Introduction to ethics rules and regulations
Introduction to ethics rules and regulations
Working in line with research integrity standards also means that the researchers carry out their activities within a legally and ethically correct scientific framework. Researchers are expected to know, respect and adhere to the legal rules and ethical practices of their own research domain, the laws and regulations, the general ethical principles and standards established in institutional, sectoral, national and international codes and standards of research integrity.
ALLEA Code:
- Researchers, research institutions, and organisations comply with relevant codes, guidelines, and regulations.
- Researchers handle research participants and subjects (be they human, animal, cultural, biological, environmental or physical) and related data with respect and care, and in accordance with legal and ethical provisions.
- Researchers have due regard for the health, safety, and welfare of the community, of collaborators, and others connected with their research.
- Researchers recognize and weigh potential harms and risks relating to their research and its applications and mitigate possible negative impacts.
- Research protocols take account of, and are sensitive to, relevant differences among research participants, such as age, gender, sex, culture, religion, worldview, ethnicity, geographical location, and social class.
Ethical considerations & responsibilities
Although their implementation and the accompanying procedures may differ from institution to institution, the main ethical considerations often come down to:
- The well-being of human participants and laboratory animals.
- The well-being of those carrying out the research activity
- The interests of the wider society
- The respect for cultural heritage, human rights and the environment
- The safety of individuals or groups with special attention for minority or vulnerable groups.
- Safeguarding the reputation of the research group, the faculty, the university and the scientific practice as a whole.
Because research is a dynamic process and can contain different legal and ethical issues in the same project, it is advised to contact your local ethics committee to align all requirements especially in complex and sensitive topics. Due to the dynamic nature of research, it is important to recognise that ethics is not a mere checkbox exercise and that after obtaining ethics approval, new ethics issues may arise that require a new check by the ethics committee.
(Too) late
Every researcher should be aware of the possible consequences of not obtaining a positive ethical advice in time. This can, for example, lead to the editorial refusal to publish research results, the refusal of a project application for subsidization or the inability to start an approved project mandate.
It is therefore of great importance that researchers contact the ethics committees and legal departments of their research institution before the research has started; retroactive approval is not possible. The legal department needs to have enough time to check the proposal and call, draft the necessary contract, arrange the signature process with the competent signatory, etc.
A faulty parachute
Helicopter research, also referred to as ‘parachute science’, is the practice where researchers from high(er)-income countries carry out research in lower-income countries or marginalized communities with little-to-no involvement of and benefits towards local researchers or communities (Nature, 2022). Examples of such practices include setting up studies without taking the local needs into account, or the isolation of interesting biological samples to be used in further R&D in the home country.
Ethics dumping
Similarly, researchers should not engage in ethics dumping, the practice in which unethical research practices that would not be tolerated within the EU are being conducted abroad under less stringent ethical controls.
The TRUST Code, also known as ‘A Global Code of Conduct for Equitable Research Partnerships’ is a useful resource for all research stakeholders who want to ensure that international research is equitable and carried out without ‘ethics dumping’ and ‘helicopter research’ (TRUST, 2018).
The good practices in these Code of Conduct are based on the principles of fairness, respect, care and honesty, which are translated into 23 good practices to take into account to avoid double standards in research and support long-term equitable research relationships between partners in lower-income and high-income settings.
Since its publication in 2018, the TRUST code has been adopted by several funders (such as the European Commission), publishers and institutions.
Several funders have taken measures to prevent ethics dumping. For example, within the Horizon Europe framework, funding cannot be granted for activities carried out outside the EU if they are prohibited in all Member States. Upon being granted the project, the researchers are required to provide a confirmation that the activity could have been legally carried out in an EU country, for instance by requesting an opinion from an appropriate ethics structure in an EU (EU Grants (2021).