Below we share the ethical-regulatory references for informed biobanking, with special attention to the limits established by the health circumstances and the vulnerable conditions in which the person, to whom biobanking is related, could be at the time of the first collection. The documents are both legislative acts with binding legal value (Regulation, European Directive, Legislative Decree, Measure, Authorization...) and documents (Recommendation, Convention, Declaration...) that address, recommend good practices but are not binding.
IN EMERGENCY: "Collection, storage and use of biological materials and associated data"- Informed biobanking for research
National level - for Italy: Decreto-legge n. 14 del 9 marzo 2020, Disposizioni per il potenziamento del Servizio sanitario nazionale in relazione all’emergenza COVID-19.
In particular, art. 14.
Data collected must be processed in compliance with principles set out in Article 5 of the GDPR by adopting measures proportional to the need, taking into account the emergency situation. Article 14 of Decree-Law [No 14 of 9 March 2020] provides, until the end of the emergency [established on 31 January 2020], the possibility of simplifying certain aspects of processing of personal data [in the name of public interest in the public health sector and, in particular, to ensure protection against health emergencies by means of appropriate prophylactic measures, as well as to ensure the diagnosis and health care of those infected or the emergency management of the National Health Service].
In particular, paragraph 5 of the Article introduces the possibility to omit the information referred to in Article 13 of the GDPR or to provide simplified information, subject to oral notification of the restriction to the persons concerned. Paragraph 4 allows data controller or data processor to assign, under their own responsibility and within their organisational structure, specific tasks and functions related to the processing of personal data to expressly designated natural persons operating under their authority, in a simplified manner, including orally. "At the end of the emergency referred to in the resolution of the Council of Ministers of 31 January 2020, the persons referred to in paragraph 1 (i.e. the health care personnel) shall adopt appropriate measures to bring the processing of personal data carried out in the context of the emergency back to the ordinary powers and rules governing the processing of personal data.https://www.gazzettaufficiale.it/eli/id/2020/03/09/20G00030/sg
(EDPB) - Statement on the processing of personal data in the context of the COVID-19 outbreak. Adopted on 19 March 2020
2.Core principles relating to the processing of personal data
Personal data that are necessary to attain the objectives pursued should be processed for specified and explicit purposes. In addition, data subjects should receive transparent information on the processing activities that are being carried out and their main features, including the retention period for collected data and the purposes of the processing. The information provided should be easily accessible and provided in clear and plain language. It is important to adopt adequate security measures and confidentiality policies ensuring that personal data are not disclosed to unauthorised parties. Measures implemented to manage the current emergency and the underlying decision-making process should be appropriately documented.
https://edpb.europa.eu/sites/edpb/files/files/file1/edpb_statement_2020_processingpersonaldataandcovid-19_en.pdf
EMA. Guidance on the Management of Clinical Trials during COVID-19 (Coronavirus) pandemic. Version 2 (27/03/2020)
By analogy, from the EMA recommendation for the management of clinical trials during COVID-19 pandemic:
“8. Changes to informed consent
In case of acute life-threatening situations, where it is not possible within the therapeutic window to obtain prior informed consent from the patient (or her/his legal representatives(s)), informed consent will need to be acquired later, when this is allowed in national legislation. In these cases, the investigator is expected to report the reason why it was not possible to obtain consent from the participant prior to enrollment”.
https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/guidanceclinicaltrials_covid19_en.pdf
World Medical Association, Helsinki Declaration, 2013
Unesco, Universal declaration on bioethics and human rights, 2005
“Article 8. Respect for human vulnerability and personal integrity
In applying and advancing scientific knowledge, clinical practice and associated technologies, human vulnerability should be taken into account. Individuals and groups of special vulnerability should be protected, and the personal integrity of such individuals respected.
https://unesdoc.unesco.org/ark:/48223/pf0000146180
In particular, art. 14.
Data collected must be processed in compliance with principles set out in Article 5 of the GDPR by adopting measures proportional to the need, taking into account the emergency situation. Article 14 of Decree-Law [No 14 of 9 March 2020] provides, until the end of the emergency [established on 31 January 2020], the possibility of simplifying certain aspects of processing of personal data [in the name of public interest in the public health sector and, in particular, to ensure protection against health emergencies by means of appropriate prophylactic measures, as well as to ensure the diagnosis and health care of those infected or the emergency management of the National Health Service].
In particular, paragraph 5 of the Article introduces the possibility to omit the information referred to in Article 13 of the GDPR or to provide simplified information, subject to oral notification of the restriction to the persons concerned. Paragraph 4 allows data controller or data processor to assign, under their own responsibility and within their organisational structure, specific tasks and functions related to the processing of personal data to expressly designated natural persons operating under their authority, in a simplified manner, including orally. "At the end of the emergency referred to in the resolution of the Council of Ministers of 31 January 2020, the persons referred to in paragraph 1 (i.e. the health care personnel) shall adopt appropriate measures to bring the processing of personal data carried out in the context of the emergency back to the ordinary powers and rules governing the processing of personal data.https://www.gazzettaufficiale.it/eli/id/2020/03/09/20G00030/sg
(EDPB) - Statement on the processing of personal data in the context of the COVID-19 outbreak. Adopted on 19 March 2020
2.Core principles relating to the processing of personal data
Personal data that are necessary to attain the objectives pursued should be processed for specified and explicit purposes. In addition, data subjects should receive transparent information on the processing activities that are being carried out and their main features, including the retention period for collected data and the purposes of the processing. The information provided should be easily accessible and provided in clear and plain language. It is important to adopt adequate security measures and confidentiality policies ensuring that personal data are not disclosed to unauthorised parties. Measures implemented to manage the current emergency and the underlying decision-making process should be appropriately documented.
