Standards for review procedures

• Deutsche Forschungsgemeinschaft. (n.d.). Fachspezifische Empfehlungen zum Umgang mit Forschungsdaten. Link
• Deutsche Forschungsgemeinschaft. (n.d.). FAQ: Informationen aus den Geistes- und Sozialwissenschaften: Wann brauche ich ein Ethikvotum. Link
• Deutsche Forschungsgemeinschaft. (n.d.). Internationale Standards. Link
• Deutsche Forschungsgemeinschaft. (n.d.). Verfahren bei Verdachtsfällen wissenschaftlichen Fehlverhaltens. Link
• Deutsche Forschungsgemeinschaft. (n.d.). Zum Umgang mit Sicherheitsrelevanter Forschung: Im Spannungsfeld zwischen Wissenschaftsfreiheit und Wissenschaftsverantwortung. Link
• Deutsche Forschungsgemeinschaft. (2013 (1997). Sicherung guter Wissenschaftlicher Praxis: Empfehlungen der Kommission Selbstkontrolle in der Wissenschaft: Safeguarding Good Scientific Practice (2. Aufl.). Denkschrift (DFG) Memorandum. VCH [Imprint]; John Wiley & Sons, Limited.
• Deutsche Forschungsgemeinschaft. (2019). Handreichung für die Umsetzung des DFG-Kodex „Leitlinien zur Sicherung guter wissenschaftlicher Praxis“. Link
• Deutsche Forschungsgemeinschaft. (2019). Leitlinien zur Sicherung guter wissenschaftlicher Praxis: Kodex. Bonn. Link
• Deutsche Forschungsgemeinschaft. (2021, 21. December). Checkliste zum Umgang mit Forschungsdaten. Link
• Gemeinsamer Ausschuss zum Umgang mit sicherheitsrelevanter Forschung von DFG und Leopoldina. (2022). Wissenschaftsfreiheit und Wissenschaftsverantwortung Empfehlungen zum Umgang mit sicherheitsrelevanter Forschung //: Scientific Freedom and Scientific ­Responsibility Recommendations for Handling of ­Security-Relevant Research. Link

RatSWD recommendation (excerpt):

“The following section will deal with several issues arising when ethics committees conduct an ethical review of studies in empirical social and economic research.

1. Is data protection ensured and has the responsible data protection officer approved it? No research project can and should be carried out without the approval of the data protection officer. Whether this review takes place after ethical (self-)examination cannot be answered at an abstract level but is contingent on the individual case.
2. Which documents must be at hand for review?
   Typically, documentation includes a detailed description of the research project and its methodological approach and elaborates on how the principles of research ethics are safeguarded (such as, e.g., the voluntary nature of participation, how informed consent was obtained, etc.). This also includes assessing the risks of participating in the study and outlining which measures were taken to minimise those risks and avoid possible harm (e.g., confidentiality, anonymisation strategies, etc.). Many ethics committees make an application form available. Procedures and required documents differ between committees, however.
3. What if not all documents can be handed in yet?
   As a rule, you apply for ethical review of research before a research project begins. In many cases, not all documents can be handed in at such an early point, e.g., because some methodological steps can only be clarified in the course of the research process. This is particularly true of qualitative studies that are committed to the principle of methodological openness as well as for longer-term, multi-phase research projects, where later steps are based on previous phases (e.g., when results from focus groups are fed into the planning of a subsequent quantitative survey or into the development of an intervention). In such cases, ethics committees should facilitate an ongoing review process and clarify which documents are required at the beginning and which documents can be handed in at a later date.
4. Must informed consent be obtained in every case or are exceptions acceptable?
   Voluntary and informed consent of participants is a central principle of research ethics, which is also grounded in (…) legal principles. As a rule, participants give their consent in writing. In individual cases, it might be methodologically necessary and ethically acceptable to obtain oral consent (e.g., qualitative studies in which the research situation does not allow for written consent to be obtained, illiterate participants, or expert interviews by telephone. In such cases, researchers should document that oral informed consent has been obtained (e.g., through an audio recording or field note)”

