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).
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
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 Ethics Committee (EC) any financial or other conflict of interests (e.g. in the EC application dossier)
- As requested by the SP-INV, fill in prior to study conduct the financial disclosure and conflict of interest form, and ensure to update forms as required during study conduct
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 (e.g. Swissmedic)
- 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
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
Basel, Departement Klinische Forschung, CTU, dkf.unibas.ch
Lugano, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.usz.ch
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
HRA – see in particular article
- Art. 10 Scientific requirements
ClinO – see in particular article
- Art. 3 Scientific integrity
ClinO-MD – see in particular
- Art. 3, a Applicable provisions
HRO – see in particular
- Art. 15, c8 Review Areas