Learning objectives
The primary objective 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 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 “normal” clinical practice from good clinical practice in research.
2. Understand and apply the principles and norms set forth in the new “Costituzione Etica” for Orthoptists and Assistants in Ophthalmology published in June 2021.
3. Be aware of the principles and norms set forth in the Belmont Report, Declaration of Helsinki, Guideline for Good Clinical Practice, European Code of Conduct for Research Integrity (ECoC).
4. Correctly apply principles and norms to research activities.
5. Recognise conflicts of interest (financial, personal, intellectual, etc.) and how they can affect our evaluations, judgement, decisions and behaviour.
6. Recognise cases of research misconduct and detrimental research practices: identify the violated principles/norms and decide the “best” course of action.
7. Recognise virtues (e.g. intellectual honesty, responsibility for one’s actions, etc.) and virtuous conduct in research.
8. Cultivate virtues in practice by seeking the “golden mean” (Aristotle) in each specific context.
9. Identify the different types of “goodness” (Von Wright, 1963) in research and in the European Code of Conduct for Research Integrity (ECoC).
Prerequisites
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Course unit content
It is essential to distinguish “normal” clinical practice from good clinical practice in research.
The Orthoptist/Assistant in Ophthalmology must be familiar with the principles and norms included in the new “Costituzione Etica”, which represents a professional ethical standard.
As regards research, in this module, two complementary approaches to Research Integrity will be developed:
1) The “principle-based” approach is focused on principles, rules, duties, or responsibilities included in the main international ethical standards (Belmont Report, Declaration of Helsinki, Guideline for Good Clinical Practice).
By learning about the Tuskegee Syphilis Study (1932-1972), the student will understand the rationale underlying the Belmont Report, that defined the fundamental ethical principles and that led to the establishment of the Institutional Review Boards (Research Ethics Committees) in the United States.
The Good Clinical Practice principles will be examined and the informed consent process will be explored in detail, also taking into account that we must comply with the General Data Protection Regulation (GDPR) that requires patient consent to the processing of personal data.
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”. During the course 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).
2) The “virtue-based” approach is focused on the devolopment 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. The primary task of education is character formation, that is accomplished 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).
During the course 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.
During the course 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).
Full programme
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Bibliography
• Costituzione Etica. Federazione nazionale Ordini dei Tecnici sanitari di radiologia medica, delle professioni sanitarie tecniche, della riabilitazione e della prevenzione. Edizione Giugno 2021.
• ALLEA (All European Academies). Il codice di condotta europeo per l’integrità della Ricerca. Edizione aggiornata; Berlino 2018.
(https://www.allea.org/wp-content/uploads/2018/11/ALLEA-European-Code-of-Conduct-for-Research-Integrity-2017-Digital_IT.pdf)
• 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)
• The Virt2UE program. The Embassy of Good Science.
(https://www.embassy.science/wiki/Main_Page)
• 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)
• David B. Resnik. Ethical virtues in scientific research. Account Res. 19(6):329-43, 2012. doi: 10.1080/08989621.2012.728908.
(https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3521635/)
• 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)
• 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 course will be conducted face-to-face, in compliance with safety standards, provided that further instructions on the ongoing health emergency are not implemented, 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 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.
In the event of an emergency the lessons will be held in synchronous streaming on the Teams platform.
The lessons will be supported by PowerPoint presentations that will be available to students on the Elly platform.
Assessment methods and criteria
In an oral examination the student must demonstrate that he/she has acquired the predefined learning outcomes of the course.
The student will be questioned on the content of the course 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 in good research practice and to concrete cases of research integrity violations.
Finally the student will demonstrate his/her ability to make judgements (make a decision) on the “best” course of action to follow in concrete cases of research integrity violations.
Other information
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