Bioethics

Objectives of the Working Group

The main objectives of this working group are:

  • To participate in the activities of Ethics and Policy Committee and in the Data Access Committee Office of the ICGC.
  • To provide support to the members of the consortium about legal and ethical issues (informed consent document, samples circulation, biobanks and international transfer of data, among others).
  • To analyse specific aspects such as biobanks, return of results and the creation of international genetic databases.
  • To be the main contact with other ethical or legal Spanish institutions.

 

The Project Policy: Ensuring the Rights of the Participants

In order to develop the objectives of the project, the participation of healthy individuals and patients, who collaborate in the research progress, is essential .

Specifically, it is necessary to obtain and store a large amount of information whose purpose won’t have any direct and immediate repercussion in their own benefit.

This project is supervised by an International Ethics Committee and by the Ethics Committee from the Hospital in order to ensure the respect for the rights of the individuals.

 

Applicable Spanish Legislation

  • LOPD. Click here
  • LOPD Regulation. Click here
  • Law 14/2007 on Biomedical Research. Click here
  • Regulation 1716/2011 on Biobanks and use of human samples for biomedical research. Click here
  • Order ECC/1404/2013, 28 of June, modification of the regulation 1716/2011. Click here

 

Reports

  • Legal Aspects of Genetic Databases for International Biomedical Research: The Example of the International Cancer Genome Consortium (ICGC). (Published in Revista de Derecho y Genoma Humano /Law and the Human Genome Review, Diciembre 2012). Link to the report.
  • The nitrogenous bases in databases. The legal status of genetic information files for biomedical research. (Published in Revista Comunicaciones en propiedad industrial y derecho de la competencia, 68, 2013). Link to the report.