What is it? Why is it important?

The sole collection of an Informed Consent or a person’s agreement to participate in a study, does not guarantee that human studies are ethically compliant.

Based on an important and often referenced publication by Emanuel, seven requirements must be met in order for research to be ethical.

What do I need to do?

As a SP-INV or Site-INV, know and implement the seven principles proposed by Emanuel.

The principles state that:

  1. A study must be socially valuable: the answer should be important enough to justify some risk or inconvenience to study participants
  2. Study conduct must be methodological and rigorous: its design must provide for understandable answers
  3. Participant selection must be fair: not based on vulnerability, privilege or other unrelated factors
  4. The risk-benefit ratio must be favourable: participant right and safety takes precedence over research interest
  5. There must be an independent review of study proposal: minimises any potential conflict of interest
  6. Participants must freely give consent: freely decide whether to participate or withdraw from the study
  7. Participants must be treated with respect: such as participant safety, privacy, right to change their mind, be informed about the study and lessons learned

Where can I get help?

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

References

  • Emanuel EJ, Wendler D, Grady C. What makes clinical research ethical? JAMA. 2000  PMID: 10819955
  • SAMS, 2nd edition, revised and adapted, 2015.  Research with human subjects. A manual for practitioners. Chapter 2 Introduction to Research Ethics

Swiss Law

HRA – see in particular articles

  • Art. 5 Scientifically relevant topic
  • Art. 10 Scientific requirements
  • Art. 11 Protection of participants / Subsidiarity
  • Art 12 Protection of participants / Risks and burdens
  • Art. 15 Safety and protective measures
Abbreviations
  • CTU – Clinical Trials Unit
  • HRA – Human Research Act
  • PMID – PubMed IDentifier
  • SAMS – Swiss Academy of Medical Sciences
  • Site-INV – Site Investigator
  • SP-INV – Sponsor Investigator
Basic ↦ Protocol ↦ Research and Ethics ↦ 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): Basic ↦ Protocol ↦ Research and Ethics ↦ Principles

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