Your Easy Guide to Clinical Studies

Researchers have an ethical obligation to make their study results public, whether they are positive, negative or inconclusive. By registering study results, the SP-INV fulfils scientific, ethical, and regulatory obligations.

 

As a minimum, study results should be published in a registry recognized by the World Health Organization (WHO) (e.g. ClinicalTrials.gov), on the federal (HumRes) website, and where else the study was initially registered.

 

A study registry has many advantages as it:

• Functions as a public record where study results are presented in a standardized format
• Complies with required ethical obligations towards study participants
• Ensures that research results contribute to overall medical knowledge
• Reduces publication and outcome reporting biases
• Facilitates systematic reviews and other research literature reviews

As SP-INV:

• Update any selected internationally recognised public registries
• Grant data access to all those who may benefit from your study results (e.g. with or without proven benefit). This is important to further medical research
• Consider informing study participants and/or their community about your study results

 

Once the Ethics Committee (EC) has approved your BASEC submitted study, all required study information is automatically updated in the FOPH HumRes registry.

 

Scientific publications:

• Make an attempt to publish your research in a scientific peer-reviewed journal, as it will make findings more easily available to the scientific community
• Include experts able to support you with the write-up of a scientific publication (e.g. statistician, medical reviewer)
• Adhere to publication agreements defined at study start (e.g. selection of publication partner(s), contribution and authorship, scientific journal publication guidelines)

 

Irrespective of publication means and source, implement robust measures to ensure that the confidentiality of study participants is protected at all times.

External Links

Swissethics – see in particular

• BASEC The Business Administration System for the Ethics Committee
• RAPS Registry, a database of all projects approved by the ethics committees in Switzerland

Swiss and international registries:

• HumRes - Coordination portal for Human Research in Switzerland
• ClinicalTrials.gov
• WHO – ICTRP Registry Network
• EudraCT – Clinical Trials Database

References

Declaration of Helsinki – see in particular principle

• 36 Registration, Publication, and Dissemination of Results

SAMS Research with human subjects – see in particular chapter

• Chapter 11 Publication of study results

CIOMS guideline – see in particular

• 24 Public accountability for health-related research

ICMJE – see in particular

• Clinical trials recommendation

Swiss Law

HRA – see in particular article

• Art. 56 Registration

ClinO – see in particular articles

• Art. 64 - 67 Registration and publication

ClinO-MD – see in particular articles

• Art. 41 Registration
• Art. 42 Publication of results