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Module 2: Ethical Guidelines and Legislation Relevant to Research

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The training curriculum is currently undergoing final revisions and quality checks. All materials will be released shortly. Until the official release, please refrain from using, distributing, or implementing any part of these resources.

Learning Objectives

  • Learning Objective 1 (LO1): Identify the relationship between existing guidelines, legislation, and research ethics.
  • Learning Objective 2 (LO2): Identify ethical procedures required for research projects funded by the EU.

Total Module Duration

Approx. 1 hour 50 minutes (without pre-session activities)

Learning Objective 1

LO1: Identify the relationship between existing guidelines, legislation, and research ethics.

Learning Activities

  • Pre-session activity: Learners are assigned reading in advance of the session (Resources 1–3)
  • Presentation (15 mins): The lecture or presentation should present the role of ethics in research. Give the learners knowledge on how to identify regulations, guidelines and laws connected to ethics in research, particularly at different stages of the life cycle.
  • Quiz (10 mins): A brief quiz following the presentation, to recap the main concepts of the session. Some questions that can be reused are provided, along with correct answers.
Quiz Questions
  1. What is a key difference between ethical and legal behaviour?
    A) Ethical behaviour is always legally compliant, while legal behaviour might not consider ethical standards.
    B) Legal behaviour ensures the highest standard of ethical conduct.
    C) Ethical behaviour is guided by moral principles, while legal behaviour focuses on compliance with laws and regulations.
    D) Legal behaviour and ethical behaviour are always aligned in research contexts.
    Correct Answer: C
  2. What is an example of an ethical concern in research involving human participants?
    A) The use of a standardised research methodology across disciplines.
    B) Accessing, using, or sharing sensitive data such as health or personal data.
    C) Adhering to legal requirements set by professional organisations.
    D) Collecting publicly available data while ensuring respect for privacy, consent, and proper attribution. Correct Answer: B
  3. Why is legal compliance not always sufficient to ensure ethical behaviour?
    A) Legal compliance primarily focuses on cultural values rather than principles of conduct.
    B) Legal compliance may only address minimal requirements, leaving ethical concerns unresolved.
    C) Ethical principles are automatically covered by laws and regulations.
    D) Legal compliance always aligns with professional ethical standards.
    Correct Answer: B
  4. How can ethical standards differ across contexts?
    A) Ethical standards are identical regardless of cultural or professional backgrounds.
    B) Ethical standards are defined solely by international law.
    C) Ethical standards may vary across cultures, disciplines, and professional organisations.
    D) Ethical standards are universally agreed upon and remain static over time.
    Correct Answer: C
  • Video (10 mins): The video in Resource 4 on Research Ethics can be watched during the session
  • Discussion activity (30 mins): The instructor can consider the following activity in breakout groups:
    • Group Formation: Split learners into small groups of 3–4 people. Each group should assign a note-taker and a spokesperson for reporting back.
    • Discussion Question: Imagine you are working with a colleague who believes that ethics in research is just about "following the law" and is not particularly important beyond that. How would you convince them that ethical principles are essential in research, even beyond legal compliance?
    • Guiding Points for Discussion: Why is it important to consider moral principles in addition to laws? How can research impact human dignity, autonomy, or society at large? What risks arise when ethical principles are overlooked, even if laws are not broken? Can you provide concrete examples of ethically questionable situations in research (such as handling sensitive data)?
    • After the group discussions, each group shares the outcome of their discussions with the whole group.

Materials to Prepare

  • Main takeaways from pre-session reading (Resources 1–3).
  • Presentation or lecture on research ethics.
  • Guiding points and questions for group discussion activity.
  • Quiz questions and answers.

Instructor Notes

The instructor should familiarise themselves with the pre-session reading materials (Resources 1–3) as well as assigning these to the learners.

Presentation:

  • Present the research life cycle (Resources 1, 2 relevant for this module).
  • Give examples of guidelines and Code of Conduct related to ethics in research (See Resources 6–8 as inspiration).

Group Activity:

  • The instructor can play the video (Resource 4) and ask learners to reflect on how they would explain the importance of ethics in research to a colleague.
  • The video is followed by the group activity where learners will learn to argue for the importance of ethics in research. The goal is that with help of this activity, the learners gain confidence when advocating for the importance of ethics in research.
  • When looking for recommendations and regulations, it is best to start from the local, that is, starting what is applicable within the learners' discipline, institution, and nationally. Then (if applicable), EU policies, directives and regulations are to be explored, as well as global recommendations (for example, from the UNESCO, see Resource 5).

