Legal obligations and Ethical reflections

Ethical clearance

Responsible Open Science involves adhering to the highest research ethics and integrity standards. The University of Antwerp deems it necessary for all researchers to always respect the fundamental ethical norms and values in their scientific research and knowledge creation to guarantee the highest quality of research. In this way, the university can present itself as a reliable and responsible knowledge actor and partner towards the government and society as a whole.  

As a researcher, you are responsible for critically asking yourself some questions concerning your research design. Will your research involve experiments on humans or animals? Will you conduct surveys or interviews with human participants? Do you use or develop technologies that might possibly be used for not only civilian but also military purposes (dual use) or can be misused for unethical purposes? Is there any chance your research activity or a partner involved might – directly or indirectly – violate human rights? If the answer to one or more of these questions is positive, you might have to apply for ethical clearance from one of the ethics committees at the University of Antwerp.  

Visit the Ethics Screening web pages to learn more about the ethics committees and contact the Ethics Team about specific issues.  

Note that in case of clinical trials or animal experiments, it is lawfully required to apply for ethical clearance.  

In case there’s a direct military application of your research or in case it could be abused for terroristic purposes, researchers have an obligation to report it to the proper internal contact point regarding dual-use items or potential misuse of their research. Visit the Ethics committee for Science and Technology webpages to learn about dual use and misuse of research and contact the dual use commission about specific issues.  

Privacy

Unlike other aspects of the research cycle, Open Science and privacy might be in tension. If you will be working with human participants it is important to take the necessary precautions to ensure their privacy. We advise you to make a Data Protection Impact Assessment (DPIA) at the start of your project on personal or sensitive data, (pseudo-)anonymization of your data, data security, etc. Consider whether and how you will obtain informed consent from the participants concerning data access, preservation, and sharing.

Visit the Privacy Office pages to learn more about privacy and principles of GDPR or contact the privacy commission with specific questions.

IP and valorisation

Ground-breaking research conducted at the University of Antwerp is creating an impact on society. The university’s role has broadened to that of a driving force in innovation. Some questions on intellectual property rights (IPR) might raise during a research project. ALLEA Statement is clear that there is no fundamental opposition between Open Science and the valorisation of research through the assertion of intellectual property rights. There is, however, a need to modernize patent law to better align it with the Open Science principles.

If you think your data potentially has commercial value, you should always try to obtain a clear overview of the various owners of the research data as early as possible (preferably before or at the start of the project) and, if necessary, conclude the necessary contracts. 

If you will be working in a collaboration with other research groups, institutes, or companies it is then important to make a third-party agreement, which limits the dissemination or exploitation of the data.

 For support, visit the Valorisation Office website and consult IOF or valosization managers and contact the legal department.

Nagoya Protocol

About

Every country has rights over the genetic resources within its borders (for example, animals and plants). The Nagoya Protocol on access to genetic resources and the fair and equitable sharing of benefits arising from their utilization is an international agreement that determines obligations regarding access and benefit sharing (ABS) of the Convention on Biological Diversity (CBD). Researchers of the University of Antwerp have a legal obligation to comply with the Nagoya Protocol.

Guiding principles of the Nagoya Protocol concerning equitable sharing and benefits complement the FAIR principles in particular and the Open Science principles in general, especially concerning transparency and accountability. Nevertheless, the implementation of the Nagoya Protocol still lacks sufficient information and training. That is why this section offers detailed information on the Nagoya Protocol implementation at UAntwerpen.

The Nagoya Protocol applies to:

1. Genetic resources are accessed from a country that is a party to the Protocol and that enforces ABS legislation (accessed directly from the country of origin or via third parties).
2. The utilization of genetic resources after 12 October 2014.
   

The Nagoya Protocol does not apply to:

1. Human genetic resources.
2. Genetic resources already covered by specialized international documents (for example, the International Treaty on Plant Genetic Resources for Food and Agriculture or the framework for pandemic preparedness of the World Health Organization)
   
3. Genetic resources as traded commodities (for example, agricultural, fishery, or forestry products - whether for direct consumption or as ingredients in food and drink products).
   
4. Genetic resources that were acquired before the Protocol came into effect.
   

Some of the specific cases in which researchers may come into contact with the Nagoya Protocol include:

• Acquiring genetic material.
• Granting access to genetic resources to researchers or units at the university or external organizations.
• Performing fieldwork abroad.
• Presenting materials from collections (laboratories, museums, libraries, botanical gardens, etc.).
• Completing ethics checklists for research funding applications (for example, Horizon and FWO).
• Commercializing or selling resources or products linked to genetic material.
• Patenting important findings based on genetic materials.
• Etc.

Researchers who are not sure whether their research falls under the Nagoya Protocol are required to use the Due Diligence Tool under the tab Procedure and Guidelines to determine their next steps.

Researchers who use genetic material are required to follow steps described under the tab Procedure and guidelines to ensure that genetic resources are accessed in accordance with applicable access and benefit sharing laws implemented by the provider country.