The Speaker

Prof. Dr. Bernhard Renard is the head of the Data Analytics and Computational Statistics research group at HPI. The focus of the group's research lies in the development of statistical and computational methods to evaluate large amounts of data, the statistical estimation of error-rates and software implementation. One core aspect of research is the targeted customization of procedures for specialized and practical problems, where biomedical issues are just one example of the application area.

Overview

The pursuit of energy production from atoms, which gave rise to nuclear energy, is an example of how research with good intentions can have terrible consequences. Researchers were experimenting with atoms, which quickly lead to the creation of atomic bombs — the most destructive weapons in history.

This example highlights how scientific research intended for good can cause harm when researchers do not consider potential ethical concerns. It is just one of many ethical questions that researchers have to consider in their work. To address these challenges, mechanisms such as ethical committees, which are responsible for setting up minimum requirements for publishing or conducting research within institutions, have been established. These measures, as well as dual use and other potential ethical concerns, will be explained further in the following.

Ethical Research

Apart from obviously ethically questionable research, researchers frequently encounter ethical dilemmas, particularly when their work falls within ethical "gray zones." These gray zones commonly include research involving potentially harmful interventions on humans, animal experimentation, or dual-use technologies. Dual-use is defined by Boston University's Office of Research as "research conducted for legitimate purposes that generates knowledge, information, technologies, and/or products that can be utilized for benevolent or harmful purposes."¹ This presents a dilemma for researchers, as a lot of research has potential harmful applications, yet research remains crucial for societal advancement. Therefore, the fundamental questions researchers face include: "Is this research ethically defensible?" and "Could publishing these results cause more harm than good?"

Historical examples show the importance of thinking thoroughly about ethical implications of one's research and how suffering could have been avoided:

For example, the Tuskegee Syphilis Study², which continued until 1972, stands as one of the most egregious violations of research ethics in modern history. Researchers deliberately withheld treatment from syphilis-infected individuals to observe the disease's progression, completely disregarding the participants' health and fundamental human rights. This case prompted the scientific community to establish minimum standards for ethical research.

The HIV Data Leak in Singapore³ represents a modern example of data misuse. In this case, an employee at the National Health Institute deliberately leaked confidential information about HIV-positive individuals. This breach of privacy had severe consequences, with many affected individuals losing their residency rights in Singapore. The incident highlights the importance of data protection protocols in research institutions.

Lastly, the Stem Cell Scandal from South Korea⁴ involved fraudulent claims of breakthroughs in stem cell research. It was later revealed that participants were not fully informed about how their biological materials would be used, and some were unaware that invasive procedures had been performed. This scandal emphasized the importance of informed consent and transparency in research practices.

Different Ethical Standards

The central question in research ethics revolves around determining what constitutes an ethical concern. The answer to this question varies depending on the stakeholder — while individual institutions like the University of Potsdam maintain high ethical standards, journals and conferences often impose stricter requirements. Ultimately, researchers themselves should maintain the highest ethical standards in their work.

The University of Potsdam specifically requires ethics approval for different categories of research. The first category is research on humans, which includes intervention studies where researchers actively interact with participants rather than simply observing them, projects that may involve physical or psychological risks to participants, and situations where obtaining informed consent is challenging, such as research involving minors or participants who are unaware of the testing parameters. The second category is research on animals, and the third concerns the aforementioned dual-use risks. For all of them, researchers need to carefully evaluate if their research might require an official ethics vote and weigh potential risks against potential benefits on a case-by-case basis.

Involved Institutions

When research potentially falls into the named categories, the researcher bears responsibility for deciding whether to pursue formal approval. This approval comes exclusively from the ethics committee of the researcher's institution, comprising diverse researchers from both within and outside the researcher's field. The committee evaluates the benefits and risks of proposals and assesses how thoroughly applicants have considered ethical aspects. In cases where the committee lacks relevant expertise, researchers must obtain approval from the nearest institution with appropriate experts — for instance, medical research at the University of Potsdam requires ethical approval from the Charité. Where necessary, the data privacy officer must also be consulted for an application to be valid.

Beyond institutional requirements, journals and conferences often impose their own, frequently stricter ethical standards to minimize potential association with questionable research. For example, in certain aspects, NeurIPS maintains stricter ethical guidelines than the University of Potsdam and subjects submitted papers to its own ethical committee review. This can create complications — while an observational human study for a master's thesis might not require ethical approval from the University of Potsdam, attempting to publish this research in a journal later could result in immediate rejection if the journal requires ethical approval for all human studies.