Excerpt taken from: Rat für Sozial- und Wirtschaftsdaten. (2017). Forschungsethische Grundsätze und Prüfverfahren in den Sozial- und Wirtschaftswissenschaften (Output Series, 5. Berufungsperiode No. 9). Berlin. doi:10.17620/02671.1 , p. 34  et sqq. Link

RatSWD recommendation (excerpt):

“Some research institutions use standardised tools for the self-assessment of researchers – with the aim of aiding them decide on whether review by an ethics committee is advisable or necessary (…) Appropriate questionnaires can help to assess the depth with which the respective research project requires ethical review. They do not replace an ethics review but rather indicate the cases in which self-assessment might suffice and those in which ethical review by a committee is necessary. (…) The tools and checklists are helpful because they account for the fact that not all studies must be reviewed by a committee. They function as indicators that help to decide when seeking approval from a committee is advisable. This also takes the strain off ethics committees. However, on the one hand, these indicators raise some substantial issues regarding definitions (e.g., how are vulnerable persons defined?). On the other hand, as mentioned above, they can lead to a situation in which issues of research ethics are addressed only superficially and researchers are lulled into a false sense of security with checklists creating a pretence of ethical review and reflexivity. The reflection of research ethics is complex and contingent on context and therefore cannot be answered by employing a simple formula. Questionnaires for self-assessment are thus helpful in providing guidance but should not encourage automatisms.
The following questions are examples of indicators that can help deciding whether ethical approval by a committee is appropriate or not:

1. Are only anonymised data used for secondary analysis? If yes, review by a committee is most likely unnecessary regarding data collection. However, further use of the data should be reflected upon in terms of research ethics.
2. Has another institution already performed an ethics review? If yes, a second review is likely unnecessary.
   However, the fact that a review has been performed elsewhere does not automatically mean that the research is ethically unproblematic, because other institutions, disciplines, and countries may apply other standards.
3. Does the planned research project involve particularly vulnerable persons? If yes, review by an ethics committee is likely necessary.
   Different persons and groups (in a social and a legal sense) can be defined as vulnerable depending on the project’s context. This concept is sometimes discussed controversially in the literature.
4. Does the research project involve deceiving participants, i.e., are the research subjects not always fully or accurately informed? If yes, review by an ethics committee might be advisable. As mentioned above, disciplines deal with deceit differently.**
5. Could the research project result in significant self-awareness, serious behavioural changes, mental stress, or physical pain?
   If yes, review by an ethics committee is likely necessary.
   This may occur, for example, in interviews about traumatising experiences.
6. Are further persons (e.g., students) used for the research project’s interviews, surveys, and observations, in addition to the researchers, which could be subjected to special risks that lie above a normal level? If yes, review by an ethics committee might be advisable.

If approval of an ethics committee is required externally, it is of course necessary to consult an ethics committee.”

*For documentation, the questions in Box 1 might be useful. For minimal documentation, the key questions for considering ethical aspects featured in the RatSWD’s guidelines on research data management might also be useful: “How were aspects of research ethics (…) taken into account? Has the application been presented to an ethics committee? Which one? Why was it not necessary to present it to an ethics committee in this case?” (RatSWD 2016:

1** In experimental economic research, for example, deception is strictly forbidden. However, it is – under certain conditions – perfectly legitimate in psychology
The text is taken from: Rat für Sozial- und Wirtschaftsdaten. (2017). Forschungsethische Grundsätze und Prüfverfahren in den Sozial- und Wirtschaftswissenschaften (Output Series, 5. Berufungsperiode No. 9). Berlin. doi: 10.17620/02671.1 , p. 25.-26 Link

• ZEVEDI (Zentrum für verantwortungsbewusste Digitalisierung). (2022). Zur forschungsethischen Begutachtung von KI-Forschungsprojekten. Handreichung zur Unterstützung der Arbeit von Ethikkommissionen an Hochschulen. Version 1.0. Darmstadt. Technische Universität Darmstadt. Link

