In this area you can find questions and answers about ROSITA and all the deliverables already approved by the ROSITA contractors. The missing deliverables will be added as soon as the respective "Work Packages" will be over. In the meanwhile drafts of documents are available in the members area for ROSITA contractors only.
If you wish to download the already approved deliverable, please go to the download area.
The project seeks to answer five questions (work packages):
Inventory of drugs and medicines that are suspected to have detrimental impact on road user performance
Based on published literature, government reports, lists of medications labelled as impairing driving (in several member states), a report will be written, which will include a table with the medicines and illicit drugs that impair driving. The aim of this report is not to do an exhaustive survey (because it is being done at the same time by other groups), but rather to provide an introduction to the other work packages.
To make an inventory of state-of-the-art road side testing equipment. Approximately twenty different immunoassays that can be used at the roadside are available on the market. With a few exceptions, they are intended for testing of urine. The participants in this package will complete the market studies that they have performed previously.
Immunoassays are available for 10 parameters: cocaine, cannabinoids, opiates, amphetamine, methamphetamine (or a test amphetamines), phencyclidine, methadone, benzodiazepines, barbiturates and tricyclic antidepressants.
The inventory will focus on:
This survey will give information on devices that are already commercialised, but also on prototypes that are in the pipeline.
The device manufacturers who are contractors in the project will supply detailed technical information on their existing prototype systems as well as the actual status and recent results from product evaluation campaigns.
- the number and types of immunoassays available;
- the cut-off used;
- the specificity of the tests and the cross-reactivities for related medications and illicit drugs;
- the ease of use;
- published and unpublished evaluation reports;
- information from the patent offices, the US Food and drug administration, and a similar studies that were performed in the United States.
To identify operational, user and legal requirements across EU member states for road side testing equipment.
In a few member states, roadside testing devices have been used on an experimental basis, with voluntary participation of the drivers. The consortium will survey the legal situation and the studies that have been performed in different places and settings to identify the requirements:
To gain a complete and representative overview on the user and operational requirements in the different member states of the EU, police units and police experts with expertise in operational and legal aspects of traffic control actions will be interviewed (based on a standardised questionnaire). Primarily these interviews will cover user and operational but also legal requirements.
A user reference group will be established. Policemen and road user representatives will be part of it. This group will advise us based on their experience with the tests and the recommendations will be submitted to them before finalisation.
- legal requirements: is there a legal basis for using roadside testing? What are the laws in different countries (drugs to test for, specimens to use, cut-off values). Must the devices be approved by a regulatory agency (as an in vitro diagnostic device), ...
- user requirements: ease of use, ability to be performed by non-laboratory personnel, ease of reading of the result, possibility of keeping a hard copy of the results, ... How are the tests being experienced by drivers?
- operational requirements: speed of results, objectivity of the assessment (inter-rater agreement), ...
To develop a methodology and experimental design, and subsequently to test and evaluate different equipment.
This will be the main part of the project. After consideration of the conclusions from the first three work packages, the consortium will meet to decide on the protocol that will be followed in the different studies. These evaluations will take place in Belgium (NICC), Finland (KTL), France (IMLS), Germany (ILMH), Italy (CBFT), Norway (NIFT), Scotland (FMS) and Spain (USDC.IML). The protocol will be adapted to different prevalence of drug use, different samples, different tests, investigated populations (conspicuous drivers, injured drivers, ...), ...
In most countries, a field sobriety test will also be conducted and the analytical results will be compared to the level of impairment. The department of Legal Medicine of the University of Saarland has contributed to the development of a training program (with a course, two videofilms and a CD-ROM) for policemen.
Another important aspect is the manner of taking the saliva or sweat sample. For saliva, different devices are commercially available, with or without stimulation (e.g. by acid). Moreover, saliva can be collected by spitting into a tube.
Before starting a field test, the contractors will agree on common evaluation rules, common cut-offs for the different analytes, etc. Round robin evaluations will be organised between the different contractors, e.g. for blood analyses, possibly by agreeing on participation in a common (existing) quality assurance program.
Participation in a common project will increase contacts and exchange of experience between people involved in roadside testing from different countries, with the possibility to travel to another country and observe the methods used there.
To give recommendations for the use of roadside testing equipment in Europe.
The objective is to summarise the findings of the research and to produce the final report. The findings of work packages 1 to 4 will be integrated, evaluated and summarised. Conclusions and recommendations concerning roadside drug testing will be formulated.
A preliminary version of the report will be submitted to the User reference group for discussion and criticisms. The findings will be made public on this website, monographs and possibly CD-ROMs.