Code of conduct
IMI’s ADVANCE project published a Code of Conduct: a document which contains a set of guiding principles for the multiple decisions that need to be taken at all stages of the planning, design, conduct and reporting of future studies. The ADVANCE Code of Conduct will facilitate and speed-up initiation, design, conduct and reporting of studies.
The ADVANCE Code of Conduct includes 45 recommendations in 10 topics (Scientific integrity, Scientific independence, Transparency, Conflicts of interest, Study protocol, Study report, Publication, Subject privacy, Sharing of study data, Research contract). Each topic includes a definition, a set of recommendations and a list of additional reading.
Adoption of the ADVANCE Code of Conduct should be stated in the study protocol, study report and publications and journal editors are encouraged to use it as an indication that good principles of public health, science and transparency were followed throughout the study.
The ADVANCE code of conduct can be downloaded here.
The ADVANCE code of conduct was tested in the the 6 proof of concept studies that were conducted as part of the ADVANCE project. Implementation of the 45 recommendations are described and listed in the following paper: Sturkenboom MCJM, et al. The ADVANCE system for evidence generation on vaccine coverage, benefits and risks based on secondary use of electronic health care data in Europe. In press Vaccine.
Although the legal framework of the ADVANCE code and ENCePP code of conduct is the same, there are key differences. The ENCePP code of conduct is created and updated by the European Network of Centers of Excellence in Pharmacoepidemiology and Pharmacovigilance. The ENCePP Code sets out rules and principles for studies, primarily pharmacoepidemiology and pharmacovigilance studies, with an emphasis on non-interventional post-authorisation studies.
The key difference with the ADVANCE code of conduct is that ENCePP CoC, restricts the roles of persons with a financial conflict of interest. In the ADVANCE CoC, declarations of interest are made, and roles are divided over multiple stakeholders, using transparency as key guiding principle
In VAC4EU the study requester may choose whether to use the ADVANCE Code of Conduct or the ENCePP code of conduct. VAC4EU Members may or may not participate with ADVANCE Code of Conduct based on own policies. All members are able to work according to the ENCePP CoC.
|ADVANCE code of conduct.|
|Sturkenboom MCJM, et al. The ADVANCE system for evidence generation on vaccine coverage, benefits and risks based on secondary use of electronic health care data in Europe. In press Vaccine.|
|European Network of Centers of Excellence in Pharmacoepidemiology and Pharmacovigilance|