New roads for compliance in research!

/ / Legal x-rays

New rules, binding or not, aimed to regulate research activities, have been recently adopted on a global level. Besides the provisions of General Data Production Regulation regarding research and the Regulation on clinical trials, new rules have been set in the revised edition of the European Code of Conduct for Research Integrity. The Code was published by the European Federation of Academies of Sciences and Humanities in the form of “soft law”.

 1) Who are bound by the European Code of Conduct for Research Integrity?

The Code sets the framework for self-regulation that should be followed by all stakeholders, legal entities and researchers, across all scientific and scholarly disciplines in all research settings. It is applicable to both publicly funded and private research. In particular, its provisions foresee obligations for universities, public and private research organizations, funding entities, scientific press publishers.

2) Why is compliance with the Code important?

As the European Commissioner for Research, Science and Innovation stated, the ALLEA Code acts as a model for organizations and researchers across Europe. It should be mentioned that the Code is referred to as a reference document setting the highest standards for research integrity which should be followed by the beneficiaries bound by a Horizon 2020 Grant Agreement. Furthermore, the recitals of the new Regulation on personal data (GDPR) stipulate that data subjects should be allowed to give their consent to certain areas of scientific research when it is conducted in compliance with recognized ethical standards for scientific research. Thus, it can be construed that compliance with ethical principles will play a crucial role in the application of the GDPR.

In any case, the Code does not promote a rigid application of its provisions, but permits a broad interpretation of its provisions in relation to social, political or technological developments. Therefore, all stakeholders should safeguard research quality and combat risks hampering research integrity and trustworthiness.

3) What are the fundamental principles of research integrity?

  • Reliability in ensuring the quality of research as far as the design, the methodology, the analysis and the use of resources are concerned.
  • Honesty in developing, undertaking, reviewing, reporting and communicating research in a transparent, fair, full and unbiased way.
  • Respect for colleagues, research participants, society, ecosystems, cultural heritage and the environment.
  • Accountability for the research from idea to publication, for its management and organization, for training, supervision and mentoring, and for its wider impacts.

4)    What are the main points of the Code?

  • The research organizations should adopt clear policies and procedures on research practice as well as a transparent and proper handling of violations.
  • When misconduct of good research practices is alleged, the Code sets out specific principles for the conduct of investigations: transparency, reasonable time, right of the accused person of defense and to be heard,restoration action when researchers are absolved of an allegation of misconduct.
  • Institutions shall protect the rights of ‘whistleblowers’ during investigations and ensure that their career prospects are not endangered. In this way, persons who observe fraudulent practices shall inform the competent bodies about the alleged violation. (whistleblowers’ protection)
  • The Code recites the most frequent unfair practices that affect research integrity. (fabrication, falsification, plagiarism). Research organizations should provide suitable and necessary infrastructure for the management and protection of data in such a way that ensures traceability and reproducibility. It is important to note that the GDPR stipulates further obligations which are aimed at research institutions and researchers acting as data controllers.
  • The Code balances the need for open scientific data and the necessary protection of IP rights or confidentiality. The same balance is sought to be achieved by the GDPR as well.
  • Research institutions should put much emphasis on researchers’ training which should encompass appropriate and adequate training in ethics and research integrity.
  • Researchers should recognize and manage potential harms and risks relating to their research.
  • All authors are fully responsible for the content of a publication, unless otherwise specified.
  • Researchers shall respect their collaborators’ contributions and shall facilitate their work.
  • Negative results should be treated as valid as positive findings for publication and dissemination and not undermined.
  • Transparency and impartiality are the main values that should be followed by reviewers and editors.  


Our law firm’s comment

 The rapid technological and scientific development, the “open science”, the “citizen science” and the social media have changed the research environment and the role of research in the society.  Legislators, or stakeholders through self-regulation texts, observe the evolution and set new rules. We should underline that philosophy and main principles of the new rules regarding research community are similar.

Compliance is important but not an end in itself.

It should be used as a tool for promoting responsibility and development that can remain steady in the long term.