Rules for biomedical research involving people and human samples

Automatic summary, not yet reviewed

1. The law regulates biomedical research involving people, biological samples, embryos and biobanks. Drug clinical trials and organ transplants are excluded, since they have their own rules. In any research, the health and well-being of participants come before the interest of science or society.
2. Taking part in research requires written consent after receiving clear information, and consent can be withdrawn at any time without losing health care. Personal data are protected and no one may be discriminated against because of genetic traits or for refusing a genetic test or participation.
3. Donating biological samples is free of charge, and donors give up any economic rights over the results. Traceability of cells and tissues must be guaranteed, and in some cases data must be kept for at least thirty years.
4. Every project with invasive procedures needs a favorable report from a Research Ethics Committee and authorization from the regional government. Anyone harmed by taking part must be compensated, and the research must carry prior insurance.
5. There are special rules for vulnerable people: pregnant women, minors, people lacking capacity and emergency patients who cannot consent. In those cases research is only allowed under strict conditions and, sometimes, with the Public Prosecutor's Office informed.
6. Creating human embryos solely for experimentation is banned, but techniques to obtain stem cells for therapeutic or research purposes are allowed. Many of these projects also need a favorable report from the Guarantees Commission.
7. Genetic testing requires prior written information and express consent, and those performing it must offer genetic counseling. Centers doing genetic testing must be accredited.
8. Using biological samples for research requires consent, with a flexible system that can cover related later research. Biobanks need authorization and registration in the National Registry of Biobanks. Violations carry fines of up to €1,000,000.

Who it affects

• People taking part in biomedical research or donating samples: They have rights to information, written consent, confidentiality and compensation for harm.
• Researchers and research centers: They must obtain ethics reports, authorizations and insurance, and follow strict rules.
• Patients getting genetic testing: They receive prior information, genetic counseling and protection of their data.
• Biobanks and cell line banks: They need authorization, registration in a national registry and inspection controls.

Words worth knowing

Biobanco (biobank)

A public or private nonprofit establishment that holds collections of biological samples for diagnosis or research.

Comité de Ética de la Investigación (Research Ethics Committee)

A body that checks whether a research project meets ethical, legal and methodological conditions before it can be authorized.

Consentimiento informado (informed consent)

Written permission given by a person after receiving adequate information about the research and its risks.

Trazabilidad (traceability)

The ability to track a biological sample at every step, from collection to use.

Células troncales embrionarias (embryonic stem cells)

Cells from embryos that can turn into many types of body cells and are used in research and therapy.

It summarizes the law as published in the BOE. It is written by artificial intelligence and may contain mistakes: the official text is what counts. Read the official text · How we make summaries