Resources

To guide presentation and discussion activity:

  1. RDMkit. How can I identify regulations, guidelines and laws connected to ethics in my research context? https://rdmkit.elixir-europe.org/ethics#how-can-i-identify-regulations-guidelines-and-laws-connected-to-ethics-in-my-research-context.
  2. Research Lifecycle. https://researchsupport.harvard.edu/research-lifecycle.
  3. UNESCO. Ethics of Science and Technology. https://www.unesco.org/en/ethics-science-technology.
  4. Video: Research Ethics | Ethics in Research (SciToons). https://www.youtube.com/watch?v=mtLPd2u4DiA.
  5. RDMkit. https://rdmkit.elixir-europe.org/.

Additional readings for inspiration:

  1. Allea.The European Code of Conduct for Research Integrity. https://allea.org/code-of-conduct/.
  2. CEU. Ethics in EU research. http://acro.ceu.edu/ethics-in-eu-research.
  3. Research Council of Finland. Research Ethics. https://www.aka.fi/en/research-funding/responsible-science/research-ethics/.

Learning Objective 2

LO2: Identify ethical procedures required for research projects funded by the EU.

Learning Activities

  • Pre-session Activity: Instructor should ask learners to read Resources 1–5 before the session.
  • Recap activity (15 mins): Instructor should recap key takeaways from the pre-assigned reading (some topics that can be highlighted are included in the instructor notes).
  • Discussion Activity (30 mins): In pairs, ask learners to discuss 2–3 stakeholders within their own institutions (e.g. ethical committees, ethics board, more senior data stewards) to whom they could turn to for further advice on ethical assessment for EU projects. If they cannot identify stakeholders, then the instructor could prepare an overview of stakeholders within their institute.

Materials to Prepare

  • Key takeaways from the pre-session reading (Resources 1–5) to recap in the session.
  • Activity: Have some examples of possible stakeholders to get the discussion started.

Instructor Notes

This learning objective is meant to help guide researchers who are applying for EU funding, and to provide a more practical illustration of research ethics at work. The instructor can choose to go into more detail using the suggested resources. An alternative way to address this topic is to make the learners aware of the resources and experts within their organisation that they could approach for more information.

Pre-session reading:

  • Topics to be covered:
    • Information about European Code of Conduct for Research Integrity, the main standard for ensuring ethical practices in EU-funded research. The European Code of Conduct for Research Integrity serves the European research community as a framework for self-regulation across all scientific and scholarly disciplines and for all research settings. The European Commission recognises the European Code of Conduct as the primary standard for upholding research integrity across all research projects funded by the EU (Resource 1).
    • Information about Horizon Europe's Ethics Appraisal Procedure, which involves pre-project ethics reviews and ongoing checks to ensure compliance and minimise risks to researchers and subjects. The aim is to ascertain that expected standards are met and that risks to research subjects and researchers are minimised. Horizon Europe puts in place an Ethics Appraisal Procedure which includes:
      • 1) the Ethics Review Procedure conducted before the start of the project, and
      • 2) Ethics Checks, Reviews and Audits conducted during the project.
    • Information for EU project applicants and beneficiaries to ensure their proposals are ethics-compliant. It covers common ethics issues, offers advice on addressing them, and assists with filling out applications. This guidance in Resource 4 is designed to help applicants and beneficiaries of EU projects make their proposal ethics-compliant. The guidance will help them identify and deal with ethics issues that may arise from their project and provide help with filling out your application. It covers most of the ethics issues that usually arise in EU projects and gives advice on dealing with classic cases.
    • As background, share with learners that the principles of the European Code of Conduct are important for all areas of research – whether publicly funded or privately conducted – and apply across disciplines. It can serve as a foundation for local, national, and field-specific guidelines, and it is designed to cover both many research methods, including approaches like citizen science or participatory research.

Activity:

  • The activity will help learners to identify the right experts within their institution.

Optional activity:

  • The instructor can also prepare 2–3 case studies, using short descriptions of Horizon Europe projects. These could be based on existing projects if the instructor has worked with some, with details modified to extract some ethical concerns, for which learners would then make ethical assessments, while explaining the decisions they would make.

Resources

  1. Allea. The European Code of Conduct for Research Integrity. https://allea.org/code-of-conduct/.
  2. ERC. Ethics Guidance. https://erc.europa.eu/manage-your-project/ethics-guidance.
  3. EU Funding and Tenders Portal. Ethics Review. https://webgate.ec.europa.eu/funding-tenders-opportunities/display/OM/Special+procedures%3A+Ethics+review%2C+security+scrutiny%2C+Ownership+control+check.
  4. EU Grants. How to complete your ethics self-assessment. https://ec.europa.eu/info/funding-tenders/opportunities/docs/2021-2027/common/guidance/how-to-complete-your-ethics-self-assessment_en.pdf.
  5. Video by DG Research and Innovation How to evaluate Ethics aspects (additional questions) in Horizon Europe proposals, https://www.youtube.com/watch?v=M1nq-NOqEEE (8 minutes).