https://edpb.europa.eu/sites/edpb/files/files/file1/edpb_statement_2020_processingpersonaldataandcovid-19_en.pdf
EMA. Guidance on the Management of Clinical Trials during COVID-19 (Coronavirus) pandemic. Version 2 (27/03/2020)
By analogy, from the EMA recommendation for the management of clinical trials during COVID-19 pandemic:
“8. Changes to informed consent
In case of acute life-threatening situations, where it is not possible within the therapeutic window to obtain prior informed consent from the patient (or her/his legal representatives(s)), informed consent will need to be acquired later, when this is allowed in national legislation. In these cases, the investigator is expected to report the reason why it was not possible to obtain consent from the participant prior to enrollment”.
https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/guidanceclinicaltrials_covid19_en.pdf
World Medical Association, Helsinki Declaration, 2013
- Research involving subjects who are physically or mentally unable of giving consent, for example, unconscious patients, may be done only if the physical or mental condition that prevents giving informed consent is a necessary characteristic of the research group. In such circumstances the physician must seek informed consent from the legally authorised representative. If no such representative is available and if the research cannot be delayed, the study may proceed without informed consent provided that the specific reasons for involving subjects with a condition that renders them unable to give informed consent have been stated in the research protocol and the study has been approved by a research ethics committee. Consent must be obtained as soon as possible from the subject or a legally authorised representative.
Unesco, Universal declaration on bioethics and human rights, 2005
“Article 8. Respect for human vulnerability and personal integrity
In applying and advancing scientific knowledge, clinical practice and associated technologies, human vulnerability should be taken into account. Individuals and groups of special vulnerability should be protected, and the personal integrity of such individuals respected.
https://unesdoc.unesco.org/ark:/48223/pf0000146180
Informed biobanking in non-emergency circumstances
- National level - for Italy: Provvedimento recante le prescrizioni relative al trattamento di categorie particolari di dati, ai sensi dell’art. 21, comma 1 del d.lgs. 10 agosto 2018, n. 101
- GDPR, in particular Art. 5-7, 13
- Recommendation CM/Rec(2016)6 of the Committee of Ministers to member States on research on biological materials of human origin
- WMA Declaration of Taipei on Ethical Considerations regarding Health Databases and Biobanks, 2016
- REGULATION (EU) No 536/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 April 2014 on clinical trials, in particular CHAP. V
Post-mortem sample collection and biobanking
National level - for Italy: LEGGE 10 febbraio 2020, n. 10. Norme in materia di disposizione del proprio corpo e dei tessuti post mortem a fini di studio, di formazione e di ricerca scientifica
The law, in force since 19 March 2020, is related to "the disposition of one's own body and post-mortem tissues for the purposes of study, training and scientific research by persons who have expressed their consent during their lifetime (art.1)". The modalities and requirements of the consent to the post-mortem donation of one's own body are established by Article 3: the declaration of consent must be drawn up, by analogy with Law n.219/2017 on informed consent and DAT, in the forms provided for the anticipated declarations of treatment (DAT), i.e. by public deed, by authenticated private deed or by private deed delivered personally by the disponer at the Civil Status Office of the municipality of residence. In addition, the declaration of consent must be delivered to the local health authority to which it belongs, which is responsible for storing it and transmitting it electronically to the DAT database. Consent may be withdrawn at any time and in the manner described above. Unlike the law n. 219/2017, the declaration of consent to post-mortem donation provides that a trustee must be indicated, who is responsible for communicating the existence of the consent to the doctor who ascertains the death.
https://www.gazzettaufficiale.it/eli/id/2020/03/04/20G00024/sg
Recommendation CM/Rec(2016)6 of the Committee of Ministers to member States on research on biological materials of human origin
“1. Biological materials should only be removed from the body of a deceased person for storage for future research with the consent or authorization provided for by law. This consent or authorization should have been preceded by appropriate information, including on the right to refuse.
The law, in force since 19 March 2020, is related to "the disposition of one's own body and post-mortem tissues for the purposes of study, training and scientific research by persons who have expressed their consent during their lifetime (art.1)". The modalities and requirements of the consent to the post-mortem donation of one's own body are established by Article 3: the declaration of consent must be drawn up, by analogy with Law n.219/2017 on informed consent and DAT, in the forms provided for the anticipated declarations of treatment (DAT), i.e. by public deed, by authenticated private deed or by private deed delivered personally by the disponer at the Civil Status Office of the municipality of residence. In addition, the declaration of consent must be delivered to the local health authority to which it belongs, which is responsible for storing it and transmitting it electronically to the DAT database. Consent may be withdrawn at any time and in the manner described above. Unlike the law n. 219/2017, the declaration of consent to post-mortem donation provides that a trustee must be indicated, who is responsible for communicating the existence of the consent to the doctor who ascertains the death.
https://www.gazzettaufficiale.it/eli/id/2020/03/04/20G00024/sg
Recommendation CM/Rec(2016)6 of the Committee of Ministers to member States on research on biological materials of human origin
“1. Biological materials should only be removed from the body of a deceased person for storage for future research with the consent or authorization provided for by law. This consent or authorization should have been preceded by appropriate information, including on the right to refuse.
- Biological materials should not be removed for storage for future research if the deceased person is known to have objected to it.”
