conditions imposed by the Ethics Advisory Board are not fulfilled,
• anything comes to light that may compromise the safety and well-being of the subjects and this is not reported without undue delay.

In principle, the Ethics Advisory Board decides after oral discussion. In justified exceptional cases, an accelerated assessment and decision-making process may be carried out in lieu of a meeting. The chairperson of the Ethics Advisory Board will decide whether such a fast-track procedure is permitted. A request for an assessment to be fast-tracked must be justified.

Procedure

The fast-track procedure involves two members of the Ethics Advisory Board reviewing an application. If this is judged to be ethically unobjectionable by both rapporteurs, a written resolution is passed by circulation by all full members. This can take up to two weeks. If the lack of ethical concerns is confirmed, the application need not be considered at a regular meeting of the Board. A letter of no objection will be issued. This will refer to the fact that the approval was fast-tracked as follows:

“Your request for an assessment of the research project was considered by the Ethics Advisory Board using a fast-track process.”

Data Protection

The data protection examination by Leipzig University’s Data Protection Officer is separate from the assessment by the Ethics Advisory Board. Please factor in enough time for this to be prepared and processed.

The Ethics Advisory Board generally decides after an oral discussion. An assessment of the research project and statement by the Ethics Advisory Board of Leipzig University using the simplified procedure can only take place if the criteria listed in the application form apply to the project. Please note the additional documents to be submitted.

Application form
PDF ∙ 125 KB

Procedure

Two members of the Ethics Advisory Board review an application using the simplified procedure. If it is deemed ethically unobjectionable by both rapporteurs, a written resolution is passed by circulation by all full members. This can take up to two weeks. If the ethical harmlessness is confirmed, the application does not have to be dealt with in an ordinary meeting of the committee. A letter of recommendation is issued. This contains a reference to the assessment using the simplified procedure in the form:

"Your application for assessment of the research project was dealt with by the Ethics Advisory Board using the simplified procedure. "

Data protection

The examination of data protection by the data protection officer of Leipzig University takes place outside the review of the Ethics Advisory Board. A corresponding lead and processing time must be allowed for.

• Chairperson
  Professor Anne Deiglmayr (Faculty of Eucation)
• Deputy chairperson
  Professor Dorothee Alfermann (Faculty of Sport Science)
• Members
  Junior Professor Nanna Notthoff (Faculty of Sport Science)
  Professor Susanne Viernickel (Faculty of Education)
  Professor Julian Schmitz (Faculty of Life Sciences)
• Alternate members
  Professor Roderich Andres Barth (Faculty of Theology)
  Professor Gesa Hartwigsen (Faculty of Life Sciences)
  Junior Professor Julia Moeller (Faculty of Education)
• Dr. Andreas Niekler (Faculty of Mathematics and Computer Science)
  Professor Nikolaos Psarros (Faculty of Social Sciences and Philosophy) 
  Dr. Thomas Rakebrand (Faculty of Social Sciences and Philosophy) 
  Professor Tanja Zimmermann (Faculty of History, Art and Area Studies)
• Permanent guests
  N.N. (Data Protection Officer)
  Prof. Dr. Christian Berger (Faculty of Law)

Support in creating study-related information materials

The documents provided serve as a guide. They can be adapted to the specific requirements of your study and contain suggested wording for describing the study, its objectives, methodologies, and the voluntary nature of participation, as well as data protection and consent guidelines. For participants who are minors, there are additional explanations tailored to children to ensure that they fully understand the study and their rights. You can use these templates to structure the information materials for participants. They provide support in complying with legal and ethical requirements and give participants a transparent understanding of the study.

• Information sheet on data protection in science and research
• (Sample) Participation information
• (Sample) Participation agreement and data protection consent form
• (Sample) Participation information for parents/guardians/legal representatives
• (Sample) Participation information/invitation for children
• (Sample) Participation information for parents/guardians/legal representatives in the presence of the participant

Note on the distinction between declarations of consent and declarations of agreement

Unlike a declaration of consent, a declaration of agreement is general and can be used in various legal contexts, whereby the requirements are less strict and specific than for a declaration of consent. A declaration of consent in the context of the EU GDPR requires specific, informed, and unambiguous consent to data processing and must comply with the strict requirements of the EU GDPR.

