Policy Governing the Use of Human Samples

Policy Governing the Use of Human Samples

1. The Right to Information

The Use of Human Samples in Biomedical Research Policy of the Instituto de Investigación Sanitaria del Principado de Asturias (Health Research Institute of Asturias) – “ISPA” – pertains to the need to regulate the fulfilment of and respect for people’s rights to integrity, and to the protection of human dignity and identity in any biomedical research that uses human samples.

In accordance with the provisions of Regulation (EU) 2016/679 on the protection of natural persons with regard to the processing of personal data (GDPR), please be informed that the personal data that you provide us will be duly registered and incorporated into the data processing systems controlled by ISPA (Avenida de Roma s/n, 33011 Oviedo, Principado de Asturias, Spain), contact e-mail: www.ispasturias.es/es/contactar.asp

Consequently, any biological material that you donate to ISPA, after having signed the appropriate informed consent document, will be stored in ISPA’s Biobank (Biobanco) or in the sample collection owned by the researcher who requested the aforementioned written authorisation.

If you would like further information about ISPA’s privacy policy, you can access it via the following link: www.ispasturias.es/politica-de-privacidad

2. Purpose

The samples will be used in biomedical research projects on a range of diseases that ISPA is studying in order to advance knowledge of their prognosis, diagnosis and treatment.

If samples are to be used in a specific research project, the project name will be included in the informed consent document that will be given to the subject and source of the sample (the participant and owner of the biological sample; hereinafter, “subject”) to sign.

Personal data will be used solely to carry out the projects to which the samples are allocated, or to contact the subject or his or her relatives again, where necessary and always with the subject’s authorisation or in accordance with the terms stipulated in the current legislation.

3. Subject Consent

An informed consent document is kept for all the samples used by ISPA, whether collected during the diagnostic session in which the subject donated the excess of his or her sample, or collected for the specific research project in which it is intended to be used.

This consent constitutes the subject’s authorisation for the use of his or her sample and the authorised processing of his or her data.

4. Security

For the purpose of the research projects, samples will undergo a process of pseudonymisation. Researchers will therefore not have access to your personal data, except in genetic studies in which these data are necessary for the research; in that case, only the project’s principal Investigators will have access to your identification details. Personal data will be used solely to carry out the projects to which the samples are allocated, or to contact the subject or his or her relatives again, where necessary and always with the subject’s authorisation or in accordance with the terms stipulated in the current legislation.

Samples will be stored on ISPA’s premises in the security and storage conditions necessary to ensure that access to them is restricted and that they are kept in the optimum conditions for use in research processes or projects.

5. Research Results

In accordance with the provisions of Spanish Law 14/2007 on Biomedical Research, each participant in a research project has the right to know the results of the procedures to which his or her biological sample has been subjected, including any genetic data that has been processed.

If you would like to obtain this information, please follow the procedure put in place by ISPA for this purpose, which is described in its privacy policy: www.ispasturias.es/politica-de-privacidad
In accordance with Article 4.5 of Law 14/2007 on Biomedical Research, a person’s right to decide not to be informed, even about any unexpected discoveries made, will be respected. However, if the assigned doctor deems this information to be necessary to avoid major harm to the person’s health or that of his or her biological relatives, a close relative or representative will be informed, after having consulted the welfare committee , where one exists. In any case, only the data necessary for these purposes will be shared.

6. Exercising your Rights and Revoking your Consent to the Use of your Biological Sample

1) In accordance with the provisions set out in ISPA’s privacy policy, you have the right to access your personal data, to request the rectification of inaccurate data or, where appropriate, to request their erasure for reasons including the data no longer being necessary for the purposes they were collected for. You may request that the processing of your data be restricted, in which case ISPA will store them only for the exercise or defence of claims. You may also object to the processing of your data, in which case ISPA will stop processing the data, except when, for legitimate grounds or due to the defence of potential claims, it is not able to meet your objection request. You may also request the portability of your data.

To exercise these rights, i) you may visit the ISPA facilities in person and request the forms provided for this purpose at reception, or you may download them (and follow the relevant instructions for submitting them) at the following link to ISPA’s privacy policy: www.ispasturias.es/politica-de-privacidad

ii) All subjects who donate a sample for biomedical research have the right to withdraw their initial consent, at which point their sample will be destroyed, but not the results obtained up until that point using the sample.

To exercise your right to withdraw your consent to the use of your biological sample, please download the following form: “Withdrawal of Consent for Sample Use Form“, and send it to the following address:
Instituto de Investigación Sanitaria del Principado de Asturias
Oficina Técnica de Gestión
Avenida Hospital Universitario s/n, 33011 Oviedo, Principado de Asturias, Spain.

7. Amendment of this Policy

ISPA reserves the right to amend this policy in order to adapt it to new legislation or case law, without prior notice.