Central Unit for Clinical Trials
Public bodies establish safety measures to protect people who decide to participate in a clinical trial.
In Spain, the Spanish Agency for Medicines and Healthcare Products and the corresponding Ethical Committee for Research on Medicines give the authorization at the beginning of each trial. In addition, both the patient and the health professionals involved in the study are permanently supervised.
All clinical trials with medicines carried out in Spain must be carried out in accordance with the rules of good clinical practice published by the Ministry of Health and Consumer Affairs.
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The conduct of any clinical trial is regulated in Spain by laws similar to those applied in the rest of the European Community. These legal provisions include:
- Law on Guarantees and Rational Use of Medicines (Law29/2006)
- Royal Decree 1090/2015 on clinical trials
- Order of the Ministry of Health 256/2007 on good clinical practice in research
The trial must be expressly approved by:
- La The Spanish Agency for Medicines and Healthcare Products (AEMPS) (AEMPS)
- The reference Medication Research Ethics Committee (mREC) that is elected by the sponsor.
The CEIm ensures that the clinical trial does not interfere with patients' rights, while the AEMPS supervises that the results of the studies may serve to reach valid conclusions on the efficacy and/or safety of the drug being tested.
The clinical trials can be inspected by the health authorities to check that the data that have been collected are real.
Informed consent is an ongoing process designed to protect the rights and safety of individuals participating in clinical trials.
To obtain informed consent, investigators must explain to patients the nature of the clinical trial. This usually involves one or more conversations between the patient and the investigators.
During the informed consent process, the research team must make sure that the patient understands all available treatment possibilities.
They should also explain the differences between the new treatment and the standard treatment, as well as mention all possible risks and benefits (if any) of the new treatment, which may or may not be different from the risks and benefits of the standard treatment.
Finally, they should explain what is required of each patient in order to participate in the clinical trial, including the number of doctor visits, tests and treatment schedule, as well as the right to withdraw from the study at any time.
After receiving all this information, the patient will be asked to read and sign an informed consent document.
The informed consent document provides the patient with written information on all aspects of the clinical trial.
Participation in a clinical trial is only possible if the person meets the specific conditions of that research:
- Participation is voluntary, and must be based on a thorough knowledge of the project which will include among others: the objectives, the tests to be performed on you, the drugs to be given to you, and the potential risks you may have by participating in the study. You should also be aware of the treatment alternatives. The agreement to participate is made in writing by signing a document called informed consent. If a patient is not capable of giving consent (children or incapacitated), his or her legal representative may do so.
- Participants are entitled to receive a copy of the patient information sheet, as well as to have a point of contact to contact in the event of questions or problems arising during participation in the study.
- Participants can withdraw from a clinical trial whenever they wish or whenever the investigator so decides. In no case should this circumstance affect their medical care.
- Participants should receive medical attention for any study-related problems that may arise during their participation in the study.
- Participation in the clinical trial will not entail any additional cost to that which would have been incurred in the context of normal clinical practice.
- The sponsor must take out insurance, under the conditions established by law, to cover the treatment of any adverse effects that may arise.
- Participants have the right to have their data or the biological samples they have donated treated confidentially. Access to identifiable data can only be made with the consent of the patient, and provided that the Personal Data Protection Act 15/1999 is complied with.
- It is very important that you inform your doctor of any disease you suffer from or any treatment you are receiving, since its omission may involve a higher than desirable risk. It is also important to follow the researcher's indications so that the conclusions obtained from the use of the drugs are real.