Additionally, ethical research compliance is maintained through the Deutsche Forschungsgemeinschaft (DFG). Researchers in Germany must adhere to DFG guidelines for proper scientific conduct and violations can be reported to the DFG if institutional resolution proves impossible or undesirable. The DFG can impose significant penalties for unethical conduct, including notifying employers and restricting the access to future funding and publishing opportunities. Through international cooperation agreements, these penalties often extend beyond Germany, ensuring proper scientific conduct and compliance with ethical standards across multiple countries. By requiring individual ethical approvals for multinational research in each participating country, the framework also prevents circumventing stricter standards by conducting research in places with more permissive ethical guidelines.

Pursuing Ethical Approval

At the University of Potsdam, the parts of an application for a vote of the ethics board are⁵:

1. Principal Investigators (5 questions)
2. General Project Information (8 questions)
3. Purpose, Short Description and Classification of the Project (19 questions)
4. Data Collection, Safety and Protection (8 questions)
5. Conflicts of interests (1 question)
6. Final statement and signatures (4 questions)

The application form contains multiple layers of sub-questions, and a complete submission can easily exceed 10 pages in length. Due to this complexity, students planning research that requires ethical approval should first consult with their advising professor rather than attempting to complete the application independently. Research groups generally maintain template applications from previous submissions, which can serve as valuable guides.

One fundamental purpose of this detailed application process is to provide researchers with a structured framework for thoroughly examining and documenting all potential ethical implications of their planned work. Rather than being a simple pass-fail submission, the ethics approval process typically involves an interactive dialogue between the researchers and the ethics committee. Applications usually go through one or two rounds of feedback and revision before final approval is granted, allowing researchers to refine and strengthen their ethical considerations based on committee input.

Since committee boards consist of active researchers, meetings are often only held monthly or quarterly. Additionally, applications are usually required to be filed at least two weeks in advance, meaning that multiple feedback iterations can easily take up to six months. At some institutions, such as the Charité, there are even multiple hierarchical ethics boards for different areas of research. Because of that, applications are commonly phrased as broadly as possible to cover multiple research projects (i.e. "umbrella" proposals). This allows e.g. Masters students to conduct research that would otherwise require an individual vote from an ethics board, which could prevent them from starting and finishing their thesis in time.

Summary

Ethical considerations are a critical aspect of research, particularly in areas involving humans, animals, or dual use risks, where knowledge intended for good can also lead to harm. Researchers have to think about potential risks and possible benefits and have to determine whether their research is ethically feasible depending on how much the benefits outweigh the risks. This is often not only a moral concern, but also strictly regulated by the research institutes. Each institute has an ethical committee, which provides specific ethical guidelines for any research that is conducted. A committee decides which aspects are of ethical concern and requires researchers to reach out for a formal approval, whenever any of those aspects are (or might be) part of their research. The future of the research then depends on the committee's decision.

Ethical guidelines and requirements may vary depending on the committee and the environment. Journals and conferences often have stricter requirements than institutions. This may lead to researchers not being able to publish even if they have their corresponding ethical committee's approval. However, less for formal than for moral reasons, the highest ethical standards should always be held by the researchers themselves.

References

¹ Institutional Biosafety Committee - Dual Use Research of Concern (DURC) and Pathogens with Enhanced Pandemic Potential (PEPP) in Research. "Dual Use Research of Concern (DURC) and Pathogens with Enhanced Pandemic Potential (PEPP) in Research." Accessed January 20, 2025. https://www.bu.edu/research/ethics-compliance/safety/biological-safety/ibc/dual-use-research-of-concern/

² Brandt, Allan M. "Racism and Research: The Case of the Tuskegee Syphilis Study." The Hastings Center Report 8, no. 6 (December 1978): 21. https://doi.org/10.2307/3561468

³ Ministry of Health Singapore. "Unauthorised Possession and Disclosure of Information from HIV Registry," January 28, 2019. https://www.moh.gov.sg/newsroom/unauthorised-possession-and-disclosure-of-information-from-hiv-registry

⁴ Cyranoski, David. "Korea's Stem-Cell Stars Dogged by Suspicion of Ethical Breach." Nature 429, no. 6987 (May 2004): 3–3. https://doi.org/10.1038/429003a

⁵ Ethikkommission Universität Potsdam. "Application Form." Accessed January 20, 2025. https://www.uni-potsdam.de/fileadmin/projects/senat/Kommissionen/5_EK/Checkliste_071219-aktuell-Netz_22-08-2019_Engl_edit.docx