Completion↦Ethics and Laws↦Publications↦Responsibilities
What is it? Why is it important?
Researchers have an ethical obligation to make their study results public, whether they are positive, negative or inconclusive.
As a minimum, study results should be published in a registry recognized by the World Health Organization (WHO). By registering study results, the SP-INV fulfils regulatory, scientific, and ethical obligations (e.g. results must also be submitted to EC and Swissmedic (e.g. category B and C studies)
A study registry has many advantages:
- It functions as a public record where basic study results are presented in a standardized format
- It complies with required ethical obligations towards study participants
- It ensures that research results contribute to overall medical knowledge
- It reduced publication and outcome reporting biases
- It facilitate systematic reviews and other research literature reviews
What do I need to do?
As SP-INV:
- Update any selected internationally recognised public registries
- Make an attempt to publish your research results in a scientific peer-reviewed journal, making 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)
- With the aim to further medical research, grant data access to all those who may benefit from your study results, (e.g. with or without proven benefit)
- Adhere to publication agreements defined at study start (e.g. selection of publication partner(s), contribution and authorship, adherence to publication guidelines such as the ICMJE)
- Consider the prospect of informing study participants and/or their community about your study results
- Ensure that for all publications, measures are taken to maintain the confidentiality of study participants
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
References
CONSORT group – see in particular
- CONSORT 2010 Statement
- CONSORT 25 items checklist
CIOMS guideline – see in particular
- 24 Public accountability for health-related research
Declaration of Helsinki – see in particular principle
- 36 Registration and Publication and Dissemination of results
International Committee of Medical Journal Editors (ICMJE) – see in particular
- Clinical Trials recommendations
SAMS Research with human subjects – see in particular chapter
- Chapter 11 Publication of study results
Swiss Law
FEDLEX – laws are available online under numbers
- 810.305 ClinO
- 810.306 ClinO-MD
ClinO – see in particular articles
- Art. 38 Notification and reporting upon completion
- Art. 65 Registration
ClinO-MD – see in particular articles
- Art. 37 Final Report
- Art. 38 Final Report Swissmedic