• Deutsche Gesellschaft für Sozial- und Kulturanthropologie. (2020). Ethische Begutachtung ethnologischer Forschungen. Policy-Brief für Institutionen der Forschungsförderung sowie lokale Ethik-Kommissionen. Link
• DFG – Fachkollegium 106 Sozial-, Kulturanthropologie, Außereuropäische Kulturen, Judaistik und Religionswissenschaften. (May 2019). Handreichung des Fachkollegiums 106 Sozial- und Kulturanthropologie, Außereuropäische Kulturen, Judaistik und Religionswissenschaft zum Umgang mit Forschungsdaten. Link

• Deutsche Gesellschaft für Erziehungswissenschaft, Gesellschaft für empirische Bildungsforschung & Gesellschaft für Fachdidaktik. (2020, 11. March). Empfehlungen zur Archivierung, Bereitstellung und Nachnutzung von Forschungsdaten im Kontext erziehungs- und bildungswissenschaftlicher sowie fachdidaktischer Forschung. Link

• DFG – Fachkollegium 111 “Sozialwissenschaften”. (2020). Stellungnahme des Fachkollegiums 111 Sozialwissenschaften“ zum Forschungsdatenmanagement in der Soziologie, der Politikwissenschaft und der Kommunikationswissenschaft. Link
• DFG – Fachkollegium 112 “Wirtschaftswissenschaften”. (November 2018). Management von Forschungsdaten: Was erwartet das Fachkollegium 112 „Wirtschaftswissenschaften“ von Antragstellenden? Link

Deutsche Gesellschaft für Psychologie (DGPs) – Kommission “Open Science”. (2020, 26. June). Management und Bereitstellung von Forschungsdaten in der Psychologie: Überarbeitung der DGPs-Empfehlungen. doi: 10.31234/osf.io/hcxtm. Link

Medicine and health sciences

Arbeitskreis Medizinischer Ethikkommissionen. (n.d.). Einreichung von Forschungsvorhaben: In welchen Fällen bedarf es eines Votums einer medizinischen Ethikkommission? Link

Arbeitskreis Medizinischer Ethikkommissionen. Prüfkriterien. Link

• Bundeszentrale für gesundheitliche Aufklärung. (2021). Gute wissenschaftliche Praxis: Richtlinien zur Sicherung guter wissenschaftlicher Praxis und zum Umgang mit wissenschaftlichem Fehlverhalten in der Bundeszentrale für gesundheitliche Aufklärung (BZgA) (BZgA-Richtlinie 02/2021). Link
• Deutsches Institut für Wirtschaftsforschung. (2017). Forschungsethische Prinzipien am DIW Berlin und Verfahren im Umgang mit wissenschaftlichem Fehlverhalten. Link
• Eurostat & Europäisches Statistisches System. (2017, 16. November). Verhaltenskodex für europäische Statistiken: Für die nationalen statistischen Ämter und Eurostat (statistisches Amt der EU). angenommen vom Ausschuss für das Europäische Statistische System. Link
• Leibniz Gemeinschaft. (2015). Empfehlungen der Leibniz -Gemeinschaft zur Sicherung guter wissenschaftlicher Praxis und zum Umgang mit Vorwürfen wissenschaftlichen Fehlverhaltens. o.O. Link
• Leibniz Gemeinschaft. (2019). Leitsätze unseres Handelns in der Leibniz-Gemeinschaft: Beschlossen durch die Mitgliederversammlung der Leibniz-Gemeinschaft am 28. November 2019. Leibnitz Gemeinschaft. Link
• Leibnizinstitut für Finanzmarktforschung. (2020). Regeln zur Sicherung guter wissenschaftlicher Praxis (Ethikkodex). Link
• Max-Planck Gesellschaft. (2009). Regeln zur Sicherung guter wissenschaftlicher Praxis. beschlossen vom Senat der Max-Planck-Gesellschaft am 24. November 2000, geändert am 20. March 2009. Link