The Itinere project is a research study that aims to know how the patterns of drug use in our country evolve in young people and with little consumption time as well as the fundamental factors, including the use of health or social services, which condition the occurrence of health or social problems associated with such consumption. The ultimate goal is to provide relevant information so that society can decide which preventive and care strategies its policy makers need to put in place to improve the health of society in this area. scope.

This project requires the collection of personal data related to sensitive personal behaviors and the area of health.

Therefore, as well as to comply with the provisions of the Organic Law 15/1999 of 13 December, the Protection of Personal Data, and thus assure the participants of the exercise of their legitimate rights, it is added a new file on the list of files managed by the Ministry of Health and Consumer Affairs according to the Order of 21 July 1994 ("Official State Gazette" of 27).

The collection of information will be done in collaboration with the Foundation for Aid against Drug Addiction, however all the data corresponding to the file of the Itinere project will be managed and guarded only by the Institute of Health "Carlos III", without any copy of them in such a foundation, as stipulated in convention.

By virtue of the above I have available:

First. -Expand the contents of Annex I "Health Ficheros" of the Order of 21 July 1994, which regulates the automated files with personal data, managed by the Ministry of Health and Consumption, referred to the Directorate General of the Health Institute "Carlos III", with the inclusion of a new automated file called "Project Itinere", whose characteristics are listed in the annex of this Order.

Second. -That the head of the organ responsible for the automated file must adopt, under the top management of the Ministry of Health and Consumer Affairs, the necessary management and organization measures, assuring the confidentiality, security and integrity of the data, as well as those aimed at making effective the guarantees, obligations and rights recognised in the Organic Law 15/1999 of 13 December, in its implementing rules, and in Royal Decree 994/1999, of 11 June.

Third. This Order shall enter into force on the day following that of its publication in the "Official Gazette of the State".

Madrid, July 18, 2001.

VILLALOBOS TALK

ANNEX

File name: Itinere project.

Administrative organs responsible for the file: National Epidemiology Center. "Carlos III" Health Institute.

Units to exercise the rights of access, rectification, opposition and cancellation: National Center of Epidemiology. Institute of Health "Carlos III". Calle Sinesio Delgado, 6, 28029 Madrid.

Basic structure and description of personal data types included in the file:

It will be composed of two databases:

a) Nominal database. It contains data that allows identifying and contacting individuals (either participants in the study or people who simply collaborate to present and assist in their follow-up): First name, national identity document, Address and contact telephones. It also includes a meaningless sequential code whose only utility is to connect this database with the epidemiological basis. Only those fields on which these people voluntarily provide information are filled.

b) Epidemiological database: It will contain all the information of the participants obtained in the interviews or in the analytical tests.

This database includes a large number of particularly sensitive data-health and behavior-. However, it does not contain any personal identifier that allows to know which individual they belong to.

Only by linking to the nominal basis would it be possible to identify the data of an individual, although this link will be performed exceptionally and only by the epidemiologist responsible for the study. The main and almost only purpose of this database is to serve the epidemiological-statistical analysis.

Security Measures: High Level.

Purpose of the file and intended uses: This is a scientific investigation of epidemiological and sociological character. It does not constitute a permanent information system for the health administration.

Persons and/or groups affected: Persons who consume psychoactive substances without medical prescription who, after signing an informed consent specifying in detail the requirements of their participation-answer a interview, give biological sample and allow serious health problems to be studied in the health records that can happen during the study period, as well as the treatment and epidemiological analysis of such data-accept voluntarily participate in the study. It also includes people close to these consumers who agree to collaborate in the conduct of the study or that the participant himself claims could help in their location. These contributors are exclusively collecting data that will enable them to be able to contact them when their collaboration is necessary to help the consumer.

Data Collection Procedures: Personal interview survey, analytical testing of biological samples, and search in already existing and authorized health records.

Predicted recessions: The nominal database will never be ceded to third parties. The epidemiological-statistical database (which does not bear any personal identifier, but which will also be removed from the code allowing its link to the nominal base) may be transferred for statistical analysis with other bases with similar epidemiological contents.