What is it? Why is it important?

A conflict of interest is a situation in which a professional judgement / action regarding a primary interest (e.g. responsibilities of a physician performing research) may be unduly influenced by a secondary interest (career progression, financial gain).

Based on ethical principles and the law, investigators responsible for study participants must maintain their scientific integrity at all times.

In order to minimise conflict of interest and preserve research integrity, study investigators must:

  • Disclose and update any conflict of interest, financial matters with respect their study and its outcome(s)
  • Abstain from deliberate misconduct or even fraud, with the intention to secure personal gain

More

In studies, deliberate misconduct or fraud includes to:

  • Falsify, fabricate or suppress research results
  • Fail to disclose conflict of interests when conducting the study
  • Slow down or prevent research activities without good reason
  • Abstain from implementing measures needed to stop scientific misconduct (e.g. closure fraudulent sites)

The Swiss Academies of Arts and Sciences and the Swiss Academy of Medical Sciences (SAMS) have issued guidelines that serve as principles and procedures regarding the integrity in scientific research.

What do I need to do?

As a SP-INV:

  • Disclose the funding of the study in the study protocol and the ICF (e.g. donations, governmental agencies, pharma companies)
  • Disclose to EC any financial or other conflict of interests (e.g. in the EC application dossier)

As Site-INV:

  • As requested by the SP-INV, fill in prior to study conduct the financial disclosure and conflict of interest form, and update as required

As SP-INV or Site INV:

  • Ensure research integrity is maintained at all times throughout study conduct
  • Immediately intervene upon suspicion of misconduct or fraud. In serious cases report to EC/RA
  • Put safety and well-being of study participants ahead of personal research interests
  • In order to mitigate potential conflict of interests on the part of the SP-INV / Site-INV, include other study staff in the patient recruitment process

More

Physicians must be aware of their conflicting roles. On one hand they are leading investigators, on the other hand they recruit and enrol patients under their care.

Where can I get help?

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

References

ISO 14155:2020 Medical device (access liable to costs) – see in particular section and annex

  • 10 Responsibilities of the principal investigator
  • Annex G EC responsibilities

SAAS Code of conduct for scientific integrity – see in particular chapters

  • Chapter 3 Basic principles

Chapter 6 Review body and policies / Legal procedures / Bias and avoiding conflicts of interest

SAMS handbook Research with human subjects – see in particular chapter

  • Chapter 4 Scientific requirements / Management of conflicts of interest

Swiss Law

FEDLEX – laws are available online under numbers

  • 810.30 HRA
  • 810.305 ClinO

HRA – see in particular article

  • Art. 10 Scientific requirements

ClinO – see in particular article

  • Art. 3 Scientific integrity
Abbreviations
  • ClinO – Clinical Trials Ordinance
  • ClinO-DM – Ordinance on Clinical Trials with Medical Devices
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • EC/RA – Ethics Committee / Regulatory Authorities
  • FEDLEX – Publication Platform for Federal Laws
  • HRA – Human Research Act
  • ICF – Informed Consent Form
  • ISO – International Organization for Standardization
  • SAAS – Swiss Academies of Arts and Sciences
  • SAMS – Swiss Academy of Medical Sciences
  • Site-INV – Site Investigator
  • SP-INV – Sponsor Investigator
Concept ↦ Ethics and Laws ↦ Research Integrity ↦ Conflict of Interest
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Basic Biobanking
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device
Development Biobanking
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
Set-Up Drug or Device
Set-Up Biobanking
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Conduct Biobanking
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Completion Biobanking
Current Path (click to copy): Concept ↦ Ethics and Laws ↦ Research Integrity ↦ Conflict of Interest

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