Learning objectives
The primary outcome of this educational module is to provide knowledge, cultivate virtues and develop the necessary skills to actively implement the ethical, professional, and legal standards that underpin research ethics and research integrity. This module values critical thinking and fosters an open dialogue on the quality of research.
Upon completion of the module each student will be able to:
1. Distinguish research ethics from research integrity.
2. Distinguish clinical practice from good clinical practice in research.
3. Be aware of the principles and norms set forth in the Belmont Report, Declaration of Helsinki, Guideline for Good Clinical Practice, Universal Declaration on Bioethics and Human Rights (UDBHR), European Code of Conduct for Research Integrity (ECoC, 2023).
4. Recognise conflicts of interest (financial, personal, intellectual, etc.) and how they can affect our evaluations, judgment, decisions, and behaviour.
5. Recognise cases of research misconduct and detrimental research practices: identify the violated principles/norms and decide the “best” course of action.
6. Recognise virtues (e.g. intellectual honesty, responsibility for one’s actions, etc.) and virtuous conduct in research.
7. Cultivate virtues in practice by seeking the “golden mean” (Aristotle) in each specific context.
8. Identify the different types of “goodness” (Von Wright, 1963) in research and in the European Code of Conduct for Research Integrity (ECoC, 2023).
9. Recognise the importance of communication in the clinician-patient/investigator-patient relationship and of the application of the FREDA (Fairness-Respect-Equality-Dignity-Autonomy) principles in the context of patient care and clinical research practice.
Prerequisites
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Course unit content
It is important to distinguish research ethics from research integrity.
As regards research ethics, in this module, two approaches will be introduced:
The “principle-based” approach is focused on the fundamental ethical principles set forth in the Belmont Report and further developed by Beauchamp and Childress.
By learning about the Tuskegee Syphilis Study (1932-1972), the student will understand why the Belmont Report was written and why the Institutional Review Boards (Research Ethics Committees) were established in the United States.
In the aftermath of the Thalidomide disaster, in 1964, the Declaration of Helsinki (DoH) was published. The DoH is regarded as the cornerstone of Good Clinical Practice.
The Good Clinical Practice principles will be examined with particular focus on the informed consent process will be explored in detail, also accounting compliance with the General Data Protection Regulation (GDPR) that requires patient consent to the processing of personal data.
The Human Rights-based approach is focused on the principles and norms in the Universal Declaration on Bioethics and Human Rights. The students will become familiar with a practical method based on the FREDA principles (Fairness-Respect-Equality-Dignity-Autonomy) in patient care and in the context of research with particular emphasis on the clinician-patient/investigator-patient relationship.
Only in the eighties in the US, research integrity became a “hot topic” following a series of high-profile cases of data fabrication, falsification and plagiarism that led to the definition of “Research Misconduct” and of other “Questionable Research Practices”. In the module the “history” of research integrity will be presented to help the student better understand the current importance and pivotal role of this topic in all international research organisations and institutions that prompted the development of many codes of conduct such as the European Code of Conduct for Research Integrity (ECoC, 2023).
The “virtue-based” approach to research integrity is focused on the development of virtuous character traits. According to Aristotle people are only born with a disposition to acquire virtues. This disposition remains at a potential level and only develops by repeatedly practicing virtue over time and by following the example of wise people, capable of acting in the “right” way according to the context. According to Aristotle a virtue is the midpoint (golden mean) between two vices (extremes), a lack of virtue or an excess of virtue.
Courage is the midpoint between too little courage (cowardice) and too much courage (recklessness).
In the module we will identify the virtues that should be practiced by all those involved in the research enterprise, and we will discuss cases of lack of virtue and excess of virtue.
In the module we will perform a further exercise to stimulate reflection and discussion on research integrity. The starting point will be the question: “What is goodness?”.
The philosopher George Henrik von Wright thought that “goodness” could be divided into categories.
We will identify the different types of goodness in the context of research and in the content of the European Code of Conduct for Research Integrity (ECoC, 2023).
Full programme
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Bibliography
• ALLEA (All European Academies). The European Code of Conduct for Research Integrity – Revised Edition 2023 (https://allea.org/code-of-conduct/)
• Commissione per l’Etica della Ricerca e la Bioetica del CNR. Linee Guida per l’integrità nella ricerca. Revisione dell’11-4-2019.
(https://www.cnr.it/sites/default/files/public/media/doc_istituzionali/linee-guida-integrita-nella-ricerca-cnr-commissione_etica.pdf?v=1)
• Buona Pratica nella Ricerca e nella Pubblicazione e Disseminazione dei Risultati. Linee Guida. Università degli Studi di Parma. 3 Agosto 2020.
(https://www.unipr.it/node/21810)
• Belmont Report; 1979.
(www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html)
• WMA Declaration of Helsinki; 2013.
(www.wma.net/en/30publications/10policies/b3/index.html)
• ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) Harmonised Guideline. Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2); November 9, 2016.
(https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf)
• Universal Declaration on Bioethics and Human Rights. UNESCO 2005
https://www.unesco.org/en/legal-affairs/universal-declaration-bioethics-and-human-rights?hub=387
• The Virt2UE program. The Embassy of Good Science.
(https://www.embassy.science/wiki/Main_Page)
• EQUATOR (Enhancing the Quality and Transparency of Health Research) Network.
(https://www.equator-network.org/)
• George Henrik von Wright. The Varieties of Goodness. 1963
(https://www.giffordlectures.org/lectures/varieties-goodness)
Teaching methods
The module will be conducted face-to-face to allow and enhance the interaction between students, “facilitated” by the instructor, using materials and exercises developed within the VIRT²UE Program, a European project on research integrity. Concrete examples of research ethics/research integrity violations will be used to stimulate and develop dialogue and critical thinking: the students will identify the violated principles and norms establishing a strict connection between theory and practice.
Assessment methods and criteria
In an oral examination the student must demonstrate that he/she has acquired the pre-defined learning outcomes of the module.
The student will be questioned on the content of the module to ascertain his/her knowledge and understanding.
The student’s ability to apply knowledge and understanding will be verified by evaluating his/her ability to apply principles, norms, and strategies to concrete cases of research ethics/research integrity violations.
Finally, the student will demonstrate his/her ability to decide the “best” course of action in concrete cases of research ethics/research integrity violations.
Other information
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2030 agenda goals for sustainable development
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