What is it? Why is it important?

Important dilemmas exist when striving for ethically based research.

 

Research strives to find solutions to problems that alleviate suffering. The aim is to provide sound knowledge that serves the interest of a special group of patients or society as a whole. Consequently, research does not primarily focus on the welfare of those who participate in a research project.

 

This dilemma becomes especially apparent when treating physicians perform research projects.

What do I need to do?

As a SP-INV or Site-INV, ensure to be aware of existing ethical dilemmas in research. Important questions to ask include:

  • How do I perceive my responsibilities as a treating physician in contrast to my responsibilities as a researcher?
  • Based on this dual role, how must I handle conflicting interests without jeopardising participant right, safety, and integrity?
  • How can I ensure that participants join the study of their own free will, free from:
    • Potential obligations
    • Fear of consequences because of study refusal or withdrawal?
  • What other conflicting interests may pose ethical concerns (e.g. financial gain, reputation as a researcher, publication pressure)?

Where can I get help?

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

References

SAMS, 2nd edition, revised and adapted, 2015.  Research with human subjects. A manual for practitioners. Chapter 2 Introduction to Research Ethics

Abbreviations
  • CTU – Clinical Trials Unit
  • SAMS – Swiss Academy of Medical Sciences
  • Site-INV – Site Investigator
  • SP-INV – Sponsor Investigator
Basic ↦ Protocol ↦ Research and Ethics ↦ Ethical Dilemma
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): Basic ↦ Protocol ↦ Research and Ethics ↦ Ethical Dilemma

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