While the Ethics Advisory Board assesses ethical aspects of research projects involving humans, the Ethics Committee at the Faculty of Medicine is required to vote on projects involving humans. Further information can be found on the website of the Ethics Committee.

The Working Group of Medical Ethics Committees is an association of 52 ethics committees. The AKEK promotes the ethical integrity and scientific quality of medical research. The protection of test subjects is just as central to our actions as the preservation of free, progressive science in medicine.

Die Deklaration von Helsinki wurde in ihrer neuesten Version aktualisiert, um den ethischen Rahmen für medizinische Forschung weiter zu präzisieren. Die überarbeitete Fassung stärkt den Schutz von Studienteilnehmenden, betont Transparenz in klinischen Studien und passt ethische Richtlinien an aktuelle wissenschaftliche Entwicklungen an. Sie bleibt der weltweite Maßstab für forschungsethische Standards.

The Ethics Committee carries out an ethical evaluation of scientific studies on animals that are carried out or administered by members of the Faculty of Veterinary Medicine at Leipzig University and do not constitute animal experiments requiring approval or notification.

• Ethik-Kodex der Deutschen Gesellschaft für Erziehungswissenschaft (DGfE)
• Ethik-Kodex der Deutschen Gesellschaft für Soziologie (DGS) und des Berufsverbands Deutscher Soziologinnen und Soziologen (BDS)
• Ethische Richtlinien der Deutschen Gesellschaft für Psychologie (DGPs) und des Berufsverbands Deutscher Psychologinnen und Psychologen (BDP) mit Bezug zur Forschung
• Forschungsethische Grundsätze und Prüfverfahren in den Sozial- und Wirtschaftswissenschaften
• Ethikleitlinie der Deutschen Gesellschaft für Sozial- und Kulturanthropologie
• Forschungsethische Prinzipin der Deutschen Gesellschaft für Soziale Arbeit
• Forschungsethik in der qualitativen Sozialforschung

Leipzig University informs researchers about the scope and requirements of the Nagoya Protocol. This came into force on October 12, 2014 and regulates access to genetic resources and the fair and equitable sharing of the benefits arising out of their utilization under the Convention on Biological Diversity as a binding treaty under international law. Department 1: Research and Transfer provides a checklist which you can use to check whether your project falls within the scope of the Nagoya Protocol. Further information can also be found on the website of the Federal Office for the Environment.
 

The German Research Foundation (DFG) has published "Explanatory notes on dealing with the legal requirements of the Nagoya Protocol and Regulation (EU) No. 511/2014 in universities and other research institutions ”.

With the recommendations for safeguarding good scientific practice, the DFG has formulated a guideline for self-regulation that has found general consensus. In its “Guidelines for Safeguarding Good Scientific Practice” (2019), it formulates appropriate standards for scientific work.

At European level, the European Code of Conduct for Research Integrity of the research community serves as a framework for self-regulation in all scientific disciplines and for all research institutions. An ethics guide from the European Commission (part “Ethics Self-Assessment”) is also available as an aid for completing applications in the Horizon 2020 framework program.
 

UREC is a network that brings together national associations, networks or comparable initiatives at European level. The network promotes capacity building and support for local Research Ethics Committees in their cooperation within the European Research Area. As an umbrella organization, the network connects the European Research Ethics Committees with other bodies relevant to research with human participants, such as the ethical review system of the European Commission and the European Medical Association (EMA).

The TRUST Code – A Global Code of Conduct for Equitable Research Partnerships sets new standards for fair and respectful research partnerships between countries with different resources. It is based on the values of fairness, respect, diligence, and honesty and provides clear, accessible guidelines for avoiding “ethics dumping” in international research projects.