What is it? Why is it important?

Based on principles of research integrity, the research community is responsible to formulate and establish good research practices, such as:

  • Reliability: to promote high quality research, reflected in the design, methodology, analysis of study results, including the use of its resources. Quality based research instils credibility and trust in research results
  • Honesty: to develop, undertake, review, report, and communicate research in a transparent, complete, fair, and unbiased manner
  • Respect: to approach and handle colleagues, study participants, society, ecosystems, environmental and cultural heritage with respect
  • Accountability: to accept responsibility for implemented research projects and its potential wider impact, starting with the research idea up until the publication of its results

What do I need to do?

Ensure to implement the principles of research integrity when planning, implementing and publishing your study results.

Where can I get help?

Your local CTU can support you with experienced staff regarding this topic

References

All European Academies (ALLEA) – see in particular publication

  • The European Code of Conduct for Research Integrity

CIOMS guidelines – see in particular guidelines

  • 2 Research conducted in low-resources settings
  • 6 Caring for participants’ health needs

SAAS Code of Conduct for Scientific Integrity – see in particular chapters

  • Chapter 3 Basic principles
  • Chapter 5 Violations of scientific integrity / Fabrication / Falsification / Plagiarism / Misconducts

SAMS handbook Research with human subjects – see in particular chapters

  • Chapter 4 Scientific requirements
  • Chapter 11 Publication of study results

UNESCO’s Universal Declaration on Bioethics and Human Rights – see in particular article

Art. 15 Sharing of benefits

Swiss Law

HRA – see in particular article

  • Art. 10 Scientific requirements

ClinO – see in particular articles

  • Art. 3 Scientific integrity
  • Art. 4 Scientific quality

ClinO-MD – see in particular

  • Art. 3, a Applicable provisions

HRO – see in particular

  • Art. 15, c8 Review Areas
Abbreviations
  • ALLEA – All European Academies
  • ClinO – Clinical Trials Ordinance
  • ClinO-MD – Ordinance on Clinical Trials for Medical Devices 
  • CIOMS – Council for International Organizations of Medical Sciences
  • CTU – Clinical Trials Unit
  • HRA – Human Research Act
  • HRO – Human Research Ordinance
  • SAAS – Swiss Academies of Arts and Sciences
  • SAMS – Swiss Academy of Medical Sciences
  • UNESCO – United Nations Educational, Scientific and Cultural Organization
Concept ↦ Ethics and Laws ↦ Research Integrity ↦ Principles
Study
Basic

Provides some background knowledge and basic definitions

Basic Monitoring
Basic Drug or Device
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Statistic Methodology
Concept Drug or Device
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
Set-Up Statistic Methodology
Set-Up Quality and Risk
Set-Up Drug or Device
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Statistic Methodology
Conduct Drug or Device
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Statistic Methodology
Completion Drug or Device
Current Path (click to copy): Concept ↦ Ethics and Laws ↦ Research Integrity ↦ Principles

Please note: the Easy-GCS tool is currently under construction.